WO2011013009A4 - Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses - Google Patents

Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses Download PDF

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Publication number
WO2011013009A4
WO2011013009A4 PCT/IB2010/002241 IB2010002241W WO2011013009A4 WO 2011013009 A4 WO2011013009 A4 WO 2011013009A4 IB 2010002241 W IB2010002241 W IB 2010002241W WO 2011013009 A4 WO2011013009 A4 WO 2011013009A4
Authority
WO
WIPO (PCT)
Prior art keywords
agent
composition
weight
vitamin
alcohol
Prior art date
Application number
PCT/IB2010/002241
Other languages
French (fr)
Other versions
WO2011013009A2 (en
WO2011013009A3 (en
Inventor
Dov Tamarkin
Enbal Ziv
Yohan Hazot
David Schuz
Original Assignee
Foamix 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
Application filed by Foamix Ltd. filed Critical Foamix Ltd.
Priority to CA2769625A priority Critical patent/CA2769625C/en
Publication of WO2011013009A2 publication Critical patent/WO2011013009A2/en
Publication of WO2011013009A3 publication Critical patent/WO2011013009A3/en
Publication of WO2011013009A4 publication Critical patent/WO2011013009A4/en
Priority to IL217783A priority patent/IL217783A/en
Priority to US13/359,709 priority patent/US9167813B2/en
Priority to US14/857,282 priority patent/US9572775B2/en
Priority to US15/401,743 priority patent/US10092588B2/en
Priority to US16/108,799 priority patent/US11219631B2/en

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Classifications

    • 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
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/7056—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • A01N25/16—Foams
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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

Abstract

A substantially surface active agent-free foamable composition which includes short-chain alcohol, water, polymer, fatty alcohol or fatty acid or a combination of fatty alcohol and fatty acid and propellant. A substantially surface active agent-free foamable composition which includes, water, polymer, fatty alcohol or fatty acid and propellant. A method of treatment using a substantially surface active agent- free foamable compositions.

