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Last Updated: December 22, 2024

Claims for Patent: 4,038,389


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Summary for Patent: 4,038,389
Title: Medroxyprogesterone acetate compositions
Abstract:A pharmaceutical vehicle for parenteral administration of medroxyprogesterone acetate is disclosed comprising an aqueous solution of sodium sulfate, quaternary ammonium wetting agent, and a member selected from glycerin, propylene glycol, polyethylene glycol, and polypropylene glycol. The compositions may contain a non-ionic hydrophilic colloid as a preferred adjuvant. Compositions are useful for suspending large amounts, e.g., from 200 to 600 mg./ml. of medroxyprogesterone acetate and maintaining suitable suspendability and syringeability characteristics and are used for the known therapeutic indications for medroxyprogesterone acetate.
Inventor(s): Lamb; Donald J. (Portage, MI)
Assignee: The Upjohn Company (Kalamazoo, MI)
Application Number:05/671,918
Patent Claims: 1. An aqueous suspension for parenteral administration comprising from about 200 to about 600 mg./ml. of suspended medroxyprogesterone acetate; water; from about 0.8% w/v to about 1.5% w/v of sodium sulfate; from about 0.1% w/v to about 1.4% w/v of a parenterally acceptable quaternary ammonium wetting agent; and from about 2% w/v to about 5% w/v of a member selected from the group consisting of glycerin, propylene glycol, polyethylene glycol and polypropylene glycol.

2. The composition of claim 1 additionally containing a parenterally acceptable non-ionic hydrophilic colloid in a concentration not exceeding 1.5% w/v.

3. The composition of claim 1 wherein the suspended medroxyprogesterone acetate is a fineness of 99% less than 10 microns and 75% less than 5 microns.

4. The composition of claim 3 additionally containing a parenterally acceptable non-ionic hydrophilic colloid in a concentration not exceeding 1.5% w/v.

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