Sustained release composition

• US 3,344,029 A
• Filed: 06/03/1963
• Issued: 09/26/1967
• Est. Priority Date: 06/03/1963
• Status: Expired due to Term

• Current Assignee: Howard H. Berger
• Original Assignee: Howard H. Berger
• Inventors: Berger, Howard H.
• Application Number:
  US04/284,827
• Time in Patent Office: 1,576 Days
• US Class Current: 424/470
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• 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 SUSTAINED ACTION THERAPEUTIC PREPARATION COMPRISING A DOSAGE UNIT CONTAINING A PLURALITY OF RESILIENT CORES EACH CONSISTING ESSENTIALY OF A COHESIVE INTIMATE ADMIXTURE OF A FINELY DIVIDED THERAPEUTICALLY ACTIVE MATERIAL IN POWDER FORM AND AN INGESTIBLE MATERIAL RESISTANT TO DISINTEGRATION IN THE GASTRO-INTESTINAL TACT, THE PROPORTION OF INGESTIBLE MATERIAL TO THERAPEUTICALLY ACTIVE MATERIAL IN EACH CORE VARYING FROM 0.1 TO 2.0:

1 AND THERE BEING SOME VARIATION IN PROPORTION AMONG THE CORES TO PROVIDE VARYING RELEASE RATES IN THE GASTRO-INTESTINAL TRACT, AT LEAST A MINOR PROPORTION OF THE CORES BEING COATED, THE COATED CORES HAVING ALTERNATING COATINGS OF THERAPEUTICALLY ACTIVE MATERIAL AND INGESTIBLE MATERIAL, AND THE PROPORTION OF THERAPEUTICALLY ACTIVE MATERIAL AND INGESTIBLE MATERIAL IN THE CORES AND THE AMOUNT OF THERAPEUTICALLY ACTIVE MATERIAL IN THE SUM OF THE COATINGS BEING SO CORRELATED THAT THE PERCENT OF THERAPEUTICALLY ACTIVE MATERIAL IN THE COATINGS PLUS THE PERCENT OF THERAPEUTICALLY ACTIVE MATERIAL IN THE CORES RELEASED DURING THE FIRST HOUR IN THE GASTRO-INTESTINAL TRACT IN THE EVENT OF ACCIDENTAL CRUSHING DURING ORAL ADMINISTRATION IS LESS THAN 50% OF THE TOTAL THERAPEUTIFALLY ACTIVE CONTENT OF THE DOSAGE UNIT.