IP Library Granted Patent US 9,918,960
Granted Patent B2
US 9,918,960 · App. 15/643,888 · Granted Mar 20, 2018

Topical oily foam compositions

Inventors: Michal N. Arnon (Midreshet Ben-Gurion, IL); Tatiana Kamenetsky (Beer Sheva, IL)
Assignee: PERRIGO ISRAEL PHARMACEUTICALS LTD.
A61K31/351A61K9/0014A61K9/122A61K31/59A61K47/14A61K47/44
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Quick Facts
Patent No.
US 9,918,960
App. No.
15/643,888
Granted
Mar 20, 2018
Kind
B2
Abstract

Topical alcohol-free thermo labile oily foam composition comprising (i) at least one active pharmaceutical ingredient or ectoparasitic active ingredient; (ii) at least about 20% w/w of at least one lipophilic component; (iii) at least about 10% w/w of at least one non-ionic surfactant; (iv) at least about 0.5% w/w of at least one fatty alcohol or fatty acid or ester thereof with melting point above 30° C., and; (v) at least about 7% w/w of propellant selected from propane, butane, isobutane and combinations thereof; said composition optionally comprising at least about 5% to about 70% w/w of a hydrophilic component, optionally comprising up to about 5% w/w hydrogenated oil and optionally comprising a penetration enhancer.

Claims (38)

1. A method of treating, alleviating or at least one of (i) a dermatological or mucosal disease or disorder and, (ii) ectoparasitosis, comprising topically administering to a subject in need thereof an effective amount of a topical alcohol-free thermo labile oily foam composition, the composition comprising

(i) at least one active pharmaceutical ingredient or ectoparasitic active ingredient;

(ii) at least about 20% w/w of at least one lipophilic component;

(iii) at least about 10% w/w of at least one non-ionic surfactant;

(iv) at least about 0.5% w/w of at least one fatty alcohol or fatty acid or ester thereof with melting point above 30° C., and;

(v) at least about 7% w/w of propellant selected from propane, butane, isobutane and combinations thereof;

said composition optionally comprising at least about 5% to about 70% w/w of a hydrophilic component, optionally comprising up to about 5% w/w hydrogenated oil and optionally comprising a penetration enhancer; and wherein the composition is a readily collapsible foam composition.

2. The method of claim 1 wherein the subject is affected with a dermatological or mucosal disease or disorder or ectoparasitosis is selected from autoimmune diseases, fungal infections, viral infections, bacterial infections, primary and secondary skin infections, inflammations of the skin, dermatoses, cut, burns, impetigo, insects bites and/or ectoparasitosis by ticks, lice, fleas or mites.

3. A method of treating, alleviating or at least one of (i) a dermatological or mucosal disease or disorder and, (ii) ectoparasitosis, comprising topically administering to a subject in need thereof a therapeutically effective amount of the topical alcohol-free thermo labile oily foam composition comprising:

(i) at least one active pharmaceutical ingredient or ectoparasitic active ingredient;

(ii) at least about 20% w/w of at least one lipophilic component;

(iii) at least about 10% w/w of at least one non-ionic surfactant;

(iv) at least about 0.5% w/w of at least one fatty alcohol or fatty acid or ester thereof with melting point above 30° C., and;

(v) at least about 7% w/w of propellant selected from propane, butane, isobutane and combinations thereof;

said composition optionally comprising about 5 to about 70% w/w of a hydrophilic component and optionally comprising up to about 5% w/w hydrogenated oil; and wherein the composition is a readily collapsible foam composition.

4. The method of claim 3 wherein the subject is affected with a dermatological or mucosal disease or disorder or ectoparasitosis is selected from autoimmune diseases, fungal infections, viral infections, bacterial infections, primary and secondary skin infections, inflammations of the skin, dermatoses, cut, burns, impetigo, insects bites and ectoparasitosis by ticks, lice, fleas or mites.

5. The method of claim 3 wherein the topical alcohol-free thermo labile oily foam composition contains at least one active pharmaceutical ingredient or ectoparasitic active ingredient that is lipophilic or hydrous sensitive.

