WO2004096119A2 - Topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same - Google Patents

Topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same

Info

Publication number
WO2004096119A2
WO2004096119A2 PCT/IL2004/000350 IL2004000350W WO2004096119A2 WO 2004096119 A2 WO2004096119 A2 WO 2004096119A2 IL 2004000350 W IL2004000350 W IL 2004000350W WO 2004096119 A2 WO2004096119 A2 WO 2004096119A2
Authority
WO
Grant status
Application
Patent type
Prior art keywords
composition
oil
pharmaceutical
invention
present
Prior art date
Application number
PCT/IL2004/000350
Other languages
French (fr)
Other versions
WO2004096119A3 (en )
Inventor
Shaul Eger
Isaac Neeman
Original Assignee
Dr. Eger - Olive Oil Products Industry Ltd.
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/36Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

A healing composition, in particular being a cream, with a broad-spectrum sanative effect, substantially comprising a mixture of a monounsaturated fatty acid and an omega-3 fatty acid, is disclosed. In a preferable embodiment the composition includes antioxidants.

Description

TOPICAL PHARMACEUTICAL COMPOSITIONS, METHODS OF MANUFACTURE THEREOF AND ARTICLES OF MANUFACTURE

CONTAINING SAME

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates generally to topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same. Specifically, the invention relates to preparations which rely primarily upon olive oil as an active ingredient and are characterized by a pleasant, texture. The skin of animals including human beings is often afflicted by various conditions and ailments. Some of these conditions are cosmetic in nature: blemishes, dryness, reddishness, pimples, spots, discolorations, scars, nicks, diaper rash, sunburn, wrinkles and the like. Some conditions are medical ailments such as severe acne, burns, cuts, scrapes, chafes, warts, venous insufficiency, ulcers and the like. Various salves, creams and unguents exist to relieve some or all of these conditions. These often contain synthetic oils and fats, minerals and preservatives. In addition, many conditions exist for which the available preparations are of dubious efficacy.

There is a need for topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same with improved efficacy in relieving symptoms of dermatologic conditions.

SUMMARY OF THE INVENTION

The above and other objectives are achieved by the composition of the present invention in a liquid form. In addition, the utility of the composition of the present invention is dramatically increased when used in a cream or ointment form.

Further, the composition prepared by the method of the present invention is exceptionally effective in alleviating discomfort and accelerating the healing of a broad spectrum of skin conditions and ailments. Further, the present invention teaches new and highly effective methods of treating a broad spectrum of conditions, both medical ailments and cosmetic conditions. By treating, herein is meant both alleviating symptoms associated with an aihnent, accelerating healing of the ailment itself, or a cosmetic improvement.

According to the teachings of the present invention there is provided a composition comprising two or more oils from natural sources so that the final composition monounsaturated fatty acids and omega-3 fatty acids. The amount of monounsaturated fatty acids includes at least 40% (preferably 50%, more preferably 60%) by weight. Although any amount of omega-3 fatty acids may have a desired effect, the inventor currently believes that a noticeable effect begins when there is at least 0.2% by weight omega-3 fatty acids, preferably more than 1%, and even more preferably more than 5%. Even higher amounts of omega-3 fatty acids such as greater than 10% or even 20% have been shown to be exceptionally effective.

In a preferred embodiment, the composition of the present invention includes antioxidants, preferably natural antioxidants.

In an additionally preferred embodiment, the composition of the present invention also includes one or more additives including ascorbyl pahnitate, alpha and or beta hydroxy acids, other glycolic acids, alpha lipoic acids, tocotrienol and dimethyl amino ethanol (DMAE).

A most preferred substance for use as a omega-3 fatty acid component of the composition of the present invention is fish oil. A most preferred substance for use as a monounsaturated fatty acid component of the composition of the present invention is olive oil which also naturally contains antioxidants such as vitamin E and polyphenols.

