WO2020141986A1 - Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées - Google Patents

Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées Download PDF

Info

Publication number
WO2020141986A1
WO2020141986A1 PCT/SA2018/050034 SA2018050034W WO2020141986A1 WO 2020141986 A1 WO2020141986 A1 WO 2020141986A1 SA 2018050034 W SA2018050034 W SA 2018050034W WO 2020141986 A1 WO2020141986 A1 WO 2020141986A1
Authority
WO
WIPO (PCT)
Prior art keywords
weight
range
gel
dimethicone
scars
Prior art date
Application number
PCT/SA2018/050034
Other languages
English (en)
Inventor
Alam SHOAIB
Arif Ansari
Iftikhar AHSAN
Ahmed JAMJOOM
Sheikh Shafiq
Original Assignee
Jamjoom Pharmaceuticals Factory Company Limited
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 Jamjoom Pharmaceuticals Factory Company Limited filed Critical Jamjoom Pharmaceuticals Factory Company Limited
Priority to PCT/SA2018/050034 priority Critical patent/WO2020141986A1/fr
Publication of WO2020141986A1 publication Critical patent/WO2020141986A1/fr

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • 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
    • A61K31/695—Silicon compounds
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
    • 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)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8962—Allium, e.g. garden onion, leek, garlic or chives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • 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
    • A61K8/58—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing atoms other than carbon, hydrogen, halogen, oxygen, nitrogen, sulfur or phosphorus
    • A61K8/585—Organosilicon compounds
    • 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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
    • 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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A61K8/89—Polysiloxanes
    • A61K8/891—Polysiloxanes saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone
    • 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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A61K8/89—Polysiloxanes
    • A61K8/891—Polysiloxanes saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone
    • A61K8/894—Polysiloxanes saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone modified by a polyoxyalkylene group, e.g. cetyl dimethicone copolyol
    • 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
    • A61K8/98—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin
    • A61K8/981—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin of mammals or bird
    • A61K8/985—Skin or skin outgrowth, e.g. hair, nails
    • 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
    • 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
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59—Mixtures
    • A61K2800/594—Mixtures of polymers

