Compression of enteric-coated pellets to disintegrating tablets

• Published in: International journal of pharmaceutics Vol. 143; no. 1; pp. 13 - 23
• Main Authors: Beckert, Thomas E., Lehmann, Klaus, Schmidt, Peter C.
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 25.10.1996; Elsevier
• Subjects: Acrylic polymer; Biological and medical sciences; Coating; Dissolution behavior; Gastrointestinal stability; General pharmacology; Medical sciences; Pellet; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Tableting; Dissolution behavior; Pellet; Coating; Acrylic polymer; Gastrointestinal stability; Tableting; Methacrylate polymer; Stability; Pharmaceutical technology; Controlled release form; Direct compression; Enteric coating; Dissolution; In vitro; Bisacodyl; Formulation; Dosage form; Tablet; Kinetics; Pellet(dosage form)
• ISSN: 0378-5173; 1873-3476
• DOI: 10.1016/S0378-5173(96)04631-5

Enteric-coated sucrose pellets containing a layer of bisacodyl beneath the coating were compressed into tablets on an instrumented single-punch machine using four different filler-binders for direct compression. Different copolymers based on polymethacrylates were applied as coatings. Pellets of two different crushing strengths were used. The quality of the films before and after tableting was evaluated by determining the amount of bisacodyl liberated after treatment for 2 h in 0.1 M HC1 according to the requirements of USP 23 for enteric-coated preparations. Results indicate that the most important parameters are the coating agent itself and the amount of coating applied to the pellets. Higher coating weights and coatings with better elastic properties lead to formulations, which liberate less bisacodyl after compression. Formulations are available that fulfil all requirements of USP 23 regarding entericcoated preparations.