QbD-based formulation development and evaluation of lipid-cellulose-based extended-release multi-particulates of cinitapride and its in-silico PBPK modeling.

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Tác giả: Shehzad Ali, Muhammad Iqbal Nasiri, Faaiza Qazi, Muhammad Talha Saleem, Muhammad Umair Saleem, Muhammad Harris Shoaib, Fahad Siddiqui, Muhammad Sikandar, Rabia Ismail Yousuf

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: Netherlands : International journal of biological macromolecules , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 643711

The study aims to develop and optimize extended-release cinitapride matrix pellets using lipid wax glyceryl monostearate (GMS) and ethyl cellulose (EC) for treating functional dyspepsia and gastrointestinal reflux disease. Pellets were prepared using the extrusion spheronization technique by applying central composite design (CCD), keeping EC-7cps (matrix former), spheronization speed, and time as variables. The drug release, sphericity, and aspect ratio were quality parameters. The predicted optimized formulation was evaluated for chemical interaction, thermal stability, accelerated stability, and surface morphology. EC effectively controlled the overall Cinitapride release for up to 12 h, but burst release was reduced by sintering the matrix pellets. A direct relationship was observed between the sphericity and aspect ratio of the pellets with the spheronization speed and time. F
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