A preferred formulation of the composition of the present invention includes about 70% by weight olive oil and about 20% by weight fish oil. According to the teachings of the present invention there is provided a method of providing a composition of the present invention in a cream or ointment form comprising generally applying the teachings of U.S. patent 6,117,476, U.S. patent 6,156,369 and/or PCT publication WO 03/005831 (included by reference as if fully set forth herein) to a composition of the present invention as described herein. There is also provided according to the teachings of the present invention a method of treating a cosmetic condition or a skin ailment by topical application of a composition (in liquid or cream form) of the present invention. The cosmetic conditions and ailments found to be treatable according to the teachings of the present invention include but are not limited to burns (first, second and third degree), abscesses, dry skin, chapped skin, chaffed skin, callused skin, irritated skin, lesions, scraped skin, acne vulgaris, skin wounds, skin ulcers (especially those found in diabetics), sunburnt skin, skin damaged by UV radiation, psoriasis, dermatitis, seborrhea, eczema, inflammation and swelling and prevention of scars.

There is also provided according to the teachings of the present invention for the use of a composition of the present invention for the manufacture of a medicament, such as an analgesic, anti-inflammatory, moisturizing, antipruritic, emollient, sanative and antiedemic medicament.

There is also provided according to the teachings of the present invention for the use of a composition of the present invention for the manufacture of a medicament for the treatment of ailments such as described above. According to one aspect of the present invention there is provided a pharmaceutical composition The pharmaceutical composition includes as an active ingredient a mixture of: (a) an olive oil; (b) an omega-3 fatty acid source; and (c) an emulsifier with carriers and excipients as required. The pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. This type of pharmaceutical composition finds especial utility in treatment of venous insufficiency, for example in treatment of diabetic ulcers.

The term "carriers" as used in this specification and the accompanying claims includes, but is not limited to, vegetable oils such as sunflower oil or soybean oil. According to another aspect of the present invention there is provided a method of manufacturing a topical pharmaceutical composition. The method includes mixing physiologically effective concentrations of: (a) an olive oil; and (b) an omega-3 fatty acid source with an emulsifier, carriers and excipients as required to form a mixture wherein the pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. According to yet another aspect of the present invention there is provided an article of manufacture which includes (a) a pharmaceutical composition including as an active ingredient a mixture of :(i) an olive oil; (ii) an omega-3 fatty acid source; and (iii) an emulsifier, carriers and excipients as required; (b) packaging material; (c) instructions for use identifying the pharmaceutical composition as effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.

According to still another aspect of the present invention there is provided an additional pharmaceutical composition. The additional pharmaceutical composition includes as an active ingredient a physiologically active mixture of: (a) an olive oil; and (b) a vitamin-derived antioxidant; and (c) an alpha hydroxy acid with an emulsifier, carriers and excipients as required. The pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. This type of pharmaceutical composition finds especial utility in treatment of herpes virus symptoms, burns, skin graft acceptance, cuts (e.g. resulting from shaving) abrasions, scars (e.g. blood vessels, acne scars).

According to an additional aspect of the present invention there is provided a method of manufacturing a topical pharmaceutical composition, the method includes mixing physiologically effective concentrations of: (a) an olive oil; and (b) a vitamin- derived antioxidant; and (c) an alpha hydroxy acid with an emulsifier carriers and excipients as required to form a mixture. The pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.

According to yet an additional aspect of the present invention there is provided an article of manufacture including: (a) a pharmaceutical composition containing as an active ingredients a physiologically effective mixture of: (i) an olive oil; (ii) a vitamin- derived antioxidant; (iii) an alpha hydroxy acid; and (iv) an emulsifier, carriers and excipients as required; (b) packaging material; and (c) instructions for use identifying the pharmaceutical composition as effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. According to further features in preferred embodiments of the invention described below, the pharmaceutical composition further includes ascorbyl palmitate.

According to still further features in the described preferred embodiments the olive oil is 40% to 92.5% of the pharmaceutical composition by weight, more preferably 60 to 80%, most preferably about 70%.

According to still further features in the described preferred embodiments at least one omega-3 fatty acid is 0.5% to 20% of the pharmaceutical composition by weight.

According to still further features in the described preferred embodiments the omega-3 fatty acid source includes at least one item selected from the group consisting of a fish oil, a primrose oil, a flaxseed oil, a safflower oil, and a bourage oil.

According to still further features in the described preferred embodiments the emulsifier is 7 to 10% of the pharmaceutical composition by weight.

According to still further features in the described preferred embodiments the emulsifier includes at least one item selected from the group consisting of a monoglyceride and a palmitic fatty acid. Alternately, or additionally, PO5 may be employed for emulsification.

According to still further features in the described preferred embodiments the method further includes heating the mixture to a temperature in the range of 45 to 75 degrees centigrade followed by cooling the mixture to room temperature.

