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  • Excipient-process interactions and their impact on tablet compaction and film coating.

Excipient-process interactions and their impact on tablet compaction and film coating.

Journal of pharmaceutical sciences (2014-09-17)
Preetanshu Pandey, Dilbir S Bindra, Shruti Gour, Jade Trinh, David Buckley, Sherif Badawy
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.

MATERIALS
Product Number
Brand
Product Description

USP
Anhydrous lactose, United States Pharmacopeia (USP) Reference Standard
Pricing and availability is not currently available.
Supelco
Lactose, Anhydrous, Pharmaceutical Secondary Standard; Certified Reference Material
Pricing and availability is not currently available.
Lactose (anhydrous), European Pharmacopoeia (EP) Reference Standard
Pricing and availability is not currently available.