Low-burst polymers and methods to produce polymer
AssigneeTolmar Therapeutics, Inc.
InventorsEric Dadey, John Middleton, Richard L. Norton
Life of this patent
Estimating the term…
Abstract
A PLG copolymer material, termed a PLG(p) copolymer material, adapted for use in a controlled release formulation for a bioactive material is provided, wherein the formulation exhibits a reduced “initial burst” effect when introduced into the tissue of a patient in need thereof. A method of preparation of the PLG copolymer material is also provided, as are methods of use.
Claims20
A controlled release formulation, comprising:
- a) a biocompatible, biodegradable, linear poly(DL-lactide-co-glycolide) (PLG) copolymer material having a weight average molecular weight of about 10 kilodaltons to about 50 kilodaltons and a polydispersity index from about 1.4-2.0, which is not a product of hydrolysis of a higher molecular weight PLG copolymer material, and from which a removed copolymer fraction characterized by a weight average molecular weight from about 4 kDa to about 10 kDa and a polydispersity index from about 1.4 to 2.5 has been separated, wherein the PLG copolymer material comprises less than about 1.0 weight % residual lactide monomer;
- b) an organic solvent;
- and
- c) leuprolide or a peptide analog thereof.
A method of preparing a biocompatible, biodegradable, linear PLG copolymer material, which is not a product of hydrolysis of a higher molecular weight PLG copolymer material, for use in a controlled release delivery system, comprising:
- dissolving a starting linear PLG copolymer material, which is not a product of hydrolysis of a higher molecular weight PLG copolymer material, in a solvent;
- precipitating a linear PLG copolymer material with a non-solvent from the dissolved starting linear PLG copolymer material;
- and separating the precipitated PLG copolymer material from a removed copolymer fraction of the dissolved starting linear PLG copolymer material, the removed copolymer fraction characterized by a weight average molecular weight of about 4 kDa to about 10 kDa and a polydispersity index of about 1.4 to 2.5.
Dependencies are inferred from the claim text.