title: Excipient-process interactions and their impact on tablet compaction and film coating.
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.
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901. Electronic address: preetanshu@gmail.com.
authors.forename: Preetanshu
authors.initials: P
authors.lastname: Pandey
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.
authors.forename: Dilbir S
authors.initials: DS
authors.lastname: Bindra
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.
authors.forename: Shruti
authors.initials: S
authors.lastname: Gour
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.
authors.forename: Jade
authors.initials: J
authors.lastname: Trinh
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.
authors.forename: David
authors.initials: D
authors.lastname: Buckley
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb1 Squibb Drive, New Brunswick, New Jersey 08901.
authors.forename: Sherif
authors.initials: S
authors.lastname: Badawy
mesh_terms: D002482:Cellulose / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D006245:Hardness Tests; D011312:Pressure; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry*; D013229:Stearic Acids / Q000737:chemistry*; D013499:Surface Properties; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D005079:Excipients; D013229:Stearic Acids; D013607:Tablets; D012967:Sodium Dodecyl Sulfate; C031183:stearic acid; D002482:Cellulose; C109691:microcrystalline cellulose
keywords: coating; compression; excipients; powder technology; processing