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KMID : 0369819920220030205
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Jorunal of Korean Pharmaceutical Sciences
1992 Volume.22 No. 3 p.205 ~ p.210
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Development of Controlled Release Oral Drug Delivery System by Membrane - Coating Method - Ⅲ Preparation of Theophylline Tablets and Pharmacokinetic Evaluation in Man
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심창구/Shim CK
김종국/이민화/김신근/Kim CK/Lee MH/Kim SK
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Abstract
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In order to develop a controlled-release oral drug delivery system (DDS) of theophylline (TP), microporous membrane-coated tablets were prepared and evaluated in vitro and in vivo. Rapidly water-soluble core tablets of TP (300 mg) were prepared by wet granulation and compression technique, Then the core tablets were spray-coated with polyvinylchloride (PVC) in which micronized sucrose particles were dispersed. Effect of formula compositions of coating suspensions on the pharmaceutical characteristics such as membrane strength and dissolution was investigated in vitro. The membranes remained unbroken in pH 1.2 buffer at 37?C at least for 2 hours after the disintergration test. TP was released from the coated-released tablets at a zero-order rate over 8 hours. The release at pH 1.2 and 4.0 was similar in rate but a little more rapid than that at pH 6.8. The coated tablets were administered to three healthy male volunteers and their saliva profiles of TP were compared with those from the commercial sustained release TP tablets such as Slobid and Asconthin. Saliva TP concentrations from the coated tablets were successfully sustained over 48 hours after the dosing and were comparable to those of the commercial sustained-release tablets. The membrane-coating technique is very simple and does not need any sophisticated equipments. In this respect, the membrane-coated tablets may be superior to the commercial sustained-release tablets and this technique is worth adopting by the pharmaceutical industries.
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KEYWORD
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oral drug delivery system, controlled release, membrane-coated tablets, theophylline, polyvinyl chloride, sugar particle, microporous membrane, zero-order release, saliva concentration, pharmacokinetics
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