Controlled Release Dosage Form
AssigneeOsmotica Kereskedelmi Es Szolgaltato Kft
InventorsGlenn A. MEYER, Cristian R. FRANCO, Gustavo A. FISCHBEIN, Alejandro A. AGUILAR, Claude E. WRIGHT
Life of this patent
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Abstract
The present invention provides a simple and improved dose form that is capable of providing a controlled release of GABAB receptor agonist contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to GABAB receptor agonist.
Claims41
1) A method for treating a condition, disorder or disease that is therapeutically responsive to arbaclofen (ARBAC), the method comprising orally administering to a subject in need thereof at least one controlled release dosage form comprising ARBAC, wherein the dosage form exhibits a positive food effect in terms of bioavailability, Tmax, Cmax, AUC0-t and/or AUC0-inf of ARBAC when comparing oral administration of the dosage form in the fed and fasting states, and the dosage form comprises:
- a) a core comprising ARBAC, at least one osmotic agent, at least one binder, at least one water swellable cellulose derivative (CD) polymer and at least one water swellable polyalkylene oxide (PAO) polymer, wherein the amount of PAO polymer exceeds the amount of CD polymer;
- and b) a semipermeable membrane surrounding the core, said membrane comprising at least two types or grades of film-forming cellulose ester polymer.
31) A method for treating a condition, disorder or disease that is therapeutically responsive to arbaclofen (ARBAC), the method comprising orally administering to a subject in need thereof at least one controlled release dosage form comprising a therapeutically effective dose of ARBAC, wherein the controlled release dosage form provides an in vitro dissolution profile approximately as depicted in FIG. 1 inclusive of the area defined by minimum and maximum profiles, wherein the release profile is determined under conditions defined in USP <711> using a Type II apparatus with 0.1 N HCl stirred at 50 rpm and maintained at a temperature of 37±0.5° C., and the dosage form comprises:
- a) a core comprising ARBAC, at least one osmotic agent, at least one binder, at least one water swellable cellulose derivative (CD) polymer and at least one water swellable polyalkylene oxide (PAO) polymer, wherein the amount of PAO polymer exceeds the amount of CD polymer;
- and b) a semipermeable membrane surrounding the core, said membrane comprising at least two types or grades of film-forming cellulose ester polymer.
32) A method for treating a condition, disorder or disease that is therapeutically responsive to arbaclofen (ARBAC), the method comprising orally administering to a subject in need thereof at least one controlled release dosage form comprising a therapeutically effective dose of ARBAC, wherein the dosage form provides a majority of drug release in the upper portion of the GI tract downstream of the stomach, and the dosage form comprises:
- a) a core comprising ARBAC, at least one osmotic agent, at least one binder, at least one water swellable cellulose derivative (CD) polymer and at least one water swellable polyalkylene oxide (PAO) polymer, wherein the amount of PAO polymer exceeds the amount of CD polymer;
- and b) a semipermeable membrane surrounding the core, said membrane comprising at least two types or grades of film-forming cellulose ester polymer.
34) A method for treating a condition, disorder or disease that is therapeutically responsive to arbaclofen (ARBAC), the method comprising orally administering to a subject in need thereof at least one controlled release dosage form comprising a therapeutically effective dose of ARBAC, wherein the dosage form provides reduced adverse events as compared to oral administration of a rapid release or immediate release dosage form containing an equimolar amount of ARBAC which may be present as racemic baclofen, and the dosage form comprises:
- a) a core comprising ARBAC, at least one osmotic agent, at least one binder, at least one water swellable cellulose derivative (CD) polymer and at least one water swellable polyalkylene oxide (PAO) polymer, wherein the amount of PAO polymer exceeds the amount of CD polymer;
- and b) a semipermeable membrane surrounding the core, said membrane comprising at least two types or grades of film-forming cellulose ester polymer.
Dependencies are inferred from the claim text.