Long-Term Delivery Formulations and Methods of Use Thereof
AssigneeUniversity of Pennsylvania
InventorsSteven Siegel, Karen Winey
Life of this patent
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Abstract
The present invention provides a method, a kit and compositions for long-term release of a drug at a constant therapeutically effective level for nervous system disorders where adherence to therapeutic regimen is problematic. In particular, to the therapy of psychotic disorders.
Claims45
A method of treating a Nervous System disorder in a subject in need, the method comprising:
- a. Administering to said subject a first formulation of a drug in complex with a biodegradable polymer, wherein said formulation delivers said drug with pseudo-zero order kinetics in-vivo;
- and
- b. Administering to said subject a second formulation of said drug in complex with a biodegradable polymer, wherein said formulation delivers said drug substantially faster, in-vivo, than said first formulation,
- Whereby administering said first and second formulation results in therapeutic circulating levels of said drug, for a period of about 14-420 days, thereby being a method of treating a nervous system disorder.
A kit for sustained delivery of a drug comprising:
- a first formulation of said drug in complex with a biodegradable polymer, wherein said formulation delivers said drug with pseudo-zero order kinetics in-vivo, and a second formulation of said drug in complex with a biodegradable polymer wherein said second formulation has a rate of release which is faster than said first formulation, in-vivo.
A composition for use in the treatment of psychotic disorders, comprising a poly(lactide/glycolide) (PLGA) copolymer at a concentration of from about 95-98% (w/w), and an antipsychotic agent, at a concentration of from about 2 to about 5% (w/w), wherein the lactide:glycolide ratio of said poly(lactide/glycolide) copolymer is from about 100:0 to 50:50 and wherein said antipsychotic agent is Risperidone or 9-OH-Risperidone.
Dependencies are inferred from the claim text.