According to still further features in the described preferred embodiments the olive oil is 40% to 91.9% of the pharmaceutical composition by weight, more preferably more than 68%.

According to still further features in the described preferred embodiments the vitamin-derived antioxidant is selected from the group consisting of vitamin C, vitamin E and derivatives thereof. For example, ascorbyl palmitate and tocotrienol are especially well suited for use in the present invention.

According to still further features in the described preferred embodiments the vitamin-derived antioxidant is 0.1% to 3% of the composition by weight, more preferably 0.2 to 0.5%, most preferably about 0.3%. According to still further features in the described preferred embodiments the alpha hydroxy acid includes a lactic acid, for example lactic acid derived from sugar cane.

According to still further features in the described preferred embodiments the alpha hydroxy acid is 0.5 to 10% of the composition by weight, more preferably 1 to 5%, most preferably about 2.5%.

According to still further features in the described preferred embodiments the pharmaceutical composition further includes dimethylamino ethanol (DMAE). When DMAE is included, it may be advantageous to add small quantities (i.e. PPM concentrations) of essential oils to mask the unpleasant smell.

According to still further features in the described preferred embodiments the emulsifier is selected from the group consisting of a monoglyceride and a palmitic fatty acid.

According to still further features in the described preferred embodiments the emulsifier is present at a concentration of 7% to 10% by weight.

The present invention successfully addresses the shortcomings of the presently known configurations by providing topical pharmaceutical compositions that are efficaceous, safe to use and readiuly accepted by subjects.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is of topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same which can be employed to provide at least symptomatic relief from a variety of dermatologic conditions. Specifically, the present invention can be used to relieve venous insufficiency, relieve symptoms of viral infection, promote wound healing and prevent skin graft rejection.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

According to one aspect of the present invention there is provided a pharmaceutical composition. The pharmaceutical composition includes as an active ingredient a mixture of an olive oil and an omega-3 fatty acid source with an emulsifier. Carriers and excipients are included as required. The pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. This type of pharmaceutical composition finds especial utility in treatment of venous insufficiency, for example in treatment of diabetic ulcers.

According to another aspect of the present invention there is provided a method of manufacturing a topical pharmaceutical composition as described hereinabove. The method includes mixing physiologically effective concentrations of an olive oil and an omega-3 fatty acid source with an emulsifier to form a mixture. Carriers and excipients are optionally included. Mixing is preferably conducted concurrently with heating as described hereinbelow.

Most prefereably the pharmaceutical composition described hereinabove is provided as an article of manufacture which includes the pharmaceutical composition including as an active ingredient a mixture of an olive oil an omega-3 fatty acid source and an emulsifier, packaging material and instructions for use identifying the pharmaceutical composition as effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.

Optionally, but preferably, the pharmaceutical composition further includes ascorbyl palmitate as an antioxidant. According to some preferred formulations, 40% to 92.5% of the pharmaceutical composition by weight is olive oil, more preferably 60 to 80%), most preferably about 70%.

According to some preferred formulations of the pharmaceutical composition the at least one omega-3 fatty acid is 0.5% to 20% by weight of the composition. According to various preferred embodiments, the omega-3 fatty acid source may include, for example, a fish oil, a primrose oil, a flaxseed oil, a safflower oil, or a bourage oil. Optionally, but preferably, the pharmaceutical composition includes 7 to 10% by weight of the emulsifier. The emulsifier may include, for example, a monoglyceride and/or a palmitic fatty acid. Alternately, or additionally, PO5 may be employed for emulsification ("Food and Marketing Technology" April 2002 pp. 44-45). According to still another aspect of the present invention there is provided an additional pharmaceutical composition. The additional pharmaceutical composition includes as an active ingredient a physiologically active mixture of an olive oil and a vitamin-derived antioxidant and an alpha hydroxy acid with an emulsifier, carriers and excipients as required. The additional pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. This type of pharmaceutical composition finds especial utility in treatment of herpes virus symptoms, burns, skin graft acceptance, cuts (e.g. resulting from shaving) abrasions, scars (e.g. blood vessels, acne scars).

