Localized vaginal delivery without detrimental blood levels
First Claim
1. A pharmaceutical composition for vaginal administration of a treating agent, other than progesterone or an anti-STD agent, normally associated with potential undesired side effects at detrimental blood levels, to achieve local tissue concentrations without detrimental blood levels of the treating agent, comprising a therapeutically effective amount of said treating agent and a bioadhesive, cross-linked water-swellable but water-insoluble polycarboxylic acid polymer.
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Abstract
The invention relates to a pharmaceutical composition for vaginal administration of a treating agent normally associated with undesired side effects at detrimental blood levels. The composition releases the treating agent at a rate to achieve local tissue concentrations without such detrimental blood levels by using a therapeutically effective amount of the treating agent and a bioadhesive, cross-linked water swellable, but water-insoluble polycarboxylic acid polymer. Using this composition and the method of treatment provides sufficient local levels of the drug to provide therapeutic efficacy, but avoids many untoward adverse events. The invention also relates to a pharmaceutical composition for use during menses that includes a treating agent and a bioadhesive, cross-linked water swellable, but water-insoluble polycarboxylic acid polymer.
76 Citations
27 Claims
- 1. A pharmaceutical composition for vaginal administration of a treating agent, other than progesterone or an anti-STD agent, normally associated with potential undesired side effects at detrimental blood levels, to achieve local tissue concentrations without detrimental blood levels of the treating agent, comprising a therapeutically effective amount of said treating agent and a bioadhesive, cross-linked water-swellable but water-insoluble polycarboxylic acid polymer.
- 2. The composition of claim I, wherein the polymer is polycarbophil.
- 7. A method of safely delivering a treating agent, other than progesterone or an anti-STD agent, normally associated with potential undesired side effects at detrimental blood levels to a female subject comprising vaginal insertion of a bioadhesive, cross-linked water-swellable but water-insoluble polycarboxylic acid polymer formulation with a therapeutically effective amount of said treating agent wherein the formulation releases the treating agent at a rate that achieves local tissue concentrations without producing detrimental blood levels of the treating agent.
- 13. A pharmaceutical composition for vaginal administration of a treating agent during menses, comprising a bioadhesive, cross-linked water-swellable but water-insoluble polycarboxylic acid polymer and a therapeutically effective amount of a treating agent.
- 18. A method of extended vaginal delivery of a treating agent during menses to a patient, comprising vaginal insertion of a bioadhesive, cross-linked water-swellable but water-insoluble polycarboxylic acid polymer formulation with a therapeutically effective amount of said treating agent.
Specification