Pharmacoat Coating in an Aqueous System : The Dissolution Behavior and Reduction in Coating Time

다국어 초록 (Multilingual Abstract)

It is sometimes said lately that the pH of the human gastric juice is significantly different among individuals. Thus, the dissolution behavior of coated solid dosage forms should preferably be independent of the pH of the test solution. With these points as a background, the effect of pH on the dissolution velocity of coated tablets was studied to compare that of Pharmacoat with other gastric soluble film coating materials. Three viscosity types of Pharmacoat have been available(3, 6 and 15cP) until now. the 6cP type has been considered to be the most suitable for a tablet coating amongst the three types. The 3 cP type with a low degree of polymerization, is capable of providing high concentration, but the film strength is so inferior that sometimes cracking of the film may occur. On the other hand, in the case of the 15cP type, high polymer concentration cannot be achieved because of the high dgree of polymerization, and thus it is uneconomical for coating. Now, there is a strong demand to reduce the coating time even when HPMC is used in the 6cP type in order to reduce the coating cost. In order to improve this problem, we have concentrated our attention on reducing the viscosity value of HPMC to an allowable lower limit from 6cP. As a result of this study, it was found that the reduction of the viscosity value to around 4.5cP enabled the use of a higher solution concentration and an incidental shorter coating time without giving any substantial adverse effects on the properties of coated preparations. These experiment results are presented in the later part of this presentation. Based on this study, we have added the viscosity type of 4.5cP as one of the Pharmacoat products as Pharmacoat-645.