EP4153321A1 - Topische zusammensetzungen, verfahren zur herstellung im grossmassstab und verfahren zur verwendung - Google Patents

Topische zusammensetzungen, verfahren zur herstellung im grossmassstab und verfahren zur verwendung

Info

Publication number
EP4153321A1
EP4153321A1 EP20936216.9A EP20936216A EP4153321A1 EP 4153321 A1 EP4153321 A1 EP 4153321A1 EP 20936216 A EP20936216 A EP 20936216A EP 4153321 A1 EP4153321 A1 EP 4153321A1
Authority
EP
European Patent Office
Prior art keywords
composition
oil
amount
per batch
skin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20936216.9A
Other languages
English (en)
French (fr)
Other versions
EP4153321A4 (de
Inventor
David Sharp
Mukhtar Siddiqui
Jennifer Aguas Hurtikant
David Bondurant
Brian HAIGHT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Progeneron LLC
Original Assignee
Progeneron LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Progeneron LLC filed Critical Progeneron LLC
Publication of EP4153321A1 publication Critical patent/EP4153321A1/de
Publication of EP4153321A4 publication Critical patent/EP4153321A4/de
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A61K31/015—Hydrocarbons carbocyclic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/06—Emulsions
    • A61K8/064—Water-in-oil emulsions, e.g. Water-in-silicone emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/31—Hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations

Definitions

  • Topical Compositions Process of Large-Scale Manufacture, and Method of Use
  • compositions for treatment of topical orphan diseases and related syndromes and methods of treatment and process of manufacture of disclosed compositions.
  • Treatments for orphan diseases poses problems not associated with more frequent diseases. First, since few people are inflected, there is little awareness of their problems, so few treatments are investigated. Additionally the low frequency of occurrence hinders the development of these treatments due to the feeling that it will be difficult for a company to recover the high costs of development.
  • An orphan disease is defined as a condition that affects fewer than 200,000 people nationwide. Collectively, however, they affect as many as 25 million Americans, according to the National Institutes of Health (NIH), and that makes the diseases— and finding treatments for them— a serious public health concern.
  • NASH National Institutes of Health
  • Orphan diseases include several well-known diseases, like cystic fibrosis and Tourette's syndrome, but most are unknown to the general public.
  • the orphan diseases of interest in this application are Dupuytren's Contracture, Peyronie's Disease, Scleroderma, Raynaud's (or Renaud's) Phenomenon, Chemotherapy / Radiation Induced Oral Mucosal Ulceration, and
  • Dupuytren' s Contracture is one of the diseases with few people but who suffer great pain and difficulty with life. About 15 million Americans age 35 and older have Dupuytren disease, which is about 5% of the US population. 3 million in the US have bent fingers from Dupuytren disease and 750,000 Americans have severe Dupuytren biology and the risk of being crippled even with available treatment. After age 55, the percent of people with Dupuytren disease increases steadily in both men and women. By age 70, one-quarter of men have signs of Dupuytren, increasing to one-third by age 80. Dupuytren is more common in women than men in those 85 and older. The total number of US Dupuytren cases increased from 14.2 million in 2000 to 16.2 million people in 2010. The percent of the US population 35 and older affected with Dupuytren disease increased from 8.7% in 2000 to 9.3% in 2010.
  • Dupuytren's Contracture is a rare connective tissue disorder characterized by fixation of the joints of certain fingers in a permanently flexed position. Due to abnormal thickening and shortening of the bands of fibrous tissue beneath the skin of the palm, a hardened nodule may develop, eventually forming an abnormal band of hardened fibrotic tissue. This causes the fingers of the affected area to begin to be drawn in toward the palm over several months or years and cannot be pulled back. The skin of the affected area may pucker. The ring and pinky fingers are most affected and usually both hands are affected.
  • Peyronie disease is similar to Dupuytren's Contracture as both involve a connective tissue disorder.
  • Peyronie disease is characterized by the development of fibrous plaques in the soft tissue of the penis of adult males which results in penile deformity. It is estimated to affect 0.5% adult males in the United States, although it is difficult to know the actual extent due to the hesitancy of disclosing the problem.
  • Affected individuals may experience pain, have cord-like lesions on the penis, and exhibit abnormal curvature of the penis when erect. The abnormal curvature of the penis may make it impossible for affected individuals to have normal sexual intercourse.
  • Scleroderma is a rare, chronic disease of the immune system, blood vessels and connective tissue. 2.5 million people worldwide have scleroderma with an estimated 300,000 people in the United States. The disease is three to four times more common in females than in males. Scleroderma may occur at any age but the symptoms most frequently begin during midlife. The symptoms of scleroderma are similar to those of other autoimmune diseases so diagnosis is difficult.
  • Scleroderma is an autoimmune connective tissue disorder characterized by abnormal thickening of the skin.
  • Connective tissue is composed of collagen, which supports and binds other body tissues.
  • Some types of scleroderma affect certain, specific parts of the body, while other types can affect the whole body and internal organs. The exact cause of scleroderma is unknown.
  • scleroderma The early symptoms of scleroderma vary considerably but distinctive abnormalities on the skin usually appear later in the course of the disease. Common symptoms include painful joints, morning stiffness, fatigue, and weight loss. People with scleroderma have areas of skin that become hard and leathery. These areas of hardness are widespread and typically appear on both sides of the body. Eventually, tissue loss occurs and the skin becomes more highly colored. The skin can become thin, shiny, and bright which results in decreased function of the fingers and toes.
  • Treatment of scleroderma is usually just symptomatic and supportive. Medications can be given to control the hardening of the skin, although not very effective, and skin care may include lubricating creams or antibiotic ointments for infected ulcerations.
  • Raynaud's phenomenon can be associated with scleroderma, although it can occur in people without scleroderma.
  • Raynaud's phenomenon is a vascular disorder characterized by the intermittent loss of blood to various parts of the body, particularly the fingers, toes, nose, and ears causing them to turn white. This typically occurs after exposure to cold and causes tingling sensations, numbness, and pain.
  • Raynaud's phenomenon is an early complaint of people with scleroderma. Drug therapy with Vasodilators may help widen the blood vessels. An estimated 28 million people in the US have Raynaud's phenomenon.
  • the major symptom is a dramatic stark white pallor of the affected areas when exposed to cold, although a blue or red color may also be present from time to time.
  • Other symptoms include a feeling of numbness, severe aching or pain, tingling or throbbing, a sensation of tightness, "pins and needles," and a profound loss of sensation.
  • oral mucosa! ulceration induced chemotherapy / radiation Another condition that causes severe pain and difficulty is oral mucosa! ulceration induced chemotherapy / radiation. Although it is not a disease itself, oral mucosa! ulceration is a result of treatments for cancer. Radiation-induced oral mucosa! ulceration occurs in up to 80% of head and neck cancer irradiated patients and reaches up to 100% in patients with altered fractionation head and neck cancer.
  • Radiation-induced oral mucosa! ulceration is a major dose-limiting toxicity in head and neck cancer patients. It is a normal tissue injury caused by radiation, which has marked adverse effects on patient quality of life and cancer therapy continuity. It is a challenge for proper treatment since it leads to cancer therapy interruption, poor local tumor control, and changes in dose fractionation. Its economic cost is estimated to be about 17,000 dollars per patient with head and neck cancers.
  • Aphthous Ulcers are similar to the oral mucosa! ulceration caused by cancer treatments, but occur in people without a known cause. Aphthous ulcers are small, shallow lesions that develop on the soft tissues in the mouth or at the base of the gums. Aphthous ulcers do not occur on the surface of the lips and they are not contagious. However, they are painful and can make eating difficult. Most sores disappear on their own in a week or two, but some can last longer.
  • the aphthous ulcers are round or oval with a white or yellow center and a red border. They form inside the mouth; on or under the tongue; inside the cheeks or lips, at the base of the gums; or on the soft palate. There is also a tingling or burning sensation a day or two before the sores appear.
  • compositions were additionally effective against more common skin and oral problems. Variations of the compositions for the orphan diseases were able to treat skin damage from cuts, abrasions, and burns; aging skin changes; and toe nail fungus. This discovery increased the population who could be helped by these compositions.
  • compositions and methods relate to treating medical conditions that are known to have few, if any, effective treatments currently available. There are many medical conditions that exist today without currently demonstrated effective medical treatments that are the subject of extensive research by major pharmaceutical companies throughout the world. The goal is to develop potentially beneficial, skin care compositions that demonstrate new effectiveness following composition component alteration and manufacturing in multiple medical conditions without known and effective treatments.
  • Tables 1 and 2 provide the percentage of hydrophobic and hydrophilic components in a disclosed composition.
  • the meaning of the stated range of 0.00% to 50.00% is that every value from 0.00 to 50.00 to the 0.01 place is disclosed and any range combining any two values in the range is possible.
  • each whole number 0, 1, 2, 3 ... 46, 47, 48, 49, 50 is disclosed.
  • every 0.1 unit between each whole number is disclosed. Therefore, between each whole number the values of 0.1, 0.2, 0.3 ... 0.6, 0.7, 0.8, and 0.9 are disclosed.
  • every 0.01 unit between each 0.1 is disclosed. Therefore, between each 0.1 unit the values of 0.01, 0.02, 0.03 ... 0.06, 0.07, 0.08, 0.09 are disclosed.
  • the stated range of 0.00% to 50.00% includes any range within this range. This range includes 5,000 values - 0.00, 0.001 ... 49.98, 49.99, 50.00. Therefore, the 12,502,500 different ranges possible by stating a minimum value and maximum value are disclosed by the stated range of 0.00% to 50.00%.
  • the temperatures in the method can be modified depending on the component being combined and the final format of the composition.
  • the temperature can be given as less than or equal to a value.
  • the temperature can be given as greater than or equal to a value.
  • the temperatures can be given as a range between any two disclosed values.
  • the composition can be a lotion, solution, balm, cream, spray or other consistency used for topical application.
  • composition can be applied topically or oral mucosa! application.
  • composition can be a pharmaceutical, medicinal, cosmetic, or over-the-counter.
  • the amount of a component is in milliliters.
  • the amount of a component is in grams.
  • the amount of a component is in percent of total.
  • the amount of a-Pinene is from 30 ml to 90 ml per batch of composition. In another embodiment the amount of a-Pinene is from 50 ml to 70 ml per batch of composition. In another embodiment the amount of a-Pinene is 60 ml per batch of composition.
  • the amount of 1 -Tetradecanol is from 1.0 g to 5.0 g per batch of composition. In another embodiment the amount of 1 -Tetradecanol is from 1.5 g to 3.5 g per batch of composition. In another embodiment the amount of 1 -Tetradecanol is 2.5 g per batch of composition.
  • the amount of Acai Berry is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Acai Berry is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Acai Berry is 10 ml per batch of composition. In one embodiment the amount of Artie Fish Collagen is from 10 g to 70 g per batch of composition. In another embodiment the amount of Artie Fish Collagen is from 30 g to 50 g per batch of composition. In another embodiment the amount of Artie Fish Collagen is 40 g per batch of composition.
  • the amount of Agave nectar is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Agave nectar is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Agave nectar is 10 ml per batch of composition.
  • the amount of Alanine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Alanine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Alanine is 5 g per batch of composition.
  • the amount of Aloe Vera Leaf Gel is from 100 g to 500 g per batch of composition. In another embodiment the amount of Aloe Vera Leaf Gel is from 200 g to 350 g per batch of composition. In another embodiment the amount of Aloe Vera Leaf Gel is 275 g per batch of composition.
  • the amount of Anethole Anise Camphor is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Anethole Anise Camphor is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Anethole Anise Camphor is 5 ml per batch of composition.
  • the amount of Apricot Kernal Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Apricot Kemal Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Apricot Kemal Oil is 5 ml per batch of composition.
  • the amount of Argan Nut Oil is from 0.5 ml to 10 ml per batch of composition. In another embodiment the amount of Argan Nut Oil is from 1.0 ml to 7.5 ml per batch of composition. In another embodiment the amount of Argan Nut Oil is 2.5 - 5.0 ml per batch of composition.
  • the amount of Arginine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Arginine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Arginine is 5 g per batch of composition. In one embodiment the amount of Baobab Oil is from 0.5 ml to 10 ml per batch of composition. In another embodiment the amount of Baobab Oil is from 1.0 ml to 7.5 ml per batch of composition. In another embodiment the amount of Baobab Oil is 2.5 - 5.0 ml per batch of composition.
  • the amount of Bees Wax is from 10 g to 70 g per batch of composition. In another embodiment the amount of Bees Wax is from 30 g to 50 g per batch of composition. In another embodiment the amount of Bees Wax is 40 g per batch of composition.
  • the amount of Benzocaine is from 1 g to 7 g per batch of composition. In another embodiment the amount of Benzocaine is from 3 g to 5 g per batch of composition. In another embodiment the amount of Benzocaine is 4 g per batch of composition.
  • the amount of Benzoin is from 1 ml to 7 ml per batch of composition. In another embodiment the amount of Benzoin is from 3 ml to 5 ml per batch of composition. In another embodiment the amount of Benzoin is 4 ml per batch of composition.
  • the amount of Benzyl Alcohol is from 1 ml to 100 ml per batch of composition. In another embodiment the amount of Benzyl Alcohol is from 25 ml to 75 ml per batch of composition. In another embodiment the amount of Benzyl Alcohol is 50 ml per batch of composition.
  • the amount of Cabreuva Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Cabreuva Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Cabreuva Oil is 5 ml per batch of composition.
  • the amount of Caffeic acid is from 1 g to 10 g per batch of composition. In another embodiment the amount of Caffeic acid is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Caffeic acid is 5 g per batch of composition.
  • the amount of Calendula Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Calendula Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Calendula Oil is 5 ml per batch of composition.
  • the amount of Camellia Oil is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Camellia Oil is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Camellia Oil is 10 ml per batch of composition.
  • the amount of Capaiba Oil is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Capaiba Oil is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Capaiba Oil is 10 ml per batch of composition.
  • the amount of Caprylic, Capric Triglyceride is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Caprylic, Capric Triglyceride is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Caprylic, Capric Triglyceride is 10 ml per batch of composition.
  • the amount of Carvacrol is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Carvacrol is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Carvacrol is 5 ml per batch of composition.
  • the amount of Carvone Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Carvone Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Carvone Oil is 2.5 ml per batch of composition.
  • the amount of Caryophyllene is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Caryophyllene is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Caryophyllene is 10 ml per batch of composition.
  • the amount of Cedarwood Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Cedarwood Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Cedarwood Oil is 2.5 ml per batch of composition.
  • the amount of Cetyl Alcohol is from 10 g to 70 g per batch of composition. In another embodiment the amount of Cetyl Alcohol is from 30 g to 50 g per batch of composition. In another embodiment the amount of Cetyl Alcohol is 40 g per batch of composition. In one embodiment the amount of Chamomile German Oil is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Chamomile German Oil is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Chamomile German Oil is 10 ml per batch of composition.
  • the amount of Distilled water is from 100 ml to 1,000 ml per batch of composition. In another embodiment the amount of Distilled water is from 250 ml to 750 ml per batch of composition. In another embodiment the amount of Distilled water is 500 ml per batch of composition.
  • the amount of Elemi Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Elemi Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Elemi Oil is 5 ml per batch of composition.
  • the amount of Ferulic Acid is from 1 g to 20 g per batch of composition. In another embodiment the amount of Ferulic Acid is from 5 g to 15 g per batch of composition. In another embodiment the amount of Ferulic Acid is 10 g per batch of composition.
  • the amount of Geranium Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Geranium Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Geranium Oil is 2.5 ml per batch of composition.
  • the amount of Ghana Shea Butter is from 100 g to 500 g per batch of composition. In another embodiment the amount of Ghana Shea Butter is from 200 g to 350 g per batch of composition. In another embodiment the amount of Ghana Shea Butter is 275 g per batch of composition.
  • the amount of Glutamine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Glutamine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Glutamine is 5 g per batch of composition.
  • the amount of Glycerol is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Glycerol is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Glycerol is 10 ml per batch of composition. In one embodiment the amount of Glycine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Glycine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Glycine is 5 g per batch of composition.
  • the amount of Histidine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Histidine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Histidine is 5 g per batch of composition.
  • the amount of Ho Wood Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Ho Wood Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Ho Wood Oil is 2.5 ml per batch of composition.
  • the amount of Hydroxyproline is from 1 g to 10 g per batch of composition. In another embodiment the amount of Hydroxyproline is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Hydroxyproline is 5 g per batch of composition.
  • the amount of Isoleucine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Isoleucine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Isoleucine is 5 g per batch of composition.
  • the amount of Jasmine Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Jasmine Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Jasmine Oil is 2.5 ml per batch of composition.
  • the amount of Kaempferol is from 1 g to 10 g per batch of composition. In another embodiment the amount of Kaempferol is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Kaempferol is 5 g per batch of composition.
  • the amount of Kanuka Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Kanuka Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Kanuka Oil is 2.5 ml per batch of composition.
