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Claims for Patent: 5,681,849

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Claims for Patent: 5,681,849

Title: Pharmaceutical composition for topical applications
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 Ltd. (Basel, CH)
Application Number:08/228,841
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, a lower alkanol, and a water-soluble or water-miscible nonionic surfactant, wherein no anionic surfactant is present.

2. A composition according to claim 1 containing from 50 to 85% by weight of water.

3. A composition according to claim 1 containing 5 to 35% by weight of a lower alkanol.

4. A composition according to claim 3 wherein the alkanol is ethanol.

5. A composition according to claim 1 which is substantially free of fatty material.

6. A composition according to claim 1 wherein said composition is a spray, a gel or a fluid gel.

7. A composition according to claim 1 wherein said surfactant is a polyoxyethylene fatty alcohol ether.

8. A composition according to claim 1 wherein the weight ratio of said active agent to said surfactant is from about 1:0.5 to about 1:15.

9. A composition according to claim 1 wherein the compound of formula I is present from about 0.1% to about 5% of the total weight of the composition on a w/w basis.

10. A method for the treatment of seborrhoic skin comprising administering a pharmaceutically effective amount of a composition according to claim 1 to a patient in need of such treatment.

11. A composition according to claim 7, wherein the weight ratio of said active agent to said surfactant is from about 1:0.5 to about 1:15.

12. A topical pharmaceutical composition in the form of an emulsion, said emulsion comprising an oil phase containing a terbinafine compound of the formula I ##STR4## in free base form or in acid addition salt form, and an aqueous phase comprising water, a lower alkanol, and a water-soluble or water-miscible nonionic surfactant, wherein no anionic surfactant is present.

13. A composition according to claim 12 containing isopropyl myristate as the oil phase.

14. A composition according to claim 12, wherein the weight ratio of said active agent to said oil phase is from about 1:5 to about 1:40.

15. A composition according to claim 13, wherein the ratio between the compound of formula I and the oil phase is from about 1:5 to about 1:40 on a w/w basis.
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