9-OH-risperidone controlled release composition

Patent metadata

Field	Value
Publication number	US-10111960-B2
Application number	US-201815863483-A
Country	US
Kind code	B2
Filing date	Jan 5, 2018
Priority date	Jan 12, 2004
Publication date	Oct 30, 2018
Grant date	Oct 30, 2018

Abstract

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.

First claim

What is claimed is:

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.

Assignees

• Univ Pennsylvania
• The Trustrees Of The Univ Of Pennsylvania

Inventors

• Siegel Steven
• Winey Karen

Classifications

• A61K31/517

  ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine · CPC title

• A61K9/7007

  Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence) · CPC title

• A61K31/451

  having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine · CPC title

• A61K31/445

  Non condensed piperidines, e.g. piperocaine · CPC title

• A61K31/4515

  having a butyrophenone group in position 1, e.g. haloperidol (pipamperone A61K31/4545) · CPC title