  • the amount of Lavodin Oil is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Lavodin Oil is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Lavodin Oil is 10 ml per batch of composition.
  • the amount of Lecithin is from 10 g to 50 g per batch of composition. In another embodiment the amount of Lecithin is from 15 g to 35 g per batch of composition. In another embodiment the amount of Lecithin is 25 g per batch of composition.
  • the amount of Leucine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Leucine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Leucine is 5 g per batch of composition.
  • the amount of Limonene Oil is from 100 ml to 1,000 ml per batch of composition. In another embodiment the amount of Limonene Oil is from 200 ml to 600 ml per batch of composition. In another embodiment the amount of Limonene Oil is 400 ml per batch of composition.
  • the amount of Linoleic Acid is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Linoleic Acid is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Linoleic Acid is 5 ml per batch of composition.
  • the amount of Litsea Cubebe Oil is from 1 ml to 10 ml. In another embodiment the amount of Litsea Cubebe Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Litsea Cubebe Oil is 5 ml per batch of composition.
  • the amount of Lysine is from 1 g to 10 g per batch of composition. In another embodiment the amount of Lysine is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Lysine is 5 g per batch of composition.
  • the amount of Manila Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Manila Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Manila Oil is 2.5 ml per batch of composition.
  • the amount of Methyl Sulfonyl Methane is from 10 g to 50 g per batch of composition. In another embodiment the amount of Methyl Sulfonyl Methane is from 10 g to 50 g per batch of composition. In another embodiment the amount of Methyl Sulfonyl Methane is 25 g per batch of composition. In one embodiment the amount of Myrrh is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Myrrh is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Myrrh is 5 ml per batch of composition.
  • the amount of Nerolina Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Nerolina Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Nerolina Oil is 2.5 ml per batch of composition.
  • the amount of Niacinamide is from 1.0 g to 5.0 g per batch of composition. In another embodiment the amount of Niacinamide is from 1.5 g to 3.5 g per batch of composition. In another embodiment the amount of Niacinamide is 2.5 g per batch of composition.
  • the amount of Niaouli Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Niaouli Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Niaouli Oil is 5 ml per batch of composition.
  • the amount of Nigella saliva Black Cumin Seed Oil is from 10 ml to 100 ml per batch of composition. In another embodiment the amount of Nigella saliva Black Cumin Seed Oil is from 25 ml to 75 ml per batch of composition. In another embodiment the amount of Nigella saliva Black Cumin Seed Oil is 50 ml per batch of composition.
  • the amount of Oleic Acid is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Oleic Acid is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Oleic Acid is 5 ml per batch of composition.
  • the amount of Palmarosa Oil is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Palmarosa Oil is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Palmarosa Oil is 2.5 ml per batch of composition.
  • the amount of Palo Santo is from 1.0% to 5.0% per batch of composition. In another embodiment the amount of Palo Santo is from 1.5% to 3.5% per batch of composition. In another embodiment the amount of Palo Santo is 2.5% per batch of composition. In one embodiment the amount of Panthenol is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Panthenol is from 5 ml to 15 ml per batch of composition. In another embodiment the amount of Panthenol is 10 ml per batch of composition.
  • the amount of Peppermint is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Peppermint is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Peppermint is 5 ml per batch of composition.
  • the amount of Praline is from 1 g to 10 g per batch of composition. In another embodiment the amount of Praline is from 2.5 g to 7.5 g per batch of composition. In another embodiment the amount of Praline is 5 g per batch of composition.
  • the amount of Pratocatechuic Acid is from 1 g to 20 g per batch of composition. In another embodiment the amount of Pratocatechuic Acid is from 5 g to 15 g per batch of composition. In another embodiment the amount of Pratocatechuic Acid is 10 g per batch of composition.
  • the amount of Rose Hip Seed Oil is from 1 ml to 20 ml per batch of composition. In another embodiment the amount of Rose Hip Seed Oil is from 2.5 ml to 15 ml per batch of composition. In another embodiment the amount of Rose Hip Seed Oil is 5 - 10 ml per batch of composition.
  • the amount of Sachi Inchi oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Sachi Inchi oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Sachi Inchi oil is 5 ml per batch of composition.
  • the amount of Sea Buckthorn Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Sea Buckthorn Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Sea Buckthorn Oil is 5 ml per batch of composition.
  • the amount of Sericin is from 10 g to 100 g. In another embodiment the amount of Sericin is from 25 g to 75 g per batch of composition. In another embodiment the amount of Sericin is 50 g per batch of composition. In one embodiment the amount of Sericin is from 5 g to 50 g. In another embodiment the amount of Sericin is from 10 g to 30 g per batch of composition. In another embodiment the amount of Sodium Polyacrylate is 20 g per batch of composition.
  • the amount of Tamanu Oil is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Tamanu Oil is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Tamanu Oil is 5 ml per batch of composition.
  • the amount of Terpineol is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Terpineol is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Terpineol is 5 ml per batch of composition.
  • the amount of Thyme Red, White is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Thyme Red, White is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Thyme Red, White is 5 ml per batch of composition.
  • the amount of Vetiver is from 1.0 ml to 5.0 ml per batch of composition. In another embodiment the amount of Vetiver is from 1.5 ml to 3.5 ml per batch of composition. In another embodiment the amount of Vetiver is 2.5 ml per batch of composition.
  • the amount of Vitamin A is from 1.0 g to 5.0 g per batch of composition. In another embodiment the amount of Vitamin A is from 1.5 g to 3.5 g per batch of composition. In another embodiment the amount of Vitamin A is 2.5 g per batch of composition.
  • the amount of Vitamin B3 or Niacin is from 1 g to 25 g per batch of composition. In another embodiment the amount of Vitamin B3 or Niacin is from 5 g to 17.5 g per batch of composition. In another embodiment the amount of Vitamin B3 or Niacin is 12.5 g per batch of composition.
  • the amount of Vitamin C is from 1.0 g to 5.0 g per batch of composition. In another embodiment the amount of Vitamin C is from 1.5 g to 3.5 g per batch of composition. In another embodiment the amount of Vitamin C is 2.5 g per batch of composition.
  • the amount of Vitamin Eis from 1.0 g to 5.0 g per batch of composition. In another embodiment the amount of Vitamin E is from 1.5 g to 3.5 g per batch of composition per batch of composition. In another embodiment the amount of Vitamin E is 2.5 g per batch of composition per batch of composition.
  • the amount of Winter Savory is from 1 ml to 10 ml per batch of composition. In another embodiment the amount of Winter Savory is from 2.5 ml to 7.5 ml per batch of composition. In another embodiment the amount of Winter Savory is 5 ml per batch of composition.
  • a method of treatment for Dupuytren' s Contracture comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Skin Damage from Cuts, Abrasions, and Bums comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Peyronie' s Disease comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Aging Skin comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Toe Nail Fungus comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Aphthous Ulcers comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Scleroderma Induced Subcutaneous Damage comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Raynaud' s Phenomenon comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • a method of treatment for Chemotherapy / Radiation Induced Oral Mucosa! Ulceration comprises administering to a mammal in need thereof a composition comprising a combination of components in Table 1 and 2.
  • Paragraph 1 A composition comprising a-pinene, ghana shea butter and methylsulfonylmethane.
  • Paragraph 2 The composition of Paragraph 1 further comprising glycerol, black cumin seed, aloe vera gel, collagen and lecithin.
  • Paragraph 3 The composition of Paragraph 2 further comprising at least one from the group consisting of functional oil, alcohol, anti-inflammatory, anti-oxidant, anti-microbial, floral, thickener, wax, fragrance, fatty acid, analgesic, amino acid, carbohydrate, vitamin, solvent, gel, moisturizer and acid.
  • Paragraph 4 The composition of Paragraph 3 wherein the functional oil is selected from the group consisting of Apricot Kernal Oil, Argan Nut Oil, Baobab Oil, Calendula Oil, Camellia Oil, Caprylic, Capric Triglyceride, Caryophyllene, Elemi Oil, Kanuka Oil, Litsea Cubebe Oil, Manila Oil, Palmarosa Oil, Palo Santo, Rose Hip Seed Oil, Sachi Inchi Oil, Sea Buckthorn Oil and Tamanu Oil.
  • the functional oil is selected from the group consisting of Apricot Kernal Oil, Argan Nut Oil, Baobab Oil, Calendula Oil, Camellia Oil, Caprylic, Capric Triglyceride, Caryophyllene, Elemi Oil, Kanuka Oil, Litsea Cubebe Oil, Manila Oil, Palmarosa Oil, Palo Santo, Rose Hip Seed Oil, Sachi Inchi Oil, Sea Buckthorn Oil and Tamanu Oil.
  • Paragraph 5 The composition of Paragraph 3 wherein the alcohol is selected from the group consisting of Benzyl Alcohol, Cetyl Alcohol and Panthenol.
  • Paragraph 6 The composition of Paragraph 3 wherein the anti-inflammatory is selected from the group consisting of Acai Berry, Chamomile German Oil, Capaiba Oil, Myrrh, Rose Hip Seed Oil, Oleic Acid and Linoleic Acid.
  • Paragraph 7 The composition of Paragraph 3 wherein the anti-oxidant is selected from the group consisting of Kaempferol, Caffeic acid and Protocatechuic Acid.
  • Paragraph 8 The composition of Paragraph 3 wherein the anti-microbial is selected from the group consisting of Anethole Anise Camphor, Cabreuva Oil, Carvacrol, Niaouli Oil, Thyme and Winter Savory.
  • Paragraph 9 The composition of Paragraph 3 wherein the floral is Rosemary Oil.
  • Paragraph 10 The composition of Paragraph 3 wherein the thickener is Benzoin.
  • Paragraph 11 The composition of Paragraph 3 wherein the wax is BeesWax.
  • Paragraph 12 The composition of Paragraph 3 wherein the fragrance is selected from the group consisting of Carvone Oil, Geranium Oil, Ho Wood Oil, Jasmine Oil, Lavodin Oil, Limonene Oil, Nerolina Oil, Peppermint, Terpineol and Vetiver.
  • Paragraph 13 The composition of Paragraph 3 wherein the fatty acid is Ferulic Acid.
  • Paragraph 14 The composition of Paragraph 3 wherein the analgesic is Benzocaine.
  • Paragraph 15 The composition of Paragraph 3 wherein the amino acid is selected from the group consisting of Alanine, Arginine, Glutamine, Glycine, Histidine, Hydroxyproline, Isoleucine, Leucine, Lysine and Praline.
  • Paragraph 16 The composition of Paragraph 3 wherein the carbohydrate is Agave nectar.
  • Paragraph 17 The composition of Paragraph 3 wherein the vitamin is selected from the group consisting of Vitamin A, Vitamin B3, Niacin, Vitamin C, Vitamin E, Niacinamide.
  • Paragraph 18 The composition of Paragraph 3 wherein the solvent is distilled water.
  • Paragraph 19 The composition of Paragraph 3 wherein the gel is Sericin.
  • Paragraph 20 The composition of Paragraph 3 wherein the moisturizer is selected from the group consisting of Sodium Polyacrylate and 1 -Tetradecanol.
  • a method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients comprising the steps of: a) placing hydrophobic components that are a liquid or become a liquid at45°C in a first vessel and placing hydrophilic components that are a liquid or become a liquid at 45°C in a second vessel; b) inserting into each of the first vessel and the second vessel a propeller mixer rotating at 400 rotations per minute (RPM) propeller mixing speed and heating each of the first vessel and the second vessel to 45 °C; c) after sufficient mixing at 45°C, placing hydrophobic components that are not liquid at 45 °C in the first vessel and placing hydrophilic components that are not liquid at 45°C in the second vessel, and increasing rotation of each propeller mixer to 800 RPM and increasing the temperature of the first vessel and the second vessel to 60°C; d) after sufficient time for mixing and completion of reaction in the first vessel and the second vessel, pouring the contents of the second vessel into the first vessel and combining the contents of both vessels,
  • a method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients comprising the steps of: a) placing hydrophobic components that are a liquid or become a liquid at 30°C - 60°C in a first vessel and placing hydrophilic components that are a liquid or become a liquid at 30°C - 60°C in a second vessel; b) inserting into each of the first vessel and the second vessel a propeller mixer rotating at 200 - 600 rotations per minute (RPM) propeller mixing speed and heating each of the first vessel and the second vessel to 30°C - 60°C; c) after sufficient mixing at 30°C - 60°C, placing hydrophobic components that are not liquid at 30°C - 60°C in the first vessel and placing hydrophilic components that are not liquid at 30°C - 60°C in the second vessel, and increasing rotation of each propeller mixer to 600 - 1,000 RPM and increasing the temperature of the first vessel and the second vessel to greater than or equal to 60°C; d)
  • Paragraph 23 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the temperature in step a) is 40°C - 50°C.
  • Paragraph 24 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 23, wherein the temperature in step a) is 45°C.
  • Paragraph 25 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the propeller mixing speed is step b) is 300 - 500 RPM.
  • Paragraph 26 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 25, wherein the propeller mixing speed is step b) is 400 RPM.
  • Paragraph 27 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the temperature in step b) is 40°C - 50°C.
  • Paragraph 28 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 27, wherein the temperature in step b) is 45°C.
  • Paragraph 29 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the temperature in step c) is 40°C - 50°C.
  • Paragraph 30 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 29, wherein the temperature in step C) is 45°C.
  • Paragraph 31 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the propeller mixing speed is step c) is 700 - 900 RPM.
  • Paragraph 32 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 31, wherein the propeller mixing speed is step c) is 800 RPM.
  • Paragraph 33 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the temperature in step c) is increased to 60°C - 80°C.
  • Paragraph 34 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 33, wherein the temperature in step c) is increased to greater than 80°C.
  • Paragraph 35 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the propeller mixing speed is step d) is 700 - 900 RPM.
  • Paragraph 36 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 35, wherein the propeller mixing speed is step d) is 800 RPM.
  • Paragraph 37 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the temperature in step d) is increased to 60°C - 80°C.
  • Paragraph 38 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 37, wherein the temperature in step d) is increased to greater than 80°C.
  • Paragraph 39 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the sufficient time is I to 8 hours.
  • Paragraph 40 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 39, wherein the sufficient time is more than 8 hours.
  • Paragraph 41 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the additional reaction time is 10 - 40 minutes.
  • Paragraph 42 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 41, wherein the additional reaction time is 20 minutes.
  • Paragraph 43 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the several hours in step f) is 2 to IO hours.
  • Paragraph 44 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 43, wherein the several hours in step f) is more than 10 hours.
  • Paragraph 45 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the propeller mixer speed in step f) is 500 - 700 RPM.
  • Paragraph 46 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 46, wherein the propeller mixer speed in step f) is 600 RPM.
  • Paragraph 47 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 22, wherein the ambient temperature in step g) is 25°C - 37°C.
  • Paragraph 48 The method of combining hydrophobic components and hydrophilic components with high dosage of active ingredients in Paragraph 47, wherein the ambient temperature in step g) is less than 25°C.
  • compositions for treatments of topical diseases and syndromes many with similarities in terms of their anti-inflammatory and anti-oxidative activities, but also multiple differences in their observed abilities that can be combined to challenge the current, underlying pathophysiology.
  • the following disorders, described below, can be treated with the disclosed compositions with the proper combination and alteration of ingredients:
  • Figure 1 shows a hand with a chord of a patient with Dupytren's Disease and Contracture [permission granted - Frank C. Muller, Baden-Baden],
  • Figure 2A shows an abrasion of the palm.
  • Figure 2B shows a cut on the leg [permission granted - ClockFace],
  • Figure 2C shows a bum to the top of a hand.
  • Figure 3 illustrates the curvature of the penis due to Peyronie's Disease.
  • Figure 4A shows damage to the skin of the forearm of an elderly person.
  • Figure 4B is a graph of age range of the United States, Year 2016.
  • Figure 5 shows toes with severe fungus infection of toe nails [permission granted - James Heilman, MD].
  • Figure 6 shows an aphthous ulcer in the mouth of a patient [permission granted - Ryanfransen at English Wikipedia],
  • Figure 7 shows several photographs of people with cutaneous scleraderma
  • Figure 8 illustrates the effects of Raynaud' s phenomenon on the hand.
  • Figure 9 shows the ulcers Induced in Oral Mucosa by Chemotherapy/ Radiation Therapy.
  • Table 3 shows the function, and scientific name or chemical formula for each hydrophobic component that can be used in a composition.
  • Table 4 shows the function, and scientific name or chemical formula for each hydrophilic component that can be used in a composition.
  • a-Pinene - Formula - C10HI6- a-Pinene is a terpene that is not toxic, which is one of two isomers of this compound with the other being -Pinene that has toxic characteristics. They originate predominantly from conifer pine trees (Pinophyta) and are both natural compositions. a-Pinene has important anti-inflammatory properties working through the PGE1 mechanism. In addition, it has important anti-microbial activities. It also been used in medicinal compositions as a bronchial dilator, anti-septic agent, and anti-cancer agent. Its primary use in the composition is its anti-inflammatory and anti-microbial effects.
