Method for preparing stabilized prostaglandin E1

Details Method for preparing stabilized prostaglandin E1 Method for preparing stabilized prostaglandin E1

1996-12-30

1998-06-23

Kishore, Gollamudi S.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

514559, 514573, 424400, A61K 31557, A61K 914

Patent

active

057702306

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-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.

REFERENCES:
patent: 3927197 (1975-12-01), Moonkhouse
patent: 3952004 (1976-04-01), Moonkhouse
patent: 4113882 (1978-09-01), Okazaki
DeLuca in Congres International de Technologie Pharmaceutique 1989, 574 vol. 1, pp. 439-447.
Congres International de Technologie Pharmaceutique, P.P. Deluca et al., "Acceleration of Freeze-Drying Cycles of Aqueous Solutions of Lactose and Sucrose With Tertiary Butyl Alcohol", 574, vol. 1, pp. 439-447.

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