The purpose of this research was to develop novel functional drug particles embedded in a gelling-swelling layer (PEGS) which are capable of achieving both taste-masking of unpalatable drugs and rapid drug elution. The functional particles had a three-layer structure consisting of a core drug layer, a gelling-swelling layer and an outer water-penetration control layer containing a water-insoluble polymer. The concept of formulation design was as follows: when water reaches the gelling-swelling layer, pulverized fine gelling-swelling particles gellate and swell from water absorption to form a rigid layer, thereby preventing drug release. After a defined lag time, the increased volume of the gelling-swelling layer breaks down the outer water-penetration control layer, leading to rapid drug release.In order to adapt this system for use in orally disintegrating tablets, PEGS were prepared at a size of about 250 μm using a fine particle-coating method. Ambroxol hydrochloride was used as a model drug for bitterness and the effects of different gelling-swelling agents and water-insoluble polymers on drug release characteristics from PEGS were examined. In in vitro dissolution tests, it was shown that the drug dissolution rate from PEGS could be suppressed to about 5% after 2 minutes and increased to more than 85% after 30 minutes by adjusting the composition and thickness of the outer layer. The PEGS expanded about 1.5-fold and the outer layer was ruptured after 5 minutes in water.
A high performance liquid chromatograph (HPLC) was used for the quality test of Ubidecarenone (CoQ10) products. CoQ10 products were exposed to light under 2000 lux for 29 days, and their stability to light was studied with HPLC. The results were as follows: 1) Good separation of CoQ10. CoQ9 and UC9 was achieved with HPLC. 2) The amount of CoQ10 in granules and fine granules packed with Pile Packer Film was between 11% and 18% after 29-day exposure to light, whereas CoQ10 in granules in lightshielded package and that in raw material powder packed with pile packer Film were 74% and 90%, respectively. 3) The main decomposition substance of the granules, the fine granules and raw material powder showed that the relative retention to CoQ10 was 0.49.
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