Issue link: https://www.e-digitaleditions.com/i/1331851
Tablets & Capsules January/February 2021 45 Technology, 2013, Vol. 18, No. 2, pages 333-342. 13. J. Albers, K. Knop, and P. Kleinebudde, "Brand-to-brand and batch-to-batch uniformity of micro- crystalline cellulose in direct tablet- ing with a pneumohydraulic tablet press," Pharmazeutische Industrie, 2 0 0 6 , V o l . 6 8 , N o . 1 2 , p a g e s 1,420-1,428. 14. Vivek S. Dave, et al., "Excipi- ent variability and its impact on dos- age form functionality," Journal of Pharmaceutical Sciences, 2015, Vol. 104, No. 3, pages 906-915. 15. M. Landín et al., "Influence of microcrystalline cellulose source and batch variation on the tablet- ting behaviour and stability of pred- nisone formulations," International Journal of Pharmaceutics, 1993, Vol. 91, Nos. 2-3, pages 143-149. 16. Gregory Thoorens et al., " U n d e r s t a n d i n g t h e i m p a c t o f microcrystalline cellulose physico- chemical properties on tabletabil- ity," International Journal of Phar- maceutics, 2015, Vol. 490, Nos. 1-2, pages 47-54. 17. Robert O. Williams et al., "Compaction properties of micro- crystalline cellulose using tableting indices," Drug Development and Industrial Pharmacy, 1997, Vol. 23, No. 7, pages 695-704. 18. IPEC, "The IPEC Significant Change Guide for Pharmaceutical Excipients," 2014. 19. Kendal G. Pitt, and Matthew G. Heasley, "Determination of the tensile strength of elongated tab- lets," Powder Technology, 2013, Vol. 238, pages 169-175. 20. Harry G. Brittain and Roger L. Blaine, "α-Monohydrate Phase in Lactose by DSC," TA instruments, 2014. Pauline H. M. Janssen is product appli- cation specialist and Bastiaan H. J. Dickhoff is development manager/senior product application specialist at DFE Pharma (+492823 9288 770, www. dfepharma.com). and compression properties of var- ious grades and brands of micro- crystalline cellulose by multivariate methods," Pharmaceutical Develop- ment and Technology, 2010, Vol. 15, No. 4, pages 394-404. 5. John F. Gamble et al., "Inves- tigation into the degree of variabil- ity in the solid-state properties of common pharmaceutical excipi- ents—anhydrous lactose," AAPS PharmSciTech, 2010, Vol. 11, No. 4, pages 1,552-1,557. 6. Food and Drug Administration, "Pharmaceutical cGMPs for the 21st Century—A Risk Based Approach: Final Report," Available at: www. fda.gov/media/77391/download. 7 . B r a d S w a r b r i c k , M a r - tin Gadsby, and Faithe Wempen, (2018). QbD & PAT for dummies. John Wiley and Sons, 2010. 8. Food and Drug Administra- tion, HHS, "International Confer- ence on Harmonisation; Guidance on Q8(R1) Pharmaceutical Devel- opment," Fed Regist. 2009 Jun 9;74(109):27325-6. 9. Mike Tobyn et al., "Multivar- iate analysis as a method to under- stan d variab ility in a co m p lex excipient, and its contribution to formulation performance," Pharma- ceutical Development and Technol- ogy, 2018, Vol. 23, No. 10, pages 1,146-1,155. 10. Bastiaan H. J. Dickhoff and Gerald Hebbink, "Multivariate anal- ysis to enable product understand- ing in a QbD era—An Excipient manufacturer's perspective," DFE Pharma, 2014. 11. Bernd Van Snick et al., "A multivariate raw material property database to facilitate drug product development and enable in-silico design of pharmaceutical dry pow- der processes," International Journal of Pharmaceutics, 2018, Vol. 549, Nos. 1-2, pages 415-435. 12. Joseph Kushner, "Utilizing quantitative certificate of analysis data to assess the amount of excip- ient lot-to-lot variability sampled during drug product development," Pharmaceutical Development and identifying a transfer of the quality laboratory to a new location, though univariate testing did not identify this change. K e y d r i v e r s f o r d i f f e r e n c e s between anhydrous lactose batches from roller dryer 1 and roller dryer 2 were the particle size distribution, moisture content, and color. Batches representing extremes of the knowl- edge space for both production lines showed no significant differences in particle size, moisture content, or functionality. Low variability, and therefore good consistency, in terms of tablet compaction, disinte- gration, and flowability implies that batch-to-batch and production line- to-line variation of SuperTab 21AN is unlikely to cause any variation in formulation development and pro- duction for users of the product. Excipient suppliers can use the approach presented in this article to better understand their products and processes. It is strongly recom- mended that excipient suppliers reg- ularly perform these types of analy- ses to avoid trends in the data or in excipients' quality attributes. Phar- maceutical companies can use the available data as part of their con- trol strategy to showcase the low probability of impact when shifting between excipient production lines. Open, data-based communication between pharmaceutical companies and excipient suppliers can help to de-risk the use of excipients in line with IPEC QbD guidelines. T&C References 1 . w w w . i p e c a m e r i c a s . o r g / what-ipec- americas/faqs (accessed November 25, 2020). 2. Bastiaan H. J. Dickhoff et al., "Using multivariate analysis of batch-to-batch excipient variation to reduce risk," Tablets & Capsules, October 2019, Vol. 17, No. 7, pages 33-39. 3. Igor Gorsky, "Chapter 6— Use of statistics in process valida- tion," Principles of parenteral solu- tion validation: A practical lifecycle approach, Academic Press, 2020. 4. Rahul V. Haware et al., "Com- parative evaluation of the powder