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Claims for Patent: 5,856,355

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Claims for Patent: 5,856,355

Title: Pharmaceutical composition
Abstract:Non-greasy topical solutions, emulsion gels or lotions comprising as the active agent a compound of formula I ##STR1## and a lower alkanol, and if desired together with a solubilizing agent or an oil phase such as isopropyl myristate are useful delivery systems.
Inventor(s): Richter; Friedrich (Schonbuhl, CH), Steiger; Michel (Bern, CH)
Assignee: Novartis Ag (Basel, CH)
Application Number:08/898,348
Patent Claims: 1. A topical pharmaceutical composition comprising as the active agent a terbinafine compound of formula I ##STR3## in free base form or in acid addition salt form, water, C.sub.1-4 alkanol, and a water-soluble or water-miscible nonionic surfactant, wherein no anionic surfactant is present wherein said composition is an emulsion gel or lotion, further comprising an oil phase and a thickener.

2. A composition of claim 1 wherein the thickener is a carbomer.

3. A composition of claim 2 wherein the carbomer is a polyacylic acid derivative.

4. A composition of claim 2 wherein the carbomer is Carbopol 1342.

5. A composition of claim 1 wherein the oil phase is isopropyl myristate.

6. A composition of claim 1 wherein the compound of formula I and the oil phase are present in a proportion of from 1:5 to 1:40 on a w/w basis.

7. A composition of claim 1 wherein the compound of formula I is present in an amount of 0.1% to 5% on a w/w basis.

8. A composition of claim 1 further comprising water.

9. A composition of claim 8 comprising 50 to 85% water, by weight.

10. A composition of claim 8 wherein the amount of alkanol, water, and oil phase is from 83 to 96% by weight of the composition.

11. A composition of claim 1 comprising 5 to 35% alkanol, by weight.

12. A composition of claim 11 wherein the alkanol is ethanol.

13. A composition of claim 1 wherein the compound of formula I is in free base form.

14. A composition of claim 1 substantially free of fatty material.

15. A composition of claim 1 further comprising a non-anionic surfactant.

16. A composition of claim 1 for the treatment of fungal infections wherein the compound of formula I is in free base form or in acid addition salt form, further comprising a solubilizing agent and excipients, as appropriate.

17. A composition of claim 16 wherein the solubilizing agent is a polyoxyethylene fatty alcohol ether.

18. A composition of claim 16 wherein the ratio between the compound of formula I and the solubilizing agent is from about 1:0.5 to about 1:15.

19. A process for the preparation of a composition of claim 1 comprising working up a compound of formula I together with C.sub.1-4 alkanol and adding further excipients as appropriate.

20. A method for the treatment of fungal infections comprising administering a pharmaceutically effective amount of a composition of claim 1 to a patient in need of such treatment.

21. A topical emulsion gel or lotion pharmaceutical composition comprising a compound of formula I ##STR4## an oil phase, a C.sub.1-4 alkanol, and a thickener.
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