Loading patent…
AssigneeLaboratorios Farmaceuticos Rovi, S.A.
InventorsIbon GUTIERRO ADURIZ, Maria Teresa GOMEZ OCHOA
Estimating the term…
The present invention is directed to a composition that can be used to deliver an antipsychotic drug such as risperidone, paliperidone or a combination thereof, as an injectable in-situ forming biodegradable implant for extended release providing therapeutic plasma levels from the first day. The composition is in the form of drug suspension on a biodegradable and biocompatible copolymer or copolymers solution using water miscible solvents that is administered in liquid form. Once the composition contacts the body fluids, the polymer matrix hardens retaining the drug, forming a solid or semisolid implant that releases the drug in a continuous manner. Therapeutic plasma levels of the drug can be achieved from the first day up to at least 14 days or more even up to at least four weeks.
1) A method of treating schizophrenia or bipolar disorder in a human subject, the method comprising intramuscularly administering to said subject an extended release injectable suspension comprising risperidone particles suspended in polymeric solution, wherein after said administering said composition forms an implant in said subject, and said implant provides therapeutically effective levels of active moiety, which is risperidone and/or 9-hydroxyrisperidone, from the first day up to at least 28 days after said administering.
4) A method of treating schizophrenia or bipolar disorder, the method comprising administering by intramuscular injection to a human subject in need thereof a dose of extended release injectable suspension consisting essentially of 25-150 mg of risperidone, wherein in said suspension, particles of risperidone are suspended in a polymeric solution of DMSO and PLGA copolymer, wherein after said administering said composition forms an implant in said subject, wherein said implant provides therapeutically effective levels of active moiety, which is risperidone and/or 9-hydroxyrisperidone, from the first day up to at least 28 days after said administering, wherein ≥1% wt and ≤20% wt of the risperidone is dissolved in said DMSO or said polymeric solution prior to administration, and wherein said administering is done every 4 to 5 weeks or every 4 weeks.
7) A method of treating schizophrenia or bipolar disorder, the method comprising
Dependencies are inferred from the claim text.