According to an additional aspect of the present invention there is provided a method of manufacturing the additional topical pharmaceutical composition. The method includes mixing physiologically effective concentrations of an olive oil and a vitamin-derived antioxidant and an alpha hydroxy acid with an emulsifier to form a mixture. Optionally, bur preferably, carriers and excipients are added as required. The pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied. Preferably, preparatioin of a phramaceutical composition according to methods of the present invention further includes heating the mixture to a temperature in the range of 45 to 75 degrees centigrade followed by cooling the mixture to room temperature.

According to yet another additional aspect of the present invention there is provided an article of manufacture including the additional pharmaceutical composition as described hereinabove, packaging material and instructions for use identifying the additional pharmaceutical composition as effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.

The additional pharmaceutical composition preferably includes 40% to 91.9% olive oil by weight, more preferably more than 68%. The vitamin-derived antioxidant may be, for example, vitamin C, vitamin E or derivatives thereof alone or in combination. Formulations including ascorbyl pahnitate and/or tocotrienol most preferred. The vitamin-derived antioxidant is preferably 0.1% to 3% of the composition by weight, more preferably 0.2 to 0.5%, most preferably about 0.3%. Preferably, the alpha hydroxy acid includes a lactic acid, most preferably lactic acid derived from sugar cane. The alpha hydroxy acid is preferably 0.5%-10%, more preferably 1% to 5%, most preferably about 2.5% of the composition by weight. The emulsifier may be, for example, a monoglyceride or a palmitic fatty acid and is preferably present at a concentration of 7% to 10% by weight.

Optionally, but preferably, the pharmaceutical composition further includes dimethylamino ethanol (DMAE). When DMAE is included, it may be advantageous to add small quantities (i.e. PPM concentrations) of essential oils to mask the unpleasant smell.

Most generally the composition is made up of a combination of natural oils from plant or animal sources (preferably not mineral or synthetic) so that the composition includes cis monounsaturated fatty acids, omega 3 fatty acids and antioxidants.

Preferred oils used in making a composition of the present invention include but are not limited to olive oil, avocado oil, peanut oil, canola oil, camelina oil, walnut oil, nut oils, macadamia oil, flaxseed oil, linseed oil, perilla oil, fish oil, sesame oil, wheat germ oil, jojoba oil, evening primrose oil, borage oil, palm oil and vernonia oil. It is preferred that the oils used in preparing the composition of the present invention do not include fatty acids that are distilled, hardened, hydrogenated or trans. It is important to note that exceptions can be found. In naturally occurring non- processed palm oil there are saturated fats. At the same time palm oil has a high percentage of anti-oxidants. Thus palm oil is a good anti-oxidant source according to the present invention.

Most preferred is a combination of olive oil as a source of monounsaturated fatty acids and fish oil as a source of omega 3 fatty acids.

It has been found that the efficacy of the composition of the present invention is unexpectedly increased by the addition of one or more of the following additives: ascorbyl palmitate, alpha and or beta hydroxy acids, other glycolic acids, alpha lipoic acids, tocotrienol and dimethyl amino ethanol (DMAE). One skilled in the art recognizes that oils are generally less convenient for use for topical application than ointments. Relative to ointment dosage of oils is difficult and the feeling on the skin is unpleasant. However most methods of giving oils a smooth, smearable texture involve the use of water. Consequently the effect of the oils is diluted and often preservatives are necessary. Other methods involve chemical modification of the oils and fatty acids that damage or reduce the useful effects of the oils.

One skilled in the art recognizes that the teachings of U.S. patent 6,117,476, U.S. patent 6,156,369 and/or PCT publication WO 03/005831 provide a simple, easy to use method for changing the liquid composition of the present invention to a ointment. These teachings require only moderate heating that does not substantially effect the molecular structure or chemical composition of the composition of the present invention.

Further, it has been unexpectedly found that the ointment is absorbed into the skin with surprising facility and leaves a pleasant and not oily feel to the skin. Although not wishing to be held to any one theory, it is believed that the additives used in producing the lamellar liquid crystal structure of the ointment composition of the present invention assist in the absorption of the composition into the skin.

Although many of the oils used in the present invention naturally include antioxidants {e.g. olive oil contains 150mg/l vitamin E and 350 mg/1 polyphenols) it has been found that the addition of extra antioxidants in relatively high concentrations amplifies the healing effects of the composition of the present invention far beyond what would be expected by one skilled in the art. There is an apparent synergistic effect of the monounsaturated fatty acid, the omega 3 fatty acid and the antioxidant. Preferred antioxidants are: ascorbyl palmitate, alpha and or beta hydroxy acids, other glycolic acids, alpha lipoic acids and tocotrienol.

