Preparations of hydrophobic therapeutic agents, methods of manufacture and use thereof
AssigneeAciex Therapeutics, Inc.
InventorsShikha P. Barman, Ritesh Vasudevan Thekkedath, Koushik Barman, Thomas Cavanagh, Tian Hao, Thomas Bovard Leland
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Abstract
The present invention further provides method of preparing nanocrystals or microcrystals of a hydrophobic therapeutic agent such as fluticasone or triamcinolone, pharmaceutical compositions (e.g., topical or intranasal compositions) thereof and methods for treating and/or preventing the signs and/or symptoms of disorders such as blepharitis, meibomian gland dysfunction or skin inflammation or a respiratory disease (e.g., asthma).
Claims41
A morphic form of triamcinolone acetonide (Form C) characterized by an X-ray powder diffraction pattern including peaks at about 9.8, 9.84, 10.5, 11.1, 12.3, 14.4, 14.5, 14.6, and 14.9 degrees 2θ.
A morphic form of triamcinolone acetonide (Form B) characterized by an X-ray powder diffraction pattern including peaks at about 11.9, 13.5, 14.6, 15.0, 16.0, 17.7, and 24.8 degrees 2θ.
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A method of manufacturing purified, stable, sterile nanocrystals or microcrystals of a hydrophobic therapeutic agent comprising:
- providing a sterile phase I solution comprising a hydrophobic therapeutic agent and a solvent for the hydrophobic therapeutic agent;
- providing a sterile phase II solution comprising at least one surface stabilizer and an antisolvent for the hydrophobic therapeutic agent;
- mixing the sterile phase I solution and the sterile phase II solution to obtain a phase III mixture, wherein the mixing is performed at a first temperature not greater than 50° C.;
- and
- annealing the phase III mixture at a second temperature of between 20° C. and 50° C. for a period of time (T1) such as to produce a phase III suspension comprising a plurality of nanocrystals or microcrystals of the hydrophobic therapeutic agent.
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Dependencies are inferred from the claim text.