Physical interactions of aqueous coating solutions with tablet cores containing superdisintegrants during pharmaceutical aqueous coatings
Abstract
This study was designed to determine the influence of the following superdisintegrants Ac-Di-Sol, crospovidone and Primojel, in tablets containing a model hydrolyzable drug on the effect of moisture penetration into the tablet cores and the drug stability after aqueous tablet coating. In order to understand the moisture uptake process, the superdisintegrants and tablets made from the superdisintegrants were characterized for their physical properties as well as the coating solutions used. The results of characterization of the superdisintegrants and the tablets showed that the superdisintegrants differ in their mechanisms of action as crospovidone attracted water by the formation of a network of pores, Primojel attracted water by swelling in contact with water and Ac-Di-Sol attracted water by the formation of a network of pores and swelling. The results of characterization of the coating solutions showed that viscosity played the major role in the penetration of water into the tablets cores as it influences coating solution penetration rate and atomization of the coating solution. In order to understand the hydrolyzable drug stability, solid state stability studies of mixtures of the drug and the superdisintegrants were conducted. The results of the solid stability studies demonstrated that moisture is not the only factor that affects the stability of the hydrolyzable drug. Superdisintegrants influenced the surface pH of the mixture which depends on the moisture level and will also affect stability of the drug. During the aqueous coating, all tablets showed significant increase in moisture content and a decrease in the stability of the hydrolyzable drug. The different tablet formulations showed differences in moisture penetration and stability as determined by moisture content, tablet hardness, and tablet physical dimension measurements and drug stability. The differences depended on the various physical or chemical properties of the disintegrant and the coating solutions.
Degree
Ph.D.
Advisors
Peck, Purdue University.
Subject Area
Pharmacology
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