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Combined use of DSC, TGA, XDR and NIR in the compatibility study of preformulation mixtures for the development of 10 mg tablets of Rupatadine Fumarate
It is essential to guarantee physico-chemical compatibility between the active pharmaceutical ingredient (API) and the components that are planned to be used in the development of a pharmaceutical formulation. A successful ...
Determination of the Impact Caused by Direct Compression on the Crystalline State of Rupatadine Fumarate 10 mg Tablets
The aim of this study is to determine the impact caused by direct compression on the crystalline state of two prototypes of Rupatadine fumarate 10 mg tablets. The tablets were manufactured through direct compression. ...
Design of Experiments for the Establishment of the Dissolution Test Conditions of Rupatadine Fumarate 10 mg tablets
Design of Experiments (DoE) is a statistical model that aims to determine if the factors under study affect the response, and if so, it determines the conditions under which this variable of interest can be optimized. In ...
Identification of rupatadine fumarate polymorphic crystalline forms in pharmaceutical raw materials
Polymorphism analysis of pharmaceutical raw materials is considered one of the most relevant evaluations that should be done. As we know, different crystal forms from the same molecule have differences in terms of their ...
Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach
The main objective of this research is to develop an immediate release Rupatadine fumarate 10 mg tablets formulation by direct compression, through a Quality by Design approach in Costa Rica. Methods: According to a ...