Abstract
The purpose of this work was to develop a practical scale-up model for a solvent-based pan-coating process. Practical scale-up rules to determine the key parameters (pan load, pan speed, spray rate, air flow) required to control the process are proposed. The proposed scale-up rules are based on a macroscopic evaluation of the coating process. Implementation of these rules does not require complex experimentation or prediction of model parameters. The proposed scale-up rules were tested by conducting coating scale-up and scale-down experiments on 24-inch and 52-inch Vector Hi-coaters. The data demonstrate that using these rules led to similar cumulative drug release profiles (f2≫50; and P Analysis of Variance [P ANOVA]≫0.05 for cumulative percentage of drug released after 12 hours [Cum 12] from tablets made at 24- and 52-inch scales. Membrane characteristics such as opacity and roughness were also similar across the 2 scales. The effects of the key process variables on coat weight uniformity and membrane characteristics were also studied. Pan speed was found to be the most significant factor related to coating uniformity. Spray droplet size was found to affect the membrane roughness significantly, whereas opacity was affected by the drying capacity.
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References
Edward PL, Atiemo-Obeng VA, Kresta SM, eds.. Handbook of Industrial Mixing: Science and Practice. Hoboken, NJ: John Wiley & Sons; 2004.
Stetsko G, Banker GS, Peck GE. Mathematical modeling of an aqueous film coating process. Pharm Technol. 1983;7:50–62.
Liu L, McCall T, Tendolkar A. The Scale-up and Process Optimization on an Ethylcellulose-based Functional Coating and Its Impact on In-Vitro/In-Vivo Performance of a Novel Controlled Release System. Paper presented at: 27th International Symposium on Controlled Release of Bioactive Materials; July 7–13, 2000; Paris, France.
Porter SC, Verseput RP, Cunningham CR. Process optimization using design of experiments. Pharm Technol. 1997;21:60–70.
Rege BD, Gawel J, Kou JH. Identification of critical process variables for coating actives onto tablets via statistically designed experiments. Int J Pharm. 2002;237:87–94.
Levin M. How to scale up scientically: scaling up manufacturing process. Pharm Technol. 2005;3:4s-12s.
Ding YL, Forster RN, Seville JPK, Parker DJ. Scaling relationships for rotating drums. Chem Eng Sci. 2001;56:3737–3750.
Frisbee SE, Mehta K, McGinity J. Processing factors influence the in vitro and in vivo performance of film-coated drug delivery systems. Drug Deliv. 2002;2:72–76.
Pondell R. Scale-up of film coating processes. In: Pharm Technol. vol. 6. 1985:S68.
Avis KE, Shukla AJ, Chang RK, eds. Pharmaceutical unit operations: coating. Drug Manufacturing Technology Series, vol. 3. Boca Raton, FL: Interpharm/CRC; 1998.
Turton R, Cheng XX. The scale-up of spray coating processes for granular solids and tablets. Powder Technol., 2005; 150:78–85.
Porter SC. Scale-up of film coating. In: Levin M, ed. Pharmaceutical Process Scale-Up. New York, NY: Marcel Dekker Inc; 2000:259–310.
Henein H, Brimacombe JK, Watkinson AP. Experimental study of transverse bed motion in rotary kilns. Metall Trans B. 1983;14:191–205.
Wang RH, Fan LT. Methods for scaling-up. Chem Eng. 1974;27:88–94.
Block L. Scale-up of liquid and semisolid manufacturing processes: scaling up manufacturing process. Pharm Technol. 2005;3:26s-33s.
Tatterson GB. Scaleup and Design of Industrial Mixing Processes. New York, NY: McGraw Hill; 1994.
Orpe AV, Khakhar DV. Scaling relations for granular flow in quasi-two-dimensional rotating cylinders. Phys Rev E. 2001;64:31302–31315.
Campbell RJ, Sackett GL. Film Coating. In: Avis KE, Shukla AJ, Chang R, eds. Pharmaceutical Unit Operations: Coating. Boca Raton, FL: Interpharm/CRC; 1998:55–176.
Pandey P, Song Y, Kahiyan F, Turton R. Simulation of particle movement in a pan coating device using discrete element modeling and its comparison with video-imaging experiments. Powder Technol. 2006;161:79–88.
Masters K. Spray Drying: An Introduction to Principles, Operational Practices, and Applications. New York, NY: Wiley; 1976.
Lefebvre AH. Atomization and Sprays. New York, NY: Taylor and Francis; 1989.
Ebey GC. A thermodynamic model for aqueous film-coating. Pharm Technol. 1987;4:1–6.
Ende M, Berchielli A. A thermodynamic model for organic and aqueous tablet film coating. Pharm Dev and Tech. 2005;1:47–58.
Sandadi S, Pandey P, Turton R. In-situ, near real-time acquistion of particle motion in a rotating pan coating equipment using imaging techniques. Chem Eng Sci. 2004;59:5807–5817.
Pandey P, Turton R. Movement of different shaped particles inside a pan coating device using novel video imaging techniques. AAPS Pharm Sci Tech. 2005;6:E237-E244.
Joshi N, Hammerman E, Wiryo S, Tuttle W, Ergun J, Lilly B. Controlling tablet surface texture in pan coating processes [abstract]. AAPS J [serial online]. 2004; Available at: http://www.aapspharmaceutica. com/search/abstract_view.asp?id=228&ct=04Abstracts.
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Published: December 28, 2006
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Pandey, P., Turton, R., Joshi, N. et al. Scale-up of a pan-coating process. AAPS PharmSciTech 7, 102 (2006). https://doi.org/10.1208/pt0704102
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DOI: https://doi.org/10.1208/pt0704102