  • Anethole Anise Camnhor-Formula - C10H12O - An organic compound that is widely used as a flavoring.
  • Anethole has potent antimicrobial properties. Reported antibacterial properties include both bacteriostatic and bactericidal action. Antifungal activity includes increasing the effectiveness of some other phytochemicals.
  • Anricot Kernal Oil (AKO) - Pressed from the kernels of the Prunus armeniaca.
  • Apricot kernels have an oil content of 40-50%. It is also used to extract an essential oil, which contains amygdalin. The oil is chiefly composed of oleic acid and linoleic acid. Arean Nut Oil -Argania spinosa is an important tree grown in Morocco. It is a dietary oil and used in cosmetics. The oil comes from the tree's nuts. Its intended use for the compositions is to support the oils with higher levels of healing.
  • Baobab Oil -Adansonia digitalia is the most common of the nine species of Baobab trees with the oil extracted from seeds. It is commonly used on the skin as a moisturizer, a stimulant for skin cell replication, a skin anti-oxidant, a wound healing agent, and an antiinflammatory agent due to its omega fatty acids. Is use in the compositions is primarily for its anti-oxidant, anti-inflammatory, and wound healing properties.
  • Bees Wax - Wax from honey bees (Apis mellifera) is utilized in some of the compositions as a temperature sensitive agent that melts at 58°C and solidifies at lower temperatures depending upon concentration that keeps the manufacturing process in the liquid phase for alterations and modifications of the natural components at a higher temperature. Upon cooling, it acts with other components to provide solidity within the final composition.
  • Benzoin (BZN1 - Styrax benzoin - A balsamic resin obtained from the bark of several species of trees in the genus Styrax. It is used in perfumes, incense, flavoring, and medicine. Benzoin is sometimes called gum benzoin or gum benjamin. Benzoin is also called storax. Benzoin has a sweet vanilla-like aroma and fixative properties.
  • Benzyl Alcohol - Formula C6HsCH20H - Benzyl Alcohol is often used as a solvent due to low toxicity, polarity, and low vapor pressure with moderate solubility in water and miscibility in other alcohols. It is commonly found in plants and fruits and along with a variety of essential oils, such as, jasmine, hyacinth, and ylang-ylang. It is also used as a bacteriostatic preservative in intravenous medications, cosmetics, and skin care compositions. It has a low toxicity value with LD50 of 1 ,2gm/kg in rats. Its use in the compositions is as a solvent and its anti-microbial properties.
  • clove bud essential oil is used in making floral notes such as rose and lily of the valley, amber bases, precious wood notes, and in Caffeic acid - Formula - C9H8O4 - An organic compound classified as a hydroxy cinnamic acid. It consists of both phenolic and acrylic functional groups. It is found in all plants because it is a key intermediate in the biosynthesis of lignin.
  • Caffeic acid has a variety of potential pharmacological effects and the inhibitory effect of caffeic acid on cancer cell proliferation by an oxidative mechanism. Caffeic acid is an antioxidant, immunomodulatory and anti-inflammatory activity.
  • Calendula Oil - Calendula officinalis is a type of marigold that is used for herbal, cosmetic, and medicinal compositions.
  • the yellow petals are edible and have been used medicinally for centuries. It is currently utilized for its pharmacologic effects for antiinflammatory, anti-tumor, and wound healing attributes.
  • Topical applications are also used on the skin for radiation damage, the prevention of dermatitis and pain, as well as, an agent to decrease healing times on skin injuries. It was a popular treatment in the Civil War and World War I to reduce wound bleeding and infection. Its use in the compositions is for its antiinflammatory and wound healing properties.
  • Camellia Oil - Camellia japonica has been used for centuries by the Japanese as skin care and moisturizing compositions, as well as, for wound healing and scar reduction as it readily absorbs into the skin. It has also been used medically as a vitamin carrier for injections. The oil is cold pressed from seeds. Camellia is part of the flowering plants from the Theaceae family with leaves from Camellia sinensis the most popular for tea products. Its primary use in the compositions is it anti-inflammatory and wound healing properties.
  • Copaiha Oil - Copaifera officinalis It reduces pain and inflammation, protects against infections, heals the skin, prevents fungal growth, and boosts the respiratory health. It improves the skin, speeds up healing, and tightens the skin.
  • Copaiba essential oil is a distilled oil from an oleoresin. This resin is produced as a sap from a tree in the Copaifera genus. The oil is a pale yellow in color with a slightly bitter taste and an aroma. Copaiba is considered to be one of the most anti-inflammatory substances on earth. In traditional medicine, this essential oil has been used extensively by indigenous people.
  • the active components in copaiba essential oil consist mainly of terpenes. It has topical applications and the copaiba essential oil has astringent properties.
  • Copaiba' s active components tighten the skin, which can help the skin look younger, reduce the appearance of wrinkles, and even strengthen the skin to prevent lesions or wounds as the body ages. Additionally, a topical application of copaiba essential oil helps reduce the appearance of acne on the face. Copaiba essential oil also heals the skin and infuses the body with powerful nutrients and organic compounds that can eliminate the appearance of blisters, marks, and pimples. Copaiba essential oil is often topically applied to scars in order to speed their healing and reduce their visibility. Copaiba essential oil is a analgesic and is a strong antibacterial agent. It can act as a shield for your skin, protecting any wounds from developing an infection. The unique terpene structures found in copaiba essential oil are very effective as antifungal agents.
  • Canric Triglyceride - Formulae - Capryllic Acid CsHieO 2, - Capric Acid CH3(CH2)sCOOH - Cocos nucifera is the cocoa nut palm from which the composition is purified as ⁇ 10% constituents of the kernal. Individual uses of these triglycerides have little direct effect on the intended use of this topical composition. However, this mixed, medium chain triglyceride composition is considered an inert energy source readily available for use by the skin cells and dermis cells that are being challenged to function properly in their limited condition brought on by their specific disease state.
  • Carvone Oil (CRY) - Formula- CIOHMO - It is a terpenoid and found naturally in many essential oils, but is most abundant in the oils from seeds of caraway (Carum carvi), spearmint (Mentha spicata), and dill. Carvone is available in both enantiomerically pure forms.
  • Carvonhyllene Oil This oil is most commonly from the stem and flowers of Syzygium aromaticum to produce clove oil. There are 14 plant sources of Caryophyllene oil. However, only 9 of these plants have their Caryophyllene levels above 10% of these oils from clove, cannabis, hops, basil, oregano, West African pepper, cinnamon, malabathrum, and ylang-ylang. Two of these, the West African pepper and the India cinnamon or malabathrum, contain up to 25% of their oils as Caryophyllene oil. Its use in the compositions is primarily for its antiinflammatory properties.
  • Cedarwood essential Oil An essential oil derived from various types of conifers, most in the pine or cypress botanical families. It has uses in medicine and perfumery, and while the characteristics of oils derived from various species may themselves vary, all have some degree of bactericidal effects. Although termed cedar or cedarwood oils, the most important oils are produced from distilling wood of a number of different junipers and cypresses (of the family Cupressaceae), rather than true cedars (of the family Pinaceae). Cedarwood oils each have characteristic woody odors which may change somewhat in the course of drying out. The crude oils are often yellowish or even darker in color. They find use in fragrance applications. The oil has antifungal and antibacterial properties.
  • Chamomile German Oil - Chamaemelum nobile is used for treating skin conditions such as eczema, chicken pox lesions, and psoriasis. It has a wide medical usage for inflammation, ulcers, and hemorrhoids.
  • Chamomile tea has long been popular and is made from the dried flowers and may be a relaxant. There also may be anti-anxiety effects from its use. Its primary use in the compositions is to aid healing and reduce inflammation.
  • Elemi Oil It is steam distilled from the resin of the Asian tree Canarium luzonicum or Canarium vulgare. Elemi Oil is rich in monoterpenes. It can be especially helpful in wound care and for supporting respiratory health. It has a clear color with a tinge of yellow. It is effective against infectious skin conditions, wounds, cuts, fatigue.
  • Geranium Essential Oil- Pelargoniun graveolens encompasses a relatively large group of plants from which this complex, essential oil comprises ⁇ 50 different oil components.
  • the number of species has been greatly increased due to significant hybrid culturing seeking to focus on different flower and scent expressions. It currently has limited medicinal use and is being used as a general oil solution and fragrance for these applications.
  • Ghana Shea Butter - Vitellaria paradoxa is the general name for the Shea trees of the Sapotacea family and is the only species in this genus, located predominantly in Africa. This species is a major food source of dietary fat.
  • Shea butter is composed of 5 fatty acids: palmitic, stearic, oleic, linoleic and arachidic of which 85 - 90% is stearic and oleic acids. These fatty acid contents change in percentages from region to region in Africa with the shea butter changing from liquid to near solid depending upon the fatty acid concentrations.
  • Shea butter is one of the largest components of the compositions and is used not only for composition consistency but also as a major anti-oxidant.
  • Glvcerol - Formula - CsHsCh - Glycerol is a colorless, odorous liquid with three -OH groups assuring solubility in water that is also hydroscopic. It is the backbone of all triglycerides. It is derived from soy beans and under large scale manufacturing. It is widely used for extractions of plant compositions and as a solvent. Its primary use in the compositions is as a solvent.
  • Ho Wood Oil (HWO) - Cinnamomum camphora var linaloo - It is steam distilled from the bark and wood.
  • Ho Wood is one of the most potent sources of naturally occurring linalol found in any steam distilled essential oil. Aromatically, Ho Wood Essential Oil is a beautifully fragrant wood oil that possesses some similarity to that of Rosewood Oil. The color is clear. A sweet, fresh and woody, with subtle floral notes. Its significant content of linalol gives it analgesic, anti-inflammatory and antibacterial properties.
  • .Jasmine Essential Oil - Jasminum officinale is a species of the olive family in Eastern Europe and Asia that has been adopted as a garden varietal with appealing flowers. It has a history of use in aromatherapy and herbal medicine predominantly as a skin anti-septic and antiinflammatory agent. Its inclusion in the compositions is for these uses, as well as, its essential oil fragrance.
  • Kaempferol is a yellow crystalline solid. It is slightly soluble in water and highly soluble in hot ethanol, ethers, and DMSO. Kaempferol acts as an antioxidant by reducing oxidative stress. Kaempferol is common in Pteridophyta, Pinophyta and Angiospermae. Studies have shown kaempferol has pharmacological activities, including antioxidant, anti-inflammatory, antimicrobial, and analgesic activities. It also has been shown to work synergistically with antibiotics.
  • Kaempferol has been shown to inhibit or decrease the activity of enzymes in viral infection, such as, reverse transcriptase, viral proteases and neuraminidase. Kaempferol has been shown to have an array of antioxidant effects. Kaempferol can prevent the oxidation of low- density lipid proteins.
  • Lavandin Oil IL VO Lavandula angustifolia (lavender) and Lavandula Intermedia (lavandin).
  • Lavandin is also commonly referred to as French lavender because it was developed for the French perfume industry. It is considered to be an antiseptic.
  • Lavandin is a hybrid plant of true lavender and spike lavender. The oil is a pale yellow color to an almost neutral hue. The essential oil may assist in removing scars and stretch marks. It enhances blood circulation, promotes cell regeneration, and heals wounds and cuts. Lavandin oil has antiseptic properties that helps prevent infections from lacerations. It also speeds up the healing of cuts. It relieves pain and inflammation. The essential oil may alleviate pain in the muscles and joints.
  • Lavandin oil is extracted by steam distilling the plant stalks and flowers. Lavandin may also be steam distilled with the help of a volatile solvent like benzene.
  • Limonene Oil (LMN) - Formula - CioHie - It is a colorless liquid aliphatic hydrocarbon classified as a cyclic monoterpene, and is the major component in the oil of citrus fruit peels. The D-isomer; occurring more commonly in nature as the fragrance of oranges, is a flavoring agent in food manufacturing. Limonene takes its name from the peel of the lemon. Limonene is a chiral molecule, and biological sources produce one enantiomer. Limonene is a relatively stable monoterpene and can be distilled without decomposition. It is a fragrance ingredient for cosmetics compositions.
  • Litsea Cubeba Oil (LCO) - Litsea cubeba is an evergreen tree or shrub in the Lauraceae family. It produces a fruit which is processed for its lemony essential oil.
  • the oil is used as a fragrance and flavoring. It is used as a raw material by the chemical industry for the synthesis of vitamin A and violet-like fragrances.
  • Marula Oil - Sclerocarya birrea produces a nut from which this oil is recovered.
  • Manila Oil contains a large proportion of mono-unsaturated fatty acids, as well as, significant anti-oxidants. Its primary anti-oxidant effects are due to tocopherols, sterols, and flavonoids.
  • the primary use in the compositions is its wide types of fatty acids, as well as, its anti-oxidants.
  • Myrrh It is a natural gum or resin extracted from a number of small, thorny tree species of the genus Commiphora. Myrrh resin is used as a perfume, incense, medicine, antiseptic and salves for abrasions and other minor skin ailments.
  • Nerolina Oil Melaleuca quinquenervia - It is a sweetly-scented oil distilled from the leaves and small branches of the paperbark tea tree or the broad-leaved paperbark tree.
  • Nerolina oil is a component of perfume and has topical antibacterial properties. Nerolina oil is a rich emollient and easily penetrates the skin's surface.
  • Nerolina oil aids in the compositionion of vitamin E and the skin proteins collagen and elastin, which make up the skin's structural layer and accelerates cell turnover.
  • Lignum vitae Palo Santo - Also called Lignum vitae, guayacan or guaiacum.
  • the wood is obtained chiefly from Guaiacum officinale and Guaiacum sanctum, both small, slow growing trees.
  • "Lignum vitae” is Latin for "wood of life,” and derives its name from its medicinal uses. Lignum vitae resin is used to treat a variety of medical conditions from coughs to arthritis.
  • Panthenol tPNTl Formula - HO- CH 2 - C(CH 3 h- CH(OH)- CONH- CH 2 CH 2 CH 2 - 0 H -
  • the alcohol analog of pantothenic acid (vitamin B5) and a provitamin of B5. It is commonly utilized in pharmaceuticals, cosmetics, and skin care products as a moisturizer and humectant. It readily penetrates the skin and mucous membranes where it is converted to pantothenic acid that readily binds water and enables reactivity with other composition components and with the tissues. It is odorless, colorless and a viscous liquid at room temperature. Panthenol is to improve wound healing in pharmaceutical and cosmetic compositions.
  • Pantothenic acid is extremely hygroscopic. It is used in the biosynthesis of coenzyme A. Panthenol is an odorless, slightly bitter, highly viscous, transparent and colorless liquid at room temperature. Itis easily soluble in water. Panthenol comes in two enantiomers, D and L. Only D-panthenol (dexpanthenol) is biologically active, however both forms have moisturizing properties.
  • Rose Hip Oil - Rosa moschata, R. rubiginosa and R. canina - Wild rose species that produce seeds are extracted for Rose Hip Oil. It contains Provitamin A with high levels of tretinoin that is an all-trans retinoic acid that can be converted to Vitamin A. Rose Hip Oil contains the essential fatty acids of linoleic acid (omega 6) and linoleic acid (omega 3). Rose Hip Oil is frequently used in a variety of skin conditions including eczema, dermatitis, and sunburn, as well as, photoaging and healing scars. Its inclusion in these formulations is primarily for its anti-inflammatory effects.
  • Rosemary Oil tRMO Rosmarinus officinalis - It is a woody, perennial herb with fragrant flowers and is a member of the mint family Lamiaceae. Rosemary leaves are used as a flavoring in foods. Rosemary oil is used for fragrant bodily perfumes and an aroma into a room.
  • the nuts contain high protein (27%) and oil (35-60%).
  • the oil is rich in essential fatty acids.
  • Sea Buckthorn Hippophae rhamnoides It accumulates lipids in the fleshy, pulp part of thefruit, as well as, in their seeds.
  • the pulp oil is preferred for these applications since it has high concentrations of the mono-unsaturated fatty acid, palmitoleic acid, and the saturated fatty acid, palmitic acid, which are at unusual levels compared to the plant kingdom.
  • Caretenoids provide the color in the oil and provide beta-carotene, zeazanthin, and lycopene that are associated with Vitamin A activity.
  • the tocopherols and tocotrienols components are major reasons for the anti-oxidant activity of this oil. Its primary purpose for the compositions is its anti-oxidant activities.
  • This oil contains Linoleic acid (38%), Oleic acid (34%), Stearic acid (13%), and Palmitic acid (12%).
  • Additional oil components include calophyllolide, quidlin, inophyllums B & P, terpenic essences, benzoic acid, oxibenzoic acid, phospho-amino lipids, glycerides, saturated fatty acids, and 4-phenylcoumarins.
  • This oil has been used for skin diseases and for treating ulcers and infected wounds. Its inclusion in the compositions is for its anti-inflammatory and wound healing characteristics.