Definitions

  • the present invention is related to the development of a novel topical dermal formulation by combining hyaluronic acid with various polysiioxane fs) derivatives and imparting a synergistic effect. More specifically, to gel formulation, useful for prevention and quick repair of scars and a process thereof.
  • Scars are result of wounds due to burns, injury and surgery or diseases such as acne. Scars are undesirable both cosmetically and functionally. Cosmetically, scars are often viewed as unsightly. Functionally, scar tissue often lacks features of undamaged skm such as a normal sense of touch and complete skin integrity. Even after surgery or wound injury, it is highly desirable to prevent the formation of scar tissue. Scars could be broadly classified as keloid scars, contracture scars, hypertrophic scars and acne scars.
  • Creams and gels currently available in market are such as Mederma scar cream with SPF, Scarguard MB, Scar zone advanced cream , Scar away scar repair gel, Celsus bio scar cream , Kelocote scar gel. Scanned silicone gel, Conlractubex gel, Scarology, 3 step system and Zenrned skin eraser kii.
  • Silicone gel works by the principle that it forms a skin surface layer on scar and seal it from outside environment.
  • the silicone gel overlying the body surface of scars, the scar body can be significantly reduce surface tension, thereby degrading synthetic collagen fibers against tensile force.
  • Silicon also has its own problems. Water absorbing property of silicone gel is poor, its use m the skin redness, itching is uncomfortable. Such gels takes time in treatment and heal the scar by natural way. Hence, it is desirable to have a better topical gel formulation which has faster action for prevention and repair of scars.
  • Hyaluronic acid is a naturally occurring substance having an important mechanical and structural functions in wound healing process. It is distributed over the connective tissue such as subcutaneous tissue, cartilage tissue and plays an important role in hydration and elasticity of skin. However, it decreases in amount and in quality with age, leading to drying out of the skin, which becomes wrinkled.
  • hyaluronic acid is used in numerous applications, among winch eye surgery, tissue reconstruction, degenerative and inflammatory joint diseases, synovial fluid replacement, release of chemical agents in surgical implants, systems of encapsulation and controlled release of drugs and topical cosmetics. In local treatment of wounds, it is used in the form of cream, gel, or impregnated gauze to promote healing.
  • U.S. Pat. No. 5,731,298 discloses that cross-linked hyaluronic acid may be used for treatment of scars.
  • U.S. Pat. No. 6,048,844, issued Apr. 11, 2000 discloses a combination product for administration to a mammal comprising a medicinal agent and hyaluronic acid, to facilitate the agent's penetration through the tissue, including scar tissue at the site to be treated through the cell membrane.
  • the tolerance of hyaluronic acid is very good and no immunogenicity has been associated with this substance. A very low incidence of side effects is thus observed.
  • Silicone or its derivatives as used in scar gel(s) alone may not be that much effective when aim is prevent scar formation along with quick wound healing process.
  • the product is an advanced version of scar gel with superior quality as compared to products already available in market.
  • the present invention has unique quality of reducing scars simultaneously at the same time when wound healing process is going on.
  • the present invention provides a gel composition and its process of preparation, for the prev ention and repair of scars arising due to wound healing. Both, new and existing scars can be treated, as well as wounds prior to scar formation.
  • the composition can be used as an aid in the natural healing process, to allow reduction of scar formation in a wound region.
  • the present invention discloses a novel pharmaceutical composition
  • a novel pharmaceutical composition comprising hyaluronic acid and /or its salts and polysiloxane(s) derivatives having a synergistic effect of prevention and quick repair of scars and thus improve biological properties thereof.
  • the present invention also provide composition of novel blend of different polysiloxane(s) in certain percentage range and infused with properties of hyaluronic acid and/or sodium hyaluronate to impart synergistic beneficial effect on scars.
  • the present invention features a pharmaceutical gel or cosmetic compositions, in particular for topical administration, comprising a formulation in a physiologically acceptable medium, hyaluronic acid and/or sodium hyaluronate and polysiloxane(s) derivatives thereof.
  • the present invention features a pharmaceutical gel or cosmetic composition or preparation comprising silicone gel infused with a biologically active material hyaluronic acid or/and salts thereof for healing of skin surface and wound mark treatment.
  • Figure 1 The prepared gel in example 1 to 9 had viscosity in a range of 2000 to 2200 cp at 25° C. The viscosity was measured by a Brookfield viscometer model no. ASTM D-445, IP71.
  • Figure 2 The prepared gel in example 1 to 9 were tested for spreadibility. It was found that gel was easily spreadable in response to the little force applied. This assured that the formulation could maintain a good wet contact tune when applied at the site of action.
  • Gel refers to a colloid in which the solid disperse phase forms a network in combination with that of the fluid continuous phase, resulting in a viscous semi-rigid solution.
  • Car refers to a growth of collagen beneath the skin that is formed as the result of wound healing.
  • Abnormal scar refers to the over-expression of collagen in a scar, leaving an anaesthetic mark.
  • Silicone refers to polymeric organic silicone compounds obtained as oils or silicone variants called as polysiloxane(s).
  • Topical administration refers to delivery of a topical drug or active pharmaceutical ingredient to the skin or mucosa, providing a local effect