Another preferred additive is dimethyl amino ethanol (DMAE) known for use in rejuvenating the skin and treating wrinkles in the skin.

An exceptionally effective composition and thus a currently preferred embodiment of the present invention is made by combining 70g olive oil, 20g fish oil, 7 g monoglyceride and 2g PO5 in accordance with the teachings of U.S. patent 6,117,476, U.S. patent 6,156,369 and/or PCT publication WO 03/005831. To this basic composition it has been found useful to add one or more of the following up to lg ascorbyl palmitate and / or lg lipoic acid and / or lg DMAE and / or up to 5g alpha hydroxy acid (such as glycolic acid, lactic acid). These patents contain no hint or fair suggestion that topical application of olive oil based formulations is desireable or advantageous.

Use of compositions according to the present invention includes the topical application of the composition of the present invention to treat a dermatologic condition. Generally once or twice daily use of an amount of composition that covers the affected area in its entirety has proven to be effective.

Beyond use as an oil, salve, unguent, ointment or lotion, embodiments of the composition of the present invention include lipstick, diaper cream, udder cream, hand lotion, after-sun lotion and aftershave.

The composition of the present invention has been applied to treat various skin ailments of various humans. Equal efficacy is expected for non-human animals especially mammals.

In various formulations the composition of the present invention has been found to be efficient in mitigating the discomfort of dry skin, irritated skin, chaffed skin, wounded skin, ulceric skin, sunburnt skin or otherwised UV-damaged skin. It has also been found that the composition of the present invention has a mitigating and healing effect on ulcers typical of patients afflicted with diabetes.

The composition of the present invention has been found efficient in the prevention of scars, for example, when applied to wounds after surgery.

The composition of the present invention has also been found effective in accelerating the healing of wounds .

Preliminary experiments on a variety of lesions, wounds, chaffs, scrapes, scars and other skin ailments such as dermatitis, seborrhea, eczema, third-degree burns, diabetic ulcers, psoriasis have all shown a clear and definite sanitive and pallitive effect.

In general compositions of the present invention have shown analgesic, anti- inflammatory, moisturizing, antipruritic, astringent, emollient, sanative and antiedemic effects. EXAMPLE

Reference is now made to the following example, which together with the above descriptions, illustrate the invention in a non limiting fashion. Before presesnting examples, reference is made to the following materials and methods employed in performance of experiments described in the excamples.

MATERIALS AND METHODS: Olive Oil/Omega-3: Olive oil base containing 20% fish oil which includes 30% EPA+DHA plus a palm oil derived monoglyceride. No water is included and the preparation is manufactured under pasteurizing conditions and vacuum pressure (-0.1 Atmosphere).

Aqua-cream: Emulsifying wax, wood alcohol, white soft paraffin, liquid paraffin, water (47%)and vitamin E.

EXAMPLE : RELIEF OF VENOUS INSUFFICIENCY

Fourteen patients with persistent bilateral venous insufficiency of the feet and legs were employed in the study. Patients topically applied aqua-cream to one leg/foot and Olive Oil/Omega-3 according to the present invention to the opposing leg/foot. Olive Oil/Omega-3 according to the present invention was far superior to the control Aqua-cream with 4/14 (29%) of patients reporting significant reduction in symptoms and 8/14 (57%) reporting disapopearance of dry skin/cracks in the Olive Oil/Omega-3 treated leg. In sharp contrast, only 4/14 patients (29%) reported improvement in the Aquua cream treated leg. These results indicate the compositions of the present invention are superior to previously available alternatives. (Results presented at 30th Annual Conference of the Israeli Society of Plastic Surgery, November 2003)

The present invention is not limited to the embodiments described herein but encompasses any and all embodiments a within the scope of the claims, including obvious variants thereof. Such obvious variants include diluting the composition of the present invention with unsuitable oils and fatty acids.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

