IQUIR   05412
INSTITUTO DE QUIMICA ROSARIO
Unidad Ejecutora - UE
congresos y reuniones científicas
Título:
Formulation development and stability studies of ACD3 multivitamin drops
Autor/es:
LEONARDI, DARÍO; SILVANA E. VIGNADUZZO; MARTINEZ, MARIA VICTORIA
Lugar:
Rosario
Reunión:
Congreso; 4° Reunión internacional de ciencias farmacéuticas (RICiFa); 2016
Resumen:
Vitamins are organic compounds which are essential for normal metabolism, growth, development, and regulation of cellular functions. Insufficient levels of vitamins in the diet or a low absorption due to diverse illness may impair health. The administration of multivitamin formulations to patients, generally allows them to reach vitamin normal levels. Therefore, in the present work, we developed and optimized multivitamin formulations based on vitamins A, C and D3 in the form of liquids oral drops. Four formulations with different excipients (with and without Polysorbate 80, Cremophor RH 40 and BHT) and different vitamin concentrations were developed. An HPLC method was used for the quantification of vitamins. The chromatographic conditions for lipophilic vitamins (A and D3) were the following: mobile phase methanol:acetonitrile:hexane (46,5:46,5:7) at 2 ml/min, 30°C temperature and UV detection at 265 nm. The chromatographic conditions for the hydrophilic vitamin (C) were: mobile phase water:methanol:phosphate buffer pH 3.8 (94,5:4:1,5) at 0,8 ml/min, 25°C temperature and UV detection at 254 nm. The stability studies were performed in plastic and glass eyedropper bottles. Besides, three different storage conditions were analyzed: 1) accelerated storage condition at 40°C and 75% humidity, 2) long-term storage condition at 25°C, and 3) refrigerator storage condition at 4°C. The test involved physical properties, microbiological analysis and recoveries of the vitamins. In the first three months, a formulation composed of: vitamin A (833300 IU/100 mL), vitamin C (8.3300 g/100 mL) and vitamin D3 (166600 IU/100 mL) with Polysorbate 80 (19.15 g/100 mL) and without neither Cremophor RH 40 nor BHT (in glass eyedropper bottles), allowed a 90% - 110% recovery of the vitamins in all the storage conditions. This formulation also fulfilled the physical and microbiological tests.