  • Ternineol - Formula - CioHisO - It is a monoterpene alcohol that has been isolated from a variety of sources such as cajuput oil, pine oil, and petitgrain oil. There are four isomers, alpha-, beta-, gamma-terpineol, and terpinen-4-ol. Beta- and gamma-terpineol differ only by the location of the double bond. Terpineol is usually a mixture of these isomers with alpha-terpineol as the major constituent. Terpineol has a pleasant odor similar to lilac.
  • Thvme Red. White An aromatic perennial evergreen herb with culinary, medicinal, and ornamental uses. The most common variety is Thymus vulgaris. Thyme is of the genus Thymus of the mint family (Lamiaceae ). Thymol, an antiseptic, is an active ingredient in various commercially produced mouthwashes. Oil of thyme was used to medicate bandages before the advent of modern antibiotics.
  • Vitamin E Formula (a-tocopherol) - C29H50C) 2 - Vitamin E has several different configurations, but the most prominent is a-tocopherol.
  • Vitamin E is a lipid soluble vitamin from wheat germ oil, sunflower oil, and safflower oil. It stops the propagation of oxygen radicals through cell membranes and protects cells from oxygen radical damage. It is used in a number of medical supplements and topical medication, but it may not be effective in wound healing or reduction of scar tissue. Its use in the compositions is to provide assistance in proper healing of wounds and its anti-oxidant properties.
  • Winter Savory- Satureja montana It is a perennial, semi -evergreen herb in the family Lamiaceae. Winter savory has antiseptic and aromatic benefits. It has been used in the treatment of bee stings or insect bites. Therapeutic-grade oil inhibits growth of yeast. Hydrophilic Components
  • 1- 1 etradecanol- Formula - C14H300 - Myristyl alcohol (Myristicafragrans - nutmeg plant) is a straight-chain saturated fatty alcohol.
  • 1 -Tetradecanol is prepared by the hydrogenation of myristic acid (or its esters). Myristic acid is found in nutmeg.
  • 1 -Tetradecanol is used as an ingredient in cosmetics, such as, cold creams for its emollient properties.
  • Alanine is a non-essential amino acid since the body readily produces it.
  • One main dietary source is in meats.
  • Alanine is an important amino acid in collagen and other similar proteins. Its use in the compositions is to enhance the ability to produce collagen.
  • Arginine - Formula - CeH14N40 2 - An a-amino acid that is used in the biosynthesis of proteins. In humans, arginine is classified as a semiessential or conditionally essential amino acid, depending on the developmental stage and health status of the individual.
  • Artie Fish Collagen -Arctogadus glacialis The artic cod lives in the artic seas at cold temperatures and is thus one of the few species whose collagen is a liquid at cold and room temperatures. Collagen from non-artic animals and non-artic fish is a solid at room temperature.
  • dissolvable collagen is a major advantage in utilizing the protein in the compositions that is in a liquid form rather than a solid form so it can readily react with the other components. Its use in the compositions is to provide collagen forwound support and softening.
  • Benzocaine - Formula - C9H11NO 2 - Benzocaine is a local or topical anesthetic to relieve topical pain. It appears in many compositions to treat a variety of pain related problems. Local anesthesia for oral and pharyngeal mucous membranes is common for sore throats, mouth ulcers, denture irritation, earache, insect bites, and similar topical irritations. Few side effects are noted as long as intended doses are utilized. Its addition in the compositions is only applicable to the two types of oral mucosa! lesions described and should not be given to young children.
  • Distilled water - Formula - H2O - It is water that has been boiled into vapor and condensed back into liquid in a separate container. Impurities in the original water that do not boil below or at the boiling point of water remain in the original container. Distilled water can also refer to reverse osmosis and ultrafdtration of tap water. Thus, distilled water is purified water.
  • Ferulic Acid- Formula - C10H10O4 - Ferulic acid is a hydroxycinnamic acid and a natural phenol that is a major anti-oxidant that readily reacts with free radicals that accelerate aging of the skin. Its use in the compositions to reduce free-radical damage at the time of attempting to stimulate new cell growth and metabolism during the use of the compositions.
  • Glutamine (GLU) - Formula - C5H10N2O3 - An a-amino acid that is used in the biosynthesis of proteins. Its side chain is similar to that of glutamic acid, except the carboxylic acid group is replaced by an amide.
  • Glvcine - Formula- C2H5NO2 - Glycine is the simplest possible formula for an amino acid and remains in dissolved in both hydrophobic or hydrophilic solutions. Its use in the compositions is to enhance the ability to form collagen.
  • Histidine HIST Formula - C6H9N3O2 - An a-amino acid and is a positively charged amino acid at physiological pH.
  • the histidine amino acid is a precursor for histamine, an amine produced in the body necessary for inflammation.
  • Hvdroxynroline (HD Pl - Formula - C5H9NO3 - A common non-proteinogenic amino acid.
  • Hydroxyproline is a major component of the protein collagen, comprising roughly 13.5% of mammalian collagen. Hydroxyproline and praline play key roles for collagen stability. They permit the sharp twisting of the collagen helix. Hydroxyproline is found in few proteins other than collagen.
  • Isoleucine (ISL) Formula - C6H13NO2 - An a-amino acid and must be ingested in the diet since it is essential in humans.
  • Lecithin - Lecithin is a generic term including animal and plant materials that are both hydrophilic and lipophilic mixtures of glycerophospholipids, that include phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, and phosphoric acid. It can be processed from soybeans, eggs, milk, marine sources, rapeseed, cottonseed, and sunflower. While it has low solubility in water, it is an excellent emulsifier. Its use in the compositions is to function as an emulsifier and dispersing agent for the combination of hydrophilic and hydrophobic components.
  • Leucine (LUO - Formula - C6H13NO2 - An essential amino acid. Leucine exhibits pharmacological activity in humans and have been demonstrated to promote protein biosynthesis. Leucine is a dietary amino acid with the capacity to directly stimulate myofibrillar muscle protein synthesis.
  • Linoleic Acid (LOA) - Formula - C18H32O2 - A polyunsaturated omega-6 fatty acid, an 18-carbon chain with two double bonds in cis-configuration. It typically occurs in nature as a triglyceride ester. Free fatty acids are typically low in foods. Linoleic acid belongs to one of the two essential fatty acids.
  • Methyl Sulfonyl Methane - Formula - C2H6O2S - Methyl Sulfonyl Methane has one additional oxygen compared to the similar Dimethyl Sulfoxide (DMSO). It is found naturally in a number of primitive plants and in the atmosphere above marine areas. It has been tested in a number of medical conditions similar to DMSO, but does not have any medical disease approval by the FDA. It is sold as a dietary supplement without any substantiated claims. For cutaneous application, its primary role may simply be enhancement of compositions through the skin rather than a primary effect by itself. Although, it may have anti-inflammatory effects as does DMSO. The FDA has approved MSM for the Generally Regarded as Safe (GRAS) status. A number of animal studies suggest MSM benefits in oxidative stress and inflammation, but not sufficient for drug approval. MSM primary use in the compositions is to enhance cutaneous transfer of agents through the skin. It may also add relief as an anti-oxidant and an anti-inflammatory.
  • DMSO Di
  • Niacinamide - Formula - CeHkbhO - Niacinamide or nicotinamide are like niacin, critical vitamins to a number of important functions, including the NAD/NADP complex.
  • NAD is critical to catabolism of fat, carbohydrate, protein, and alcohol and cell signaling and DNA repair.
  • NADP is important for anabolic reactions in fatty acid and cholesterol synthesis. Its use in the compositions along with niacin is to provide these required compounds that are important in these types of reactions.
  • OVA Oleic Acid
  • oleic acid is classified as a monounsaturated omega-9 fatty acid. It is the most common fatty acid in nature.
  • Proline - Formula - C5H9NO 2 - Praline is a non-essential amino acid that the body can produce.
  • Praline is biosynthetically derived from the amino acid L-glutamate. However, its commercial synthesis is from diethyl maionate and acrylonitrile. It is used in the compositions to enhance the production of collagen.
  • Protocatechuic Acid (PCT) - Formula - C7H6O 4 - A dihydroxybenzoic acid which is a type of phenolic acid. Protocatechuic acid is antioxidant and anti-inflammatory.
  • Silk consists of 70-80% fibroin and 20-30% sericin. Fibroin is the structural center of the silk and sericin being the gum coating the fibers and allowing them to stick to each other. Composed structurally of 18 different amino acids, and 32% serine in a randomized amorphous coil. Sericin can be easily converted into a -sheet conformation, via repeated moisture absorption and mechanical stretching. Sericin has been used in medicine and cosmetics. Sericin is primarily used in medicine for wound suturing due to its elasticity, tensile strength, and a natural affinity for keratin.
  • This super absorbent polymer has the ability to absorb as much as 100 to 1000 times its mass in water.
  • Vitamin A A group of unsaturated nutritional organic compounds that includes retinal, retinal, retinoic acid, and several provitamin A carotenoids (most notably beta-carotene). Vitamin A has multiple functions. It is important for growth and development, maintenance of the immune system and good vision. Vitamin A is needed by the retina of the eye in the form of retinal. Vitamin A also functions in a very different role as retinoic acid (an irreversibly oxidized form of retinal), which is an important hormone-like growth factor for epithelial and other cells.
  • Vitamin B3 (VTB31 or Niacin - Formula - C6H5NO2 -Niacin cannot be directly converted to niacinamide, but both are critical precursors of the important NAD/NADP complex.
  • NAD is critical to catabolism of fat, carbohydrate, protein, alcohol, cell signaling and DNA repair.
  • NADP is important for anabolic reactions in fatty acid and cholesterol synthesis.
  • Niacin also is a vasodilator that can also aid in the absorption of the composition on the skin. Their uses in the compositions along with niacinamide are to provide these required compounds that are important in these reactions.
  • Vitamin C - Formula - CeHsCk - Vitamin C or Ascorbic Acid is water soluble and found in dairy and food supplies.
  • Vitamin C is an essential nutrient that is required for tissue repair and a cofactor in multiple enzymatic reactions. Vitamin C is critical for collagen production, carnitine production, and neurotransmitter production. It functions importantly in the body as an anti-oxidant protecting against oxidative stress. It is used in the compositions as an anti-oxidant, for tissue repair, and collagen production.
  • An alternative to Vitamin C is D-iso- ascorbic acid that blocks collagen formation, opposite to Vitamin C. It is only used in the one composition as atopical use in cutaneous Scleroderma to attempt to limit the excessive collagen production that causes skin thickening and joint movement limitations. It is the excessive collagen formation in the subcutaneous site that builds up as a response in Scleroderma that is stimulated by its inflammation and the responses to that inflammation.
  • Emu Oil - Dromaius novaehollandiae is the emu that is indigenous to Australia.
  • the oil is extracted from adipose tissue with this industry refined product containing 70% unsaturated fatty acids.
  • Oleic acid a mono-unsaturated omega-9-fatty acid, is the largest component. It also contains 20% linoleic acid, an omega-6-fatty acid and 2% linoleic acid, an omega-3-fatty acid. Its claims as a dietary supplement have not been confirmed.
  • recent clinical studies suggest efficacy in its use as a skin moisturizer and as an insect repellent. Its proposed use in the product is as a skin moisturizer.
  • Emu Oil Solids - Dromaius novaehollandiae is the emu that is indigenous to Australia. After the oil is extracted from processed adipose tissue, there is a residual oil based, semi-solid product that can be used as a thickener for skin care products. It is used in the product as a thickener replacement for bees wax.
  • Helichrvsum Italicum Essential Oil- Helichrvsum Italicum is one of 600 species of Helichrysum with its oil designated as an essential oil. It is part of the sunflower family occurring in South Africa, Madagascar, Australasia, and Euroasia. Its primary use in the formulation is as a standard fragrance.
  • Hvsson Oil - Hyssopus officinalis is from southern Europe and the Middle East commonly used as a medicinal plant, predominantly as an antiseptic, expectorant, and cough depressant that can also stimulate the gastrointestinal system. Its use in the product is as an oil with an antiseptic nature. It is limited to products for use only in adults as it can cause seizures in young children.
  • Lavender Essential Oil - Lavendula augustiflora is a species of lavender from which the oil is produced that is a complex mixture of natural phytochemicals with the major components being linalool and linalyl acetae and the major supply produced in Bulgaria. It has a long usage in perfumes and aromatherapy. Its primary contribution to the product is fragrance.
  • Patchouli Essential Oil Pogostemon patchouli or P cabin are shrub-like plants originally in tropical regions of Asia, but are now cultivated widely in tropical areas due to the popular nature of this fragrance. This essential oil is prepared by steam distillation of the leaves. Three primary components of this oil are Patchoulol - Formula - ClsH260 - that is the primary essence of the scent of the product, Norpatchoulenol - Formula - C14H220 - that is a terpenoid component that also effects the primary scent, and Germacrene - Cl 5H24 - that has anti-microbial properties. This essential oil has been used in perfumes for centuries and is now found in insect repellents and alternative medicines. Its use in the product is primary for fragrance but also for its anti-microbial component.
  • Ylang-Ylang Essential Oil - Cananga odorata known as the tropical cananga tree in Indonesia, Malaysia, and the Philippines, is valued for its Ylang-Ylang flowers that produce a popular oil through steam distillation that has been used for centuries in perfume. Its primary components are Linalool, Germacrene, Caryophyllene, p-cresyl methyl ether, methyl benzoate, and sesquiterpenes. Its proposed medicinal usages include reduction of blood pressure, reduction of sebum secretion in the skin, and as an aphrodisiac. Its primary use in the product is as a fragrance, although it contains several components that are in other valuable oil products from this region that we use.
  • Berberine HCL - Formula- C20HigNO4 - Berberis vulgaris is one of several plants with berberine as a quarternary ammonium salt with a very strong yellow color used for dying wool and other fabrics. It was reported in use in China as a folk medicine in 3,000 BC. It currently is a research product for different potential treatments of arrhythmia, diabetes, hyperlipidemia, and cancer. Berberine is considered an antibiotic and is being evaluated as a treatment for methicillin- resistant Staph infections. It is used in the product as a potential anti-microbial as well as a marker for the lack of anti-oxidant activity that would reduce the yellow color.
  • Chlorhexidine - Formula - C22H30Ch N10 - Chlorhexidine is used in disinfectants, cosmetics, and pharmaceutical products as an anti-microbial agent that appears more potent than provodone-iodine (Betadine). It is active against Gram-positive and Gram-negative organisms, facultative anaerobes, aerobes, and yeasts. It is particularly effective against Gram-positive bacteria (2: 1 pg/1). Significantly higher concentrations (10 to 73 pg/ml) are required for Gramnegative bacteria and fungi. At physiologic pH, it disassociates and releases the positively charged chlorhexadine cation that readily binds to the negatively charged bacterial cell wall.
  • Betadine provodone-iodine
  • Natamax - Formula - C33H4?NO13 - Natamycin (Natamax) is a naturally occurring antifungal agent produced during fermentation by Streptomyces natalensis that is commonly found in soil. It is used in the food industry as a natural preservative. It is listed on the World Health Organization's List of Essential Medicines. It has been used in the food industry for decades in dairy products and other foods to retard microbial growth. Its medical use is usually in the form of a cream, lozenge, or drops for the eye or ear. It does not have any acute toxicity in animals or humans. It inhibits fungal growth by inhibiting amino acids and glucose passage across plasma membranes. It is used in the product to inhibit fungal growth.
  • Panthenol - Formula - C9H19NO4 - Panthenol is an alcohol analogue of Vitamin B5 or pantothenic acid that is commonly utilized in pharmaceuticals, cosmetics, and skin care products as a moisturizer and humectant. It readily penetrates the skin and mucous membranes where it is converted to pantothenic acid that readily binds water and enables reactivity with the other product components and with the tissues. It is odorless and colorless. Its inclusion in the product is for its moisturizing and humectant qualities.
  • Ouercitin - Formula - C15H10O7 - Quercitin is a plant polyphenol in the flavonoid group that is widely found in many vegetables and in many supplements. It is a form of many flavonoid glycosides.
  • quercitin has a very short half-life in the human body. The question for the product is if its halflife can be longer in these topical to subcutaneous products. Its in vitro pharmacology supports the anti-oxidant activities of this compound. Its use in the product is to be an anti-oxidant in the skin and subcutaneous sites.
  • TJhiguitin - Formula - C89H151N27O24 - Ubiquitin is a small, regulatory protein that exists in all eukaryotic cells, those with a nucleus and membrane bound organelles. It has 4 genes in the human genome that code for it. Ubiquitin carries out a multitude of functions predominantly through protein conjugations that result in many different protein modifications, from induced degradation, to change cellular location, to alter their activities, and to either promote or inhibit protein interactions. They can also form chains together to add another dimension to their protein interactions. Ubiquitin is highly conserved with human cells and yeast sharing 96% sequence identity.
  • Abnormal ubiquitin activity is associated with many different diseases that can have tissue sections staining for excessive accumulations of ubiquitin based compounds including Alzheimer's (neurofibrillary tangles), Parkinson's (Lewy body), Huntington's (inclusions in motor neurons), alcoholic liver disease (Mallory bodies), and brain astrocytes (Rosenthal fibers).