WHAT IS CLAIMED:
1. A pharmaceutical composition, the pharmaceutical composition comprising as an active ingredient a mixture of:
(a) an olive oil;
(b) an omega-3 fatty acid source; and
(c) an emulsifier with carriers and excipients as required; wherein the pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.
2. The pharmaceutical composition of claim 1, further comprising ascorbyl palmitate.
3. The pharmaceutical composition of claim 1, wherein said olive oil comprises 40% to 92.5%) of the pharmaceutical composition by weight.
4. The pharmaceutical composition of claim 1 , wherein at least one omega-3 fatty acid comprises 0.5% to 20% of the pharmaceutical composition by weight.
5. The pharmaceutical composition of claim 1, wherein said omega-3 fatty acid source includes at least one item selected from the group consisting of a fish oil, a primrose oil, a flaxseed oil, a safflower oil, and a bourage oil.
6. The pharmaceutical composition of claim 1, wherein said emulsifier comprises 7 to 10% of the pharmaceutical composition by weight.
7. The pharmaceutical composition of claim 1, wherein said emulsifier includes at least one item selected from the group consisting of a monoglyceride and a palmitic fatty acid.
8. A method of manufacturing a topical pharmaceutical composition, the method comprising mixing physiologically effective concentrations of:
(a) an olive oil; and
(b) an omega-3 fatty acid source; with an emulsifier, carriers and excipients as required to form a mixture; wherein the pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.
9. The method of claim 8, further comprising including ascorbyl palmitate in the topical pharmaceutical composition.
10. The method of claim 8, wherein said olive oil comprises 40% to 92.5% of the pharmaceutical composition by weight.
11. The method of claim 8, wherein at least one omega-3 fatty acid comprises
0.5% to 20% of the pharmaceutical composition by weight.
12. The method of claim 8, wherein said omega-3 fatty acid source includes at least one item selected from the group consisting of a fish oil, a primrose oil, a flaxseed oil, a safflower oil, and a bourage oil.
13. The method of claim 8, wherein said emulsifier comprises 7 to 10% of the pharmaceutical composition by weight.
14. The method of claim 8, wherein said emulsifier includes at least one item selected from the group consisting of a monoglyceride and a palmitic fatty acid.
15. The method of claim 8, further comprising heating said mixture to a temperature in the range of 45 to 75 degrees centigrade followed by cooling said mixture to room temperature.
16. An article of manufacture comprising :
(a) a pharmaceutical composition comprising as an active ingredient a mixture of :
(i) an olive oil; (ii) an omega-3 fatty acid source; and
(iii) an emulsifier, carriers and excipients as required;
(b) packaging material; (c) instructions for use identifying the pharmaceutical composition as effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.
17. The article of manufacture of claim 16, further comprising ascorbyl palmitate.
18. The article of manufacture claim 16, wherein said olive oil comprises
40% to 92.5%) of the pharmaceutical composition by weight.
19. The article of manufacture of claim 16, wherein at least one omega-3 fatty acid comprises 0.5% to 20% of the pharmaceutical composition by weight.
20. The article of manufacture of claim 16, wherein said omega-3 fatty acid source includes at least one item selected from the group consisting of a fish oil, a primrose oil, a flaxseed oil, a safflower oil, and a bourage oil.
21. The article of manufacture of claim 16, wherein said emulsifier comprises
7 to 10% of the pharmaceutical composition by weight.
22. The article of manufacture of claim 16, wherein said emulsifier includes at least one item selected from the group consisting of a monoglyceride and a palmitic fatty acid.
23. A pharmaceutical composition, the pharmaceutical composition comprising as an active ingredient a physiologically active mixture of:
(a) an olive oil; and
(b) a vitamin-derived antioxidant; and (c) an alpha hydroxy acid with an emulsifier, carriers and excipients as required; wherein the pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.
24. The pharmaceutical composition of claim 23, wherein said olive oil comprises 40%> to 91.9% of the pharmaceutical composition by weight.
25. The pharmaceutical composition of claim 23, wherein said vitamin- derived antioxidant is selected from the group consisting of vitamin C, vitamin E and derivatives thereof.
26. The pharmaceutical composition of claim 23, wherein said vitamin- derived antioxidant comprises 0.1% to 3% of the composition by weight.
27. The pharmaceutical composition of claim 23, wherein said alpha hydroxy acid includes a lactic acid.
28. The pharmaceutical composition of claim 23, wherein said alpha hydroxy acid comprises 0.5-10% of the composition by weight.
29. The pharmaceutical composition of claim 23, further comprising dimethylamino ethanol (DMAE).
30. The pharmaceutical composition of claim 23, wherein said emulsifier is selected from the group consisting of a monoglyceride and a pahnitic fatty acid.
31. The pharmaceutical composition of claim 23, wherein said emulsifier is present at a concentration of 7% to 10% by weight.
32. A method of manufacturing a topical pharmaceutical composition, the method comprising mixing physiologically effective concentrations of:
(a) an olive oil; and
(b) a vitamin-derived antioxidant; and
(c) an alpha hydroxy acid with an emulsifier carriers and excipients as required to form a mixture; wherein the pharmaceutical composition is effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.
33. The method of claim 32, wherein said olive oil comprises 40% to 91.9% of the pharmaceutical composition by weight.
34. The method of claim 32, wherein said vitamin-derived antioxidant is selected from is selected from the group consisting of vitamin C, vitamin E and derivatives thereof.
35. The method of claim 32, wherein said vitamin-derived antioxidant comprises 0.1% to 3 % of the composition by weight.
36. The method of claim 32, wherein said alpha hydroxy acid includes lactic acid.
37. The method of claim 32, wherein said alpha hydroxy acid comprises 0.5% to 10 % of the composition by weight.
38. The method of claim 32, further comprising including dimethylamino ethanol (DMAE) in the pharmaceutical composition.
39. The method of claim 32, wherein said emulsifier is selected from the group consisting of a monoglyceride and a palmitic fatty acid.
40. The method of claim 32, wherein said emulsifier is present at a concentration of 7% to 10% by weight.
41. The method of claim 32, further comprising heating said mixture to a temperature in the range of 45 to 75 degrees centigrade followed by cooling said mixture to room temperature.
42. An article of manufacture comprising:
(a) a pharmaceutical composition containing as an active ingredients a physiologically effective mixture of :
(i) an olive oil; (ii) a vitamin-derived antioxidant;
(iii) an alpha hydroxy acid; and
(iv) an emulsifier, carriers and excipients as required;
(b) packaging material;
(c) instructions for use identifying the pharmaceutical composition as effective in at least partially ameliorating at least one symptom of a dermatologic condition when topically applied.
43. The article of manufacture of claim 42, wherein said olive oil comprises 40% to 91.9% of the pharmaceutical composition by weight.
44. The article of manufacture of claim 42, wherein said vitamin-derived antioxidant is selected from the group consisting of vitamin C, vitamin E and derivatives thereof.
45. The article of manufacture of claim 42, wherein said vitamin-derived antioxidant comprises 0.1% to 3% of the composition by weight.
46. The article of manufacture of claim 42, wherein said alpha hydroxy acid includes lactic acid.
47. The article of manufacture of claim 42, wherein said alpha hydroxy acid comprises 0.5% to 10% of the composition by weight.
48. The article of manufacture of claim 42, further comprising dimethylamino ethanol (DMAE).
49. The article of manufacture of claim 42, wherein said emulsifier ipresent at a concentration of 7% to 10% by weight.
50. The article of manufacture of claim 42, wherein said emulsifier is selected from the group consisting of a monoglyceride and a palmitic fatty acid.
PCT/IL2004/000350 2003-04-30 2004-04-25 Topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same WO2004096119A3 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US46640903 true 2003-04-30 2003-04-30
US60/466,409 2003-04-30

