Process for manufacturing a stationary state of crystalline polymer of a biodegradable polymer matrix carrying an active substance and a polymer matrix produced thereby

摘要

A method for manufacturing a stationary state of polymer crystallinity of an active substance charged polylactide matrix for a stent, comprising the steps of: preparing the active substance charged polylactide matrix containing (a) a polylactide in amorphous or semicrystalline modification or with amorphous domains, and (b) at least one active substance on a surface or in a cavity of the stent communicating with the surface; and heating of the active substance charged polylactide matrix to a temperature ranging from TG-20° C. to TS-10° C., where TG represents a glass transition temperature and TS a melting temperature of the crystallites of the polylactide.

主权项

1. A method for manufacturing a storage stable stationary state of polymer crystallinity of an active substance charged polylactide matrix for a stent, the method comprising:
(i) preparing the active substance charged polylactide matrix containing,
(a) a semicrystalline polylactide, wherein the polylactide has a glass transition temperature TG of from 60-70° C. and a melting temperature TS of from 170-180° C., with an average TG and TS, (TG+TS/2) of 115° C. to 125° C., where TG represents a glass transition temperature and TS a melting temperature of the crystallites of the polylactide, and(b) at least one active substance, wherein the active substance charged polylactide matrix is on a surface or in a cavity of the stent communicating with the surface; and (ii) heating the active substance charged polylactide matrix to a temperature ranging from 45° C. to 55° C. for one week to form the storage stable stationary state of polymer crystallinity of the active substance charged polylactide matrix containing less than 10% by weight of amorphous polymer domains that can be crystallized at room temperature based on the total weight of polylactide.