  • Alzheimer's neuroofibrillary tangles
  • Parkinson's Lewy body
  • Huntington's inclusions in motor neurons
  • alcoholic liver disease Mallory bodies
  • brain astrocytes Rosenthal fibers
  • a number of studies have related that defects and alterations in ubiquination processes are often found in a variety of cancers, including renal cell, breast, cervical, colorectal, and glioblastoma.
  • Ubiquitin is utilized in the product to potentially promote normal cell replication and growth, both intimately involved with the product.
  • Vanzan - Formula - C13H10O - Zanthan gum a polysaccharide, that was discovered as a product of fermentation from a strain of bacteria, Xanthomohas campestris, that can be commercially produced using these bacteria given simple sugars and the proper fermentation conditions. It has many uses regarding its ability to readily increase viscosity in a variety of liquids, including in foods and drinks. It is used in the product to increase thickening as required above that achieved by phase change and other agents.
  • CCT Caprylic, Capric Triglyceride
  • KNO Kanuka Oil
  • CTA Cetyl Alcohol
  • OPA Oleic Acid
  • LPA Linoleic Acid
  • PCT Protocatechuic Acid
  • HDP Hydroxyproline
  • ISL Isoleucine
  • VTA Vitamin A
  • Vitamin B3 (VTB3) orNiacin
  • VTC Vitamin C
  • NCM Niacinamide
  • Dupytren' s Disease of the hands is an early form of what most likely will evolve overtime into Dupytren's Contracture of the hands. This relatively infrequent disease is based on northern European ancestry that increases in incidence typically from age 45-50 years of age with increasing incidence and severity of existing disease throughout the rest of these people's lives. There is a mild increase in the incidence of males over females in the progression of the disease. The earlier in life it begins the expectation of more accelerated progression and the involvement of more fingers will be experienced. It converts from Dupuytren' s Disease to Dupuytren's Contracture when the fingers begin to bend in towards the palms.
  • the abnormality begins as the Disease with the discovery of a subcutaneous nodule on the palmar surface of the hand that is usually not tender at the base of fingers 3, 4, and 5 on either hand. After a relatively short time, abnormal skin folds begin to develop below the nodule into the palm. Additional nodules may form then or at any time in the future on either hand mostly involving fingers 3, 4, and 5. Another example of involvement of any finger is observed by placing the palm on a flat surface and determining the ability to raise the affected finger up off the table. Over time, the involved fingers will not be able to rise above the flat surface.
  • the disclosed composition halts the progression of Dupuytren's disease to the Dupuytren's contracture stage. All nodules show significant decrease in size which appears to happen within the first 2-4 months of treatment.
  • the first is a 73 year old male, 5 foot 6 inches weighing 139 pounds who had untreated contractures on the right hand for 11 years and on the left hand for 16 years.
  • the right hand Prior to treatment, the right hand had a fifth finger Stage 3 contracture with 100° of flexion and a left hand fifth finger Stage 4 contracture with 150° of flexion.
  • the right hand fifth finger contraction reduced to a Stage 2 contracture with 55° of flexion, but the left hand Stage 4 contraction treated for the same time remained a stage 4 lesion that only reduced to a 140° of flexion.
  • the second patient in this preliminary trial was also a 73 year old male, 5 foot 8 inches weighing 194 pounds who had untreated contractures on the right fifth digit Stage I with 25° of flexion and a fourth digit Stage 2 with 75° of flexion for 13 years.
  • the left hand had a fifth digit Stage 3 contraction with 95° of flexion and a fourth finger Stage 4 contraction with 140° contraction for 9 years.
  • the right hand fith digit Stage 1 lesion with 25° of flexion remained a Stage 1 but no longer had any degrees of flexion.
  • the right hand fourth digit Stage 2 contracture with 75° flexion reduced to 55° of flexion.
  • Table 5 lists the composition formulation for treatment of Dupuytren' s Disease
  • Cocoa butter contains Oleic acid (34.5% - Omega-9, used in food and soap), Stearic acid (34.5% - surfactant, detergents, soaps, lubricants), Palmitic acid (26.0% - soaps, food compositions, cosmetics), Linoleic acid (3.2% - Omega-6, essential oil, surfactant, anti-inflammatory), Arachidic acid (1.0% - detergents, lubricants) and Palmitoleic acid (0.3% - Omega-7).
  • Cottonseed oil is a cooking oil. Sodium pyruvate protects against peroxides. Tocopherol acetate is a form of Vitamin E that can resist acid destruction. None of these NEOSPORINTM components are able to hasten healing in the skin.
  • a 39 year white male was a bicycle rider going on trails in the area. He fell while riding a trail and landed on his left side inducing a large, 5 by 12 cm skin abrasion with bleeding. On return from the ride, he washed it off and placed NEOSPORINTM on the wound. The next day, he was offered to replace the NEOSPORINTM with the disclosed composition. His experience with NEOSPORINTM for this kind of partial thickness skin wound, would take 10 to 14 days for it to heal. The three times a day usage of this product permitted the healing to be essentially over in 5-6 days with little evidence of scarring.
  • the disclosed composition was applied to the injury after cleaning.
  • the disclosed composition was applied three times a day. By the second day, the wound was closed and no longer weeping fluid and had lost most of its pain. By the fourth day, the wound was essentially healed over and without pain or sign of infection.
  • a 52 year old white male applied the disclosed composition on multiple occasions of scratches, scrapes, and cuts.
  • the disclosed composition treats injuries without infection, and healed in half the time usually required for NEOSPORINTM.
  • Table 6 lists the composition formulation for treatment of cuts, abrasions, and minor bums.
  • Peyronie' s Disease is a connective tissue disorder of the penis affecting 5% of the male population. It involves fibrous plaques developing along the fibrous sheath, the tunica albuginea, that surrounds the spongy erectile tissue, the corpus cavernosa, in the penis. When the penis fills with blood and erects, these fibrous plaques or bands prevent that portion of the penis from erecting properly. This leads to two types of deformities of the penis: the more common is a marked curvature of the penis in any direction at the point of the stricture ( Figure 3) while the least common is an hour glass stricture completely around the penis. Regardless of the type of stricture, as it progresses it causes more deformity.
  • Table 7 lists the composition formulation for treatment of Peyronie' s Disease or Induration Penis Plastica. Table 7
  • the age relating skin changes include thinning of the outer surface of the skin, loss of substance and softness in both the outer and deeper skin components, wrinkles, easy bruising, appearance of pigmented flat lesions, scaly lesions, skin tags, loss of hair, and scratches which take much longer to heal (Figure 4A).
  • the appearance and the rate of the increasing incidence of these aging disorders predominantly depend upon the individual's history of sun exposure, history and the degree of routine skin care, race, as well as, genetics. An increasing incidence of skin cancers also will occur with increasing age.
  • test subject was allowed to apply the disclosed composition to both forearms after the changes became quite obvious when examining both forearms.
  • Several months of continued use of the disclosed composition on both forearms shows established hair, both dark and white, growing well to its normal length, increased dermal thickening, strengthening and thickening of the epidermis without any new tears, and ongoing reduction in the actinic keratoses size and appearance.
  • Table 8 lists the composition formulation for treatment of exposed aging skin.
  • Toe nail fungus is medically known as onychomycosis, or tinea unguium, commonly affects toe nails and can be progressive to the state of nail destruction, if not treated properly (Figure 5). It can also affect the finger nails. It is the most common of all the nail afflictions affecting 10% of the population and represents 50% of all nail afflictions. The progression is from mild forms to the most severe with loss of most of the normal nail.
  • the pathogens involved in onchyomy cosis are all represented in the fungus kingdom that includes dermatophytes in the western world and Candida and non-dermatophyes in the tropics and subtropics.
  • the dermatophytes most common representative is Trichophyton rubrum with multiple related species.
  • Candida species predominantly affect the finger nails, rather than the toe nails.
  • the non-dermatophytes are predominantly molds, mostly from the genus of Neoscytalidium, Scopulariopsis, and Aspergillus.
  • Conditions that can be confused with onychomycosis include nail psoriasis, lichen planus, contact dermatitis, and nail bed tumors such as melanoma, thrauma, and Q yellow nail syndrome.
  • Example 15 Six patients with this condition have used the disclosed composition for treating infected toe nails. One patient had the most involvement with all ten toe nails involved to the severe stage. His podiatrist suggested he needed to have all ten nails removed to enable healing his problem. He was supplied with the disclosed formulation with application once a day after showering, as well as, keeping his nails trimmed well through out the treatment. Within one month, most all of the nails were growing out with normal nails below the fungal infected outer edge. By two to three months, all of the toe nails had been eliminated from their fungus. The other patients had involvements of lesser degree, but all patients had eliminated their toe nail fungus in a similar time frame. Example 15
  • Table 9 lists the composition formulation for treatment of toe nail fungus.
  • Aphthous ulcers or stomatitis are characterized by repeated, benign and non-contagious oral cavity ulcerations that are self-limited to usually 7-10 days, as shown in Figure 6. These are painful and sensitive to increased pain by topical exposure to compositions with excessive pH, spices, and increased temperature. Episodes usually occur 3-6 times a year for several years around the time of adolescence. There is no known cause, but are thought to be multi-factorial.
  • the ulcers develop due to immune cell reactions from T-cells, mast cells, and macrophages to unknown triggers with the emphasis on T- cell involvement. Forty percent of persons getting these lesions have a family history of involvement. Some episodes seem to clearly be responding to acute, excessive stress in those who get these ulcers, but most do not.
  • the natural duration of 7-10 days remains fairly uniform, even in spite of several different types of proposed treatments.
  • the disclosed composition has demonstrated the ability to reduce the duration of these ulcers to 2-4 days while relieving the pain. However, it does not appear to prevent the regular occurrence of these ulcers. Approximately 10 patients have used this formulation and uniformly experience a shorter duration of time and a reduction of pain.
  • a 65 year old white male was having occasional episodes of aphthous ulcers of the mouth that were typical in severity and duration with pain lasting 7 to IO days and final clearing from 2 to 2.5 weeks. These aphthous ulcers were occurring every three to four months without an obvious cause.
  • the disclosed composition was applied at the start of an episode.
  • the disclosed composition was designed to be thick enough to stay within the bed of the ulcer with application 2 to 4 times a day. From starting the use of the disclosed composition on the first day of the lesion appearing, and treating it 3 times a day after meals and again at bed time, the ulcer lost its pain in 2-3 days and disappeared in 4-5 days. Due to benzocaine being used as a product ingredient, the ulcer had a significant decrease in pain during the treatment phase and prior to its healing.
  • Table IO lists the composition formulation for treatment of aphthous ulcers of the mouth.
  • Scleroderma is a systemic disease that results in progressive fibrosis of organs starting with skin lesions that can then progress to involving major organs, such as, the heart, lungs, intestines and kidneys.
  • the pathophysiology for the skin appears to involve the laying down in a random orientation of collagen much like scar formation diffusively in the subcutaneous tissues. This leads to joint immobilization starting in the fingers and spreading into the wrists and elbows as well as in the toes and ankle (Figure 7). Its increased pressure beneath the skin also reduces blood flow causing extensive Raynaud's phenomenon, or skin blanching episodes on the digits that readily leads to poorly healing ulcerations and potential digit loss.
  • Table 11 lists the composition formulation for treatment of cutaneous scleroderma.
  • Raynaud's Phenomenon or Syndrome is a medical condition that involves episodic spasm of the arteries that markedly reduces blood flow to the hands and/or feet that can eventually lead to poorly healing ulcers and to gangrene with loss of digits (Figure 8).
  • the episodes affecting the hands or feet initially turn white and later blue, often with associated numbness or pain.
  • the affected parts turn red and are typically painful. These episodes usually only last a few minutes, but can last for hours.
  • the secondary conditions that can cause these episodes include immune disorders, such as, lupus and scleroderma, former trauma including frost bite, smoking, thyroid problems, and certain medications, such as, birth control pills.
  • the existing primary treatment is to eliminate known stimulants, such as, smoking and to avoid exposing the affected extremities to cold temperatures. If these are not effective, then calcium channel blockers or a vasodilator can be tried. There currently are no other known remedies.
  • the patient that presented with scleroderma also suffered from Raynaud's phenomenon in both hands with sufficient frequency and intensity that multiple ulcers formed on the dorsum of several digits.
  • the disclosed composition for treatment of Raynaud' s Phenomenon was applied to the hands, between episodes of Raynaud's attacks, of the patient with scleroderma and improved the color of the fingers which also were found by palpation to be warmer.
  • Table 12 lists the composition formulation for treatment of Raynaud' s Phenomenon.
  • Table 13 lists the composition formulation for treatment of chemotherapy / radiation therapy induced oral mucosa! lesions.
  • the methods involved in producing these compositions are generally similar, but have different components for each composition.
  • the first temperature level for the first mixture is set at40°C to 50°C, preferably 45 °C, with a 300 to 500 rotations per minute (RPM), preferably 400 RPM, propeller mixing speed. All of the components that are a liquid or become a liquid at that temperature are mixed together in one of two vessels: a hydrophobic vessel and a hydrophilic vessel. The remaining unmixed components require higher temperatures to become liquid.
  • the temperatures of the mixtures are increased to 60°C to 80°C, preferably 60°C, and the speed of rotation is increased to 700 to 900 RPM, preferably 800 RPM.
  • the remaining hydrophobic group components are added to its vessel and the hydrophilic group components are added to its vessel.
  • the mixed hydrophilic group of components is then poured into the hydrophobic group vessel, maintaining the 700 to 900 RPM, preferably 800 RPM andthe60°Cto 80°C, preferably 60°C, temperature for another 10- 40 minutes, preferably 20 minutes, of reaction time.
  • the mixture is slowly cooled to room temperature over several hours of 2 to 10 hours while reducing the mixing speed to 500-700 RPM, preferably 600 RPM, continuing to insulate the mixing container.
  • This lets the mixture cool to ambient room temperature of 25°C to 37°C, preferably 25°C, over a slow period time while continuously being thoroughly mixed.
  • the propeller is stopped and this final mixing vessel is removed to a surface top.
  • This final composition will remain semisolid until it is returned to partial liquid at 37°C by design to melt onto the skin when applied.
  • Filling individual pumps (15 ml to 50 ml) is the final step prior to storage and then for delivery of this composition to the purchaser on a regular basis.
  • a “composition” of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, and other hydrophobic and hydrophilic components as discussed throughout the application, for instance in Tables 1-4 above and Tables I and II below.
  • a composition of the present invention is a topical composition, formulated to be applied topically to the skin.
  • a composition of the present invention may be formulated for and administered to a subject for instance by parenteral or enteral routes, injection, intravenous delivery, intramuscular, transdermal, intraperitoneal, or other routes of administration.
  • a composition of the present invention is formulated for oral delivery, for instance in a discrete solid dose unit, including for instance tablets, capsules, powders, liquids, chews, gummies, transdermals, injectables, dietary supplements, topical creams, lozenges, pills, and so forth.
  • a composition of the present invention may further comprise one or more excipients, additives, and/or other substances.
  • a composition of this invention is a water-in-oil emulsion.
  • a water-in-oil emulsion of this invention further comprises water and an emulsifier.
  • water is distilled water, and comprises about 25-70% w/w of the emulsion and the composition.
  • water comprises about 25-50% w/w or about 50%-about 70% w/w of the emulsion.
  • an emulsifier that may be used in a water-in-oil emulsion of this invention is Tri-(polyglyceryl-3/Lauryl) Hydrogenated Trilinoleate (Cithrol PGTL); Polyglyceryl-3 Sorbityl Linseedate (Sinerga); Polyglyceryl-2 Oleate (and) Polyhydroxystearic Acid (and) Polyglyceryl-2 Stearate (Innovacos); Polyglyceryl-3 Triolivate (Acme Hardesty); Polyglyceryl-3 Polyricilinoleate (IOI Oleo); Polyglyceryl-2 Dipolyhydroxystearate (BASF); Polyglyceryl-2 Sesquiisostearate (Clariant); Polyglyceryl-3 Diisostearate (Gattefosse, BASF); Polyglyceryl-6 Polyricinoleate (and) Polyglyceryl-3 Diisostearate (and) Disteardimonium Hectorite (E
  • a water-in-oil emulsion of the present invention comprises about 0.1-10.0% w/w of emulsifier; about 0.5% to 5% w/w emulsifier; about 1% to about 3% emulsifier w/w; in another embodiment; or about 1% to about 2% emulsifier w/w.
  • the water-in-oil composition is a topical composition.
  • a composition of this invention may comprise, consist of, or consist essentially of components, ingredients, and/or other substances identified in this application as part of a composition, in any combination, including in particular those identified in Tables 1-4 above and Tables I -III below and emulsifiers identified in Example A.
