Artículos de revistas
Influence Of The Type Of Enteric Coating Suspension, Coating Layer And Process Conditions On Dissolution Profile And Stability Of Coated Pellets Of Diclofenac Sodium
Powder Technology. Elsevier, v. 269, n. , p. 185 - 192, 2015.
In this work, diclofenac sodium pellets were produced through an extrusion/spheronization process and subsequently coated in a fluidized bed coater column with a Wurster insert. The aim of this work was to study the coating of pellets with two commercial aqueous enteric polymer suspensions, Advantia® Performance and Acryl-Eze® MP. The coating process was studied with a 23 experimental design. The variables were as follows: inlet air temperature, suspension flow rate and coating polymer. The response variables were as follows: the process efficiency, which generated results above 78.2%, and the agglomeration fraction, which generated results below 8%. The polymer coating type was the variable that influenced the response variables the most. The minimum masses gain needed to achieve enteric release were also determined: Acryl-Eze® MP: 9.7% and Advantia® Performance: 8.6%. The coated pellets were tested for drug content, dissolution and stability. Neither the drug content nor the release profiles were significantly affected by storage at 40°C and 75%. The suspensions were tested for rheology, contact angle and static wettability to investigate the characteristics of the polymer.269185192Hamdani, J., Moës, A.J., Amighi, K., Development and evaluation of prolonged release pellets obtained by the melt pelletization process (2002) Int. J. Pharm., 245, pp. 167-177Nande, V., Barabde, U., Morkhade, D., Patil, A., Joshi, S., Sustained release microspheres of diclofenac sodium using PEGylted rosin derivatives (2007) Drug Dev. Ind. Pharm., 33, pp. 1090-1100Salsa, T., Veiga, F., Pina, M.E., Oral controlled-release dosage forms. I. Cellulose ether polymers in hydrophilic matrices (1999) Drug Dev. Ind. Pharm., 23 (9), pp. 929-938Silva, O.S., Rocha, S.C.S., Prediction of efficiency and particles growth in the granules coating and drying process by statistical experimental design (2004) Proceedings of the 14th International Drying Symposium, pp. 860-867Nitz, M., Taranto, O.P., Film coating of theophylline pellets in a pulsed fluid bed coater (2008) Chem. Eng. Process., 47, pp. 1412-1419Satturwar, P.M., Mandaogade, P.M., Fulzele, S.V., Darwhekar, G.N., Joshi, S.B., Dorle, A.K., Synthesis and evaluation of rosin-based polymers as film coating materials (2002) Drug Dev. Ind. Pharm., 28 (4), pp. 381-387Dewettinck, K., Huyghebaert, A., Fluidized bed coating in food technology (1999) Trends Food Sci. Technol., 10, pp. 163-168Hampel, N., Bück, A., Peglow, M., Tsotsas, E., Continuous pellet coating in a Wurster fluidized bed process (2013) Chem. Eng. Sci., 86, pp. 87-98da Cunha, R.L.G., Pereira, M.M.C., Rocha, S.C.S., Conventional and modified fluidized bed: comparison of the fluid dynamics and application in particle granulation (2009) Chem. Eng. Process. Process Intensif., 48, pp. 1004-1011Albanez, 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) Adv. Powder Technol., 24, pp. 659-666Yang, S.T., Vansavage, G., Weiss, J., Ghebresellassie, I., The effect of spray mode and chamber geometry of fluid-bed coating equipment and other parameters on an aqueous-based ethylcellulose coating (1992) Int. J. Pharm., 86 (2-3), pp. 247-257Lorck, C.A., Grunenberg, P., Jünger, H., Laicher, A., Influence of process parameters on sustained-release theophylline pellets coated with aqueous polymer dispersions and organic solvent-based polymer solutions (1997) Eur. J. Pharm. Biopharm., 43, pp. 149-157Teunou, E., Poncelet, D., Batch and continuous fluid bed coating-review and state of the art (2002) J. Food Eng., 53, pp. 325-340. , (L.)Yang, L., Fasihi, R., Modulation of diclofenac release from a totally soluble controlled release drug delivery system (1997) J. Control. Release, 44, pp. 135-140Palomo, M.E., Ballesteros, M.P., Frutos, P., Analysis of diclofenac sodium and derivatives (1999) J. Pharm. Biomed., 21, pp. 83-94de Castro, W.V., Pires, M.A., Oliveira, M.A., Vianna-Soares, C.D., Nunan, E.A., Pianetti, G.A., Moreira-Campos, L.M., Derendorf, H., The influence of formulation on the dissolution profile of diclofenac sodium tablets (2006) Drug Dev. Ind. Pharm., 32, pp. 1103-1109(2009) The United States Pharmacopeia (USP XXXII)Shelukar, S., Ho, J., Zega, J., Roland, E., Yeh, N., Quiram, D., Nole, A., Reynolds, S., Identification and characterization of factors controlling tablet coating uniformity in a Wurster coating process (2000) Powder Technol., 100, pp. 29-36Box, G.E.P., Hunter, W.G., Hunter, J.S., (1978) Statistics for Experimenters - An Introduction to Design, Data Analysis and Model Building, p. 653. , John Wiley & Sons, New YorkDacanal, G.C., Menegalli, F.C., Selection of operational parameters for the production of instant soy protein isolate by pulsed fluid bed agglomeration (2010) Powder Technol., 203, pp. 565-573Nikowitz, K., Kása, P., Pintye-Hódi, K., Regdon, G., Study of the preparation of a multiparticulate drug delivery system with a layering technique (2011) Powder Technol., 205, pp. 155-159