Process to manufacture implants containing bioactive peptides
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United States of America Patent
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Jun 20, 2000
Grant Date -
N/A
app pub date -
May 14, 1999
filing date -
Sep 4, 1996
priority date (Note) -
Expired
status (Latency Note)
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Abstract
A pharmaceutical implant for the delivery of an effective amount of a bioactive peptide or peptide analog over a period of 1 to 12 months. This implant has a diameter of about 1 to 2 mm, a length of between about 10 and 25 mm and is obtainable from a process which 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 a cylindrical rod from the extruded mixture to form the pharmaceutical implant.
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