  • said compositions comprise, consist of, or consist essentially of components and/or ingredients in percentages by weight of the composition as specified throughout the application or generally discussed in the antepenultimate paragraph of this application.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, and a shea butter preparation.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, and an emulsifier.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more functional oils.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, and one or more of the following functional oils: Black Cumin Seed Oil, Baobab Oil, Apricot Kernal Oil, Argan Nut Oil, Camellia Oil, Marula Oil, Sea Buckthorn Oil, Tamanu Oil, Calendula Oil, caprylic/capric triglyceride, caryophyllene, Elemi Oil, Kanuka Oil, Litsea Cubebe Oil, Palmarosa Oil, Palo Santo, Rose Hip Seed Oil, and Sachi Inchi Oil.
  • functional oils Black Cumin Seed Oil, Baobab Oil, Apricot Kernal Oil, Argan Nut Oil, Camellia Oil, Marula Oil, Sea Buckthorn Oil, Tamanu Oil, Calendula Oil, caprylic/capric triglyceride, caryophyllene, Elemi Oil, Kanuka Oil, Litsea Cub
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, and Black Cumin Seed Oil.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more soluble collagens.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more alcohols.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more anti-inflammatories.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, one or more functional oils, caryophyllene, caprylic/capric triglyceride, and one or more of the following anti-inflammatories: chamomile oil, copaiba oil, oleic acid, and linoleic acid.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more anti-oxidants.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, one or more functional oils, caryophyllene, caprylic/capric triglyceride, ferulic acid, one or more anti-inflammatories, and one or more of the following anti-oxidants: tocopherol, tocopheryl acetate, retinyl palmitate, and tetrahexyldecyl ascorbate.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more anti-microbials.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, one or more functional oils, caryophyllene, caprylic/capric triglyceride, ferulic acid, one or more anti-inflammatories, one or more anti-oxidants, and one or more of the following anti-microbials: carvacrol, niacinamide, and one or more amino acids.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more florals.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more thickeners.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more waxes.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more fragrances.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more fatty acids.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more analgesics.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more amino acids. In an embodiment, a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more carbohydrates.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more vitamins.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more solvents.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more gels.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more moisturizers.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, and one or more additional components selected from the group consisting of functional oils, soluble collagens, alcohols, anti-inflammatories, antioxidants, anti-microbials, florals, thickeners, waxes, fragrances, fatty acids, analgesics, amino acids, carbohydrates, vitamins, solvents, gels, and moisturizers.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, one or more functional oils, caryophyllene, caprylic/capric triglyceride, ferulic acid, methyl sulfonyl methane, magnesium sulfate, propylene glycol, one or more anti-inflammatories, one or more anti-oxidants, and one or more antimicrobials.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, an emulsifier, soluble collagen, one or more functional oils, caryophyllene, caprylic/capric triglyceride, ferulic acid, methyl sulfonyl methane, magnesium sulfate, propylene glycol, betaine, sodium PCA, sodium lactate, PCA, 1,2-hexane diol, caprylyl glycol, one or more anti-inflammatories, one or more anti-oxidants, and one or more anti-microbials.
  • a composition of the present invention comprises alpha-pinene, an aloe vera preparation, a shea butter preparation, Tri-(polyglyceryl-3/Lauryl) Hydrogenated Trilinoleate, soluble collagen, one or more functional oils, caryophyllene, caprylic/capric triglyceride, ferulic acid, methyl sulfonyl methane, magnesium sulfate, propylene glycol, betaine, sodium PCA, sodium lactate, PCT, 1,2- hexane diol, caprylyl glycol, one or more anti-inflammatories, one or more anti-oxidants, and one or more anti-microbials.
  • compositions of this invention does not comprise a drug of addiction in pharmacologically significant amounts, beta-pinene added individually or as a substantial component of a natural product, a propellant such as for a mousse or spray, and/or trans-tert-butyl-cyclohexanol.
  • compositions of the present invention are not formulated as a sunblock, not formulated to complement other specific compounds or families of compounds other than those identified in the present application, not formulated to prevent diaper rash or provide a barrier on the skin to protect from urine and feces, and/or are not formulated as an additive to other compositions.
  • a composition of the present invention requires water, and is not anhydrous.
  • a composition of the present invention may include any or all of the above.
  • an “effective amount” of a composition refers to an amount of alphapinene, an aloe preparation, a shea butter preparation, and other components and/or ingredients of a composition of the present invention needed to be administered to a subject, for instance enough composition to be topically applied to the skin, in an area of the skin for treatment or alleviation, and if necessary for treatment or alleviaton to reach a subject’s bloodstream and/or bodily tissues and thereby improve the condition to be treated or alleviated, such as Dupuytren’s disease and/or contracture and others as discussed throughout this application.
  • a composition of the present invention is formulated to include an effective amount to treat one or more of the conditions described throughout this application.
  • Percentages by weight of at least alpha-pinene, an aloe preparation, a shea butter preparation, along with other components and/or ingredients described throughout this application, in a composition of the present invention provide an effective amount of these substances, when the composition is topically applied to the affected area in sufficient volume.
  • the present invention is directed to a method of treatment or alleviation of Dupuytren’s Disease and Contracture; Abrasions, Cuts, and Minor Bums; Peyronie’s Disease or Induratio Penis Plastica; Aging Skin; Nail Fungus; Aphthous Ulcers; Cutaneous Involvement of Scleroderma; Raynaud’s Phenomenon; Chemotherapy/Radiation Therapy Induced Oral Mucosal Lesions; Plantar Fasciitis; Arthritis; Sun Bum; and/or Baldness.
  • the method comprises the step of applying a composition of the present invention to an area affected by the above diseases or wounds.
  • the present invention is directed to a method of promoting Wound Healing, for instance by decreasing time for a wound to heal, and a method of promoting hair growth on the arms, legs, and scalp.
  • Example A treats or alleviates Dupuytren’s disease when topically applied over the affected area, for instance by decreasing nodule size and/or contracture.
  • 15-30 ml of the composition of Table III prepared according to the process of Example A was applied to the hands of an adult male suffering from Dupuytren’s Disease and Contracture.
  • the topical application, twice daily, reduced symptoms including contracture symptoms prevented progression of the disease for a period of several months, as of the date of fding this application.
  • compositions of the present invention improve Wound Healing (that is, healing of abrasions, cuts, and/or minor bums).
  • the large-scale composition described in Example A provides Wound Healing properties and treats abrasions, cuts, and minor bums according to the present invention.
  • compositions of the present invention for the treatment of Peyronie’s Disease or Induratio Penis Plastica, improvements by the topical application of a composition of the present invention to the penis, such as described in Table 7 and Examples 9-11 above, including for instance a reduction in curvature of the penis and ability of the subject to resume/participate in intercourse.
  • the large-scale composition described in Example A treats Peyronie’s Disease or Induratio Penis Plastica when applied to the penis of a subject suffering from the condition.
  • Example A For the treatment of the condition of Aging Skin, improvement by the topical application of a composition of the present invention to aging skin, such as described in Table 8 and Examples 12-13 above.
  • a composition of the present invention to aging skin, such as described in Table 8 and Examples 12-13 above.
  • the large-scale composition described in Example A treats Aging Skin for instance by improving its thickness and ability to grow hair.
  • the improvement by the topical application of a composition of the present invention to the area afflicted with fungus is elimination or reduction of the fungal infection.
  • the topical application of the large-scale composition described in Example A treats Nail Fungus such as Toe Nail Fungus.
  • the improvement by the topical application of a composition of the present invention to the aphthous ulcer reduces the duration and/or relieves pain from the ulcer.
  • the topical application of the large-scale composition described in Example A treats Aphthous Ulcers.
  • the large-scale composition described in Example A treats skin lesions associated with Scleroderma.
  • the large-scale composition described in Example A treats Raynaud’s Phenomenon.
  • the improvement by the topical application of a composition of the present invention to said lesions includes reducing the size of the lesion and/or associated pain.
  • the large-scale composition described in Example A treats Oral Mucosal Lesions induced by Chemotherapy/Radiation Therapy.
  • compositions of the present invention may be treated by the topical application of a composition of the present invention to the affected area, such as the large-scale composition described in Table III and Example A, and other compositions described throughout this application, including those described in Tables 5-13.
  • Plantar Fasciitis is treated by the topical application of a composition of the present invention to the heels and surrounding areas of the feet, such as the large-scale composition described in Example A, and other compositions described throughout this application.
  • Treatment of Plantar Fasciitis according to the present invention relieves inflammation and/or pain in the heels and feet of the subject.
  • Arthritis may be treated by the topical application of a composition of the present invention to a joint of the body such as a knee, elbow, hands, or other area affected by arthritis, such as the large-scale composition described in Example A and Table III, and other compositions described throughout this application. Treatment of Arthritis according to the present invention relieves pain and inflammation in the joints.
  • Sun Bum of the skin may be treated or alleviated by the topical application of a composition of the present invention to a sun burned area, such as the large-scale composition described in Example A, and other compositions described throughout this application. Treatment or alleviation of Sun Bum of the skin according to the present invention relieves redness and/or pain on the affected area.
  • unwanted Baldness may be treated by the topical application of a composition of the present invention to an area of the scalp where hair growth is desired, such as the large-scale composition described in Example A, and other compositions described throughout this application. Treatment of Baldness of the scalp according to the present invention increases hair growth on the scalp.
  • a composition of the present invention is prepared by a process of the present invention.
  • a composition of the present invention may be used for the treatment of one or more of the conditions identified above.
  • the present invention is directed to the use of a composition of the present invention for the preparation of a medicament to treat one of the above conditions.
  • Tables I and II summarize ingredients that may be included in a composition of the present invention, in addition to those discussed elsewhere and throughout this application. Indications of functions are intended as descriptive of an embodiment of the invention and not limiting, and are not meant to bind the present invention by theory. In an embodiment, a component of a composition of this invention may provide one, and/or more than one, function in the composition.
  • the below Tables are intended to add to Tables 1-4, above, and to be understood in that context.
  • optional components of the present invention are individually less than 10% of a composition of this invention (w/w); less than 5% of a composition of this invention (w/w); less than 3%, less than 2%, less than 1%, or less than 0.5% w/w of a composition of this invention (w/w).
  • an “aloe vera preparation” of the present invention is prepared or otherwise derived from leaves of the aloe vera plant, otherwise known as Aloe barbadensis mil.
  • an aloe vera preparation is a hydrophilic component of a composition of the present invention.
  • an aloe vera preparation is and/or includes gel taken from the inner portion of aloe vera leaves (also known as “aloe vera inner leaf gel”), for instance as described above.
  • Aloe vera inner leaf gel is a gel that contains proteins, lipids, amino acids, vitamins, enzymes, inorganic compounds, organic compounds, and carbohydrates.
  • the gel may be in its natural form, taken directly from the aloe vera leaf, or for instance in a processed form, for instance as a 1 OX or 200X concentrated dried powder.
  • an aloe vera preparation of this invention may include part of or all of whole aloe vera leaves, for instance in the form of aloe vera leaf juice or an aloe vera leaf extract.
  • An aloe vera preparation that is or includes leaf juice or is or includes leaf extract may also be in a concentrated form, for instance in a 1 OX or 200X dried powder.
  • an aloe vera preparation of the present invention does not include the aloin or yellow or brown latex portion of the aloe leaf, and/or does not include the dark green outer covering of the leaf.
  • the aloe vera inner leaf gel is in powder form, 200x concentrated.
  • the 200x powder may be a spray-dried, light-cream-to-beige colored powder, having characteristics such as pH(l: 199 w/w) 3.5-5.0, specific gravity(l: 199 w/w) 0.997-1.004, 8% maximum moisture, 100% particle size through 80 mesh, certifications such as is made from pure aloe i.e. does not include fillers and/or adulterants, and/or has no pathogens present ( ⁇ 10 cfu/g total plate count, ⁇ 10 cfu/g yeast and mold).
  • the 200x aloe vera inner leaf gel powder is spray-dried to 200x the concentration of aloe vera inner leaf gel, is light cream to beige powder, pH 4.5, specific gravity (1 : 199 w/w) 1.001, about 4-5% moisture (water), 100% particle size through 80 mesh, is pure aloe i.e. does not include fillers and/or adulterants, and has no pathogens present ( ⁇ 10 cfu/g total plate count, ⁇ 10 cfu/g yeast and mold).
  • the aloe vera preparation is Terra-PureTM Certified Spray Dried Aloe Vera Inner Leaf Powder Regular, 200X (Terry Laboratories, Melbourne FL, USA).
  • an aloe vera preparation including a 200x aloe vera preparation comprises or consists of inner leaf juice, made by removing the rind of the leaf prior to processing and then rinsing away aloe latex. The remaining, gelatinous inner-leaf material is then ground/crushed into aloe vera inner leaf juice.
  • aloe vera according to the present invention includes other parts of the aloe vera plant.
  • the aloe vera preparation may be a powder made from Aloe barbadensis leaf juice (e.g. CAS 94349-62-9).
  • leaf juice is extracted from fresh aloe leaves with a juice extractor, decolorized and filtered, separated via organic membrane. The membrane-separated concentrate juice is then freeze dried to be converted into the 200: 1 Aloe Vera freeze dried gel powder.
  • an aloe vera preparation according to the present invention is Aloe Vera freeze dried gel powder 200: 1 (Selco, Wald-Michelbach, Germany).
  • 200: 1 aloe powder includes about 0.5% soluble solid of Aloe Vera gel.
  • 200 kg of 1 : 1 Aloe Vera gel juice is frozen and dried into 1kg of Aloe Vera freeze dried gel powder that becomes Aloe vera 200: 1.
  • aloe vera according to the present invention is a 200X powder produced through the water extraction oiAloe barbadensis leaf to prepare leaf juice powder.
  • aloe leaves are harvested, washed and fdeted, aloin removed from filets, then the leaves ground, excess pulp removed, treated with heat, filtered, and spray dried.
  • Aloe vera according to the present invention in unconcentrated or concentrated (e.g. 200X) form, is a hydrophilic component/ingredient of this invention. While 200X concentrated powders are a preferred embodiment according to the present invention, other concentrations may also be included in the present invention.
  • aloe vera preparations of the present invention include aloe polysaccharides consisting of linear (unbranched) chains of b-l-4-linked glucose and mannose molecules (often called glucomannans, and because more mannose than glucose is present, polymannans). These linear chains range from a few molecules to several thousand molecules. By convention, the lower limit is usually taken as a molecular weight of about 1,000 Daltons for the material to qualify as a polysaccharide.
  • aloe vera preparations for instance as provided by Terry Laboratories are microbiologically clean, color stable, processed as quickly as possible following harvest, and processed at the lower temperature possible.
  • an aloe vera preparation including for instance 10X or 200X aloe vera preparations retains polysaccharide molecular weight distribution comparable to unprocessed aloe vera and reduces polysaccharide degradation such that not less than 50% of polysaccharides are greater than 1 million Daltons.
  • an aloe vera preparation includes acemannan (beta-l-4-acetylated glucomannans).
  • a composition according to the present invention may include 0. 1-50% aloe vera gel.
  • a composition according to the present invention includes about 5% to about 30% w/w of an aloe vera preparation; about 10% to about 20% w/w; about 13% to about 18% w/w; about 14 to about 16% w/w; or about 15% w/w, as shown in Tables 5-13 above and in Table III below.
  • the aloe vera preparation may be in a natural, IX, single -strength equivalent form, or in a concentrated 10X, 200X, or other concentrated form, as discussed above and shown in the Examples.
  • alpha-pinene may be included in a composition of the present invention.
  • alpha-pinene is provided as a colorless liquid with a pine, turpentine-like odor.
  • alpha-pinene is from a natural source.
  • alpha-pinene is from a synthetic source.
  • alpha-pinene has a specific gravity (25°C) of 0.8550-0.8600, a refractive index (20°C) of 1.4640-1.4680, optical rotation 20.00-30.00, and/or is provided with no salmonella (AOAC, negative), lead, aflatoxin, arsenic, or mercury detected.
  • the alpha-pinene may weigh about 7 pounds per gallon.
  • alpha-pinene is 95-100% pure, preferably 99-100% pure.
  • pure alpha-pinene is obtained from Flavorchem Orchidia Fragrances, Downers Grove, IL, USA.
  • alpha-pinene is a hydrophobic component of this invention.
  • a composition according to the present invention may include 0.1-50% alpha-pinene.
  • a composition according to the present invention includes about 0.5% to about 20% w/w alpha-pinene; about 1% to about 10% w/w alpha-pinene; about 2% to about 7% w/w alpha-pinene; or about 3 to about 4% w/w alpha-pinene, for instance as shown in Tables 5-13 above and in Table III below.
  • a “shea butter preparation” is included in a composition of the present invention.
  • a shea butter preparation such as shea butter, and/or oil extracted from shea butter (“shea butter oil”), is prepared from or otherwise derived from any Shea tree, including but not limited to a Shea tree from Ghana.
  • shea butter or shea butter oil is Butyrospermum parkii butter (CAS 194043-92-0; EC 293-515-7); Butyrospermum parkii oil (CAS 91080-23-8, EC 293-515-7), and/or vegetable oil (CAS 68956-68-3, EC 273-313-5).
