Sustained release dosage form unit having latex coating and method of making the same

• US 6,251,432 B1
• Filed: 07/01/1999
• Issued: 06/26/2001
• Est. Priority Date: 07/01/1999
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Mazer, Terrence B., Walton, Joseph E., Hamilton, Daniel, Walker, Sherri A., Tucker, Larry G., Kropczynski, John J. Jr., Evans, Monty L., Arnholt, Barbara S., Murawski, Frank A., Walsh, Michael V., Geckle, Ronita K., Walsh, Rhonda Cole
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): MCQUEENEY, PATRICIA E
• Application Number:
  US09/345,915
• Time in Patent Office: 726 Days
• Field of Search: 424/468, 424/464, 424/472, 424/473, 424/474, 424/475, 424/480
• US Class Current: 424/480
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/286 Polysaccharides, e.g. gums; Cyclodextrin
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

Dosage form unit is provided to deliver one or more beneficial agents into a fluid, such as liquid enteral nutritional product. The dosage form unit includes a core containing at least one beneficial agent, preferably a marker dye, which is dispersible in the fluid. The core also contains a compatible binding agent to bind the beneficial agent together. Additional components of the core may include a plasticizer, a standard flow agent, a lubricant, additional tableting aids and at least one hydrophilic agent. A latex coating encases the core. The latex coating includes a mixture containing a substantially hydrophobic base material, preferably formed from an emulsion of cellulose acetate microspheres, which is capable of defining a matrix-type membrane, and at least one hydrophilic component being dispersible in the fluid. A dispersible beneficial agent is preferred as one of the hydrophilic components of the latex coating to allow immediate release of the beneficial agent therefrom. A method of making the dosage form unit also is provided.

Claims

1. A method of forming a dosage unit to deliver a beneficial agent into a fluid, the method comprising the steps of:

forming a core containing at least one beneficial agent dispersible in a fluid and a compatible binding agent to bind the beneficial agent together;

preparing a latex formulation including a mixture containing an emulsion of a substantially hydrophobic base material capable of defining a matrix-type membrane and at least one hydrophilic component dispersible in the fluid; and

applying the latex formulation onto the core to form a latex coating thereon, wherein the forming step includes providing cellulose acetate as the binding agent of the core, the forming step further including softening the cellulose acetate with a plasticizer to enhance construction of the core.

2. The method of claim 1, wherein the plasticizer of the softening step is triacetin.

3. The method of claim 1, wherein the preparing step includes mixing an emulsion of cellulose acetate as the base material with the at least one hydrophilic component.

4. The method of claim 1, wherein the applying step includes spraying the latex formulation onto the core.