WO2001043698A9 - Topical ointment - Google Patents
Topical ointmentInfo
- Publication number
- WO2001043698A9 WO2001043698A9 PCT/US2000/034185 US0034185W WO0143698A9 WO 2001043698 A9 WO2001043698 A9 WO 2001043698A9 US 0034185 W US0034185 W US 0034185W WO 0143698 A9 WO0143698 A9 WO 0143698A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- oil
- base material
- aqueous solution
- ointment
- topical ointment
- Prior art date
Links
Classifications
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
Definitions
- the present invention relates to a topical ointment and more particularly to a topical ointment which may act as a moisturizer and delivery system of substances to bodily areas upon which it is applied.
- Another method of delivering a drug or pharmaceutical is through application of a substance carrying the drugs or pharmaceuticals to a mucosal surface of the body.
- the drug or other pharmaceutical composition may be mixed with a petroleum-based jelly and the combination topically applied to a mucosal surface, such as those in the nasal passageway.
- a mucosal surface such as those in the nasal passageway.
- the placement of petroleum-based products in the airways may have certain medical side effects.
- the inventors have recognized that a topical ointment may be provided which upon application to various bodily surfaces may provide moisturization. In situations where the ointment includes additional substances such medications, the ointment may further provide for the controlled delivery of these substances to surfaces upon which the ointment has been applied. The inventors have further recognized that upon application of the topical ointment to different bodily cavities, the delivery of the additional substances to the surfaces within the cavity may be performed at a slow release rate.
- the topical ointment described herein may include a base material which may be comprised of a combination of mineral oil and polyethylene glycol. Encapsulated within the base material may be a predetermined quantity of an aqueous solution such as bacteriostatic water.
- aqueous solutions which may be encapsulated include a mixture of NaCl with sterile H 2 O.
- an additional substance which may include, but is not limited to various drugs or pharmaceutical substance such as antibiotics, steroids, aromatic oils, nitroglycerine, painkillers, nicotine and humalog insulin.
- a predetermined quantity of the base material is placed in a device which acts to mix, beat, whip, blend and/or stir the materials contained therein. The material is mixed at a predetermined rate to control the size of the encapsulations formed therein. The lower the rate at which the mixing process may occur the smaller the encapsulations created in the base material.
- the percentages of the aqueous solution versus the additional materials encapsulated may be varied to control the concentration or the additional substances to be delivered. Further, the percentage of the base material versus the other elements may also be changed to vary the delivery rate.
- predetermined portions of the aqueous solution may be added.
- the mixing process may act to encapsulate the aqueous solution within the encapsulations created in the base material. Additional portions of the aqueous solution may be added to the base material during the mixing process until each portion is encapsulated within the base material.
- the ointment may be employed as a moisturizer.
- additional substances may also be encapsulated during a further mixing process. Predetermined portions of the additional substance may be added to the base material and aqueous solution during the mixing process. All portions of the additional substance may be added until the entire amount is encapsulated.
- topical ointment may be applied to various bodily surfaces.
- body heat may act to dissolve the base material providing for the release to the surface of the aqueous solution and other substances encapsulated therein.
- the rate the base material dissolves may be related to the proximity of that portion of the ointment to the bodily surface as well as other environmental factors.
- the base material dissolves the materials encapsulated within the base material are delivered to the bodily surface. This continuous exposure act to hydrate the affected area as well as provide exposure to the additional substances. Through this exposure medications may be absorbed into the blood stream.
- topical ointment which may be applied to various parts of the human body, and through exposure to body heat, provide delivery of moisturizing agents as well as other substances.
- the topical ointment comprises a base material which is combined with an aqueous solution which may provide hydration upon application.
- Also included may be additional substances such as a medications or aromatic oils which when encapsulated within the topical ointment provides for a slow release of the substance to a bodily surface.
- additional substances such as a medications or aromatic oils which when encapsulated within the topical ointment provides for a slow release of the substance to a bodily surface.
- the topical ointment includes a base material which may be comprised of mineral oil and polyalkylene (e.g., polyethylene glycol). This material may be known as plasticized base, which is manufactured by Professional Compounding Associates of Houston
- Plasticized base may comprise approximately five percent of a low-molecular weight polyethylene glycol and approximately ninety-five percent mineral oil. The polymer is soluble in mineral oil above ninety degrees Fahrenheit, which is close to its melting point.
- a first element encapsulated in the topical ointment may be an aqueous solution.