  • Other shea butters and shea butter oils may be used in shea butter preparations of this invention, including those having different CAS or EC, or other identifying numbers.
  • a Shea butter oil preparation includes chemicals having the general structure CH 2 OC(O)RI
  • Shea butter oil is prepared by a series of processes including mechanical extraction, solvent extraction, refinement, deodorization, and solvent fractionation.
  • Shea tree nuts undergo mechanical pressing and solvent extraction with hexane to prepare crude oil, which is then subjected to degumming with acidified water (phosphoric or citric acid) (degumming removes phospholipids, metals, and proteins), neutralization with alkaline water (sodium hydroxide) (neutralization removes free fatty acids, metals, and proteins), and bleaching with bleaching earth (clay) and citric acid (bleaching removes pigments, metals, and proteins) to prepare a bleached oil.
  • acidified water phosphoric or citric acid
  • alkaline water sodium hydroxide
  • the bleached oil is mixed with solvent and cooled (separating solid and liquid constituents), filtered, solvent (hexane and/or acetone) recovered; and then deodorized with steam (removes flavors, free fatty acids, oxidation products and residual solvent).
  • Shea butter oil according to the present invention is liquid at room temperature, has a red color, a density (25°C) of 0.9-0.94 g/cm 3 , a fatty acid composition (w/w) for instance as follows: 5% C16:0, 28% C18:0, 56% C18: l, 9% C18:2, 0.3% C18:3, 1% C20:0, 1% C22:0, available as Lipex SheaLiquidTM (AAK Sweden AB, Karlshamn, Sweden, SE-374- 82).
  • a composition according to the present invention may include about 0.1 %-50% of a shea butter preparation, such as shea butter or shea butter oil.
  • a composition according to the present invention includes about 1% to about 30% w/w of a shea butter preparation wherein the preparation is shea butter; about 8% to about 20% w/w shea butter; about 12% to about 18% w/w shea butter; about 14 to about 16% w/w shea butter; or about 15% w/w shea butter, for instance as shown in Tables 5-13 above.
  • a composition according to the present invention includes about 1% to about 20% w/w of a shea butter preparation wherein the preparation is shea butter oil; about 2% to about 15% w/w of a shea butter oil preparation; about 3% to about 8%; or about 4 to about 6% w/w of a shea butter oil preparation, for instance as shown in Table III below.
  • the below components/ingredients are individually less than 10% of a composition of this invention (w/w); less than 5% of a composition of this invention (w/w); less than 3%, less than 2%, less than 1%, or less than 0.5% w/w of a composition of this invention (w/w).
  • Tri(Polyglyceryl-3/Lauryl) Hydrogenated Trilinoleate may be used in a composition of this invention.
  • Tri(Polyglyceryl-3/Lauryl) Hydrogenated Trilinoleate according to the present invention is available in 100% pure form, as a brown, clear to hazy viscous liquid, with acid value 0-1 mg KOH/g and hydroxyl value 100-115 mg KOH/g as Cithrol PGTL (Croda Europe Ltd, East Yorkshire, DN14 9AA).
  • a composition according to the present invention may include 0-10% w/w of Tri(Polyglyceryl-3/Lauryl Hydrogenated Trilinoleate), preferably about 0.5% to about 5% w/w, more preferably about 1% to about 2% w/w.
  • Tri(Polyglyceryl-3/Lauryl Hydrogenated Trilinoleate) preferably about 0.5% to about 5% w/w, more preferably about 1% to about 2% w/w.
  • tetrahexyldecyl ascorbate may be included in a composition of this invention.
  • tetrahexyldecyl ascorbate according to the present invention is in liquid form at room temperature, colorless to pale yellow, soluble in oil (hydrophobic).
  • its specific gravity (20°C) is 0.930-0.943
  • its refractive index (25°C) is 1.459-1.465
  • assay results show tetrahexyldecyl ascorbate used according to the present invention is at least 95% pure.
  • tetrahexyldecyl ascorbate is at least 95% (w/w) pure, at least 96%, at least 97%, at least 98%, at least 99%, or is 100% (w/w) pure.
  • Tetrahexyldecyl ascorbate may include substances categorized as CAS 183476-82-6 and/or CAS 1445760-15-5; and/or as EINECS 430-110-8.
  • tetrahexyldecyl ascorbate according to this invention includes no more than 20ppm heavy metals and no more than 2ppm arsenic.
  • loss of tetrahexyldecyl ascorbate on drying is no more than 0.5%(w/w).
  • tetrahexyldecyl ascorbate is provided as BV-OSC (Barnet Products, Englewood Cliffs, NJ, USA).
  • caryophyllene oil may be included in a composition of this invention.
  • caryophyllene is a hydrophobic component of the present invention, and is at least 85% pure (w/w).
  • caryophyllene oil is at least 90% pure, at least 95% pure, 98%-100% pure; and/or 100% pure.
  • caryophyllene oil has a specific gravity (25°C) of 0.8990-0.9080, a refractive index (20°C) of 1.4900-1.5040, and is free of mold Carvacrol
  • carvacrol may be included in a composition of this invention.
  • carvacrol also known as cymophenol, is a monoterpenoid phenol and an ingredient in the oil of wild bergamot, Origanum vulgare, and oil of thyme.
  • at room temperature carvacrol is a corrosive liquid, acidic.
  • carvacrol is at least 90% (w/w) pure by assay, at least 95% pure, at least 97% pure, at least 98% pure, at least 99-100% pure.
  • carvacrol according to the present invention is available from Flavorchem Orchidia Fragrances, Downers Grove, IL, USA.
  • Copaiba oil may be included in a composition of this invention.
  • Copaiba oil according to the present invention is the substance accorded CAS 8013-97-6, EINECS 232-288-0; INCI name Copaifera Officinalis (Balsam Copaiba) Resin, and/or sold as a 100% natural oil, CaribpureTM Copaiba Oil, CaribOrgTM Copaiba Oil (Caribbean Natural Products Inc., Fairfield, NJ, USA).
  • the present invention includes Copaiba oil (100% natural oil/balsam extracted from Copaifera Officinalis), CAS 8001-61-4.
  • DL-alpha-Tocopheryl Acetate also known as 3,4-Dihydro-2,5,7,8-tetramethyl-2-(4,8,12- trimethyltridecyl)-2H- 1 -benzopyran-6-yl acetate
  • DL-alpha-Tocopheryl Acetate may be included in a composition of this invention.
  • DL-alpha-Tocopheryl Acetate is a colorless-to-yellow viscous liquid oil, melting point about -27.5°C, boiling point 184°C (0.01 hPa), 267°C (3.2 hPa), >300°C (1,013 hPa) with decomposition, flash point about 243-266°C (per DIN 51758), hydrophobic/practically insoluble in water but easily soluble in acetone, chloroform, diethylether, alcohol, molecular weight 472.73 g/mol.
  • DL-alpha-Tocopheryl Acetate of this invention is 96-100% (w/w) CAS 7695-91-2, molecular formula C31H52O3.
  • DL-alpha-Tocopheryl Acetate of this invention is from DSM Nutritional Products (Parsippany, NJ, USA).
  • DL-alpha-Tocopherol also known as 3,4-Dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-l- benzopyran-6-ol
  • DL-alpha-tocopherol tocopherol (INCI); vitamin E
  • DL-alpha-tocopherol may be included in a composition of this invention.
  • DL-alpha-tocopherol is the substance identified as CAS 10191-41-0, EINECS 233-466- 0, C29H50O2, molecular mass 430.72 g/mol.
  • 0.91 mg of DL-alpha-tocopherol is equivalent to 1.0 IU of vitamin E.
  • DL-alpha-tocopherol of this invention is a clear, viscous oil, colorless to yellowish brown, optical rotation -0.01° to +0.01°, refractive index (589 nm, 20°C) 1.503-1.507, absorbance in ethanol (292nm (max)) 71.0 - 76.0, acidity max. l.OmL 0.10 N NaOH, sulphated ash (residue on ignition) max 0.1%, heavy metals max. 10 ppm (lead max 2ppm, arsenic max Ippm, mercury max. Ippm, cadmium max.
  • DL-alpha-tocopherol is in an embodiment 97.0-102.0%. Also, DL-alpha-tocopherol is insoluble in water, soluble in ethanol, miscible with chloroform, acetone, ether, vegetable oils; and/or sensitive to air and light. In an embodiment, oils and fats used for dilutions are low in peroxides, as rancid oils and fats may destroy the activity of DL-alpha-tocopherol.
  • DL-alpha-tocopherol is prepared synthetically by condensation of trimethylhydroquinone and isophytol.
  • the crude product is purified by distillation in vacuo.
  • Vitamin E may be helpful for instance as an anti-oxidant and in skin conditioning/wound healing.
  • DSM Nutritional Products Ltd. Baseel, Switzerland.
  • ferulic acid may be included in a composition of this invention.
  • ferulic acid is a synthetic, slightly yellow powder, >99% pure by HPLC assay, with less than 0.5% loss on drying at 105°C for 1 hour, and/or having a melting point of 170°C-175°C.
  • ferulic acid of this invention is at least 90% (w/w) pure, at least 95% (w/w) pure, at least 97% (w/w) pure, at least 99% pure, and/or is 100% pure.
  • the ferulic acid of the present invention is about 99.7% (w/w) pure.
  • the CAS number for ferulic acid is 1135-24-6.
  • ferulic acid of this invention is from GfN compassion von Naturex Monthen GmbH, Wald- Michelbach, Germany. Oleic Acid and Linoleic Acid
  • oleic acid (CAS 112-80-1, EINECS 204-007-1) and linoleic acid (CAS 60-33- 3, EINECS 200-470-9)) may be included in a composition of the present invention individually or as a blend, such as GLB Custom Oleic Acid & Linoleic Acid Blend SF (Green Line Botanicals, Hazlet, NJ, USA).
  • the blend is a colorless to golden yellow liquid, dispersible in oil, with maximum 0.1% moisture and impurities. Under a cold test, 0°C/5.5 hours (Cc 11-53), the blend is clear.
  • a composition of the present invention includes one or more of the following functional oils: Black Cumin Seed Oil, Baobab Oil, Camellia Oil, Manila Oil, Sea Buckthorn Oil, Tamanu Oil, Apricot Kernel Oil, Argan Oil.
  • a composition of the present invention includes all of the above oils.
  • Indian Oil Blend Roshakesh Sandal Industries, Kanpur, India
  • oils all from Rakesh Sandal Industries, Kanpur, India and may be used in this invention:
  • Black Cumin Seed Oil (58% w/w of the Indian Oil Blend): Cold pressed oil from black cumin seeds (Nigella sativa), brownish color with a disagreeable, unpleasant odor. Acid value 8.3, refractive index 1.4728, specific gravity 0.9186, soluble in oil and insoluble in water, stable under normal conditions but oxidizing materials should be avoided.
  • Baobab Oil (3% w/w of the Indian Oil Blend): Cold pressed oil from Adansonia digitata seeds, yellow color, with a bland, fatty oil odor. Acid value 32.78, refractive index 1.4703, specific gravity 0.9172, soluble in oil and insoluble in water, stable under normal conditions but oxidizing materials should be avoided.
  • Camellia Oil (12% w/w of the Indian Oil Blend): Cold pressed oil from Camellia sinensis seed, yellow color, with a bland and fatty oil odor. Acid value 0.18, refractive index 1.4736, specific gravity 0.9181, soluble in oil and insoluble in water, stable under normal conditions but oxidizing materials should be avoided.
  • Sea Buckthorn Oil (6% w/w of the Indian Oil Blend): Cold pressed from berries and seeds, with a yellow-brown to a red brown oil liquid and having a strong musky smell, characteristic neutral odor.
  • Tamanu Oil (6% w/w of the Indian Oil Blend): Cold pressed from seeds/nuts of Calophyllum inophyllum, with a dark yellow oil and heavy fatty, odoriferous odor.
  • Optical rotation +1.40, refractive index 1.4983, specific gravity 1.0371, soluble in oil and insoluble in water, stable under normal conditions but oxidizing materials should be avoided.
  • Apricot Kernel Oil (6% w/w of the Indian Oil Blend): Cold pressed oil from apricot kernels, light yellow to golden yellow liquid, with a bland, fatty, nutty, deep odor. Acid value 1.34, refractive index 1.4728, specific gravity 0.9205, soluble in oil and insoluble in water, stable under normal conditions but oxidizing materials should be avoided.
  • Argan Nut Oil (6% w/w of the Indian Oil Blend): Cold-pressed oil from argan nuts, light yellow color with a nutty, oily, spicy odor. Acid value 0.1, refractive index 1.4704, specific gravity 0.9148, soluble in oil and insoluble in water, stable under normal conditions but oxidizing materials should be avoided.
  • the Indian Oil Blend is characterized by a dark yellow color, pleasant odor, acid value 1 to 10, refractive index 1.4510 to 1.4980, specific gravity 0.8830 to 0.9360, soluble in oil and insoluble in water, stable under normal conditions (oxidizing materials to be avoided). Soluble collagen
  • soluble collagen may be included in a composition of the present invention.
  • soluble collagen such as ichtyocollagen of this invention comprises native fish collagen.
  • IchtyocollagenTM may be used as a soluble collagen component of this invention.
  • ichtyocollagen has film-forming and moisturizing, skin conditioning properties.
  • ichtyocollagen is in liquid form at 25°C, colorless to pale yellow, with appearance clarity of clear to slightly opalescent.
  • ichtyocollagen includes 0.4-0.7% protein (by BCA), pH 3.5-4.5, specific gravity (20°C) 1.000-1.020, refractive index (25°C) 1.34-1.36, hydroxyproline content 0.06-0.09%, and/or maximum 100CFU/G total aerobic microbial count and maximum 10 CFU/G total combined yeast/mold count.
  • ichtyocollagen comprises soluble collagen (INCI), CAS 9007-34-5, EINECS 232-697-4; as well as propylene glycol (approx. 10%), phenoxyethanol (1.5%), potassium sorbate (0.05%), trisodium EDTA (0.1%).
  • ichtyocollagen includes about 88% of natural origin content.
  • IchtyocollagenTM PH (Croda/Sederma Inc., Edison, NJ, USA) Magnesium Sulfate
  • magnesium sulfate may be a component of the present invention.
  • Magnesium Sulfate is from Spectrum Chemical Manufacturing Corp (New Brunswick, NJ, USA), is anhydrous, and assays at 99-100.5% (w/w) magnesium sulfate.
  • the pH of magnesium sulfate in solution (1 in 20) is 5.0-9.2, loss on drying is at most 2%, chloride content is at most 0.014%, iron content is at most 20 ug/g.
  • caprylic and capric triglycerides (“caprylic, capric” or “caprylic/capric”, or “cocoglycerides” (INCI Name, US/EU/CN)) may be included in a composition of the present invention.
  • caprylic/capric triglycerides according to the present invention provide a low viscosity oil at room temperature.
  • Myritol® 331 (BASF Corporation, Florham Park, NJ, USA) the low viscosity oil is clear and slightly yellowish, with a faint inherent odor. The acid value of Myritol® 331 is max.
  • niacinamide may be included in a composition of the present invention.
  • Niacinamide is a white crystalline powder, particle size 90% w/w greater than or equal to 50 um and 10% w/w smaller than 50 um, pH 6.0-7.5 in aqueous solution, and/or pKa about 3.35.
  • Niacinamide is freely soluble in water (e.g. 691 g/L (20°C)) and in alcohol, soluble in glycerol.
  • niacinamide is CAS 98-92-0, EC 202-713-4, IENECS 202-713-4.
  • the niacinamide is at least 90% pure, at least 95% pure, at least 98% pure, at least 99% pure, and/or at least 100% pure.
  • niacinamide in a composition of the present invention includes the above properties and assays as 99-101% niacinamide w/w (99-100% pure) (DSM Nutritional Products, Parsippany, NJ, USA).
  • MSM Methyl Sulfonyl Methane
  • MSM may be included in a composition of the present invention.
  • MSM is a white crystalline powder, 90-100% pure (w/w; preferably 99-100% pure MSM), 80 mesh. (Orient Stars, Long Beach, CA, USA).
  • Roman Chamomile Oil may be included in a composition of the present invention.
  • Roman Chamomile Oil may be used in a composition of this invention.
  • the oil may be from the flower of the Anthemis nobilis flower, a colorless to yellow liquid, and 100% oil, unadulterated by other substances.
  • Roman Chamomile Oil of this invention is the substance accorded CAS 8015-92-7.
  • Roman Chamomile Oil that may be used in this invention is 100% oil from the Anthemis nobilis flower as provided by GlobalIngredientSolutions.com (Tustin, CA, USA).
  • Retinyl Palmitate may be used in a composition of this invention.
  • the Retinyl Palmitate is provided as a yellowish viscous oil and in combination with Tocopherol. The oil is crystalline when cooled.