  • hyaluronic acid is used as a conceptual term that includes hyaluronic acid and a salt thereof within i ts scope. Therefore, the term“hyaluronic acid and a salt thereof” sometimes simply refers to“hyaluronic acid”.
  • the salt of hyaluronic acid is not particularly limited, and examples of the salt include sodium hyaluronate, potassium hyaluronate, magnesium hyaluronate and calcium hyaluronate. In the present invention, hyaluronic acid and the salts thereof may be used singly or two or more of them may be used in combination.
  • the present disclosure relates to a synergistic dermatological composition for scar prevention and repair.
  • Composition is distinguishable over the prior art by infusing a biologically active material such as hyaluronic acid and /or salts along with various polysiloxane(s) derivatives such as silicone for healing of skin surface and wound mark as opposed to products available in the market which are solely silicone based and have slow progress.
  • a synergistic dermatological gel composition by loadings hyaluronic acid/sodrum hyaluronate provides enhanced advantageous performance, which include, inter alia, improved skin repair of scar tissue with time.
  • Silicone gel w'orks by the principle that it forms a skin surface layer on scar and sealing it from outside environment. Silicone covering prevent the environmental effect on scars but does not in any way aid in quick wound healing and thus allows skm to heal by natural way thus taking a long time. Skin after wounding, granulation tissue tends to fill the wound, synthesize collagen fibers, to combat wound outward tension. Excessive collagen synthesis, wall form a hypertrophic scarring. The silicone gel overlying the body surface scars, scar body can be significantly reduced surface tension, thereby degrading synthetic collagen fibers against tensile force. Further, it was found that a silicone coating on the skin surface can reduced skin moisture evaporation, promoting hydration of scar tissue, inhibiting fibroblast proliferation and collagen deposition.
  • Silicone in gel treatments may work in the same way as silicone sheets. Silicone may be effective at softening and flattening of scars.
  • Transdermai gel may include long chain silicone polymer (polysiloxanes), and silicone dioxide. Long chain silicone polymers cross link with silicone dioxide. Silicone increases hydration of stratum corneum and therefore facilitates regulation of fibroblast production and reduction in collagen production resulting in softer and flatter scar.
  • silicone within the transdermai gel may protect the scarred tissue from bacterial invasion and may prevent bacteria-induced excessive collagen production in the scar tissue.
  • Hyaluronic acid (CAS No. 9004-61-9) is the natural glycosaminogiycan formed by bonding N- Acetyi-D-Glucosamine with glucuronic acid.
  • Hyaluronic acid, sodium hyaluronate, and potassium hyaluronate function in cosmetics as skin conditioning agents at concentrations up to 2%.
  • Hyaluronic acid primarily obtained from bacterial fermentation and rooster combs, does penetrate to the dermis.
  • a synergistic silicone based gel for topical application and for treatment of scars is disclosed herein by present invention.
  • the silicone variant used are combination of different types of polysiloxane (s).
  • the silicone-based gel include a non-zero percentage of silicone or a silicone variant.
  • the various polysiloxanes present in silicone based gel composition are decamethylcyclopentasiloxane in a range of 25% to 40% by weight, polymethyldisiloxane in a range of 30% to 50 % by weight. Fumed Silica in a range of 1 % to 5%. Cyclopentasiloxane (and) dimethicone cross polymer in a range of 1% to 2% and t PEG- 10 Dimethicone in a range of 3% to 10 % by weight.
  • Emulsifiers based on silicone polyether structure are generally known as PEG/PPG-X/Y dimethicone, such as PEG-10 dimethicone, PEG/PPG-19/19 dimethicone, lauryl PEG/PPG-18/18 dimethicone and bis-isobutyl PEG/PPG- 10/7/dimethicone copolymer.
  • Emulsifier from other category could be used in place of emulsifiers based on silicone poly ether structure such for e.g. cetyl stearyl alcohol, Carrageenan, Cetearyl Glucoside, Sorbitan Olivate and cetearyl olivate.
  • Decamethylcyclopentasiloxane a colorless and odorless liquid that is slightly volatile, available as Dow Corning ST-Cyclomethicone 5-NF.
  • the present invention uses it blended with other silicones or organic excipients to provide a fluid base for the formulations. It features good solubility in most anhydrous alcohols and in many pharmaceutical solvents.
  • volatile silicone oils could be tried in place decamethylcyclopentasiloxane are such as octamethylcyciotetrasiioxane and dodecamethylcyclohexasiloxane.
  • examples of commercially available volatile silicone oils include oils having grade designations 344, 345, 244, 245 and 246 from Dow corning Corporation.
  • the volatile silicone oil decamethylcyclopentasiloxane which is made commercially available, for example, from supplier like Dow Corning Corporation.
  • Pofydimethylsiloxane is a clear liquid, available in a range of different narrow viscosities.
  • Dow corning Q7-9120 silicone fluid is one of the brand of Polydimethylsiloxane available in the market. Careful blending of polydimethylsiloxane and choosing a correct viscosity grade is desired to prepare a gel formulation which could have desired results.
  • Fumed silica is commonly used as a rheology control additive to provide sag resistance, anti- settling of fillers and shear-thinning viscosity.
  • the generic term“fumed silica” defines a range of products with different surface chemistries from hydrophilic to hydrophobic. These products have differing compatibility to polymer systems, which enable formulators to fine-tune rheology performance. Formulators may use hydrophilic fumed silica or hydrophobic fumes silica depending the type of result desired in final gel formulation.