- the aqueous solution may also comprise approximately 0.9% NaCl, and the remaining portion sterile H 2 O.
- This aqueous solution may include other compounds which the ointment may deliver upon application to a bodily surface.
- these may include a large variety of drugs, oils, dietary supplements and other medications.
- the desired substances may be selected from a group of nontoxic, water soluble or miscible materials that are capable of being absorbed through the human skin.
- One type of substance which may be encapsulated in the topical ointment are antibiotics.
- the antibiotic may include: Gentamycin, Tetracycline, Erythromycin, Cephalexin.
- steroids Another substance which may be encapsulated in the ointment includes steroids.
- the group steroids may include: Prednisone, Dexamethasone, Prednisolone.
- oils may be employed in treatments such as aroma therapy.
- the oils may include: Eucalyptus Oil, Rosemary Oil, Pine Needle Oil, Tea Tree Oil, Wintergreen Oil, Peppermint Oil, Spearmint Oil, Camphor Oil, Sage Oil, Jojoba Oil, Cinnamon Oil, Anise Oil, Lemon Oil, Lime Oil, Orange Oil, Clove Oil, Almond Oil, White Pine Oil, Cardamon Oil and Cedar Leaf oil.
- Still yet another substance which may be encapsulated within the base material are dietary supplements. These supplements may include: various vitamins, iron, potassium, calcium, potassium, magnesium, copper, zinc. Other substances which may be encapsulated include various medications.
- These medications may include: humalog insulin, anti-nausea medication (Prochloroperazine or Promethazine) , smoking prevention medication (nicotine resin), painkilling medication (codeine, hyrocodone), nitro-glycerin.
- the formulation for the topical ointment may comprise approximately 50-80% by weight of the base material. Additionally, the formulation may comprise approximately 0-50% by weight of the aqueous solution. In formulations where an additional substance is included, 0-30% by weight of the additional substance may be included.
- the composition of the topical ointment is such that one or more different substances (for example antibiotics and aromatic oils) may be encapsulated therein.
- the ointment may be used without encapsulating any additional substances.
- the ointment may be prepared by continuous or batch processes. As in preparing conventional emulsions, shear force may be applied to the components by use of mixers, blenders, homogenizers, mills, impingement surfaces, ultra-sound, shaking or vibration. To get the desired encapsulations within the base material, the mixing shear should be at low levels. The higher the shear the larger the encapsulations. Temperature is not usually a critical factor in the preparation of the systems.
- the steps to manufacture the ointment include the encapsulation of the aqueous solution and any additional substances within the base material.
- a quantity of the base material (Plasticized Base) is placed in a mixing device such as commercially know table top mixer, like the type manufactured by companies such as Sunbeam.
- a whipping or mixing process is then performed on the base material at a low sheer rate.
- the rate at which the base material is mixed or whipped is directly related to the size of the encapsulations created within the material. As mentioned above, the faster and shorter the mixing process, the larger the encapsulations will be.
- the size of the encapsulations is relevant because this is directly related to the rate at which the aqueous solution and the additional substances are delivered to the bodily area to which the ointment is applied.
- the base material is mixed in the container until encapsulations of the desired size are forced. This determination may made through a visual or other examination of the base material.
- a predetermined quantity of the aqueous solution is added during the mixing process to hydrate the base material. The entire amount of the aqueous solution may be added at once, or it may be added in separate portions to avoid any loss of solution due to splashing or other effects.
- the base material mixture Upon the addition of the aqueous solution, the base material mixture is monitored to detect when the desired amount aqueous solution has been encapsulated therein.
- One sign that encapsulation is complete, is the lack of standing liquids in the container employed for mixing.
- the mixing of the base materials continues after encapsulation of the aqueous solution.
- a quantity of the additional substances is then added. If loss of the additional substance may be a problem (i.e., due to splashing, etc.) the additional substance may be added in predetermined portions. It should be noted that the above process may be performed at room temperature however, the ambient temperature should not to exceed the melting temperature of the base material.
- the percentages of the base material, aqueous solution, and additional substances used during the formulation process can be varied depending upon the type of additional material employed and the desired rate or delivery of the encapsulated materials. For example, if the percentage of base material versus aqueous solution and additional substances is increased, the delivery rate will be increased. Conversely, if the percentage is decreased, the rate of delivery will increase. In use, the omtment can be applied directly to various bodily surfaces. As was described above, the base material has a melting temperature of approximately ninety degrees Fahrenheit.
