Drug-containing implants and methods of use thereof
AssigneeThe Trustees of the University of Pennsylvania
InventorsSteven Siegel, Karen WINEY
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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.
Claims81
An implantable, long term delivery system for improving medication adherence in disorders associated with a likelihood of non-compliance, comprising:
- a therapeutic drug in an implantable, rod-shaped structure, wherein said rod-shaped structure further comprises 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, thereby forming a long term delivery system for improving medication adherence in subjects having disorders associated with a likelihood of non-compliance.
A biodegradable implant 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 10%-60% of the mass of said implant, and said polymer is present in an amount of 40%-90% of the mass of said implant.
A method for treating a subject for a disorder associated with a likelihood of non-compliance, comprising administering to said subject a therapeutic drug in a long term delivery system, wherein said long term delivery system comprises an implantable, rod-shaped structure, said implantable, rod-shaped structure comprising the target 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, such that said subject is treated for said disorder associated with a likelihood of non-compliance.
A method for maintaining a therapeutic level of a therapeutic drug in a subject for a period of at least about 1 month, comprising administering to said subject a set of biodegradable implants, said set of biodegradable implants consisting of one or more individual biodegradable implants, said individual biodegradable implants each comprising said 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 10%-60% of the mass of said individual biodegradable implants, and said polymer is present in an amount of 40%-90% of the mass of said individual biodegradable implants, and wherein said individual biodegradable implants, if more than one in number, do not differ substantially from one another in said PLA:PGA molar ratio, thereby maintaining a therapeutic level of a therapeutic drug in a subject for a period of at least about 1 month.
A method for maintaining a therapeutic level of a drug in a subject for a period of at least about 3 months, comprising
- a. administering to said subject an initial set of one or more biodegradable implants, wherein said initial set consists of one or more individual biodegradable implants, said individual biodegradable implants each 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 10%-60% of the mass of said individual biodegradable implants, and said polymer is present in an amount of 40%-90% of the mass of said individual biodegradable implants, and wherein said individual biodegradable implants, if more than one in number, do not differ substantially from one another in said PLA:PGA molar ratio;
- b. administering to said subject a maintenance set of one or more biodegradable implants to said subject near the point of peak release of said initial set of biodegradable implants, wherein said maintenance set of biodegradable implants consists of additional individual biodegradable implants equivalent in said PLA:PGA molar ratio to the individual biodegradable implants in said initial set of biodegradable implants;
- and
- c. repeating step (b) as necessary,
- thereby maintaining a therapeutic level of a drug in a subject for a period of at least about 3 months.
Dependencies are inferred from the claim text.