Open AccessEvaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)
Author(s) -
Matheus da Silva Ferreira,
Gilmar Antônio de Carvalho Teles Júnior,
Carlos Magno Ramos Carvalho Júnior,
Fernanda de Souza Dias,
Wilson Saback Dias dos Santos Júnior,
Marluce Oliveira da Guarda Souza,
Aníbal de Freitas Santos Júnior
Publication year - 2020
Publication title -
revista colombiana de ciencias químico-farmacéuticas/revista colombiana de ciencias quimico-farmaceuticas
Language(s) - English
Resource type - Journals
eISSN - 1909-6356
pISSN - 0034-7418
DOI - 10.15446/rcciquifa.v49n2.89486
Subject(s) - hydrochlorothiazide , dissolution , solubility , raw material , chemistry , dosage form , differential scanning calorimetry , pharmaceutics , dissolution testing , chromatography , thermogravimetry , materials science , chemical engineering , pharmacology , organic chemistry , medicine , biopharmaceutics classification system , inorganic chemistry , physics , blood pressure , radiology , engineering , thermodynamics
The purpose of this study was to evaluate physicochemical properties and dissolution studies of furosemide (FUR), hydrochlorothiazide (HCTZ) and nifedipine (NIF), low water solubility drugs, in raw materials and pharmaceutical formulations. Surface and physicochemical characterization techniques -scanning electronic microscopy (SEM), thermogravimetry (TG), X-ray diffraction (XRD) and infrared (IR) spectrometry- as well as physical and physicochemical tests on tablets and capsules were applied as supporting information on drug quality control. Simple, rapid, and efficient UV-Vis methods were developed and validated for the determination of FUR, HCTZ and NIF samples. SEM exhibited considerable differences in the crystal morphological structures. Among the drugs studied, except for furosemide, more than one polymorph was present in the samples. Drug release profiles were satisfactory for all products. FUR and HCTZ tablets exhibited similar dissolution profiles, with very rapid release to the pharmaceutical specialties (reference, similar and generic). For HCTZ tablets, the similar drug (f2= 48.74) is not equivalent to the reference drug. NIF capsules (reference and compounded) showed a release ≥80% of stated on product labels, in 10 minutes. The results obtained in this study suggest that the quality parameters and drug dissolution profiles may have been influenced by the morphology and size of the crystals, excipients, and technological processes.