Controlled release dosage form containing water-swellable beadlet

• US 3,247,066 A
• Filed: 09/12/1962
• Issued: 04/19/1966
• Est. Priority Date: 09/12/1962
• Status: Expired due to Term

• Current Assignee: Milosovich J.R. George
• Original Assignee: Milosovich J.R. George
• Inventors: MILOSOVICH JR GEORGE
• Application Number:
  US04/223,093
• Time in Patent Office: 1,315 Days
• US Class Current: 424/495
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/1658 Proteins, e.g. albumin, gelatin
• CPC Class Codes: A61K 9/5042 Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077

Claims

1. A CONTROLLED RELEASE DOSAGE FORM FOR INTERNAL ADMINISTRATION COMPRISING A SOLID BEAD AND CONTACTING AND SURROUNDING THE BEAD A RUPTURABLE PLASTIC, NON-TOXIC, INSOLUBLE, NON-DIGESTIBLE FILM COATING WHICH IS INERT TO GASTROINTESTINAL FLUID AND PERMEABLE TO DIFFUSION OF WATER, THE BEAD CONSISTING ESSENTIALLY OF A UNIFORM DISPERSION OF MEDICAMENT IN A WATER-SWELLABLE COLLOID, THE THICKNESS OF THE COATING AND THE SWELLABILITY OF THE BEAD BEING SUCH THAT ON PROLONGED EXPOSURE TO GASTROINTESTINAL FLUID DIFFUSION OF WATER TAKES PLACE THROUGH THE COATING INTO THE BEAD CAUSING THE BEAD TO SWELL AND BUILD UP PRESSURE EXCEEDING THE COHESIVE STRENGTH OF THE COATING THEREBY RESULTING IN OUTWARD RUPTURE OF THE COATING AND SUBSTANTIALLY IMMEDIATE AND TOTAL RELEASER OF THE MEDICAMENT FROM THE BEAD INTO THE GASTROINTESTINAL FLUID.