  • Cyclopentasiloxane (and) Dimethicone Cross polymer is film forming and thickening agent for water-in-oil and water-in-silicone formulations and silicone fluid. It is a non-occlusive mixture of high molecular weight crosslinked silicone (12%) in decamethylcyclopentasiloxane.
  • One of marketed brand currently available is Dow corning ST - Elastomer 10.
  • Cyciopentasiioxane (and) Dimethicone Cross polymer which could be replaced with Dow coming ST - Elastomer 10 if, required. It may be formulated with organic oil or silicone based materials with the use of mixers and high shear devices, such homogemzers or sonolators.
  • PEG- 10 dimethicone is a type of silicone. Silicones are synthetic polymers made up of repeating units of siloxane (elemental silicon and oxygen), which is why silicones may also be referred to as polysiloxanes. Dow Corning TI-6021 is one of the marketed brand for PEG-10 Dimethicone is. More specifically, PEG- 10 dimethicone functions to condition, lubricate, and protect the skin.
  • Hyaluronic acid and/or sodium hyaluronate and its variants should be added in percentage range 0.5% to 10 % by weight.
  • the composition may also include a second active ingredient in a second amount of between approximately 0.1% and approximately 3% by weight of the silicone-based gel.
  • the second active ingredient is selected from a preferable list of vitamin E acetate. Collagen I, Collagen II Collagen III.
  • the topical application of the silicone-based gel may allow for the transdermal administration of the first and second active ingredients simultaneously.
  • Hyaluronic acid and/or sodium hyaluronate as used in present invention may be a self-crosslinking hyaluronic acid particles.
  • the average volume particle size of hyaluronic acid particles according to one of the preferred embodiment of the present invention is in a range of 10 pm to 500 mm, more preferably 10 pm to 100 pm.
  • Hyaluronic acid can be obtained from various sources of animal and non-ammal origin. Sources of non-animal origin include yeast and preferably bacteria.
  • the molecular weight of a single hyaluronic acid molecule is typically in the range of 0.1-10 MDa, but other molecular weights are possible.
  • the molecular weight of hyaluronic acid is not particularly limited as long as a gel can be formed.
  • the invention provides synergistic gel of sodium hyaluronate and polysiloxanes derivatives for scar prevention and early repair and a preparation method of the same.
  • the preferred available market brands used in formulation for decamethylcyclopentasiloxane is cyclomethicone 5NF
  • polymethyldisiloxane is Dow corning Q7-9120
  • fumed Silica is aerosil 200
  • cyclopentasiloxane (and) dimethicone cross-polymer is Dow corning ST -elastomer 10
  • peg- 10 dimethicone is Dow corning TI- 6021.
  • Other brands could also be used if the preferred brands are not available in the market.
  • the composition comprises preferably 370 mg/g by weight Cyclomethicone 5NF, 420 mg/g by weight Dow corning Q7-9120, 20 mg/g by weight aerosil 200, 20 mg/g weight Dow corning ST - elastomer 10, 50 mg/g by weight Dow coming Tl-6021, and was prepared by adding the aqueous phase containing 10 mg/g by weight glycerin, 10 mg/g by weight sodium hyaluronate dispersed into water.
  • the composition comprises preferably 370 mg/g by weight decamethylcyclopentasiloxane, 420 mg/g by weight polymethyldisiloxane, 20 mg/g by weight fumed silica (aerosil 200), 20 mg/g weight cyclopentasiloxane (and) dimethicone cross- polymer, 50 mg/g by weight PEG- 10 dimethicone and was prepared by adding the aqueous phase containing 10 mg/g by weight glycerin, 10 mg/g by weight sodium hyaluronate dispersed into water.
  • the composition comprises preferably 370 mg/g by weight cyclomethicone 5NF, 415 mg/g by weight Dow corning Q7-9120, 20 mg/g by weight aerosil 200, 20 mg/g weight Dow corning ST - elastomer 10, 50 mg/g by weight Dow- corning TT- 6021 and 5 mg/g vitamin E acetate, was prepared by adding the aqueous phase containing 10 mg/g by weight glycerin, 10 mg/g by weight sodium hyaluronate dispersed into water.
  • the composition comprises preferably 370 mg/g by weight decamethylcyclopentasiloxane, 415 mg/g by weight polymethyldisiloxane, 20 mg/g by weight fumed silica (aerosil 200), 20 mg/g weight cyclopentasiloxane (and) dimethicone cross polymer, 50 mg/g by weight PEG- 10 dimethicone and 5 mg/g vitamin E acetate, was prepared by adding the aqueous phase containing 10 mg/g by weight glycerin, 10 mg/g by weight sodium hyaluronate dispersed into water.
  • the composition comprises preferably 37% by weight cyclomethicone 5NF, 41.5% by weight Dow coming Q7-9120, 2% by weight aerosil 200, 2% by weight Dow coming ST - elastomer 10, 5% by weight Dow coming TI-6021 and 0.5% by weight vitamin E acetate and adding the aqueous phase containing 1 % glycerin and 1% by weight Sodium hyaluronate dispersed into water.
  • the composition comprises preferably 37% by weight cyclomethicone 5NF, 42% by weight Dow coming Q7-9120, 2% by weight aerosil 200, 2% by weight Dow corning ST - elastomer 10, 5% by weight Dow coming TI-6021 and adding the aqueous phase containing 1 % glycerin and 1% by weight sodium hyaluronate dispersed into water.
  • the composition comprises preferably 370 mg/g by weight decamethylcyclopentasiloxane, 415 mg/g by weight polymethyldisiloxane, 20 mg/g by weight fumed silica (aerosil 200), 20 mg/g weight cyclopentasiloxane (and) dimethicone cross- polymer, 50 mg/g by weight PEG- 10 dimethicone and 5 mg/g collagen (s), is prepared by adding the aqueous phase containing 10 mg/g by weight glycerin, 10 mg/g by weight sodium hyaluronate dispersed into water.
  • the method of preparation of at least one silicone-based gel composition comprises following steps: Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution/or dispersion and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxane (s) was prepared separately.
  • the blend was prepared by adding cyclomethicone 5NF, Dow corning Q7-9120, aerosil 200, Dow ST - elastomer 10, Dow corning TI-6021 and vitamin E Acetate under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature.
