INVESTIGADORES
PALMA Santiago Daniel
congresos y reuniones científicas
Título:
Coprocessed excipients production for direct compression of orally disintegrating tablets
Autor/es:
GARCIA, MAXIMILIANO; GALLO LOREANA; PALMA SANTIAGO; ALLEMANDI, DANIEL; PIÑA, JULIANA; BUCALA, VERONICA
Lugar:
Córdoba
Reunión:
Congreso; 1era Reunión Internacional de Ciencias Farmacéuticas; 2010
Institución organizadora:
Facultad de Ciencias Químicas - UNC
Resumen:
INTRODUCTION The tablets are currently the most widely used solid form for administering oral medications because they can be accurately dosed, easily manufactured and give good patient compliance (1-2). In particular, the preparation of orally disintegrating tablets (ODTs) requires adequate excipients to ensure a high disintegration rate in the mouth without need of water (3-4). The use of ODTs has been growing, however the excipients tobe used for these formulations are limited since they have to accomplish desired properties such as: water solubility, pleasant taste and mouth feel, sweetness and rapid dissolution (5-6). Many of the excipients used nowadays have been developed in the last decades, therefore there is still room to explore new formulations with better flowability, compressibility, hygroscopicity, palatability, dissolution and disintegration properties. MATERIALS AND METHODS In this study, different co-processed excipients with flow characteristics suitable for the production of ODTs, using a single processing step (spray drying) prior to direct compression, were obtained. For this purpose, different low-cost and easy accessibility excipients available in the market were first selected: lactose monohydrate (LACT), mannitol (MAN), microcrystalline cellulose (MCC) and silicon dioxide (SiO2). A Buchi Spray Drier B-191 was used to process different aqueous solutions containing different excipients and concentrations. Powders were obtained using one, two (binary mixtures) or three (ternary mixtures) excipients. For all the cases, the solutions had 10wt% as total solid concentration and they were processed using the same spray drying operating conditions . The powders were subjected to different characterization tests: repose angle, Carr and Hausner indexes and tablets wettability and strength obtained at different compression pressures. RESULTS The ternary mixture of MAN:MCC:SiO2 13:6:1 showed the better flowability properties, tablet strength (higher than 3 Kg) and adequate wettability times (of about 30 seconds) when tablets of 200 mg were obtained using a pressure of 0.3 tons. The SiO2 was added in order to improved the yield of the process, however higher quantities are not recommended because the wettability times increase considerably. Insert tables CONCLUSIONS The use of lactose was not found suitable, even this excipient allows to improve the powders flowability, the yield of the process drops to unfeasible levels.