Polymorph Compositions, Methods of Making, and Uses Thereof
AssigneesEdge Therapeutics, Inc., Evonik Corporation
InventorsR. Loch Macdonald, Cara R. Davis, Kevin Burton, Gary Winchester, Angela R. Stella
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Abstract
The described invention provides a biodegradable, biocompatible delivery system of flowable sustained release microparticulate composition of a substantially pure crystalline form of a bioactive agent such as, for example, nimodipine, a process of preparing a therapeutic form of a substantially pure crystalline form of the bioactive agent and a method for treating an interruption of a cerebral artery in a subarachnoid space at risk of interruption caused by brain injury in a mammal, which reduces signs or symptoms of at least one delayed complication associated with brain injury.
Claims30
A process for producing a substantially pure polymorphic form of a bioactive agent encapsulated into microparticles, wherein the process comprises:
- (a) providing a substantially pure crystalline form of the bioactive agent;
- (b) adding the substantially pure crystalline form of the bioactive agent to a polymer solution, thereby creating a mixture of the crystalline form of the bioactive agent and the polymer solution;
- (c) homogenizing the mixture to form a disperse phase;
- (d) mixing the disperse phase with a continuous phase comprising a continuous process medium, thereby forming an emulsion comprising the bioactive agent;
- (e) forming and extracting the microparticles comprising the substantially pure polymorphic form of the bioactive agent;
- and
- (f) drying the microparticles.
The process according to claim 14, wherein the surfactant is polyvinyl alcohol (PVA).
(canceled)
A semisolid, biodegradable, biocompatible delivery system capable of sustained release kinetics comprising
- (i) a flowable microparticulate formulation comprising a substantially pure crystalline form of a polymorphic bioactive agent, and
- (ii) a pharmaceutically acceptable carrier,
- wherein the microparticulate formulation comprises a plurality of microparticles of uniform size distribution,
- wherein the bioactive agent is dispersed throughout each microparticle,
- the delivery system being characterized by delayed release of the bioactive agent with a half-life of from 1 day to 30 days.
27-39. (canceled)
Dependencies are inferred from the claim text.