  • the method of preparation of present silicone-based gel composition comprising the following steps Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1 % Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately.
  • the blend was prepared by adding Decamethyicyclopentasiloxane, Polymethyldisiloxane, Fumed Silica, Cyclopentasiloxane (and) Dimethicone Cross polymer, PEG- 10 Dimethicone and Vitamin E Acetate under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature and obtaining the sodium hya!uornate and polysiloxane gel composition.
  • the method of preparation of present silicone-based gel composition comprising the following steps: Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately.
  • the blend was prepared by adding Decamethylcyclopentasiloxane, Polymeth yldisiloxane, Fumed Silica, Cyclopentasiloxane (and) Dimethicone Cross polymer and PEG- 10 Dimetlncone under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature and obtaining the sodium hyaluornate and polysiloxane gel composition.
  • polysiloxanes blend as prepared contain cyelomethicone 5NF in a range of 30% to 40% by weight, Dow corning Q7-9120 in a range of 35% to 43% by weight, Aerosil 200 in a range of 1% to 5% by weight, Dow- Corning ST - Elastomer 10 in range of 1% to 4% by weight, Dow Corning TI- 6021 in a range of 2% to 5% by weight and Vitamin E Acetate in a range of 0.2% to 0.9% by weight under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature.
  • blend of different polysiloxanes was prepared separately.
  • the blend was prepared by adding decamethylcyclopentasiloxane in a range of 30% to 40% by weight, polymethyldisi!oxane in a range of 35% to 43% by weight, fumed silica in a range of 1% to 5% by weight, cyclopentasiloxane (and) dimethicone cross-polymer in range of 1% to 4% by weight, PEG- 10 dimethicone in a range of 2% to 5% by weight and vitamin E acetate in a range of 0.2% to 0.9% by weight under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature and obtaining the sodium hyaluornate and polysiloxane gel composition.
  • the pharmaceutical composition comprises a blend of polysiloxane(s) or polysiloxane variants and a biologically active material such as acellular dermis of human or animal origin and/or hyaluronic acid and its salts in a pharmaceutically acceptable base for early repair of scars and skin surface texture improvement.
  • a biologically active material such as acellular dermis of human or animal origin and/or hyaluronic acid and its salts in a pharmaceutically acceptable base for early repair of scars and skin surface texture improvement.
  • the pharmaceutical composition comprises a blend of polysiloxane(s) selected from a group comprising of decamethylcyclopentasiloxane, polymethyidisiloxane, fumed silica, cyclopentasiloxane, dimethicone cross polymer, peg- 10 dimethicone with hyaluronic acid and its salts, glycerin and purified water, for use in early repair of scars and skin surface texture improvement.
  • polysiloxane(s) selected from a group comprising of decamethylcyclopentasiloxane, polymethyidisiloxane, fumed silica, cyclopentasiloxane, dimethicone cross polymer, peg- 10 dimethicone with hyaluronic acid and its salts, glycerin and purified water, for use in early repair of scars and skin surface texture improvement.
  • a pharmaceutical composition comprising: a) decamethylcyclopentasiloxane in a range of 25% to 40% by weight, b) polymethyidisiloxane in a range of 30% to 50 % by weigh, c) fumed silica in a range of 1 % to 5% by weight, d) cyclopentasiloxane (and) dimethicone cross polymer in a range of 1% to 2% by weight, e) peg- 10 dimethicone in a range of 1% to 2% by weight, f) glycerin in a range of 0.5% to 2% by weight, g) sodium hyaluronate in a range of 0.5% to 2% by weight and h)purified water to q. s is disclosed whereas the gel composition has an viscosity in a range of 1.4 to 3.8 Pa. s at 25°C.
  • the present silicone-based gel composition can be in the form of a gel or cream or liquid formulation of such is known to those skilled in the art.
  • the formulation described herein can be formulated by any conventional manner using one or more acceptable carriers and/or excipients as described in, for example, Remington's Pharmaceutical Sciences.
  • the silicone-based gel may include several active ingredients, such as a collagen, saffron and glucocorticoid.
  • Saffron is a flower from family iridaceae a perennial flower crocus, is also known for fragrances.
  • Saffron as pharmaceutically acceptable powder could be used in present gel formulation.
  • Saffron has beneficial antioxidants effects and works synergistically to help nourish, hydrate and protect the skin especially after a day in sun or exposing skin to any damaging elements.
  • the present embodiments also may relate to methods of manufacturing silicone-based transdermal creams or gels.
  • the present silicone-based gel may also include heparin intended for use as a cosmetic.
  • the present silicone-based gel may also include use of methylsulfonylmethane for the preparation of a formulation. Methylsulfonylmethane helps in treatment of irregular connective tissue formations of the skin and subcutaneous tissue, such as in particular of scar tissue, combustion related scars and stretch marks.
  • the present invention is also suitable for the treatment of scarring, such as post-operative or injuries resulting from scars or of combustion scars, as well as for the treatment of stretch marks (Striae cutis atrophicae or Striae distensae cutis (also pregnancy strip).
  • scarring such as post-operative or injuries resulting from scars or of combustion scars
  • stretch marks Striae cutis atrophicae or Striae distensae cutis (also pregnancy strip).
  • humectants such as glycerol, propylene glycol, penty!ene glycol or urea
  • Macrogol-20-glycerol monostearate preservatives, such as alkali metal sorbates, e.g.
  • potassium sorbate pH stabilizers, such as citric acid, essential oils, such as a-bisaboJol, gelling agent, such as carbomer, sodium carmeilose, cellulose ethers, such as hydroxyl ethyl cellulose, or gelatin or pectin, or mixtures of two or more thereof, such as in a proportion, based on the total preparation, of 0 to 20 -% by weight.
