From lab-to-clinic with model informed formulation development: a case study of ...

연구 요약

From lab-to-clinic with model informed formulation development: a case study of hydroxyzine SR tablets.

Xenobiotica; the fate of foreign compounds in biological systems 학술지에 발표된 이 연구는 Murthy A, Jamdade S, Gundeti M 외 연구팀이 수행하였습니다.

이 연구는 'From lab-to-clinic with model informed formulation development: a case study of hydroxyzine SR tablets.'에 대한 과학적 분석을 제공합니다.

핵심 내용

Model Informed Formulation Development (MIFD) uses physiologically based pharmacokinetic (PBPK) modelling and other in silico tools to facilitate new product development. These tools help set target profiles, predict in vivo formulation performance, guide iterative development, define dissolution parameters, and convince the regulatory agencies about a drug's safety and efficacy.This study involves development of a sustained release formulation for Hydroxyzine, an anti-histamine with sedation as a significant side effect. The aim was to design a formulation that releases the drug slowly, reducing the peak plasma concentration without losing on the effectiveness. A preliminary absorption model was developed using immediate release formulation data, and various hypothetical dissolution profiles were evaluated in this model. The new drug product, manufactured using MatrixealTM technology, underwent preliminary bioequivalence (BE) studies in healthy volunteers. These results were used to refine the model and further modify the formulation, whose performance was predicted via virtual BE studies. Confirmatory BE studies with 70 volunteers under fasting state validated the new formulation. The model also established clinically relevant dissolution specifications and assessed the food effect on the drug product.This work showcases the application of PBPK modelling in developing new modified release drug product of Hydroxyzine.

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의사/약사의 전문적 판단을 대체하지 않습니다 (PMID: 40276815)