Claims

AMENDED CLAIMS received by the International Bureau on 11 April 2011 (11.04.2011)
1. A surfactant free foamable composition comprising:
a) a short chain alcohol;
b) water;
c) a foaming booster comprising:
i) about 0.1% to about 5% by weight of a polymer; and
ii) of at least one fatty alcohol or at least one fatty acid or a combination thereof ; and
d) a liquefied or compressed gas propellant at a concentration of about 3% to about 30% by weight of the total composition,
wherein the composition is free of surfactant,
wherein the percent by weight is based on weight foamable
composition;
wherein the ratio range of composition other than propellant to propellant is from about 100:3 to about 100:30; and
wherein upon dispensing the foamable carrier composition forms a foam of quality that is thermally stable, at a temperature of 36°C having a collapse time about or more than 60 seconds.
2. The composition of claim 1 wherein short chain alcohol is selected from the group consisting of ethanol or isopropanol.
3. The composition of claim 1, wherein the foaming booster combination is a synergistic combination that can improve the foam quality and or thermal stability of the composition.
4. The composition of claim 1, further comprising at least one active agent.
5. The composition of claim 4, wherein the active agent is selected form the group consisting of an active herbal extract, an acaricides, an age spot and keratose removing agent, an allergen, an alpha hydroxyl acid, an analgesic agent, an anesthetic, an immunogenic substance, an antiacne agent, an antiallergic agent, an antiaging agent, an antibacterial agent, an antibiotic, an antiburn agent, an anticancer agent, an antidandruff agent, an antidepressant, an antidermatitis agent, an antiedemic anent, an antifungal agent, an antihistamine, an antihelminth agent, an antihyperkeratolyte agent, an anti-infective agent, an antiinflammatory agent, an antiirritant, an antilipemic agent, an antimicrobial agent, an antimycotic agent, an antioxidant, an antiparasitic agent, an anti-pigmentation agent, an antiproliferative agent, an antipruritic agent, an antipsoriatic agent, an antirosacea agent, an antiseborrheic agent, an antiseptic agent, an antisweiling agent, an antiviral agent, an anti-wart agent, an anti-wrinkle agent, an antiyeast agents, an astringent, a beta-hydroxy acid, benzoyl peroxide, benzoyl chloride, a topical cardiovascular agent, a chemotherapeutic agent, a corticosteroid, an immunogenic substance, a dicarboxylic acid, a disinfectant, a fungicide, a hair growth regulator, a haptene, a hormone, a hydroxy acid, an immunosuppressant, an
immunoregulating agent, an immunomodulator, an insecticide, an insect repellent, a keratolytic agent, a lactam, a local anesthetic agent, a lubricating agent, a masking agent, a metals, a metal oxide, a mitocide, a neuropeptide, a non-steroidal anti-inflammatory agent, an oxidizing agent, a pediculicide, a peptide, a protein, a photodynamic therapy agent, a radical scavenger, a refatting agent, a retinoid, a sanative, a scabicide, a self tanning agent, silicone talc, a skin protective agent, a skin whitening agent, a steroid, a steroid hormone, a steroidal antiinflammatory agent ,a vasoconstrictor, a vasodilator, a vitamin, a vitamin A, a vitamin A derivative, a vitamin B, a vitamin B derivative, a vitamin C, a vitamin C derivative, a vitamin D, a vitamin D derivative, a vitamin D analog, a vitamin F, a vitamin F derivative, a vitamin K, a vitamin derivative, a wound healing agent and a wart remover and mixtures thereof.
6. The composition of claim 4, wherein the active agent is selected from the group consisting of Mometasone furoate or Betamethasone Valerate, Diclofenac sodium,
Metronidazole, Clindamycin phosphate and Benzoyl Peroxide.
7. The composition of claims 1, wherein the composition is transparent upon
pressurization by the gas propellant. '
8. The composition of claims 1, wherein the composition further includes a pH buffering agent.
9. The composition of claims 1 , wherein the composition further includes about 0.1% to about 5% of a humectant.
10. The composition of claims 9, wherein the humectant is selected from the group consisting of PEG 400, propylene glycol and glycerin.
1 1. The composition of claims 1, wherein the polymer is a cellulose-based polymer.
12. The composition of claims 1 1, wherein the polymer is selected from the group consisting of hydroxypropyl methycellulose and hydroxypropyl cellulose.
13. The composition of claim 1, wherein the fatty acid or fatty alcohol is selected from the group comprising of (i) 14 to 18 carbon atoms in its carbon chain or (ii) 16 to 18 carbon atoms in its carbon chain.
14. The composition of claim 3, where the synergistic combination is of at least two fatty alcohols.
15. The composition of claim 1 1 , wherein the combination of fatty alcohols is selected form a group comprising (i) a stearyl alcohol and cetyl alcohol or (ii) cetyl alcohol and myristyl alcohol or (iii) stearyl alcohol and myristyl alcohol.
16. The composition of claim 14, wherein the ratio between at least two fatty alcohols of the combination is between about 1 1 :5 and about 5: 1 1.
17. The composition of claim 14, wherein the ratio between at least two fatty alcohols of the combination is between about 1 : 1 and about 5: 1 1.
18. The composition of claim 1 , wherein the ratio of fatty alcohol/fatty acid to polymer is selected from the group consisting of a) about 100: 1 to about 1 :50 b) about 20: 1 and about 1 :20 and c) about 10: 1 and about 1 : 10.
19. The composition of claim 1 , wherein the short chain alcohol is selected from the group comprising of (i) at least about 15% by weight of the composition or (ii) is between about 20% and 60% by weight of the composition or (iii) is between about 30% and 60% by weight of the composition or (iv) is between about 40% and 60% by weight of the composition.
20. The composition of claim 1 , which is thermally stable at 36 °C having a collapse time of about or more than 120 seconds.
21. The composition of claim 1, which is thermally stable at 36 °C having a collapse time of about or more than 180 seconds.
22. The composition of claim 1, further comprising a hydrophilic solvent.
23. The composition of claim 1 , wherein the short chain alcohol is replaced by a hydrophilic solvent.
24. The composition of claim 1 , wherein the foam is a breakable foam that is thermally stable upon dispensing yet breaks easily upon application of shear force.
25. A surfactant free foamable composition comprising:
1 ) a short chain alcohol;
2) water;
3) a foaming booster comprising:
(i) about 0.1% to about 5% by weight of a polymer; and
(ii) at least one fatty alcohol or at least one fatty acid or a combination thereof or a synergistic combination of two or more fatty alcohols ; and
4) a liquefied or compressed gas propellant at a concentration of about 3% to about 30% by weight of the total composition,
wherein the percent by weight is based on weight foamable composition; wherein the ratio range of composition other than propellant to propellant is from about 100:3 to about 100:30; and wherein the ratio between the two fatty alcohols is between about 1 1 :5 and about 5: 1 1 .
26. The composition of claim 25, wherein the ratio between fatty alcohols of the synergistic combination is between about 1 : 1 and about 5: 1 1.
27. The composition of claim 25, further comprising an active agent.
28. A method of preventing or treating or ameliorating or eliminating or alleviating a dermatological or mucosal disorder, comprising: applying a surfactant free foamable composition to a surface having a dermatological or mucosal disorder in need of treatment, said composition comprising:
a) a short chain alcohol;
b) water;
c) a foaming booster comprising:
(i) about 0.1% to about 5% by weight of a polymer; and (ii) a at least one fatty alcohol or at least one fatty acid or
combination thereof or a synergistic combination of two or more fatty alcohols; and
d) a liquefied or compressed gas propellant at a concentration of about 3% to about 30% by weight of the total composition,
wherein the percent by weight is based on weight foamable composition; wherein the ratio range of composition other than propellant to propellant is from about 100:3 to about 100:30; and wherein upon dispensing the foamable carrier composition forms a foam that is thermally stable at a temperature of 36°C having a collapse time of about or more than 60 seconds.
29. The method of claim 28, further comprising at least one active agent.