6. The method of claim 3 wherein the active pharmaceutical ingredient is one or more agent selected from mupirocin, calcipotriene, calcitriol, betamethasone, clobetasol, mometasone, tacrolimus, pimecrolimus, and their therapeutically active analogs, salts and derivatives thereof.

7. The method of claim 3 wherein the ectoparasitic active ingredient is one or more agent selected from permethrin, lindane, malathion and their analogs, salts or derivatives, and mixtures thereof.

8. The method according to claim 3 wherein said hydrogenated oil is hydrogenated castor oil.

9. A method for topically delivering a therapeutically effective amount of an active pharmaceutical ingredient or ectoparasitic active ingredient by topically applying a therapeutically effective amount of a topical alcohol-free thermo labile oily foam composition to a subject in need thereof, the composition comprising

(i) at least one active pharmaceutical ingredient or ectoparasitic active ingredient;

(ii) at least about 20% w/w of at least one lipophilic component;

(iii) at least about 10% w/w of at least one non-ionic surfactant;

(iv) at least about 0.5% w/w of at least one fatty alcohol or fatty acid or ester thereof with melting point above 30° C., and;

(v) at least about 7% w/w of propellant selected from propane, butane, isobutane and combinations thereof;

said composition optionally comprising at least about 5% to about 70% w/w of a hydrophilic component, optionally comprising up to about 5% w/w hydrogenated oil and optionally comprising a penetration enhancer; and wherein the composition is a readily collapsible foam composition.

10. A method according to claim 9 wherein said topical delivery is for topical and/or systemic treatment, alleviation of a disease, condition and/or disorder, and ectoparasitosis selected from autoimmune diseases, fungal infections, viral infections, bacterial infections, primary and secondary skin infections, inflammations of the skin, dermatoses, cuts, burns, impetigo, insect bites and/or ectoparasitosis by ticks, lice, fleas or mites.

11. A method of treating, alleviating or at least one of (i) a dermatological or mucosal disease or disorder comprising topically administering to a subject in need thereof a therapeutically effective amount of the topical alcohol-free thermo labile oily foam composition comprising:

(i) at least one active pharmaceutical ingredient;

(ii) at least about 20% w/w of at least one lipophilic component;

(iii) at least about 10% w/w of at least one non-ionic surfactant;

(iv) at least about 0.5% w/w of at least one fatty alcohol or fatty acid or ester thereof with melting point above 30° C., and;

(v) at least about 7% w/w of propellant selected from propane, butane, isobutane and combinations thereof;

said composition optionally comprising about 5 to about 70% w/w of a hydrophilic component and optionally comprising up to about 5% w/w hydrogenated oil; and wherein the composition is a readily collapsible foam composition.

12. The method of claim 11 wherein the subject is affected with a dermatological or mucosal disease or disorder selected from autoimmune diseases, fungal infections, viral infections, bacterial infections, primary and secondary skin infections, inflammations of the skin, dermatoses, cut, burns or impetigo.

13. The method of claim 11 wherein the topical alcohol-free thermo labile oily foam composition contains at least one active pharmaceutical ingredient that is lipophilic or hydrous sensitive.

14. The method of claim 11 wherein the active pharmaceutical ingredient is one or more agent selected from mupirocin, calcipotriene, calcitriol, betamethasone, clobetasol, mometasone, tacrolimus, pimecrolimus, and their therapeutically active analogs, salts and derivatives thereof.

Assignments (2)
CHANGE OF NAME Recorded Aug 13, 2021
From: PERRIGO ISRAEL PHARMACEUTICALS LTD.
To: PADAGIS ISRAEL PHARMACEUTICALS LTD.
Reel/Frame 057261/0583 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 7, 2017
From: ARNON, MICHAL N.; KAMENETSKY, TATIANA
To: PERRIGO ISRAEL PHARMACEUTICALS LTD.
Reel/Frame 042931/0451 →
Continuity (3)
Division 14233198
Provisional Application 61509888 · Jul 20, 2011
Related Publication 20170304257A1 · Oct 26, 2017