| Summary: | 碩士 === 高雄醫學大學 === 藥學研究所 === 88 === Biperiden is helpful in managing significant tremor of Parkinson’s disease and antipsychotic-induced extrapyramidal symptoms (EPS). The major purposes of the study are fixed to compare the difference of the brand product (A) and the four generic products (B, C, D, and E) in vitro, then to find the most different generic product from the brand product and administrate to rabbits to figure out the appropriate in vitro/in vivo correlation of biperiden tablets.
In this study, simulated intestinal fluid, water, and 0.1N hydrochloric acid were used as the dissolution media to confirm the relationship between pH value and dissolution profile. The difference factor (f1) and similarity factor (f2) published by FDA were employed to compare the similarity of multipoint dissolution profiles of brand and the generic products in the media. The pharmacokinetic parameters were determined by PCNONLIN software. Thereafter, the appropriate in vitro/in vivo correlation of biperiden tablets could be approached.
Biperiden tablets were fast dissolved in first 20 minutes. The pH value and biperiden concentration in media was found to be an inverse relationship. All f1 values of generic products are more than 15 and f2 values of generic products are less than 50. This means no significant similarity was observed in dissolution profiles between the brand and the generic products. Peak concentration (Cmax) of brand and the generic biperiden tablets were 25 to 28 ng ml-1 reached after 1.1 to 1.5 h (Tmax). Absorption rate constant (Kabs) of brand and the generic biperiden tablets were 1.084 h-1. No significant difference was observed in pharmacokinetic parameters between the brand and the generic products. Therefore, there is no close in vitro/in vivo correlation in the biperiden tablets studied.
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