Process to manufacture implants containing bioactive peptides

Details Process to manufacture implants containing bioactive peptides Process to manufacture implants containing bioactive peptides

1997-07-21

1999-08-31

Azpuru, Carlos A.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424502, 264 41, A61K 950, B01J 1302

Patent

active

059451289

ABSTRACT:
A process for manufacturing a pharmaceutical composition for the delivery of an effective amount of a bioactive peptide or peptide analog over a period of 1 to 12 months. This process includes the steps of grinding a copolymer of lactic acid and glycolic acid having a ratio of glycolide to lactide units of from about 0 to 5:1 to a particle size of between about 50 and 150 .mu.m; sterilizing the ground copolymer with a dose of between about 1 and 2.5 Mrads of ionizing .gamma.-radiation; wetting the ground and sterilized copolymer with a sterile aqueous slurry of a bioactive peptide or peptide analog; aseptically blending the copolymer and the slurry to obtain a homogeneous mixture of the copolymer and between about 10 and 50% of the bioactive peptide or peptide analog; drying the mixture at reduced pressure and at temperature not exceeding 25.degree. C.; aseptically extruding the dried mixture at a temperature between about 70 and 110.degree. C.; and aseptically cutting cylindrical rods of about 1 to 2 mm diameter and between about 10 and 25 mm in length from the extruded mixture to form the pharmaceutical implants.

REFERENCES:
patent: 5134122 (1992-07-01), Orsolini
patent: 5192741 (1993-03-01), Orsolini et al.
patent: 5225205 (1993-07-01), Orsolini
patent: 5439688 (1995-08-01), Orsolini et al.
patent: 5456917 (1995-10-01), Wise et al.

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