Risperidone-containing implants and methods of use thereof

Patent metadata

Field	Value
Publication number	US-9439905-B2
Application number	US-201414286168-A
Country	US
Kind code	B2
Filing date	May 23, 2014
Priority date	Jan 12, 2004
Publication date	Sep 13, 2016
Grant date	Sep 13, 2016

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 method for treating schizophrenia in a subject in need thereof, the method comprising: administering to said subject a controlled release composition for providing an implant, 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%-60% of the mass of said composition, wherein the presence of said polymer in said composition extends the release duration of said therapeutic drug in a subject, and wherein said therapeutic drug is risperidone or 9-OH-risperidone, thereby treating said schizophrenia in said subject.

2. The method of claim 1 , wherein said drug is present in an amount of about 40%.

3. The method of claim 1 , wherein said drug is present in an amount of about 30%.

4. The method of claim 1 , wherein said drug is present in an amount of about 20%.

5. The method of claim 1 , wherein said drug is present in an amount of about 10%.

6. The method of claim 1 , wherein said at least one biodegradable polymer is present in an amount of about 20-90%.

7. The method of claim 1 , wherein said polymer is a biodegradable polymer.

8. The method of claim 1 , wherein said polymer is present in an amount of about 20%.

9. The method of claim 1 , wherein said polymer is present in an amount of about 30%.

10. The method of claim 1 , wherein said polymer is present in an amount of about 40%.

11. The method of claim 1 , wherein said composition exhibits an inherent viscosity ranging from about 0.2 dl/g to about 0.9 dl/g.

12. A method for treating schizophrenia in a subject in need thereof, the method comprising: administering to said subject a controlled release composition for providing an implant, said composition comprising a therapeutic drug and a polymer, said polymer comprising polylactic acid (PLA) and optionally polyglycolic acid (PGA), wherein said therapeutic drug is risperidone or 9-OH-risperidone and is present in an amount of about 10%-60% of the mass of said composition, said composition maintaining a therapeutic level of the therapeutic drug over a period ranging from about 1 month to about 6 months upon subcutaneous placement into a subject, thereby treating said schizophrenia in said subject.

13. A method for treating schizophrenia in a subject in need thereof, the method comprising: administering to said subject a biodegradable implant 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%-60% of the mass of said implant, said therapeutic drug is risperidone or 9-OH-risperidone, and wherein said implant maintains a therapeutic level of the therapeutic drug over a period ranging from about 1 month to about 6 months and said implant is of a shape suitable for tolerability in the subcutaneous space of a subject, thereby treating said schizophrenia in said subject.

14. A method for treating schizophrenia in a subject in need thereof, the method comprising: subcutaneously providing a controlled release composition into said subject, said 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%-60% of the mass of said composition, wherein said therapeutic drug comprises risperidone or 9-OH-risperidone, wherein said composition provides a biodegradable implant, and wherein said implant is capable of maintaining a therapeutic level of said drug for a period ranging from about 1 month to about 6 months, thereby treating said schizophrenia in said subject.

Assignees

• Univ Pennsylvania

Inventors

• Siegel Steven
• Winey Karen

Classifications

• A61K9/7007

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

• A61K31/4515

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

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61K31/60

  Salicylic acid; Derivatives thereof · CPC title

• A61K31/445

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