A New Crystalline Ketoprofen Sodium Salt: Solid-State Characterization, Solubility, and Stability

Autor: Magali Benjamim Araújo, Thulio Wliandon Lemos Barbosa, Rudy Bonfilio, Bruno Arantes Borges, Homero de Oliveira Junior, Ataislaine Batista, Maria Teresa Leite Braga
Přispěvatelé: Federal University of Alfenas (UNIFAL-MG), Universidade Estadual Paulista (UNESP)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Scopus
Repositório Institucional da UNESP
Universidade Estadual Paulista (UNESP)
instacron:UNESP
Popis: Made available in DSpace on 2022-04-28T19:47:45Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-01-01 Ketoprofen (KTP) is an Active Pharmaceutical Ingredient (API) that has low solubility in aqueous solvents. The use of KTP salts has attracted attention due to its improvements in terms of solubility, tolerability, higher rate and extent of absorption, and faster onset of the therapeutic effect. In this work, a crystalline KTP sodium salt (coded as KTP-Na) was successfully obtained and widely characterized by X-ray powder diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), solubility and accelerated stability studies. XRD results showed that KTP-Na is not yet reported in the literature. Moreover, FTIR, DSC and TGA were useful for differentiation of KTP-Na from the KTP commercialized form (coded as KTP-R1). The solubility of KTP-Na in water was about 80 times greater than the KTP-R1. However, KTP-Na showed lower physical stability in storage conditions at 40 ± 2°C/ 75% ± 5% RH when compared to KTP-R1, which was shown to be related to a high hygroscopicity of KTP-Na. Therefore, due to its higher solubility, KTP-Na may be a viable alternative for use in solid dosage forms. However, the presence of moisture must be strictly controlled to avoid water absorption and consequent amorphization. Faculty of Pharmaceutical Sciences Federal University of Alfenas (UNIFAL-MG) Institute of Chemistry Federal University of Alfenas (UNIFAL-MG) Faculty of Pharmaceutical Sciences São Paulo State University (UNESP-SP) Faculty of Pharmaceutical Sciences São Paulo State University (UNESP-SP)
Databáze: OpenAIRE