392
Views
2
CrossRef citations to date
0
Altmetric
Research Articles

Step-wise approach to developing a scale-independent design space for functional tablet coating process

, , , , , , & show all
Pages 566-575 | Received 08 Aug 2019, Accepted 10 Mar 2020, Published online: 01 Apr 2020

References

  • U.S. Department of Health and Human Services. Guidance for Industry: Q8(R2) Pharmaceutical Development [Internet]. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); 2009. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20978363
  • Thomson NM, Seibert KD, Tummala S, et al. Case studies in the applicability of drug substance design spaces developed on the laboratory scale to commercial manufacturing. Org Process Res Dev. 2015;19(8):925–934.
  • Harms J, Wang X, Kim T, et al. Defining process design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol Prog. 2008;24(3):655–662.
  • Banerjee A. Designing in quality: approaches to defining the design space for a monoclonal antibody process. BioPharm Int. 2010;23:26–40.
  • Hakemeyer C, McKnight N, St. John R, et al. Process characterization and design space definition. Biologicals. 2016;44(5):306–318.
  • Eon-Duval A, Valax P, Solacroup T, et al. Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space. J Pharm Sci. 2012;101(10):3604–3618.
  • Bergum J, Pfahler L, Senderak E, et al. Statistical considerations in design space development (part II of III). Pharm Technol. 2011;34(8):52–60.
  • FDA/EMA. Questions and answers on design space verification [Internet]; 2013. Available from: https://www.ema.europa.eu/en/documents/other/questions-answers-design-space-verification_en.pdf
  • Pisano R, Fissore D, Barresi AA, et al. Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol. Pharm Dev Technol. 2013;18(1):280–295.
  • Fissore D, Pisano R, Barresi AA. Advanced approach to build the design space for the primary drying of a pharmaceutical freeze-drying process. J Pharm Sci. 2011;100(11):4922–4933.
  • Giordano A, Barresi AA, Fissore D. On the use of mathematical models to build the design space for the primary drying phase of a pharmaceutical lyophilization process. J Pharm Sci. 2011;100(1):311–324.
  • Hallow DM, Mudryk BM, Braem AD, et al. An example of utilizing mechanistic and empirical modeling in quality by design. J Pharm Innov. 2010;5(4):193–203.
  • Koganti VR, Shalaev EY, Berry MR, et al. Investigation of design space for freeze-drying: use of modeling for primary drying segment of a freeze-drying cycle. AAPS PharmSciTech. 2011;12(3):854–861.
  • Goshima H, Do G, Nakagawa K. Impact of ice morphology on design space of pharmaceutical freeze-drying. J Pharm Sci. 2016;105(6):1920–1933.
  • Mortier S, Van Bockstal PJ, Corver J, et al. Uncertainty analysis as essential step in the establishment of the dynamic design space of primary drying during freeze-drying. Eur J Pharm Biopharm. 2016;103:71–83.
  • Debevec V, Srčič S, Horvat M. Scientific, statistical, practical, and regulatory considerations in design space development. Drug Dev Ind Pharm. 2018;44(3):349–364.
  • Bley O, Siepmann J, Bodmeier R. Protection of moisture-sensitive drugs with aqueous polymer coatings: importance of coating and curing conditions. Int J Pharm. 2009;378(1–2):59–65.
  • Ruotsalainen M, Heinämäki J, Taipale K, et al. Influence of the aqueous film coating process on the properties and stability of tablets containing a moisture-labile drug. Pharm Dev Technol. 2003;8(4):443–451.
  • Felton LA. Mechanisms of polymeric film formation. Int J Pharm. 2013;457(2):423–427.
  • Ruotsalainen M, Heinämäki J, Guo H, et al. A novel technique for imaging film coating defects in the film-core interface and surface of coated tablets. Eur J Pharm Biopharm. 2003;56(3):381–388.
  • Colorcon. The effect of coating process conditions and coating formula type on the quantity and location of water in film coated tablets [Internet]; 2009. Available from: https://www.colorcon.com/literature/marketing/fc/OpadryII/ads_opadry_II_coat_proc_cond.pdf
  • Pandey P, Bindra DS, Felton LA. Influence of process parameters on tablet bed microenvironmental factors during pan coating. AAPS PharmSciTech. 2014;15(2):296–305.
  • Pandey P, Bindra DS. Real-time monitoring of thermodynamic microenvironment in a pan coater. J Pharm Sci. 2013;102(2):336–340.
  • Pandey P, Ji J, Subramanian G, et al. Understanding the thermodynamic micro-environment inside a pan coater using a data logging device. Drug Dev Ind Pharm. 2014;40(4):542–548.
  • Melanie M. An introduction to genetic algorithms. A Bradford book. Cambridge (MA): The MIT Press; 1999.
  • Deb K. An introduction to genetic algorithms. Artif Life. 1999;24(4&5):293–315.
  • Gabrielsson J, Lindberg NO, Lundstedt T. Multivariate methods in pharmaceutical applications. J Chemometrics. 2002;16(3):141–160.
  • Kestur U, Pandey P, Badawy S, et al. Controlling the chemical stability of a moisture-sensitive drug product through monitoring and identification of coating process microenvironment. Int J Pharm. 2014;476(1–2):93–98.
  • Niblett D, Porter S, Reynolds G, et al. Development and evaluation of a dimensionless mechanistic pan coating model for the prediction of coated tablet appearance. Int J Pharm. 2017;528(1–2):180–201.
  • Porter SC, Verseput RP, Cunningham CR. Process optimization using design of experiments. Pharm Technol. 1997;21:60–70.
  • Pourkavoos N, Peck GE. Effect of aqueous film coating conditions on water removal efficiency and physical properties of coated tablet cores containing superdisintegrants. Drug Dev Ind Pharm. 1994;20(9):1535–1554.
  • Carlin B, Li J-X, Felton LA. Pseudolatex dispersions for controlled drug delivery. In: Aqueous polymeric coatings for pharmaceutical dosage forms. 3rd ed. Boca Raton (FL): Taylor & Francis Group: CRC Press; 2008. p. 1–46.
  • Suzzi D, Radl S, Khinast JG. Local analysis of the tablet coating process: impact of operation conditions on film quality. Chem Eng Sci. 2010;65(21):5699–5715.
  • Naveršnik K, Bohanec S. Predicting drug hydrolysis based on moisture uptake in various packaging designs. Eur J Pharm Sci. 2008;35(5):447–456.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.