  • the Peroxide value of the combination of Retinyl Palmitate and tocopherol is, at most, 10 meq/kg; the acid value is at most 2.0 mg KOH/g; the amount of retinol is at most 1.0%; related substances absorbance ratio A 300/A 326 nm is at most 0.6; related substances absorbance ratio A 350/A 326 nm is at most 0.54; related substances absorbance ratio A 370/A 326 nm is at most 0. 14.
  • the Retinyl Palmitate oil described above meets “Vitamin A” and “Vitamin A Concentrate (Oily Form), synthetic” specifications of the Ph. Eur., and “Vitamin A” of USP.
  • 1,2-Hexanediol (CAS 6920-22-5, EC 230-029-6) and/or Caprylyl Glycol (1,2- Octanediol; CAS 1117-86-8, EC 214-254-7) may be included in a composition of the present invention. In an embodiment, they are provided in a composition as SymDiol® 68 (Symrise, Elk Grove Village, IL, USA), a colorless clear liquid with a mild characteristic odor, having a refractive index (n25/D) of 1438- 1448.
  • SymDiol® 68 Symrise, Elk Grove Village, IL, USA
  • 1,2-Hexanediol and Caprylyl Glycol are each present in amounts of greater than 25% w/w and less than or equal to 50% w/w of the overall composition (about 25-50%).
  • the total amount of the two substances combined comprises about 98% of the Symdiol® 68 combination, such that 1,2-Hexanediol and Caprylyl Glycol are each present in amounts of about 49-50% w/w of the SymDiol.
  • aqueous solution Trimethylglycine (26.87%) (“Betaine” CAS 107-43-7, EINECS 203-490-6), Sodium L- pyrrolidonecarboxylate (9.75%) (“Sodium PCA”, CAS 28874-51-3, EINECS 249-277-1), Sodium Lactate (5.00%) (CAS 72-17-3, EINECS 200-722-0), DL-Pyrrolidonecarboxylic Acid (3.78%) (“PCA”, CAS 149-87-1 EINECS 205-748-3), L-Serine (1.12%) (“Serine”, CAS 56-45-1, EINECS 200-274-3), L- Alanine (1.06%) (“Alanine”, CAS 56-41-7, EINECS 200-273-8), Glycine (1.00%) (CAS 56-40-6, EINECS 200-272-2),
  • the process of Example 22 may prepare a water-in-oil emulsion, as described, or an oil-in-water emulsion, by controlling mixing and temperature properly. In that process, solid components could be selected that melted at 35°C-40°C to maintain stability of the product when cooled and liquid during mixing, and also to melt on the skin as it was applied.
  • composition prepared according to this Example A contains the following ingredients:
  • hydrophilic and hydrophobic components will separate from each other, reducing delivery and effectiveness of the components to the target, and rendering the composition difficult to apply and undesirable for topical application.
  • This composition contains both oil soluble and water soluble ingredients.
  • the physical form of these ingredients is either liquid or solid (crystalline/powder/flakes).
  • some of these ingredients are blends that will make the ingredient list appear much longer than in Table IV. See below Table VII.
  • emulsion When a formulation contains water soluble and oil soluble ingredients the common practice is to make an emulsion.
  • the emulsion can exist in various forms such as cream, lotion, milk, and thin liquid.
  • the emulsions are sensitive to changes in temperature and time. If not formulated properly an emulsion will separate over time due to hot/cold temperature fluctuations and /or even with passage of time
  • emulsions fall in two groups: oil in water (O/W) and water in oil (W/O).
  • O/W emulsions As part of the tests, a number of emulsifiers, co emulsifiers, and thickeners were used to develop O/W emulsion.
  • the stability in the O/W tests was not as reliable, which may be attributable to the fact that this composition contains high amount of electrolytes.
  • Electrolytes are ingredients that provide ions (electrically charged entities) in solution.
  • Next step was to move to water in oil (W/O) 17 emulsion system which, without being bound by theory, may have a slightly better electrolyte tolerance than oil in water (O/W) emulsion.
  • W/O oil in water
  • O/W oil in water
  • Table V lists the emulsifiers and thickener evaluated in this phase.
  • Emulsifiers and thickeners evaluated in W/O system were evaluated in W/O system
  • emulsifiers although support W/O emulsion, are different in chemical structure and properties.
  • the water in oil emulsion is conventionally made by adding the aqueous phase into the oil phase while mixing at a moderate to high speed, and then homogenizing.
  • the emulsion made by adding water phase into oil phase while mixing at a moderate to high speed was found to be stable for 4 weeks at 40°C. After 4weeks slight oil was observed floating on the surface that disappears after shaking.
  • Emulium Illustro a polyglyceryl based emulsifier
  • Cithrol PGTL was the next emulsifier, another polyglyceryl based emulsifier.
  • the process involved adding of water phase into the oil phase with moderate to high speed mixing followed by homogenizing and then normal mixing.
  • Water and oil phases were prepared separately.
  • Water phase contained water and all water soluble ingredients including powders and electrolytes.
  • the oil phase contained oils, waxes and other oil soluble ingredients such as esters. After all the water phase is added to the oil phase the product is homogenized and mixed for a few minutes.
  • This process is specific to one emulsifier Easynov 1 .
  • the water and oil phases were prepared separately. This process has water phase to be thick like gel consistency.
  • the oil phase is then added to the top of the water phase before the mixing starts.
  • the bulk is then mixed very slowly until all the oil phase on top blends in.
  • the conventional process was also evaluated using Easynov.
  • the emulsion made with the conventional process using Easynov emulsifier was stable at 40C for 4 weeks, indicating that a process change can make a difference in the stability and other properties of the end product.
  • Long term slight oil floating was observed on top. Upon shaking the bottle this oil goes back into emulsion.
  • the product did not remain stable when frozen and thawed later. Once separated as a result of freezing and thawing (“F/T”) the product did not go back into emulsion by shaking.
  • Easynov is PEG-based emulsifier.
  • Emulium illustro is a Polyglyceryl 6 or Polyglycerol 6 based emulsifier.
  • Cithrol PGTL based conventional W/O emulsion was stable for 5 weeks at 40C.
  • the long term stability at 40°C exhibited the similar slight oil floating on the surface as in case of Easynov. After shaking the product becomes uniform again. This product did not remain stable when frozen and thawed. Once separated in F/T test it did not go back to uniform emulsion by shaking.
  • Solagum - at 1% level 2. Sepimax Zen - at 1%, 0.5%, 0.25% and 0.1%
  • Sepimax Zen appeared to improve the F/T stability, but at the expense of normal or accelerated stability. It means that the F/T stability is improved but the stability at 40°C is adversely affected, and it does not seem to go back after shaking. It seems like Sepimax Zen kicks out of the system.
  • Stability translates into shelflife. Shelf life indicates how long a product can stay on the shelf under normal/ambient conditions without deteriorating its utility. Stability testing therefore consists of the following parts.
  • PET Preservative efficacy testing
  • accelerated stability gives an indication of 2 years of shelf life within 3 months of testing.
  • the PET testing tells that the product will be safe throughout the shelf life. Usually the product is sold and used well before 2 years. PET also indicates that under normal use conditions product will not grow microbes (bacteria/yeast/mold).
  • Emulsifiers commonly contains water and oil, with one end being water loving (hydrophilic) and the other end oil loving (lipophilic).
  • Each emulsifier has a balance of hydrophilic and lipophilic parts which is called hydrophilic/lipophilic balance (HLB 16 ).
  • HLB 16 hydrophilic/lipophilic balance
  • One emulsifier can be more hydrophilic than lipophilic and the other can be less hydrophilic then lipophilic. Also the hydrophilic and lipophilic may be equal in some emulsifiers.
  • the two emulsifiers can have the same HLB but may differ in structure. One of the two with same HLB may work for a given composition and the other may not depending on the chemical structure indicating that the structure function is more important than just the HLB 16 . Sometimes one or more additional emulsifier is added to assist the primary emulsifier. This is considered a co-emulsifier.
  • the HLB to the given composition may be finetuned, which may results in the improved stability and other properties of the emulsion.
  • emulsifiers that work only based on the structure function and the physical behavior in the emulsion for example synthetic acrylic acid based polymers, copolymers and cross polymers.
  • Other example may be polyethylene glycol (PEG) based, PPG based, polysorbate based, and poly silicone based emulsifiers which may or may not exhibit the HLB because of their specific structure configuration.
  • the emulsifier has to be more hydrophilic than lipophilic.
  • the emulsifier has to be less hydrophilic and more lipophilic.
  • Emulium illustro is a blend of two ingredients which are Polyglyceryl-6 Polyhydroxy stearate and Polyglyceryl-6 Polyricinoleate. Both have 6 polyglyceryl groups attached to a C18 carbon chain. The carbon chain provides a lipophilic character to the compound. Polyglyceryl group on the other hand provides a hydrophilic character because of the hydroxyl (OH) groups. Higher the number of OH groups higher the hydrophilic character. In this case C18 carbon chains each with 6 polyglyceryl groups.
  • Cithrol PGTL is Tri (Polyglyceryl-3/Lauryl) Hydrogenated Trilinoleate.
  • the lipophilic part is hydrogenated linoleate which is C18 chain.
  • the other part is not only polyglyceryl 3, it has a lauryl chain (Cl 2) attached to it. It means that polyglyceryl 3 is attached to two carbon chains C12 and Cl 8. This shows that compared to Emulium illustro, Cithrol PGTL has more lipophilic character and differs in chemical structure too.
  • two emulsifiers may behave differently even if they have same HLB but different structure. In this case two emulsifiers worked equally well with different chemistries Easynov and Cithrol PGTL.
  • Polyglyceryl-3 Sorbityl Linseedate (Slnerga); Polyglyceryl-2 Create (and) Polyhydroxystearic Acid (and) Polyglyceryl-2 Stearate (Innovacos); Polyglyceryl-3 Triolivate (Acme Hardesty); Polyclyceryl-3 Polyricinoleate (101 Oleo); Polyglyceryl-2 Dipolyhydroxystearate (BASF); Polyclyceryl-2 Sesquiisostearate (Clariant); Polyglyceryl-3 Diisostearate (Gattefosse, BASF); Polyglyceryl-6 Polyricinoleate (and) Polyglycery-3 Diisostearate (and) Disteardimonium Hectorite (Elementis); Olive Oil Polyglyceryl-6 Esters (and) Polyglyceryl-6 Pentaoleate (Coast Southwest); Polyglycery-6 Polyricilinoleate (and) Polyglyceryl-1 0 Dioleate (Grant
  • the above large-scale composition is useful in treating or alleviating Dupuytren’s contracture according to the present invention.
  • 15-30 ml of the composition of Table III prepared according to the process described herein was applied to the hands of an adult male suffering from Dupuytren’s Disease and Contracture.
  • a large-scale composition according to the present invention is prepared by a large-scale process, which may be as small as 100-300 mL, or as large as 3,000L (100,000 units x 30mL each). In an embodiment, a large-scale process according to this invention is about 40 kiloliters per batch to more than 100,000 kiloliters per batch.
  • a large-scale process according to the present invention is directed to combining hydrophobic and hydrophilic components with high dosage of active ingredients to prepare a water-in-oil emulsion, comprising the steps of:
  • a manufacturing procedure for the large scale process to prepare a large-scale composition of this invention is as follows:
  • Water (hydrophilic) phase In a side mixing tank equipped with a lightening mixer, add water (57.93 g) and Aloe Vera Gel 200X (15.42g). Mix 15-20 minutes until all Aloe powder dissolves and a yellow colored solution is formed. Continue mixing and add rest of the water phase ingredients from one by one (Ferulic Acid (0.2g), MSM (1.00g), Niacinamide (0.14g), Magnesium Sulfate (0.70 g), Ichtycollagen (2.2g), Prodew 600 (3.08g), Symdiol 68 (0.80g). Using sodium hydroxide 10% solution adjust pH of water phase to 6.7-7. Mix thoroughly until uniform and homogenous.
  • Oil (hydrophobic) Phase In the main mixing tank equipped with central turbine, side sweeps and a homogenizer, add all the oil phase ingredients (Tocopheryl Acetate (0.03g), BVOSC (0.03g), Retinyl Palmitate (0.03g), Liquid Shea TR (5.28g), Indian Oil Blend (5.08g), Custom Sens Al (1.68g), GLB Oleic Acid, Linoleic Acid (0.56g), Alpha Pinene (3.24g), Caryophyllene (0.56g), Carvacrol (0.80g), Cithrol PGTL (1.20g)) one by one with continued mixing at a slow speed that barely creates a vortex. After all the oil phase ingredients have been added mix for additional 10-15 minutes until a uniform oil blend is formed. Increase the oil phase mixing speed to create a vortex (speed to be determined depending upon the equipment at the manufacturing site).
  • Oil phase ingredients Tocopheryl Acetate (0.03g), BVOSC (0.03g), Retinyl Palmitate (0.03
  • the portions can be determined from the batch size. Mix for 2-3 minutes after each addition. After few portions of water phase have been added the mixing speed can be increased depending upon the viscosity or thickness of the emulsion. Rapid mixing may be used at this step.
  • the appearance of the composition starts changing at the time of emulsification.
  • water phase is added to the oil phase.
  • the above exemplary process is not intended as limiting. Other embodiments may be envisioned. Variations such as a change in emulsifiers from the listing included above, and a change of mixology depending upon available equipment, are and included embodiments of this invention.
  • a side sweep mixer can be used, coupled with different ways of homogenizing like using colloidal mill in place of a homogenizer.
  • a smaller emulsion particle size may aid stability of the emulsion.
  • a large-scale process preparing a water-in-oil emulsion according to this invention does not require heat.
  • no external heat source is needed.
  • the hydrophilic phase may be heated for instance by a heat source to 40°C-45°C to speed up the process, and the hydrophobic phase may be heated to help the hydrophobic phase become uniform.
  • a water-in-oil emulsion for instance as prepared by the above process is filled into a pump bottle that may hold about 1 or about 2L of emulsion.
  • the pump bottle may be used to prevent or reduce ambient air from accessing the stored emulsion.
  • the pump bottle dispenses 15 ml of the emulsion.
  • the emulsion prepared by this invention is an elegant, light-brown, easy to apply cream or lotion.
  • to treat Dupuytren’s disease on both hands of a subject 1-2 15ml doses of emulsion are applied between both hands, twice a day.
  • the pump bottle will hold an approximate one-month supply of emulsion for a subject.
  • Dupuytren’s symptoms will decrease over time, for instance as discussed in the Examples above.
  • compositions of the present invention are set out below.
  • an aloe vera preparation a shea butter preparation, alpha-pinene, and water.
  • Hydrophobic and hydrophilic components are included in a composition of the present invention.
  • hydrophobic and hydrophilic components are included in approximately the same total amounts in a composition of this invention (for instance each totaling about 40%-60% w/w of the composition, not including water).
  • compositions of the present invention include about 25 — 70% water (e.g. distilled water).
  • compositions prepared on a large scale according to the present invention are water-in-oil emulsions and include an emulsifier, as discussed for instance in Example A above.
  • a composition of the present invention is an oil-in-water emulsion.
  • Additional hydrophobic components include black cumin seed oil, baobab oil, camellia oil, marula oil, sea buckthorn oil, tamanu oil, apricot kernel oil, and/or argan oil.
  • Additional hydrophilic components include soluble collagen, amino acids, niacinamide, oleic acid, and/or protocatechuic acid.
  • composition according to the present invention may include the following:
  • a composition of the present invention comprises an aloe vera preparation, a shea butter preparation, alpha-pinene, and water.
  • a composition of this invention comprises a combination of other components identified throughout this application - hydrophilic components, hydrophobic components, and emulsifiers (which may be categorized as hydrophilic or hydrophobic).
  • a composition of this invention further comprises black cumin seed oil, alone or in combination with other functional oils.
  • a composition of this invention further comprises glycerol as a hydrophobic component.
  • a composition of this invention further comprises soluble collagen, MSM, and/or lecithin as a hydrophilic component.
  • a composition of this invention further comprises an alcohol, including for instance benzyl alcohol, cetyl alcohol, and/or panthenol.
  • a composition of this invention further comprises an anti-inflammatory such as linoleic acid or oleic acid (hydrophilic), or chamomile oil or copaiba oil (hydrophobic).
  • a composition of this invention further comprises an antioxidant, including for instance protocatechuic acid (hydrophilic).
  • a composition of this invention further comprises an antimicrobial such as carvacrol (hydrophobic).
  • a composition of this invention further comprises benzoin as a thickener.
  • a composition of this invention further comprises lauryl wax (35°C -45°C melting point), or cetyl esters wax (43°C - 47°C melting point).
  • the sum of hydrophilic and hydrophobic components of a composition of the present invention, not including water, may be approximately equal.
  • a composition of this invention may include about 15-30% hydrophilic components w/w, about 15-30% hydrophobic components w/w, and about 50-70% water.
  • a composition of this invention may include for instance about 25-45% hydrophilic components w/w, about 25-45% hydrophobic components w/w, and about 20%-50% w/w water.

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