Extended, controlled-release pharmaceutical compositions using charged polymers
First Claim
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1. A bioadhesive pharmaceutical composition comprising an ionic treating agent and an ionic polymer, wherein the composition is free of an oil phase;
- the polymer is sufficiently ionized to provide bonding with the treating agent to release the treating agent in a controlled manner over an extended period of time; and
the composition is in the form of a gel at the time of administration.
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Abstract
The present invention relates to a delivery system for pharmaceutical compositions relying in part on an ionic interaction to control and facilitate release of the treating agent. More specifically, the invention relates to an extended controlled-release system having an ionic treating agent and an ionic polymer, wherein the polymer is sufficiently ionized to release the treating agent in a controlled manner over an extended period of time and the composition does not require an emulsion system for administering the treating agent.
60 Citations
38 Claims
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1. A bioadhesive pharmaceutical composition comprising an ionic treating agent and an ionic polymer, wherein the composition is free of an oil phase;
- the polymer is sufficiently ionized to provide bonding with the treating agent to release the treating agent in a controlled manner over an extended period of time; and
the composition is in the form of a gel at the time of administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- the polymer is sufficiently ionized to provide bonding with the treating agent to release the treating agent in a controlled manner over an extended period of time; and
- 20. A pharmaceutical composition comprising a treating agent and a bioadhesive, water swellable, but water-insoluble cross-linked polycarboxylic acid polymer, wherein the composition is free of an oil phase and is in the form of a gel at the time of administration, and the treating agent comprises one or more of amitriptyline, amantadine, amiodarone, meclizine, diphenhydramine, hydroxyzine, atropine, lidocaine, benzocaine, procaine, buprenorphine, morphine, bromocriptine, bupropion, buspirone, butorphanol, chlorpromazine, clindamycin, clonidine, clomiphene, cyclobenzaprine, doxazosin, fentanyl, fluoxetine, leuprolide, octreotide, ondansetron, pioglitazone, oxybutynin, raloxifene, ticlopidine, or terbutaline and is released in a controlled manner over an extended period of time.
- 22. A pharmaceutical composition comprising a treating agent and a bioadhesive, water swellable, but water-insoluble cross-linked polycarboxylic acid polymer, wherein the composition is free of an oil phase and is in the form of a gel at the time of administration, and the treating agent comprises one or more of naproxen, phenobarbital, foscarnet, ganciclovir, acyclorvir, cidofovir, fanciclovir, penciclovir, fosinopril, divalproex, cefuroxime, pravastatin, rabeprazole, or warfarin and is released in a controlled manner over an extended period of time.
- 24. A pharmaceutical composition for treating or preventing pelvic pain, or for treating or improving infertility, associated with uterine dysrhythmia comprising a therapeutically effective amount of an ionic, anti-dysrhythmic treating agent and a bioadhesive, water swellable, but water-insoluble cross-linked polycarboxylic acid polymer, wherein the composition is free of an oil phase and is in the form of a gel at the time of administration, and the treating agent is released in a controlled manner over an extended period of time.
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26. A method of treating a disease or condition in a patient in need thereof comprising administering a composition in the form of a gel that comprises a therapeutically effective amount of an ionic treating agent and an ionic polymer;
wherein the polymer is sufficiently ionized to provide bonding with the treating agent;
wherein the composition is free of an oil phase and is in the form of a gel at the time of administration; and
the treating agent is released in a controlled manner over an extended period of time through chemical bonding with the polymer.- View Dependent Claims (27, 28, 29, 30, 31, 38)
- 32. A method of treating pelvic pain, or for treating or improving infertility, associated with uterine dysrhythmia comprising vaginally administering a composition that comprises a therapeutically effective amount of an ionic, anti-dysrhythmic treating agent and a bioadhesive, water swellable, but water-insoluble cross-linked polycarboxylic acid polymer, wherein the composition is free of an oil phase and is in the form of a gel at the time of administration, and the treating agent is released in a controlled manner over an extended period of time.
- 34. A pharmaceutical composition comprising a treating agent and a bioadhesive, water swellable, but water-insoluble cross-linked polycarboxylic acid polymer, wherein the composition is free of an oil phase and is in the form of a gel at the time of administration, and the treating agent comprises one or more agents selected from the group consisting of calcium channel blockers, autocoid agents prostaglandins, and prostaglandin blockers, non-steroidal anti-inflammatory drugs, COX inhibitors, thromboxane synthase inhibitors, and leukotriene inhibitors, wherein the treating agent is in the ionic form and is released in a controlled manner over an extended period of time.
Specification