  • pH stabilizers such as citric acid, essential oils, such as a-bisaboJol
  • gelling agent such as carbomer, sodium carmeilose, cellulose ethers, such as hydroxyl ethyl cellulose, or gelatin or pectin, or mixtures of two or more thereof, such as in a proportion, based on the total preparation, of 0 to 20 -% by weight.
  • the present silicone-based gel may include a viscosity modulating agent, such as a gelling agent. Concentrations of viscosity modulating agent may be determined by one skilled in the art depending on the viscosity desired.
  • the formulations of the invention are packaged in conventional containers, for example in tubes, spray cans, jars, dosing dispensers, bottles made of glass or plastic, capsules or (in the case of plaster preparations) transdermal therapeutic systems.
  • the application of the usable according to the invention takes place topically by application such as spraying, brushing or rubbing, preferably at the locations of the skin, the scars have to be treated, and if appropriate also in regions lying immediately around it.
  • treating skin and scars further including repeating the topically applying step on at least a daily basis to the skin surface area for treatment.
  • the skin surface area for treatment undergoes whitening, collagen formation and lightening of scar tissue with time.
  • the benefiting ingredients disclosed herein may be ground in, for example, a pulverizer or a jet mill, prior to being incorporated into the formulation.
  • the silicone-based gel may include several other active ingredients, such as antioxidants suitable as one or more of the hydrophilic benefiting ingredients disclosed herein, include, but are not limited to, green tea extracts, grape seed extracts, alpha-iipoic acid, potassium sulfite, propyl gallate, quinones, rosmarinic acid, sodium ascorbate, sodium erythorbate, sodium metabisulfite, sodium sulfite, superoxide dismutase, sorbityl furfural, tocopheryl succinate, genistein, quercetin, passiflora extract, chrysin, naringenin-7-glucoside, Vitamin C and combinations thereof.
  • antioxidants suitable as one or more of the hydrophilic benefiting ingredients disclosed herein, include, but are not limited to, green tea extracts, grape seed extracts, alpha-iipoic acid, potassium sulfite, propyl gallate, quinones, rosmarinic acid, sodium ascorbate,
  • the present disclosure provides a transdermal formulation that may be employed potentially as scar prevention formulation.
  • Scars types that may be treated with the disclosed formula may include new scars, old scars, surgical scars, keloids, hypertrophic scars, stretch marks or skin conditions that would benefit from barrier protection.
  • the disclosed formula may have mild penetration. Additionally, the disclosed formula may be employed to treat skin spots and may be useful for psoriasis and rosacea.
  • the compositions of the present invention also contain glycerin. Glycerin is the most commonly used as a humectant.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1 % Sodium hyaluronate solution and to it added glycerin 1 % to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 37% by weight decamethylcyclopentasiloxane, 42% by weight polymethyldisiloxane, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer and 5% by weight peg- 10 dimethicone under stirring at ambient temperature.
  • the above prepared aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer, under anhydrous conditions and obtaining the sodium hyaluomate and polysiloxane gel composition.
  • the resultant product comprised a gel having a viscosity of about 2150 to 2200 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 42% by weight decamethylcyclopentasiloxane, 37% by weight polymethyldisi!oxane, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer and 5% by weight peg- 10 dimethicone under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant product comprised a gel having a viscosity of about 2189 to 2200 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 37% by weight decamethylcyclopentasiloxane, 41.5% by weight polymethyldisiloxane, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer, 5% by weight peg- 10 dimethicone and 0.5% by weight Vitamin E Acetate under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant product comprised a gel having a viscosity of about 2100 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 41.5% by weight decamethylcyclopentasiloxane, 37% by weight polymethyldisiloxane, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer, 5% by weight peg- 10 dimethicone and 0.5% by weight vitamin E acetate under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant product comprised a gel having a viscosity of about 2200 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 42% by weight decamethylcyclopentasiloxane, 37% by weight polymethyidisiloxane having viscosity of 1000 cSt, 2% by weight fumed silica, 2% by weight cyclopentasiloxane (and) dimethicone cross- polymer and 5% by weight PEG- 10 dimethicone under stirring at ambient temperature.
  • the aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant gel product has viscosity of about 1640 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 42% by weight decamethylcyclopentasiloxane, 37% by weight polymethyidisiloxane having viscosity of 500 cSt, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer and 5% by weight peg- 10 dimethicone under stirring at ambient temperature.
  • the aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant gel product has a viscosity of about 1140 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 42% by weight decamethylcyclopentasiloxane, 37% by weight polymethyidisiloxane having viscosity of 350 cSt, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer and 5% by weight peg- 10 dimethicone under stirring at ambient temperature.
