Relating to organic compounds

• US 6,353,030 B1
• Filed: 06/03/1998
• Issued: 03/05/2002
• Est. Priority Date: 08/01/1990
• Status: Expired due to Fees

• Current Assignee: Novartis Ag
• Original Assignee: Novartis Ag
• Inventors: Prikoszovich, Walter
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US09/089,836
• Time in Patent Office: 1,371 Days
• Field of Search: 424/486, 424/426, 424/428, 514/772.1, 514/772.7, 528/357
• US Class Current: 514/772.1
• CPC Class Codes: A61K 9/1647 Polyesters, e.g. poly(lactide-co-glycolide)
• CPC Class Codes: C08G 63/08 Lactones or lactides
• CPC Class Codes: C08G 63/90 Purification; Drying

Abstract

A polylactide in a purified state, which meets the requirements of

the color strengths of reference solutions B₂-B₉ of the brown color test of the European Pharmacopoeia, 2nd Edition (1980) part I, Section V, 6.2 and

containing one or more metals in cationic form, the metal ion(s) having a concentration of at most 10 ppm.

The polylactide is especially suitable for use as microparticles or implants, and contains preferably a hydrophilic drug, like octreotide or a lipophilic drug like bromocriptine.

Claims

1. A purified linear polylactide polymer which is a linear polylactide-glycolide having a mean molecular weight Mw of from 46,000 to 60,000, a polydispersity Mw/_Mn of from 1.7 to 3.0, prepared by the process of polymerizing lactide and glycolide in the presence of tin di-(2-ethylhexanoate), followed by treatment with an amount of active charcoal equal to the weight of the polymer and ultrafiltration to yield a colorless or off-white product containing 1 to 1.5 parts per million Sn⁺⁺ residue.

2. The polylactide polymer of claim 1 having a lactidal glycolide molar ratio of 100-25/0-75.

3. The polylactide polymer of claim 1 having a lactide/glycolide molar ratio of 75-25/25-75.

4. The polylactide polymer of claim 1 having a lactide/glycolide molar ratio of 60-40/40-60.