Biopharmaceutics classification by high throughput solubility assay and PAMPA.
The purpose of the present study was to examine the relevancy of the high throughput solubility assay and permeability assay to the biopharmaceutics classification system (BCS). Solubility and permeability were measured by high throughput solubility assay (HTSA) and parallel artificial membrane permeation assay (PAMPA), respectively. High throughput solubility assay was performed using simulated gastric fluid (SGF, pH 1.2) and simulated intestinal fluid without bile acid (SIF, pH 6.8). We categorize 18 drugs based on the BCS using HTSA and PAMPA. Fourteen out of 18 drugs were correctly classified (78% success rate). The result of the present study showed that HTSA could predict BCS class with a high success rate, and PAMPA could also be useful to predict the permeation of drugs.
Obata
Kouki
K
Pre-Clinical Research Department I, Chugai Pharmaceutical Co., Ltd., Gotemba, Shizuoka, Japan. obatakuk@chugai-pharm.co.jp
Sugano
Kiyohiko
K
Machida
Minoru
M
Aso
Yoshinori
Y
D008567:Membranes, Artificial; D010539:Permeability; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000145:classification*; D011237:Predictive Value of Tests; D012995:Solubility
D008567:Membranes, Artificial; D004364:Pharmaceutical Preparations