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.
Claims48
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.
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A method for maintaining a therapeutic level of a drug in a subject for a period of at least about 4 months, 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 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, thereby maintaining a therapeutic level of a drug in a subject for a period of at least about 4 months.
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A method for maintaining a therapeutic level of a drug in a subject for a period of at least about one year, 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 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 one year.
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A biodegradable implant comprising a therapeutic drug and a polymer, said polymer comprising polylactic acid ALA) and optionally polyglycolic acid (PGA) in a PLA:PGA molar ratio between 75:25 and 100:0, wherein said therapeutic drug is present in an amount of 20-50% of the mass of said implant, and said polymer is present in an amount of 50-80% of the mass of said implant.
A method for maintaining a therapeutic level of a drug in a subject for a period of at least about 4 months, 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 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 75:25 and 100:0, wherein said therapeutic drug is present in an amount of 20%-50% of the mass of said individual biodegradable implants, and said polymer is present in an amount of 50%/80% 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 drug in a subject for a period of at least about 4 months.
Dependencies are inferred from the claim text.