Bioadhesive drug delivery system
First Claim
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1. An essentially pH neutral vaginal drug delivery system, which comprises:
- an essentially pH neutral emulsion having globules having two phases, an internal water-soluble phase and an external water-insoluble phase or film;
said internal water-soluble phase comprises an acidic buffered phase containing a therapeutically active drug or drugs, wherein the acidic buffered phase comprises said therapeutically active drug or drugs either alone or in combination with an additional buffering agent;
wherein the acidic buffered phase is isotonic, hypertonic, or hypotonic.
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Abstract
The present invention relates to a novel essentially pH neutral vaginal drug delivery system suitable for modified delivery of a therapeutically active material in the vaginal cavity. The vaginal drug delivery system comprises an essentially pH neutral emulsion having globules having two phases, an internal water soluble phase and an external water-insoluble phase or film, wherein the water-soluble interior phase contains a therapeutically active drug or drugs. One novel aspect of the vaginal drug delivery system is that the internal water soluble phase comprises an acidic buffered phase.
47 Citations
57 Claims
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1. An essentially pH neutral vaginal drug delivery system, which comprises:
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an essentially pH neutral emulsion having globules having two phases, an internal water-soluble phase and an external water-insoluble phase or film;
said internal water-soluble phase comprises an acidic buffered phase containing a therapeutically active drug or drugs, wherein the acidic buffered phase comprises said therapeutically active drug or drugs either alone or in combination with an additional buffering agent;
wherein the acidic buffered phase is isotonic, hypertonic, or hypotonic. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. An essentially pH neutral vaginal drug delivery system, which comprises:
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an essentially pH neutral emulsion having globules having two phases, an internal water-soluble phase and an external water-insoluble phase or film;
said internal water-soluble phase comprises an acidic buffered phase containing a micronized therapeutically active drug or drugs, wherein the acidic buffered phase comprises said micronized therapeutically active drug or drugs either alone or in combination with an additional buffering agent;
wherein the acidic buffered phase is isotonic, hypertonic, or hypotonic; and
wherein the micronized therapeutically active drug has a particle size ranging from about 0.1 microns to less than 60.0 microns, wherein the efficacy of the therapeutically active drug is maximized by the acidic buffered phase; and
wherein the acidic buffered phase is present in an amount sufficient to provide a cessation of symptoms of irritation and itching of the vaginal mucosa. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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48. An essentially pH neutral vaginal drug delivery system, which comprises:
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an essentially pH neutral emulsion having globules having two phases, an internal water-soluble phase and an external water-insoluble phase or film;
said internal water-soluble phase comprises an acidic buffered phase having an internal pH of about 2.0 to about 6.0 and a therapeutically active drug or drugs, wherein the acidic buffered phase comprises said therapeutically active drug or drugs either alone or in combination with an additional buffering agent. - View Dependent Claims (49)
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50. Method for treating a vaginal disorder comprising:
- administering to a patient an essentially pH neutral vaginal drug delivery system, which comprises;
an essentially pH neutral emulsion having globules having two phases, an internal water-soluble phase and an external water-insoluble phase or film;
said internal water-soluble phase comprises an acidic buffered phase containing a therapeutically active drug or drugs, wherein the acidic buffered phase comprises said therapeutically active drug or drugs either alone or in combination with an additional buffering agent;
wherein the acidic buffered phase is isotonic, hypertonic, or hypotonic; and
wherein the therapeutically active drug has a particle size ranging from about 0.1 microns to less than 60.0 microns. - View Dependent Claims (51, 52, 53, 54, 55, 56, 57)
- administering to a patient an essentially pH neutral vaginal drug delivery system, which comprises;
Specification