Examinando por Autor "Abdala-Saiz, Ariadna"

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Interaction and Compatibility Studies in the Development of Olmesartan Medoxomil and Hydrochlorothiazide Formulations under a Real Manufacturing Process
(Multidisciplinary Digital Publishing Institute (MDPI) (Suiza), 2022) Murillo Fernández, Mac Arturo; Montero Zeledón, Ernesto; Abdala-Saiz, Ariadna; Jose-Roberto, Vega-Baudrit; Araya Sibaja, Andrea Mariela
Abstract. Adrug–drug and drug–excipient interactions and compatibilities studywas conducted for two fixed-dose combination (FDC) products containing olmesartan medoxomil (OLM)/hydrochlorothiazide (HCT) 20/12.5 mg and OLM/HCT 40/12.5 mg during their development including storage. The study consisted of the evaluation of samples retrieved during all stages of a real manufacturing process. Powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), thermogravimetry (TGA), Fourier transform infrared spectroscopy (FT-IR), and contact angle techniques were applied to the samples to determine interactions and incompatibilities. Dissolution tests and long-term stability studies were conducted to evaluate dosage form performance. Results showed weak solid–state interactions able to obtain a eutectic mixture of OLMand HCT while microcrystalline cellulose (MC) impacted the thermal stability of both drugs. Reliable dissolution and long-term stability tests confirmed that the interactions observed were not considered incompatibilities because they were not influenced by the performance of the final products.