THE EFFECTS OF MICROCRYSTALLINE CELLULOSE IN A SUGAR COATING SUSPENSION ON THE COATING PROCESS AND ON THE PHYSICAL PROPERTIES OF THE COATED TABLETS (STATISTICS, DESIGN, OPTIMIZE)
Abstract
Microcrystalline cellulose was incorporated into subcoating suspension formulations used to sugar coat tablets. The effect of microcrystalline cellulose on the flow behavior of the suspension formulations was investigated. The viscosities of the suspensions were affected by the amount of mixing and the solids content in the formulations. The extreme vertices statistical design was used to select subcoating suspension formulations to evaluate the effects of formulation factors on response parameters that measured process and product quality. The formulation factors studied were the level of inorganic components, microcrystalline cellulose, sucrose, povidone and water. The response parameters considered included measurements of the subcoating rate, mechanical strength, shape and the weight variation of the sugar coated tablets. Optimized formulas were determined for each response parameter. Microcrystalline cellulose was found to reduce the time required to subcoat tablets and to increase the mechanical strength of the sugar coated tablets. It is believed that microcrystalline cellulose accelerated the coating process by affecting the moisture content of the tablets during the coating process. Microscopic examinations of the subcoated tablets indicated that microcrystalline cellulose improves the mechanical strength of a sugar coated tablet by affecting the recrystallization of sucrose. Microcrystalline cellulose was compared to cellulose powder as a formulation additive. Microcrystalline cellulose was determined to be equivalent or superior to cellulose powder with respect to the responses measured. Formulations containing 5% microcrystalline cellulose optimally enhanced the dissolution of phenylpropanolamine hydrochloride sugar coated tablets. Microcrystalline cellulose inhibited the decrease in the dissolution rate of the drug from aged sugar coated tablets. A subcoating formulation containing 3% microcrystalline cellulose was successfully applied by a semi-automated spray process. This demonstrated the potential for applying subcoating suspensions containing microcrystalline cellulose by a production technique.
Degree
Ph.D.
Subject Area
Pharmaceuticals
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