Controlled Release Dosage Form
AssigneeOsmotica Kereskedelmi Es Szolgaltato Kft
InventorsGlenn A. MEYER, Cristian R. FRANCO, Gustavo A. FISCHBEIN, Alejandro A. AGUILAR, Claude E. WRIGHT
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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.
Claims30
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 arbaclofen, 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.
24) 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 arbaclofen, wherein the controlled release dosage form provides an in vitro dissolution profile as described herein or 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.
25) 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 arbaclofen, wherein the dosage form provides a majority of drug release in the upper portion of the GI tract.
27) 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 arbaclofen, 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 arbaclofen which may be present as racemic baclofen.
Dependencies are inferred from the claim text.