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Mechanism and Kinetics of Punch Sticking of Pharmaceuticals.
J Pharm Sci. 2017 01; 106(1):151-158.JP

Abstract

Adherence of powder onto tablet tooling, known as punch sticking, is one of the tablet manufacturing problems that need to be resolved. An important step toward the resolution of this problem is to quantify sticking propensity of different active pharmaceutical ingredients (APIs) and understand physicochemical factors that influence sticking propensity. In this study, mass of adhered material onto a removable upper punch tip as a function of number of compression is used to monitor sticking kinetics of 24 chemically diverse compounds. We have identified a mathematical model suitable for describing punch sticking kinetics of a wide range of compounds. Chemical analyses have revealed significant enrichment of API content in the adhered mass. Based on this large set of data, we have successfully developed a new punch sticking model based on a consideration of the interplay of interaction strength among API, excipient, and punch surface. The model correctly describes the general shape of sticking profile, that is, initial rise in accumulated mass followed by gradual increase to a plateau. It also explains why sometimes sticking is arrested after monolayer coverage of punch surface by API (punch filming), while in other cases, API buildup is observed beyond monolayer coverage.

Authors+Show Affiliations

Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota 55455.Pfizer Worldwide Research & Development, Sandwich, Kent CT13 9NJ, UK.Pfizer Worldwide Research & Development, Groton, Connecticut 06340.Pfizer Worldwide Research & Development, Groton, Connecticut 06340.Pfizer Worldwide Research & Development, Sandwich, Kent CT13 9NJ, UK.Pfizer Worldwide Research & Development, Groton, Connecticut 06340.Pfizer Worldwide Research & Development, Groton, Connecticut 06340.Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota 55455. Electronic address: sunx0053@umn.edu.

Pub Type(s)

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

Language

eng

PubMed ID

27649886

Citation

Paul, Shubhajit, et al. "Mechanism and Kinetics of Punch Sticking of Pharmaceuticals." Journal of Pharmaceutical Sciences, vol. 106, no. 1, 2017, pp. 151-158.
Paul S, Taylor LJ, Murphy B, et al. Mechanism and Kinetics of Punch Sticking of Pharmaceuticals. J Pharm Sci. 2017;106(1):151-158.
Paul, S., Taylor, L. J., Murphy, B., Krzyzaniak, J., Dawson, N., Mullarney, M. P., Meenan, P., & Sun, C. C. (2017). Mechanism and Kinetics of Punch Sticking of Pharmaceuticals. Journal of Pharmaceutical Sciences, 106(1), 151-158. https://doi.org/10.1016/j.xphs.2016.07.015
Paul S, et al. Mechanism and Kinetics of Punch Sticking of Pharmaceuticals. J Pharm Sci. 2017;106(1):151-158. PubMed PMID: 27649886.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mechanism and Kinetics of Punch Sticking of Pharmaceuticals. AU - Paul,Shubhajit, AU - Taylor,Lisa J, AU - Murphy,Brendan, AU - Krzyzaniak,Joseph, AU - Dawson,Neil, AU - Mullarney,Matthew P, AU - Meenan,Paul, AU - Sun,Changquan Calvin, Y1 - 2016/09/17/ PY - 2016/05/26/received PY - 2016/07/07/revised PY - 2016/07/20/accepted PY - 2016/9/22/pubmed PY - 2017/12/13/medline PY - 2016/9/22/entrez KW - adhesion-cohesion KW - compaction KW - model fitting KW - punch sticking KW - tablets SP - 151 EP - 158 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 106 IS - 1 N2 - Adherence of powder onto tablet tooling, known as punch sticking, is one of the tablet manufacturing problems that need to be resolved. An important step toward the resolution of this problem is to quantify sticking propensity of different active pharmaceutical ingredients (APIs) and understand physicochemical factors that influence sticking propensity. In this study, mass of adhered material onto a removable upper punch tip as a function of number of compression is used to monitor sticking kinetics of 24 chemically diverse compounds. We have identified a mathematical model suitable for describing punch sticking kinetics of a wide range of compounds. Chemical analyses have revealed significant enrichment of API content in the adhered mass. Based on this large set of data, we have successfully developed a new punch sticking model based on a consideration of the interplay of interaction strength among API, excipient, and punch surface. The model correctly describes the general shape of sticking profile, that is, initial rise in accumulated mass followed by gradual increase to a plateau. It also explains why sometimes sticking is arrested after monolayer coverage of punch surface by API (punch filming), while in other cases, API buildup is observed beyond monolayer coverage. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/27649886/Mechanism_and_Kinetics_of_Punch_Sticking_of_Pharmaceuticals_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(16)41603-5 DB - PRIME DP - Unbound Medicine ER -