- the body heat which may be approximately ninety-five to one hundred degrees Fahrenheit will begin to dissolve the bonds of the polyethylene glycol in the Plasticized base, which in turn releases an amount of the encapsulated aqueous solution and additional substance, if encapsulated, to the bodily area.
- the combination of the aqueous solution and mineral oil act as a moisturizing element for the exposed area.
- the slow release of the aqueous solution and additional substances is made possible by the fact that due to the chemical make-up of the polyethylene glycol, it will retain its structure and bond the mineral oil and hold the encapsulated material until a melting temperature is reached.
- the portion of the ointment in contact with the skin will have a higher temperature than the amount which is further from the skin.
- the portion of the ointment next to the skin will dissolve delivering its encapsulated material to the area while the portions away from the skin will remain cooler and thus retaining the encapsulated materials.
- the ointment has special applicability for use within the nasal cavity upon the nasal mucosa.
- the portion in contact with the skin will dissolve and deliver the encapsulated materials.
- the portion of the ointment exposed to the air will stay in the gelatinous state due to, in most cases, the lower ambient temperature of the air.
- the cooler temperatures are also due to evaporative cooling effects which are caused by the movement of air through the nasal cavity.
- This provides the benefit that the entire amount of ointment applied to the bodily surface does not dissolve and expose the entire amount of the encapsulated material to the area at once. All of the dissolved materials may be absorbed by the skin and the delivery of the additional substance to the bloodstream may occur.
- the ointment may be applied to other mucosal surfaces (vagina, rectum) but the rate of delivery may be greater due to the lack of moving air.
- 500 grams of Plasticized base may be placed in the mixing apparatus, such as a table top mixer.
- the mixer is started at a low sheer rate and the Plasticized base is mixed until the desired encapsulations are formed. With 500g of the material, it may take approximately 1 hour.
- the next step is to add all or a portion of the 193.75 cc's of bacteriostatic H 2 O to the Plasticized base.
- the mixing process is monitored to note when the desired amount of the bacteriostatic H 2 O is encapsulated within the Plasticized base. With the above recited amounts, the encapsulation of the bacteriostatic water may take approximately 8 - 12 hours.
- the ointment Upon completion of the mixing process, the ointment is ready for topical use. If the ointment is to be applied in the nasal cavity, a typical dosage may be 0.5g per nostril. Upon application, the total amount may dissolve in approximately 8-12 hour period. The dosage of the antibiotic in the ointment is approximately the same amount of the drug as if it had been prescribed orally. In situations where a higher dosage of an additional substance is called for, the amount of aqueous solution may be varied to compensate.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU22708/01A AU2270801A (en) | 1999-12-15 | 2000-12-15 | Topical ointment |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US46429399A | 1999-12-15 | 1999-12-15 | |
US09/464,293 | 1999-12-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2001043698A1 WO2001043698A1 (en) | 2001-06-21 |
WO2001043698A9 true WO2001043698A9 (en) | 2002-07-25 |
Family
ID=23843329
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/034185 WO2001043698A1 (en) | 1999-12-15 | 2000-12-15 | Topical ointment |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU2270801A (en) |
WO (1) | WO2001043698A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2942397B1 (en) | 2009-02-20 | 2011-03-25 | Daniel Frajdenrajch | DEVICE FOR MASSAGE BY LOW PRESSURE FORMING MULTIPLE PLY COMPOSITE PLASTS |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6160620A (en) * | 1984-09-03 | 1986-03-28 | Teijin Ltd | Pharmaceutical composition containing pyroglutamic acid ester |
US4917892A (en) * | 1988-06-28 | 1990-04-17 | Temple University | Encapsulated topical delivery system |
US5322689A (en) * | 1992-03-10 | 1994-06-21 | The Procter & Gamble Company | Topical aromatic releasing compositions |
IT1275955B1 (en) * | 1995-03-22 | 1997-10-24 | Dompe Spa | PHARMACEUTICAL FORMULATIONS IN THE FORM OF THISSOTROPIC GEL |
US5891465A (en) * | 1996-05-14 | 1999-04-06 | Biozone Laboratories, Inc. | Delivery of biologically active material in a liposomal formulation for administration into the mouth |
-
2000
- 2000-12-15 AU AU22708/01A patent/AU2270801A/en not_active Abandoned
- 2000-12-15 WO PCT/US2000/034185 patent/WO2001043698A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
WO2001043698A1 (en) | 2001-06-21 |
AU2270801A (en) | 2001-06-25 |
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