Osmotic capsules: A universal oral, controlled-release drug delivery dosage form

• Published in: Journal of controlled release Vol. 152; no. 2; pp. 264 - 269
• Main Authors: Waterman, Kenneth C., Goeken, G. Scott, Konagurthu, Sanjay, Likar, Michael D., MacDonald, Bruce C., Mahajan, Nidhi, Swaminathan, Vidya
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 10-06-2011; Elsevier
• Subjects: Acetone; Administration, Oral; Banding; Biological and medical sciences; Capsules - chemistry; Cellulose; Cellulose - analogs & derivatives; Cellulose - chemistry; cellulose acetate; clinical trials; Controlled release; Delayed-Action Preparations - chemistry; Drug delivery; Drug development; drug formulations; drugs; General pharmacology; Lasers; Medical sciences; Molds; molecular weight; Oral controlled release; Osmosis; Osmotic drug delivery; Permeability; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Polyethylene; Polyethylene glycol; Polyethylene Glycols - chemistry; polyethylene oxide; Shells; Sodium chloride; Solubility; Tablets; Tablets - chemistry; Oral controlled release; Osmotic drug delivery; Pharmaceutical technology; Controlled release form; Control release polymer; Oral administration; Dosage form; Drug carrier; Capsule
• ISSN: 0168-3659; 1873-4995
• DOI: 10.1016/j.jconrel.2011.02.001

An osmotic, oral, controlled-release capsule is described. This capsule provides drug delivery at fixed delivery rates (T
80%
=
6 or 14
h) independent of drug properties (e.g., solubility) or drug loading, thereby allowing rapid development of investigational or commercial drugs, especially for proof-of-concept type clinical studies. The capsule body and cap are prepared with cellulose acetate and polyethylene glycol in acetone and water using high density polyethylene molds as templates and a conventional tablet pan coater. After the shells are removed from the molds manually, a laser hole is drilled in the end of the capsule body. The drug is introduced as a shaped tablet admixed with polyethylene oxide. A “push” tablet consisting of high molecular weight polyethylene oxide, microcrystalline cellulose, and sodium chloride is also inserted into the capsule body. The capsule halves lock together due to ridges, alleviating the need for a banding operation.
Osmotic capsule showing shell body, drug tablet, push tablet, and shell cap as produced and after start of drug delivery.
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