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Drug Development and Industrial Pharmacy Volume 46, 2020 - Issue 1
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Research Articles

Optimization of the coating process of minitablets in two different lab-scale fluid bed systems

Maja SzczepanskaDepartment of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland;
,
Piotr PaduszynskiResearch and Development Department, Polpharma SA, Starogard Gdanski, Poland
,
Hanna KotlowskaDepartment of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland;
&
Malgorzata SznitowskaDepartment of Pharmaceutical Technology, Medical University of Gdansk, Gdansk, Poland; Correspondence[email protected]
Pages 31-41 | Received 11 Jul 2019, Accepted 21 Nov 2019, Published online: 06 Dec 2019

References

  • European Medicines Agency (EMA). ICH guideline Q8 (R2) on pharmaceutical development. London: EMA; 2017. Standard No. EMA/CHMP/ICH/167068/2004.
  • Teżyk M, Jakubowska E, Milanowski B, et al. Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets – a case study. Drug Dev Ind Pharm. 2017;43(10):1626–1636.
  • Aleksovski A, Dreu R, Gašperlin M, et al. Mini-tablets: a contemporary system for oral drug delivery in targeted patient groups. Expert Opin Drug Deliv. 2015;12(1):65–84.
  • Mohamed F, Roberts M, Saleem R. Hydrocortisone mini-tablets for pediatric delivery. J Pharm Pharmacol. 2010;62(10):1441.
  • Tissen C, Woertz K, Breitkreutz J, et al. Development of mini-tablets with 1 mm and 2 mm diameter. Int J Pharm. 2011;416(1):164–170.
  • Bodea M, Napoca C. Film coating preparation of metoprolol tartrate mini-tablets and in vitro drug release studies. Clujul Med. 2010;83(3):457–464.
  • Gaber DM, Nafee N, Abdallah OY. Mini-tablets versus pellets as promising multiparticulate modified release delivery systems for highly soluble drugs. Int J Pharm. 2015;488(1-2):86–94.
  • Souza DF, de Goebel K, Andreazza IF. Development of enteric coated sustained release minitablets containing mesalamine. Braz J Pharm Sci. 2013;49(3):529–536.
  • Saleh K, Steinmetz D, Hemati M. Experimental study and modeling of fluidized bed coating and agglomeration. Powder Technol. 2003;130(1-3):116–123.
  • Knowlton TM, Karri SBR, Issangya A. Scale-up of fluidized-bed hydrodynamics. Powder Technol. 2005;150(2):72–77.
  • ProCepT.be [Internet]. Belgium: ProCepT; [cited 2019 Jun 14]. Available from: http://www.procept.be/products.
  • Romaco & INNOJET [Internet]. Germany: Romaco Group; [cited 2019. June 14]. Available from: https://www.romaco.com/files/Dokumente/delivering-solutions/romaco_aircoater-EN.pdf.
  • Reynolds GK, Le PK, Nilpawar AM. High shear granulation. In: Salman AD, editor. Handbook of powder technology: Volume 11 Granulation. 1st ed. Amsterdam: Elsevier; 2007. p. 3–19.
  • Evonik. Eudragit Application Guidelines. 12th ed. Germany: Evonik Industries AG; 2012.
  • Rani N, Goel A, Bhardwaj MK. Optimization of coating process parameters by Design of experiment (DoE). Int J PharmTech Res. 2015;8(3):499–513.
  • Czajkowska M, Sznitowska M. Taguchi method used for optimization of coating process for minitablets. 1st European Conference on Pharmaceutics: Drug Delivery; 2015 April 13–14; Reims, France.
  • Szczepanska M, Sznitowska M. Comparison of the coating process and in vitro dissolution of 3 mm gastro-resistant minitablets and 5 mm gastro-resistant tablets with pantoprazole. Pharmazie. 2019;74(8):467–470.
  • Choudhry P, Kuldeep S, Jain PK, et al. Design, in vitro evaluation and in vivo studies of novel delayed release tablets of pantoprazole. Int J Biomed Adv Res. 2012;3(11):828–840.
  • Antony J. Full factorial designs: design of experiments for engineers and scientists. 2nd ed. London: Elsevier; 2014.
  • Wilkinson L. Revising the Pareto chart. Am Stat. 2006;60(4):332–334.
  • Derringer G, Suich R. Simultaneous optimization of several response variables. J Qual Technol. 1980;12(4):214–219.
  • Henseler J, Ringle C, Sinkovics R. New challenges to international marketing. In: Sinkovics RR, Ghauri PN, editors. Advances in International Marketing. Bingley: Emerald; 2009. p. 277–319.
  • Turton R, Cheng XX. The scale-up of spray coating processes for granular solids and tablets. Powder Technol. 2005;150(2):78–85.
  • Sonar G, Rawat S. Optimization of pantoprazole enteric pellets coating process by QbD: effect of coating process variables on the intermediate quality of the product and scale up. Int J Pharm Pharm Sci. 2015;7(12):80–87.
  • Klingmann V, Linderskamp H, Meissner T, et al. Acceptability of multiple uncoated minitablets in infants and toddlers: a randomized controlled trial. J Pediatr. 2018;201:202–207.
  • Kluk A, Sznitowska M, Brandt A, et al. Can preschool-aged children swallow several minitablets at a time? Results from a clinical pilot study. Int J Pharm. 2015;485(1-2):1–6.
  • Colorcon.com [Internet]. United Kingdom: Colorcon; [cited 2019 Sep 2]. Available from: https://www.colorcon.com/products-formulation/process/fluid-bed-coating.
  • Huttlin H. Apparatus for treating particulate material. US patent 2006/0112589 A1.

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