RESUMO
BACKGROUND: Our previous study found that spray-dried glutinous rice starch (sGRS) is larger in size, rounder in shape and better in flowability than native GRS. It has the potential to be used for direct compression hydrophilic matrix (HM) tablets. OBJECTIVE: This study aimed to investigate the factors that affect the propranolol release from directly compressed sGRS HM tablets. METHODS: The effects of the amount of sGRS, the compaction pressure and the amount of magnesium stearate on the drug release rate from sGRS directly compressed HM were investigated. In vitro drug releases were performed. The dilution potential of sGRS was investigated. RESULTS: The higher the sGRS content, the slower the release rate of propranolol. The compaction pressure and the amount of magnesium stearate did not significantly affect the release rate of the drug. The sGRS showed plastic deformation under compaction with a dilution potential of 46%. CONCLUSIONS: sGRS can be used as a direct compression HM. The amount of sGRS significantly affected the release rate of the drug from the matrix.
Assuntos
Composição de Medicamentos/métodos , Oryza/química , Secagem por Atomização , Amido/química , Comprimidos , Acetaminofen/administração & dosagem , Acetaminofen/química , Acetaminofen/farmacocinética , Fenômenos Químicos , Força Compressiva/fisiologia , Portadores de Fármacos/síntese química , Portadores de Fármacos/química , Liberação Controlada de Fármacos , Glutens/química , Humanos , Interações Hidrofóbicas e Hidrofílicas , Teste de Materiais , Concentração Osmolar , Tamanho da Partícula , Pressão , Solubilidade , Comprimidos/síntese química , Comprimidos/química , Comprimidos/farmacocinéticaRESUMO
Glutinous rice starch (GRS) is a biopolymer used widely in the food industry but not at all in the pharmaceutical industry. There are several ways to modify this biopolymer. Physical modification is simple and cheap because it requires no chemicals or biological agents. The aim of this study was to characterize the physicochemical properties of a spray dried glutinous rice starch (SGRS) produced from pregelatinized GRS. The surface morphology changed from an irregular to concave spherical shape as revealed by Scanning Electron Microscopy (SEM). SGRS was almost amorphous as determined by X-ray Diffraction (XRD) spectroscopy. The water molecules became linked through hydrogen bonds to the exposed hydroxyl group of amorphous SGRS as determined by Near Infrared (NIR) spectroscopy. Then, SGRS formed a colloid gel matrix with water and developed a highly viscous gelatinous form as determined using Differential Scanning Calorimetry (DSC) and a stress control type rheometer. In addition, SGRS can swell and produce a gelatinous surface barrier like a hydrophilic matrix biopolymer which controls drug release. Therefore, a novel application of SGRS is as a sustained release modifier for direct compression tablets in the pharmaceutical industry.
