FIELD: pharmacology.
SUBSTANCE: invention is a sustained release pharmaceutical composition for topical administration to the skin surface, which comprises: a pharmaceutically active agent selected from the group consisting of estrogens, antiestrogens, androgens, antiandrogens, progestins, and mixtures thereof, 0.01-5 wt % of the total weight of the pharmaceutical composition of the fatty acid ester selected from the group consisting of ethyl oleate, isopropyl myristate, isopropyl isostearate, isopropyl palmitate, ethyl octanoate, ethyl dodecanoate, ethyllinoleate, ethyl palmitoleate, ethyl isostearate and ethyllleleate, water, C2-C6 mono-alcohol selected from the group consisting of ethanol, n-propanol, isopropanol, n-butanol, isobutanol, t-butanol and mixtures thereof, a fatty acid selected from the group consisting of capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, isostearic acid, palmitoleic acid, linoleic acid and linolenic acid, and from 0.05 to 5 wt % of gelling agent, wherein the weight ratio of the fatty acid ester in the composition to the total active agent in said composition is at least 4:1 (fatty acid ester:active agent), preferably 4:1 to 20:1.
EFFECT: invention provides sustained release, corresponding delivery profiles in the concentration range of active agents, and reproducibility from application to application and from patient to patient.
21 cl, 11 ex, 10 dwg, 24 tbl
