Abstract
Dissolution and other pharmaceutical properties of four kinds of oral potassium products stored under two different conditions were examined. The potassium products examined were tablets of aspartate (A) and gluconate (B), sustained release tablet and enteric coated granule of chloride (C and D, respectively). One of the storage conditions was standing in desiccator at room temperature for 30 days (ordinary condition) and the other at RH 92% at 30° for 30 days (accelerated condition).
Despite the labeling of enteric coating, the dissolution of D into the first fluid in J. P. IX disintegration test showed apparently a sustained release profile. When stored under the accelerated condition, D as well as A showed significantly more rapid dissolution than when stored under the ordinay condition. No change was observed in B and. C.
The effects of two apparatus (J. P. IX disintegration test test apparatus and Desaga Resomat II 147003) on dissolution time were observed in B, C and D, and both 50% and 90% dissolution times were reduced significantly when J. P. IX apparatus was used. This suggested that vigorous mixing with the J. P. IX apparatus facilitated disintegration of dosage form to accelerate dissolution of the component. The properties other than dissolution, i. e., weight, hardness, fineness and content, were almost satisfactory under the ordinay and accelerated conditions. Under the accelerated condition, A was found insufficient moistureproof inner package.
