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US 2019/0290722 A1Published application
Two part formulation system for ophthalmic delivery
AssigneeAllergan, Inc.
InventorsAnuradha V. Gore, Sai M. Shankar, Sukhon Likitlersuang, Chetan P. Pujara, Sesha Neervannan
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Abstract
Ophthalmic products and related methods are described herein. These methods include a stabilizing composition comprising a therapeutically active agent which is separated from a liquid vehicle composition by a barrier. The barrier may be removed to allow the two compositions to mix to provide an ophthalmically acceptable liquid comprising the therapeutically active agent.
Claims20
An ophthalmic pharmaceutical product comprising:
- a stabilizing composition comprising a therapeutically active agent;
- a liquid vehicle composition;
- a removable barrier;
- wherein the removable barrier is in simultaneous contact with the stabilizing composition and the liquid composition and the removable barrier is configured to prevent contact between the stabilizing composition and the liquid vehicle composition;
- and
- wherein the product is configured to allow removal of the barrier;
- wherein the product is configured so that removal of the barrier allows mixing of the stabilizing composition and the vehicle composition to provide a sterile ophthalmically acceptable liquid;
- and
- wherein the ophthalmically acceptable liquid comprises a therapeutic amount of the therapeutically active agent;
- and
- wherein the therapeutically active agent is selected from the group consisting of phentolamine, cyclosporin, ketorolac, testosterone or a derivative thereof, docosehexaenoic acid, eicosapentaenoic acid, alpha-linolenic acid,
- or a pharmaceutically acceptable salt thereof.
9 more elements
A method of stabilizing a therapeutically active agent for use in an ophthalmically acceptable liquid comprising:
- providing a stabilizing system comprising:
- a stabilizing composition comprising the therapeutically active agent;
- a vehicle composition comprising at least one of:
- a solubilizer, a surfactant, an osmolality agent, a buffer, and a preservative;
- and
- a removable barrier separating the stabilizing composition from the vehicle composition;
- wherein the system is configured so that removal of the barrier allows mixing between the stabilizing composition and the vehicle to provide a sterile ophthalmically acceptable liquid;
- and
- wherein the ophthalmically acceptable liquid comprises about 0.0001% to about 5% therapeutically active agent by weight and
- wherein the therapeutically active agent is selected from the group consisting of phentolamine, cyclosporin, ketorolac, testosterone or a derivative thereof, docosehexaenoic acid, eicosapentaenoic acid, alpha-linolenic acid,
- or a pharmaceutically acceptable salt thereof.
8 more elements
Dependencies are inferred from the claim text.