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Excipient-process interactions and their impact on tablet compaction and film coating.
J Pharm Sci. 2014 Nov; 103(11):3666-3674.JP

Abstract

The objective of this study was to establish the effects of the level of minor formulation components (sodium lauryl sulfate: SLS, and magnesium stearate: MgSt) and manufacturing process on final blend compaction properties and the performance of the tablets during film coating. A 2 × 2 × 3 factorial study was conducted at two levels of SLS (0% and 1%, w/w) and MgSt (0.5% and 1.75%, w/w), along with three different manufacturing processes (direct compression, high-shear wet granulation, and dry granulation). The tablets were compressed to the same solid fraction (0.9) and the resulting tablet hardness values were found to vary over a range of 13-42 SCU, highlighting large compactability differences among these batches. Increase in the level of SLS or MgSt in the formulation had a significant negative effect on compactability and the performance of film-coated tablets. The detrimental effects on compaction and coating performance were magnified for the dry granulation process, likely due to the overall increased shear experienced by excipients (SLS, MgSt, microcrystalline cellulose) during the roller compaction and milling steps. The findings of this study highlight the importance of the manufacturing process when considering the use-level of formulation components such as SLS and MgSt in the formulation.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901. Electronic address: preetanshu@gmail.com.

Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.

Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.

Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.

Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.

Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.

MeSH

CelluloseChemistry, PharmaceuticalExcipientsHardnessHardness TestsPressureSodium Dodecyl SulfateStearic AcidsSurface PropertiesTabletsTechnology, Pharmaceutical

Pub Type(s)

Comparative Study

Journal Article

Language

eng

PubMed ID

25223603

Citation

Pandey, Preetanshu, et al. "Excipient-process Interactions and Their Impact On Tablet Compaction and Film Coating." Journal of Pharmaceutical Sciences, vol. 103, no. 11, 2014, pp. 3666-3674.

Pandey P, Bindra DS, Gour S, et al. Excipient-process interactions and their impact on tablet compaction and film coating. J Pharm Sci. 2014;103(11):3666-3674.

Pandey, P., Bindra, D. S., Gour, S., Trinh, J., Buckley, D., & Badawy, S. (2014). Excipient-process interactions and their impact on tablet compaction and film coating. Journal of Pharmaceutical Sciences, 103(11), 3666-3674. https://doi.org/10.1002/jps.24169

Pandey P, et al. Excipient-process Interactions and Their Impact On Tablet Compaction and Film Coating. J Pharm Sci. 2014;103(11):3666-3674. PubMed PMID: 25223603.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Excipient-process interactions and their impact on tablet compaction and film coating. AU - Pandey,Preetanshu, AU - Bindra,Dilbir S, AU - Gour,Shruti, AU - Trinh,Jade, AU - Buckley,David, AU - Badawy,Sherif, Y1 - 2014/09/15/ PY - 2014/06/17/received PY - 2014/08/21/revised PY - 2014/08/29/accepted PY - 2014/9/17/entrez PY - 2014/9/17/pubmed PY - 2015/6/27/medline KW - coating KW - compression KW - excipients KW - powder technology KW - processing SP - 3666 EP - 3674 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 103 IS - 11 N2 - The objective of this study was to establish the effects of the level of minor formulation components (sodium lauryl sulfate: SLS, and magnesium stearate: MgSt) and manufacturing process on final blend compaction properties and the performance of the tablets during film coating. A 2 × 2 × 3 factorial study was conducted at two levels of SLS (0% and 1%, w/w) and MgSt (0.5% and 1.75%, w/w), along with three different manufacturing processes (direct compression, high-shear wet granulation, and dry granulation). The tablets were compressed to the same solid fraction (0.9) and the resulting tablet hardness values were found to vary over a range of 13-42 SCU, highlighting large compactability differences among these batches. Increase in the level of SLS or MgSt in the formulation had a significant negative effect on compactability and the performance of film-coated tablets. The detrimental effects on compaction and coating performance were magnified for the dry granulation process, likely due to the overall increased shear experienced by excipients (SLS, MgSt, microcrystalline cellulose) during the roller compaction and milling steps. The findings of this study highlight the importance of the manufacturing process when considering the use-level of formulation components such as SLS and MgSt in the formulation. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/25223603/Excipient_process_interactions_and_their_impact_on_tablet_compaction_and_film_coating_ DB - PRIME DP - Unbound Medicine ER -