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Evaluation of tablet punch configuration on mitigating capping by a quality by design approach.
Drug Deliv Transl Res. 2018 12; 8(6):1635-1643.DD

Abstract

Capping is a common problem in the manufacture of some types of tablets and unless resolved, the tableting process cannot proceed. Hence, all factors that can help to lessen the likelihood of capping without unnecessarily reduce turret speed and/or compaction force would be tenable. This study investigated the influence of tablet punch configuration on mitigation of tablet capping. Tablets were prepared from high-dose paracetamol-potato starch granules in a rotary tablet press with flat face plain (FFP), flat face bevel edge (FFBE) and flat face radius edge (FFRE) punch configurations. The directly compressible (DC) fillers tested were microcrystalline cellulose (MCC), pre-gelatinised starch (PGS) and lactose. Design of experiments (DoE), a tool of quality by design (QbD) paradigm, was used and the interaction of input variables (compression force, tablet punch configuration and DC filler) affecting the response factors (tablet hardness and capping rating) were evaluated. FFP punches were able to mitigate capping best. FFRE punches showed more potential than FFBE punches at alleviating capping in a particular compression force range, without the limitations of the FFP punches that produce cylindrical tablets that were more friable. Incorporation of PGS in the tablet formulation was observed to be more efficient at mitigating capping than the other DC fillers when FFBE and FFRE punches were used. Overall, this study serves as a model for prospective product development based on the QbD framework and the optimal use of compaction tools.

Authors+Show Affiliations

GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore. Product and Process Engineering Department, GlaxoSmithKline, King of Prussia, PA, 19406, USA.GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore.GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore.GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore.GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore. phalcv@nus.edu.sg.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28849387

Citation

Desai, Parind M., et al. "Evaluation of Tablet Punch Configuration On Mitigating Capping By a Quality By Design Approach." Drug Delivery and Translational Research, vol. 8, no. 6, 2018, pp. 1635-1643.
Desai PM, Anbalagan P, Koh CJN, et al. Evaluation of tablet punch configuration on mitigating capping by a quality by design approach. Drug Deliv Transl Res. 2018;8(6):1635-1643.
Desai, P. M., Anbalagan, P., Koh, C. J. N., Heng, P. W. S., & Liew, C. V. (2018). Evaluation of tablet punch configuration on mitigating capping by a quality by design approach. Drug Delivery and Translational Research, 8(6), 1635-1643. https://doi.org/10.1007/s13346-017-0425-0
Desai PM, et al. Evaluation of Tablet Punch Configuration On Mitigating Capping By a Quality By Design Approach. Drug Deliv Transl Res. 2018;8(6):1635-1643. PubMed PMID: 28849387.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of tablet punch configuration on mitigating capping by a quality by design approach. AU - Desai,Parind M, AU - Anbalagan,Parthiban, AU - Koh,Cheryl J N, AU - Heng,Paul W S, AU - Liew,Celine V, PY - 2017/8/30/pubmed PY - 2019/6/14/medline PY - 2017/8/30/entrez KW - Capping KW - Design of experiments KW - Formulation KW - Punch configuration KW - Quality by design KW - Tablets SP - 1635 EP - 1643 JF - Drug delivery and translational research JO - Drug Deliv Transl Res VL - 8 IS - 6 N2 - Capping is a common problem in the manufacture of some types of tablets and unless resolved, the tableting process cannot proceed. Hence, all factors that can help to lessen the likelihood of capping without unnecessarily reduce turret speed and/or compaction force would be tenable. This study investigated the influence of tablet punch configuration on mitigation of tablet capping. Tablets were prepared from high-dose paracetamol-potato starch granules in a rotary tablet press with flat face plain (FFP), flat face bevel edge (FFBE) and flat face radius edge (FFRE) punch configurations. The directly compressible (DC) fillers tested were microcrystalline cellulose (MCC), pre-gelatinised starch (PGS) and lactose. Design of experiments (DoE), a tool of quality by design (QbD) paradigm, was used and the interaction of input variables (compression force, tablet punch configuration and DC filler) affecting the response factors (tablet hardness and capping rating) were evaluated. FFP punches were able to mitigate capping best. FFRE punches showed more potential than FFBE punches at alleviating capping in a particular compression force range, without the limitations of the FFP punches that produce cylindrical tablets that were more friable. Incorporation of PGS in the tablet formulation was observed to be more efficient at mitigating capping than the other DC fillers when FFBE and FFRE punches were used. Overall, this study serves as a model for prospective product development based on the QbD framework and the optimal use of compaction tools. SN - 2190-3948 UR - https://www.unboundmedicine.com/medline/citation/28849387/Evaluation_of_tablet_punch_configuration_on_mitigating_capping_by_a_quality_by_design_approach_ L2 - https://dx.doi.org/10.1007/s13346-017-0425-0 DB - PRIME DP - Unbound Medicine ER -