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|Title:||Stabilized prostaglandin E1|
|Abstract:||A stable and lyophilized formulation of prostaglandin E-1 made by the process comprising a) dissolving PGE-1 in a solution of lactose and tertiary butyl alcohol wherein said tertiary butyl alcohol is present in an amount of from about 15% to about 33% volume/volume and the ratio of said lactose to PGE-1 is from about 40,000 to 1 to about 10,000 to 1 weight/weight whereby a formulation of PGE-1dispersed in lactose is formed; b) adjusting and maintaining the pH of said formulation from about 3.5 to about 6 with an organic acid buffer; c) freezing said formulation to about -50.degree. C.; and d) drying said formulation to obtain a moisture content of less than 1% by dry weight and a tertiary butyl alcohol content of less than 3% by dry weight. Preferably, step c) includes after freezing said formulation to about -50.degree. C., warming to about -25.degree. C. for about 2 hours then refreezing to about 50.degree. C. Preferably, the prostaglandin is in an amount of about 25 to 100 ppm in lactose and the pH is maintained at about 4 to 5.|
|Inventor(s):||Teagarden; Dirk L. (Kalamazoo, MI), Petre; William J. (Kalamazoo, MI), Gold; Paul M. (Vicksburg, MI)|
|Assignee:||Pharmacia & Upjohn Company (Kalamazoo, MI)|
Patent Claim Types:|
see list of patent claims
|PCT Filed||September 06, 1994||PCT Application Number:||PCT/US94/09648|
|PCT Publication Date:||May 04, 1995||PCT Publication Number:||WO95/11683|
|Country||Document Number||Estimated Expiration||Supplementary Protection Certificate||SPC Country||SPC Expiration|
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