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11261640 US7201927B2 (en) 2004-04-25 2005-10-31 Nutritional olive oil based compositions, and method of consumption thereof

Publications (2)

Publication Number Publication Date
WO2004096119A2 true true WO2004096119A2 (en) 2004-11-11
WO2004096119A3 true WO2004096119A3 (en) 2005-06-30

Family

ID=33418375

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2004/000350 WO2004096119A3 (en) 2003-04-30 2004-04-25 Topical pharmaceutical compositions, methods of manufacture thereof and articles of manufacture containing same

Country Status (1)

Country Link
WO (1) WO2004096119A3 (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007051829A1 (en) * 2005-11-03 2007-05-10 Laboratorios Belmac, S.A. Oleuropein for the treatment of conditions associated to the peripheral vascular disease
EP2279667A1 (en) 2009-07-30 2011-02-02 Brudy Technology, S.L. Vegetable and marine oil or fat compositions enriched with DHA or EPA and C18 or higher fatty acid
WO2011141611A1 (en) * 2010-05-14 2011-11-17 Sanidad Y Residencias 21, S.A., Oleuropein compositions for healing wounds and ulcers in elderly people and/or diabetics
ES2395539A1 (en) * 2011-06-16 2013-02-13 Agencia Pública Empresarial Sanitaria Hospital Alto Guadalquivir Use olive oil in the prevention and treatment of diseases associated with ischemia
EP2632414A1 (en) * 2010-10-27 2013-09-04 Nestec S.A. Methods and compositions suitable for promoting healthy skin

