Patent Number: 6,251,432

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

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.

Inventors: Mazer; Terrence B. (Reynoldsburg, OH), Walton; Joseph E. (Westerville, OH), Arnholt; Barbara S. (Worthington, OH), Evans; Monty L. (Johnstown, OH), Geckle; Ronita K. (Columbus, OH), Hamilton; Daniel (Plain City, OH), Kropczynski, Jr.; John J. (Dublin, OH), Murawski; Frank A. (Westerville, OH), Tucker; Larry G. (Powell, OH), Walker; Sherri A. (Sunbury, OH), Walsh; Michael V. (Westerville, OH), Walsh; Rhonda Cole (Westerville, OH)

Assignee: Abbott Laboratories

International Classification: A61K 9/20 (20060101); A61K 9/28 (20060101); A61K 009/30 ()

Expiration Date: 06/26/2018