  • the aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant gel product has a viscosity of about 890 cp at 25° C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 37% by weight decamethylcyclopentasiloxane, 42% by weight polymethyldisiioxane having viscosity of 12500 eSt, 2% by weight fumed silica, 2% by weight cyelopentasiloxane (and) dimethicone crosspolymer and 5% by weight PEG-9 polydimethylsilicone under stirring at ambient temperature.
  • the aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant gel product has a viscosity of 890 cp at 25°C.
  • Purified water was added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes was prepared separately. The blend was prepared by adding 37% by weight decamethylcyclopentasiloxane , 42% by weiht polymethyldisiioxane having viscosity of 12500 cSt, 2% by weight fumed silica, 2% by weight cyelopentasiloxane (and) dimethicone crosspolymer and 5% by weight Oxy ethyl polydimethylsilicone under stirring at ambient temperature.
  • the aqueous phase dispersion of sodium hyaluronate was added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer.
  • the resultant gel product has a viscosity of 890 cp at 25° C.
  • Purified water is added to sodium hyaluronate and evenly stirred to prepare a 1% Sodium hyaluronate solution and to it added glycerin 1% to make aqueous phase dispersion.
  • a blend of different polysiloxanes is prepared separately. The blend is prepared by adding 37% by weight decamethylcyclopentasiloxane, 41.5% by weight pofymethyldisiloxane, 2% by weight Fumed Silica, 2% by weight cyclopentasiloxane (and) dimethicone crosspolymer, 5% by weight peg-10 dimethicone and 0.5% by weight collagen II under stirring at ambient temperature.
  • the above aqueous phase dispersion of sodium hyaluronate is added into the polysiloxanes blend and stirred for two hours at an ambient temperature using a high shear mixer under anhydrous conditions and obtaining the sodium hyaluornate and polysiloxane gel composition.
  • the present silicone gel is mild to the skin, no redness, itching side effects as well as improved anti-inflammatory effect.
  • Hyaluronic acid salt such as sodium hyaluronate and a polydimethylsiloxane components found to exhibit fantastic synergy, exhibiting a strong repair function to the damaged skin and to prevent scar formation at early stage when used.
  • formulation is used for preventing abnormal scar formation or treating abnormal scars by applying the gel product to a subject transdermally, directly onto a scar site.
  • Gel was examined for their physical properties by visual inspection. Physical properties of prepared gel such as color, appearance, homogeneity, washability, consistency, phase separation and odor were observed and are shown in Table 1 and 2. From the physical evaluation the color of the prepared gels was off white and appearance of gel was translucent and it was smooth on application. The gel was found to be homogenous and washable.
  • the gel was centrifuged in the REM! centrifugation unit at the 5000 rprn for 30 minutes and the phase separation, creaming or cracking was checked and screened out. The gel did not show any phase separation on high speed centrifugation. The gel was evaluated microscopically for the presence of particles if any and no appreciable particulate mater was seen under light microscope.
  • the spreadability of formulation depends on its viscosity. Spreadability of gel was determined by compressing the 0.5g of topical sample under glass plates of known weight. Glass plates were subsequently placed over the sample one by one at intervals of 1 min. The spreading area was determined after addition of each glass plate and results expressed in terms of the spreading area as a function of applied mass (weight of glass plate). The slides were fixed to a stand without slightest disturbance. Study has indicated that the gel was easily spreadable in response to the little force applied. These assured that the formulation could maintain a good wet contact time when applied at the target site.
  • Tins study was conducted for accelerated stability testing of gel formulation.
  • this study we placed the formulation at two different temperature i.e. 2°C to 8°C and 40 ⁇ 2°C/75 ⁇ 5 % RH.
  • three such cycle should be run and to check the appearance and viscosity of the product.
  • Step 1 Prepare samples. (3 test 1 control)
  • Step 2 Take initial readings (Appearance & Viscosity)
  • Step 3 Put test samples in the freezer (2°C to 8°C ) for 24 hours
  • Step 4 Remove samples and allow to thaw at room temperature
  • Step 5 Put samples in 40 ⁇ 2°C/75 ⁇ 5 % RH for 24 hours
  • Step 6 Remove samples & allow to equilibrate at room temperature.
  • Step 7 Take end of the cycle readings
  • the viscosity of the gel was determined using Brookfield DV III ultra V6.0 RV cone and plate rheometer (Brookfield Engineering Laboratories, Inc., Middieboro, MA) using spindle # CPE40 at 25 ⁇ 0.5 °C.
  • the software used for viscosity calculations was Rheocalc V2.6.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Birds (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Gerontology & Geriatric Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne une composition de gel de silicone cicatrisant basée sur un nouveau concept consistant à imprégner un matériau biologiquement actif tel que l'acide hyaluronique et/ou ses sels avec divers dérivés de polysiloxane(s) selon des proportions spécifiques afin d'obtenir la plage de viscosité et l'effet souhaités. Cela est réalisé en utilisant un ou des émulsifiant(s) combiné(s). Les cicatrices apparaissent suite à des plaies dues à des brûlures, des blessures ou une chirurgie, ou à des maladies telles que l'acné. Le gel possède une fonction de réparation des cicatrices, et agit également à un stade précoce en empêchant la formation de cicatrices. Aussi bien les nouvelles que les anciennes cicatrices peuvent être traitées.
PCT/SA2018/050034 2018-12-30 2018-12-30 Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées WO2020141986A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/SA2018/050034 WO2020141986A1 (fr) 2018-12-30 2018-12-30 Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SA2018/050034 WO2020141986A1 (fr) 2018-12-30 2018-12-30 Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées

