Stabilized prostaglandin E composition
First Claim
1. A storage stable prostaglandin E group composition comprising:
- (a) a prostaglandin E group compound;
(b) a (C1-C4)-alkyl (C8-C22) carboxylic ester;
(c) an N,N-di(C1-C8) alkylamino substituted, (C4-C18) alkyl (C2-C18) carboxylic ester, a pharmaceutically acceptable addition salt thereof, or a combination thereof; and
(d) optionally, a viscosity enhancing agent;
the composition being substantially free from C1-C4 alcohols.
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Accused Products
Abstract
A prostaglandin E composition comprises are substantially free from C1-C4 alcohols and include the prostaglandin E compound together with a (C1-C4)-alkyl (C8-C22) carboxylic ester (e.g., ethyl laurate), an N,N-di(C1-C8) alkylamino substituted, (C4-C18) alkyl (C2-C18) carboxylic ester and/or a pharmaceutically acceptable addition salt thereof, and optionally, a viscosity enhancing agent such as guar gum. The prostaglandin E composition can be combined with an aqueous alcoholic diluent to form a pharmaceutical composition for topical application to a patient, for example, to treat sexual dysfunction. The prostaglandin E compositions are stable for prolonged periods of storage at room temperature.
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Citations
23 Claims
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1. A storage stable prostaglandin E group composition comprising:
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(a) a prostaglandin E group compound; (b) a (C1-C4)-alkyl (C8-C22) carboxylic ester; (c) an N,N-di(C1-C8) alkylamino substituted, (C4-C18) alkyl (C2-C18) carboxylic ester, a pharmaceutically acceptable addition salt thereof, or a combination thereof; and (d) optionally, a viscosity enhancing agent; the composition being substantially free from C1-C4 alcohols. - View Dependent Claims (2, 3, 4, 5, 6, 18, 19)
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7. A storage stable prostaglandin E group composition comprising:
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(a) about 0.025 percent to about 10 percent by weight of a prostaglandin E group compound; (b) about 0.025 to about 40 percent by weight of a (C1-C4)-alkyl (C8-C22) carboxylic ester; (c) about 0.025 to about 40 percent by weight of an N,N-di(C1-C8) alkylamino substituted, (C4-C18) alkyl (C2-C18) carboxylic ester, a pharmaceutically acceptable addition salt thereof, or a combination thereof; and (d) about 0.025 to about 40 percent by weight of a viscosity enhancing agent; the composition being substantially free from C1-C4 alcohols. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 21)
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17. A storage stable prostaglandin E group composition comprising:
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(a) about 0.025 percent to about 10 percent by weight of prostaglandin E1; (b) about 0.025 to about 40 percent by weight of a ethyl laurate; (c) about 0.025 to about 40 percent by weight of dodecyl 2-(N,N-dimethylamino)-propionate or a pharmaceutically acceptable addition salt thereof; and (d) about 0.025 to about 40 percent by weight of guar gum; the composition being substantially free from C1-C4 alcohols. - View Dependent Claims (22, 23)
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Specification