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6078542A (en) * 1983-10-03 1985-05-04 Nikken Sutamii Kk Production of food oil having balanced fatty acid content

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007051829A1 (en) * 2005-11-03 2007-05-10 Laboratorios Belmac, S.A. Oleuropein for the treatment of conditions associated to the peripheral vascular disease
EP2279667A1 (en) 2009-07-30 2011-02-02 Brudy Technology, S.L. Vegetable and marine oil or fat compositions enriched with DHA or EPA and C18 or higher fatty acid
WO2011141611A1 (en) * 2010-05-14 2011-11-17 Sanidad Y Residencias 21, S.A., Oleuropein compositions for healing wounds and ulcers in elderly people and/or diabetics
EP2632414A1 (en) * 2010-10-27 2013-09-04 Nestec S.A. Methods and compositions suitable for promoting healthy skin
JP2013542222A (en) * 2010-10-27 2013-11-21 ネステク ソシエテ アノニム The methods and compositions suitable for promoting healthy skin
EP2632414A4 (en) * 2010-10-27 2014-03-12 Nestec Sa Methods and compositions suitable for promoting healthy skin
US9301973B2 (en) 2010-10-27 2016-04-05 Nestec S.A. Methods and compositions suitable for promoting healthy skin
ES2395539A1 (en) * 2011-06-16 2013-02-13 Agencia Pública Empresarial Sanitaria Hospital Alto Guadalquivir Use olive oil in the prevention and treatment of diseases associated with ischemia
WO2012172150A3 (en) * 2011-06-16 2013-03-21 Agencia Pública Empresarial Sanitaria Hospital Alto Guadalquivir Use of olive oil to prevent and to treat diseases involving an ischemic process

Also Published As

Publication number Publication date Type
WO2004096119A3 (en) 2005-06-30 application

Similar Documents

Publication Publication Date Title
US4593046A (en) Method of reducing skin irritation from benzoyl peroxide
US20020039591A1 (en) Topical applications for skin treatment
US5266318A (en) Skin therapeutic mixture containing cold-processsed aloe vera extract, with yellow sap and aloin removed
US6193987B1 (en) Lubricating composition for hands and skin
US6645510B1 (en) Method of treating topical ailments
US20040214750A1 (en) Medicaments for healing skin conditions in humans
US20050226945A1 (en) Compositions and methods for the treatment of radiation burns and other traumatic skin conditions
US6096326A (en) Skin care compositions and use
US20070280898A1 (en) Dermatological compositions
EP0133151A2 (en) Skin ointment
US4235889A (en) Therapeutic agent for the external treatment of psoriasis, tinea and eczemas
Maddocks-Jennings et al. Novel approaches to radiotherapy-induced skin reactions: a literature review
US20030104018A1 (en) Skin product having micro-spheres, and processes for the production thereof
EP1074245A2 (en) Composition using mineral salts for therapeutic treatment
FR2504551A1 (en) Compsn. for treating skin, e.g. burns, eczema or acne - contains essential oils from Labiatae and other plant families
US20030008022A1 (en) Medical effect of jojoba oil
Burlando et al. Honey in dermatology and skin care: a review
WO2003011303A1 (en) Dermal therapy using phosphate derivatives of electron transfer agents
US20020176876A1 (en) Topical therapeutic skin care system
RU2166309C1 (en) Treatment-and-prophylactic and cosmetic composition
WO1989000853A1 (en) Agent containing salicylic acid for treating lepidosis
US20010001665A1 (en) Cream compositions for skin management
DE4022815A1 (en) Topical preparation contg. omega-3-fatty acids - for prophylaxis and treatment of skin inflammation e.g. eczema, burns, acene, contact allergies etc.
WO2006111633A2 (en) Use of lecithin as a medicament for treating psoriasis
US20050255166A1 (en) Composition

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 11261640

Country of ref document: US

122 Ep: pct application non-entry in european phase