Artículos de revistas
Film Coating Of Nifedipine Extended Release Pellets In A Fluid Bed Coater With A Wurster Insert
Biomed Research International. Hindawi Publishing Corporation, v. 2014, n. , p. - , 2014.
De Souza L.F.G.
The objective of this work was to study the coating process of nifedipine extended release pellets using Opadry and Opadry II, in a fluid bed coater with a Wurster insert. The coating process was studied using a complete experimental design of two factors at two levels for each polymer. The variables studied were the inlet air temperature and the coating suspension flow rate. The agglomerate fraction and coating efficiency were the analyzed response variables. The air temperature was the variable that most influenced the coating efficiency for both polymers. In addition, a study of the dissolution profiles of coated and uncoated pellets using 0.5% sodium lauryl sulfate in simulated gastric fluid without enzymes (pH 1.2) was conducted. The results showed a prolonged release profile for the coated and uncoated pellets that was very similar to the standards established by the U.S. Pharmacopoeia. The drug content and the release profiles were not significantly affected by storage at 40°C and 75% relative humidity. However, when exposed to direct sunlight and fluorescent light (light from fluorescent bulbs), the coated pellets lost only 5% of the drug content, while the uncoated ones lost more than 35%; furthermore, the dissolution profile of the uncoated pellets was faster. © 2014 Luciane Franquelin Gomes de Souza et al.2014Reynolds, A.D., A new technique for the production of spherical particles (1970) Manufacturing Chemist and Aerosol News, 41, pp. 40-43Bechgaard, H., Hagermann, N.G., Controlled-release multi-units and single unit doses. A literature review (1978) Drug Development and Industrial Pharmacy, 4, pp. 53-67Eskilson, C., Controlled release by microencapsulation (1985) Manufacturing Chemist, 56, pp. 33-39Dietrich, R., Food technology transfers to pellet production (1989) Manufacturing Chemist, 60, pp. 29-33Conine, J.W., Hadley, H.R., Preparation of small solid pharmaceutical spheres (1970) Drug and Cosmetic Industry, 106, pp. 38-41Kranz, H., Gutsche, S., Evaluation of the drug release patterns and long term stability of aqueous and organic coated pellets by using blends of enteric and gastrointestinal insoluble polymers (2009) International Journal of Pharmaceutics, 380 (1-2), pp. 112-119. , 2-s2.0-69549109850 10.1016/j.ijpharm.2009.07.013Wurster, D.E., Particle Coating Process, , US Patent 3.253.944, Wisconsin Alumni Research Foundation, 1966KuShaari, K., Pandey, P., Song, Y., Turton, R., Monte Carlo simulations to determine coating uniformity in a Wurster fluidized bed coating process (2006) Powder Technology, 166 (2), pp. 81-90. , DOI 10.1016/j.powtec.2006.05.001, PII S0032591006001604Teunou, E., Poncelet, D., Batch and continuous fluid bed coating - Review and state of the art (2002) Journal of Food Engineering, 53 (4), pp. 325-340. , DOI 10.1016/S0260-8774(01)00173-X, PII S026087740100173XAlbanez, R., Nitz, M., Taranto, O.P., Enteric coating process of diclofenac sodium pellets in a fluid bed coater with a Wurster insert: Influence of process variables on coating performance and release profile (2013) Advanced Powder Technology, 24, pp. 659-666O'Connor, R.E., Schwartz, J.B., Spheronization II: Drug release from drug-diluent mixtures (1985) Drug Development and Industrial Pharmacy, 11 (9-10), pp. 1837-1857Xxxii, U., (2009) The United States Pharmacopeia, NF 27, , 3rdWalley, T.J., Heagerty, A.M., Woods, K.L., Pharmacokinetics and pharmacodynamics of nifedipine infusion in normal volunteers (1987) British Journal of Clinical Pharmacology, 23 (6), pp. 693-701Soons, P.A., Schoemaker, H.C., Cohen, A.F., Breimer, D.D., Intraindividual variability in nifedipine pharmacokinetics and effects in healthy subjects (1992) Journal of Clinical Pharmacology, 32 (4), pp. 324-331. , 2-s2.0-0026524185Toal, C.B., Formulation dependent pharmacokinetics - Does the dosage form matter for nifedipine? (2004) Journal of Cardiovascular Pharmacology, 44 (1), pp. 82-86. , DOI 10.1097/00005344-200407000-00011Huang, J., Wigent, R.J., Schwartz, J.B., Nifedipine molecular dispersion in microparticles of ammonio methacrylate copolymer and ethylcellulose binary blends for controlled drug delivery: Effect of matrix composition (2006) Drug Development and Industrial Pharmacy, 32 (10), pp. 1185-1197. , DOI 10.1080/03639040600832827, PII M0L7230055007048Zhu, X.-J., Yuan, W., Li, P., Liu, X., He, J.-Q., Pharmacokinetics of a novel nifedipine and pH-sensitive N-succinyl chitosanalginate hydrogel bead in rabbits (2010) Drug Development and Industrial Pharmacy, 36 (12), pp. 1463-1468. , 2-s2.0-78149374547 10.3109/03639045.2010.488644Emara, L.H., Badr, R.M., Elbary, A.A., Improving the dissolution and bioavailability of nifedipine using solid dispersions and solubilizers (2002) Drug Development and Industrial Pharmacy, 28 (7), pp. 795-807. , DOI 10.1081/DDC-120005625Santos, H.M.M., Veiga, F.J.B., Pina, M.E.T., Sousa, J.J.M.S., Production of pellets by extrusion and spheronization pharmaceutical - Part i - tion of technological variables and formulation (2004) Revista Brasileira de Ciências Farmacêuticas, 40, pp. 455-470Box, G., Hunter, J.S., Hunter, W.G., (2005) Statistics for Experimenters - Design, Innovation and Discovery, , Business & EconomicsRowe, R.C., Sheskey, P.J., Quinn, M.E., (2009) Handbook of Pharmaceutical Excipients, , 6th London, UK Pharmaceutical PressRocha, S.C.S., Taranto, O.P., Mujundar, A.S., Coating and agglomeration in fluidized beds (2013) Maria Laura Passos, Marcos Antonio S e Barrozo, pp. 96-119. , Laval, Canada Fluidization Engineering Pratice