Medical item for long term durg release

A solid, non-porous composite comprised of:

• a) a non-biodegradable thermoplastic polymer material melt-processable at a temperature not exceeding 260° C., said polymer material suitable for implantation in a living mammal, a 1.6 mm thick disk of said polymer material having less than about one percent by weight dissolution in distilled water at 35° C. in 30 days;
• and
• b) one or more bioactive agents dispersed uniformly throughout said polymer material;
• said bioactive agents comprising about 1 to about 60 percent by weight of said polymer plus bioactive agents;
• wherein at least one said bioactive agent has less than about 5 percent weight loss at a temperature of 200° C. when measured in a pure state by thermogravimetric analysis at a heating rate of 10° C./min;
• and,
• wherein said bioactive agent is present in said polymer material as:
• i) a solid solution phase with said polymer material comprised of from about 0.1 to about 30 percent by weight of said bioactive agent;
• and
• ii) a solid solution phase with said polymer material comprised of from about 95 to about 99.99 percent by weight of said bioactive agent;
• and
• iii) a phase selected from a supersaturated solution, an essentially pure bioactive agent, a solid solution comprised of bioactive agents, and their combination.

A solid, non-porous composite comprised of:

• a) a non-biodegradable thermoplastic polymer material melt-processable at a temperature not exceeding 260° C., said polymer material suitable for implantation in a living mammal, a 1.6 mm thick disk of said polymer material having less than about one percent by weight dissolution in distilled water at 37° C. in 30 days;
• and
• b) one or more bioactive agents dispersed uniformly throughout said polymer material;
• said bioactive agents comprising about 1 to about 60 percent by weight of said polymer plus bioactive agents;
• wherein at least one said bioactive agent has less than about 5 percent weight loss at a temperature of 200° C. when measured in a pure state by thermogravimetric analysis at a heating rate of 10° C./min;
• wherein, as measured by Horiba Instruments, Inc., Model LA-900 Laser Scattering Particle Size Distribution Analyzer before dispersion in said polymer material, at least one said bioactive agent has a particle size distribution best described by a Weibull function with an index of determination of at least about 0.90, said distribution having a characteristic size of from about 5 to about 100 micrometers and a shape factor from about 1.1 to about 5;
• and,
• wherein said bioactive agent is present in said polymer material as:
• i) a solid solution phase with said polymer material comprised of from about 0.1 to about 30 percent by weight of said bioactive agent;
• and
• ii) a solid solution phase with said polymer material comprised of from about 95 to about 99.99 percent by weight of said bioactive agent;
• and
• iii) a phase selected from a supersaturated solution, an essentially pure bioactive agent, a solid solution comprised of bioactive agents, and their combination.

A method of making a non-porous solid composite comprising the steps of:

• a) selecting one or more thermoplastic polymer materials melt-processable at a temperature not exceeding 260° C., wherein said one or more polymer materials are suitable for implantation in a living mammal;
• b) optionally granulating said polymer materials to particles of a size that pass through a 0.25 mm sieve opening;
• c) fluxing said polymer materials at elevated temperature;
• d) selecting one or more solid bioactive materials in powder form, wherein at least one said bioactive material exhibits a weight loss of less than about 5 percent at a temperature of 200° C. when measured by thermogravimetric analysis at a heating rate of 10° C./min, and wherein, as measured by Horiba Instruments, Inc., Model LA-900 Laser Scattering Particle Size Distribution Analyzer, at least one said bioactive agent has a particle size distribution best described by a Weibull function with an index of determination of at least about 0.90, said distribution having a characteristic size of from about 5 to about 100 micrometers and a shape factor from about 1.1 to about 5.
• e) adding said bioactive materials to said fluxed polymer materials and mixing under sufficient shear, time and temperature to form a uniform mixture comprising from about 1 to about 60 percent by weight of said bioactive materials;
• f) cooling said mixture to room temperature to form a non-porous solid composite material containing un-dissolved bioactive agent.