9-OH-risperidone controlled release composition
The present invention provides implants comprising a therapeutic drug and a polymer containing polylactic acid (PLA) and optionally polyglycolic acid (PGA). The present invention also provides methods of maintaining a therapeutic level of a drug in a subject, releasing a therapeutic drug at a substantially linear rate, and treating schizophrenia and other diseases and disorders, utilizing implants of the present invention.
1. A controlled release composition, said composition comprising a therapeutic drug and a polymer, said polymer comprising polylactic acid (PLA) and optionally polyglycolic acid (PGA) in a PLA:PGA molar ratio between 50:50 and 100:0, wherein said therapeutic drug is present in an amount of about 10%-20% of the mass of said composition, wherein said therapeutic drug is risperidone or 9-OH-risperidone, and wherein said composition maintains a therapeutic level of said therapeutic drug over a period ranging from about 1 month to about 6 months upon subcutaneous placement into a subject.
2. The composition of claim 1 , wherein said polymer is present in an amount of about 20-90%.
3. The composition of claim 1 , wherein said polymer is a biodegradable polymer.
4. The composition of claim 1 , wherein said polymer is present in an amount of about 20%.
5. The composition of claim 1 , wherein said polymer is present in an amount of about 30%.
6. The composition of claim 1 , wherein said polymer is present in an amount of about 40%.
7. The composition of claim 1 , wherein said polymer is PLGA polymer.
8. The composition of claim 1 , wherein said PLA:PGA molar ratio is 75:25.
9. The composition of claim 1 , wherein said PLA:PGA molar ratio is 80:20.
10. The composition of claim 1 , wherein said PLA:PGA molar ratio is 85:15.
11. The composition of claim 1 , wherein the therapeutic drug is risperidone.
12. The composition of claim 1 , wherein said composition exhibits an inherent viscosity ranging from about 0.2 dl/g to about 0.9 dl/g.
13. A biodegradable composition comprising a therapeutic drug and a polymer, said polymer comprising polylactic acid (PLA) and optionally polyglycolic acid (PGA), wherein said therapeutic drug is present in an amount of about 10%-20% of the mass of said composition, wherein said therapeutic drug is risperidone, and wherein said composition maintains a therapeutic level of said therapeutic drug over a period ranging from about 1 month to about 6 months and said composition is of a shape suitable for tolerability in the subcutaneous space of a subject.