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.
Claims43
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) a core comprising ARBAC and at least two water-swellable excipients;
- and
- b) a semipermeable membrane surrounding the core, said membrane comprising at least two film-forming cellulose esters and at least one preformed passageway.
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) a core comprising ARBAC, at least one osmotic salt, at least one binder, at least two water swellable excipients, wherein said at least two water-swellable excipients comprise a majority of a first type of polymer and a minority of a second type of polymer;
- and
- b) a semipermeable membrane surrounding the core, said membrane comprising at least two different types or grades of film-forming cellulose ester, and at least one preformed passageway;
- wherein
- following oral administration of said dosage form, the dosage form releases a majority of ARBAC downstream of the stomach and upstream of the colon.
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) a core comprising ARBAC, at least one osmotic salt, at least one water swellable cellulose derivative, and at least one water swellable polyalkylene oxide;
- and
- b) a semipermeable membrane surrounding the core, said membrane comprising at least two different types or grades of film-forming cellulose ester, and at least one preformed passageway;
- wherein
- following oral administration of said dosage form, the dosage form releases a majority of ARBAC downstream of the stomach, upstream of the colon and in the upper portion of the GI tract;
- and
- the dosage form exhibits a sigmoidal in vitro release profile as follows 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., wherein about 60 to about 100% wt of the drug is released over a period of about 6 to about 16 hours.
Dependencies are inferred from the claim text.