Pharmacia & Upjohn Company

Other

Dirk L Teagarden

William J Petre

Paul M Gold

Ching-Chiang Su

Nancy Jean Britten

Scott A Brown

Niki Ann Waldron

James F Caputo

Susan Marie Machkovech

Ondrej Hendl

Stanley M Speaker

Monica L Whitmire

Terry R Urban

Jean M Steele

Susan M Machkovech

Randal Lee Schapaugh

Harry M King

Syed F Huda

Leslie C Eaton

Niki A Waldron

Pharmaceutical composition having modified carrier

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-1 dispersed 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.

Method for preparing stabilized prostaglandin E1

Stabilized prostaglandin E1

Growing community of inventors

Kalamazoo, MI, United States of America

Dirk L Teagarden