Publications (1)

Publication Number Publication Date
WO2020141986A1 true WO2020141986A1 (fr) 2020-07-09

Family

ID=71407185

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SA2018/050034 WO2020141986A1 (fr) 2018-12-30 2018-12-30 Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées

Country Status (1)

Country Link
WO (1) WO2020141986A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202000001831A1 (it) * 2020-01-30 2021-07-30 Caprika Srl Composizione per applicazione rettale a base di sale di acido butirrico per il trattamento delle patologie proctologiche
CN113476343A (zh) * 2021-07-19 2021-10-08 丹东欣时代生物医药科技有限公司 一种疤痕修复硅酮霜
CN113694015A (zh) * 2021-09-14 2021-11-26 河南沃迈生物科技有限公司 一种瘢痕凝胶
CN114699508A (zh) * 2022-04-12 2022-07-05 南京天朗制药有限公司 一种硅酮凝胶及其制备方法和应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5731298A (en) * 1992-01-03 1998-03-24 Reinmuller; Johannes Method for the treatment of scars and keloids
WO2010148310A1 (fr) * 2009-06-18 2010-12-23 Advanced Bio-Technologies, Inc. Préparation de traitement de cicatrices avec de la silicone

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5731298A (en) * 1992-01-03 1998-03-24 Reinmuller; Johannes Method for the treatment of scars and keloids
WO2010148310A1 (fr) * 2009-06-18 2010-12-23 Advanced Bio-Technologies, Inc. Préparation de traitement de cicatrices avec de la silicone

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202000001831A1 (it) * 2020-01-30 2021-07-30 Caprika Srl Composizione per applicazione rettale a base di sale di acido butirrico per il trattamento delle patologie proctologiche
WO2021152492A1 (fr) * 2020-01-30 2021-08-05 Caprika Srl Composition à base de sel d'acide butyrique pour application rectale pour le traitement de troubles proctologiques
CN113476343A (zh) * 2021-07-19 2021-10-08 丹东欣时代生物医药科技有限公司 一种疤痕修复硅酮霜
CN113694015A (zh) * 2021-09-14 2021-11-26 河南沃迈生物科技有限公司 一种瘢痕凝胶
CN114699508A (zh) * 2022-04-12 2022-07-05 南京天朗制药有限公司 一种硅酮凝胶及其制备方法和应用

Similar Documents

Publication Publication Date Title
WO2020141986A1 (fr) Composition de gel de silicone contenant de l'acide hyaluronique et/ou son sel permettant la prévention et la réparation de cicatrices cutanées
JP6598207B2 (ja) 水溶性ヒアルロン酸ゲル及びその製造方法
CN102449073B (zh) 成膜的含硅酮组合物
KR101461121B1 (ko) 고농도 비타민c 및 비타민c 유도체의 투명 졸, 겔 조성물
KR102394532B1 (ko) 분자량이 상이한 히알루론산들을 함유하는 화장료 조성물
HU230156B1 (hu) Hagymakivonatot és zsírolajat tartalmazó szer előállítása károsodott bőrszövet, különösen sebhelyek ellátására, megelőzésére vagy kezelésére
JPH0215022A (ja) 抗炎症性皮膚湿潤組成物及びその調製方法
US9226890B1 (en) Polysilicone base for scar treatment
WO2005044216A1 (fr) Preparation pour la peau a usage externe
US20200012989A1 (en) Compositions and methods for treating cutaneous conditions
WO2019013670A1 (fr) Masque cosmétique à appliquer sur la peau et procédé d'application
TW200817040A (en) Emulsion composition with good feeling of use
JP6821054B2 (ja) シリコーン樹脂組成物、その製造方法及びそれを含む瘢痕治療剤
CN110522659A (zh) 一种妊娠纹修复霜及其制备方法
JP2021098655A (ja) 皮膚外用組成物
JP2005060234A (ja) 皮膚外用剤
US8529966B2 (en) Burn treatment composition and method
KR20210096056A (ko) 흉터 예방 또는 치료를 위한 국소용 약학적 조성물
US20140348873A1 (en) Urea-Silicone Gel for Hyperkeratosis Treatment
KR20150107288A (ko) 유화제를 함유하지 않는 유화 화장료 조성물
WO2002004004A1 (fr) Procedes a haute pression/cisaillement eleve de preparation de dispersions contenant des cires et autres semi-solides et huiles
EP1467702B1 (fr) Composition de soin de cicatrices
CN110403839A (zh) 疤痕修复乳霜及其制备方法和应用
CA3099843A1 (fr) Formulation de putrescine saline topique sterile et ses utilisations
JP2001354510A (ja) 水中油型外用組成物

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18945394

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18945394

Country of ref document: EP

Kind code of ref document: A1