Controlled releases system containing temozolomide

1. A controlled release system, consisting essentially of 4-10 wt % of temozolomide and biodegradable polyanhydrides, wherein the polyanhydrides are condensed from 1,3-bis(p-carboxyphenoxy) propane (CPP) and sebacic acid (SA), wherein the controlled release system releases temozolomide for a period ranging from 6 hours to 4 weeks in vivo.

2. The controlled release system according to claim 1 , which is an implantable tablet.

3. A process of preparing temozolomide controlled release tablets, comprising:

a. Dissolving polyanhydrides in a solvent to give a solution of polyanhydrides, wherein the polyanhydrides are condensed from 1,3-bis(p-carboxyphenoxy) propane (CPP) and sebacic acid (SA);

b. Dispersing temolozomide in or mixing temolozomide with the solution of polyanhydrides to produce a mixture of polyanhydrides and temolozomide;

c. Spray-drying the mixture of polyanhydrides and temolozomide to obtain microspheres; and

d. Tabletting the microspheres to obtain implantable tablets;

wherein the controlled release system releases temozolomide for a period ranging from 6 hours to 4 weeks in vivo.

4. The process according to claim 3 , wherein the solvent in step (a) is methylene chloride.

5. A process of preparing temozolomide controlled release tablets, comprising:

a. Dissolving polyanhydrides in a solvent to give a solution of polyanhydrides, wherein the polyanhydrides are condensed from 1,3-bis(p-carboxyphenoxy) propane (CPP) and sebacic acid (SA);

b. Adding temolozomide into the solution of polyanhydrides and ultrasonic-emulsifying the resultant solution to obtain a first emulsion;

c. Mixing the first emulsion with polyvinyl alcohol (PVA), followed by evaporating the solvent to obtain hard microspheres;

d. Eliminating PVA and residual solvent by washing with water to obtain microspheres; and

e. Tabletting the microspheres to obtain implantable tablets;

wherein said controlled release system releases temozolomide for a period ranging from 6 hours to 4 weeks in vivo.

6. The process according to claim 5 , wherein the solvent in step (a) is methylene chloride.

7. The process according to claim 3 , wherein the resultant controlled release system consists essentially of temozolomide and biodegradable polyanhydrides.

8. The process according to claim 5 , wherein the resultant controlled release system consists essentially of temozolomide and biodegradable polyanhydrides.