Mechanism and Kinetics of Punch Sticking of Pharmaceuticals

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 phys...

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Bibliographic Details
Published inJournal of pharmaceutical sciences Vol. 106; no. 1; pp. 151 - 158
Main Authors Paul, Shubhajit, Taylor, Lisa J., Murphy, Brendan, Krzyzaniak, Joseph, Dawson, Neil, Mullarney, Matthew P., Meenan, Paul, Sun, Changquan Calvin
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.01.2017
Subjects
adhesion-cohesion
Adsorption
compaction
Drug Compounding - instrumentation
Equipment Design
Kinetics
model fitting
Models, Chemical
Pharmaceutical Preparations - chemistry
Powders - chemistry
punch sticking
tablets
Tablets - chemistry
compaction
punch sticking
tablets
model fitting
adhesion-cohesion
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ISSN0022-3549
1520-6017
DOI10.1016/j.xphs.2016.07.015

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Summary: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.
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ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2016.07.015