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A way forward for generic development of telmisartan tablets: Integrating critical material attributes and bio-predictive dissolution for target product profile

European Journal of Pharmaceutics and Biopharmaceutics
This study systematically integrated critical material attributes (CMAs) influencing drug release, focusing on factors such as particle size and excipient composition, and characterization of polymorphic form. As a model compound, a BCS class II drug Telmisartan was selected, and the methodology was evaluated using seven different formulations of ...
Megha Pillai   +2 more
openaire   +2 more sources

[Critical quality attribute assessment of big brand traditional Chinese medicine: quality control method of ginkgo leaves extract material based on powder physical properties].

Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica, 2021
The physical properties of ginkgo leaves extract(GLE) are the critical quality attributes for the control of the manufacturing process of ginkgo leaves preparations. In this study, 53 batches of GLE with different sources from the real world were used as the objects to carry out the research from 3 levels.
Jing, Zhang   +8 more
openaire   +1 more source

On the influence of raw material attributes on process behaviour and product quality in a continuous WET granulation tableting line

International Journal of Pharmaceutics, 2023
Martin Spoerk   +2 more
exaly  

Effect of processing conditions and material attributes on the design space of lysozyme pellets prepared by extrusion/spheronization

Journal of Drug Delivery Science and Technology, 2021
Yousif H-E Y Ibrahim   +2 more
exaly  

Critical Excipient Attributes Relevant to Solid Dosage Formulation Manufacturing

Journal of Pharmaceutical Innovation, 2019
Naseem A Charoo
exaly  

Estimation of the critical quality attributes for hydroxypropyl methylcellulose with near-infrared spectroscopy and chemometrics

Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy, 2017
Lei Nie, Lian Li, Zang Hengchang
exaly  

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