Statement Under Article 19(1) (Rule 46.4)

Applicant respectfully submits that the claims have been amended without prejudice to Applicant's right to prosecute any subject matter no longer being claimed.

Claims 1, 25, and 28 are amended to remove the term "substantially" so that the claims now recite "surfactant free" instead of "substantially surfactant free" and "free of surfactant" instead of "substantially free of surfactant." Applicant respectfully submits that these claim amendments submitted herewith are fully supported by the description in accord with the requirements of Articles 5 and 6 of the Patent Cooperation Treaty.

Specifically, support for this amendment is found on page 34, paragraph [0132].

Applicant submits that the presently claimed subject matter meets the requirements of novelty, inventive step, and industrial applicability.

PCT/IB2010/002241 2009-07-29 2010-07-29 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses WO2011013009A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA2769625A CA2769625C (en) 2009-07-29 2010-07-29 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses
IL217783A IL217783A (en) 2009-07-29 2012-01-26 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses
US13/359,709 US9167813B2 (en) 2009-07-29 2012-01-27 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses
US14/857,282 US9572775B2 (en) 2009-07-29 2015-09-17 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses
US15/401,743 US10092588B2 (en) 2009-07-29 2017-01-09 Foamable compositions, breakable foams and their uses
US16/108,799 US11219631B2 (en) 2009-07-29 2018-08-22 Foamable compositions, breakable foams and their uses

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US22933209P 2009-07-29 2009-07-29
US61/229,332 2009-07-29

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/359,709 Continuation US9167813B2 (en) 2009-07-29 2012-01-27 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses

Publications (3)

Publication Number Publication Date
WO2011013009A2 WO2011013009A2 (en) 2011-02-03
WO2011013009A3 WO2011013009A3 (en) 2011-05-05
WO2011013009A4 true WO2011013009A4 (en) 2011-06-23

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PCT/IB2010/002241 WO2011013009A2 (en) 2009-07-29 2010-07-29 Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses

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Country Link
US (4) US9167813B2 (en)
CA (1) CA2769625C (en)
IL (1) IL217783A (en)
WO (1) WO2011013009A2 (en)

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