411442 Density Surrogate for Fine Tuning Dissolution of an Extended Release Tablet to Increase Manufacturing Process Robustness

Thursday, November 12, 2015: 5:10 PM
Ballroom B (Salt Palace Convention Center)
Christopher Mancinelli1, Jennifer Monaldi1, Johnny Chowoe1, Stelios C. Tsinontides1, James Wright1, Eda Ross Montgomery1, Mani Sundararajan1, Maury Winkler2 and Marty Shelton3, (1)Global Pharmaceutical Technology, Shire Pharmaceuticals, Wayne, PA, (2)OSD Technical Services, Patheon Manufacturing Services, Greenville, NC, (3)Analytical Lab Operations, AAI Pharma Services, Wilmington, NC

Tablet dissolution can be affected by several factors including raw materials, formulation and processing conditions.  For a tablet with a fixed formulation, such as that of a commercial drug product, there remain few levers by which to improve tablet critical quality attributes (CQA).  Tablet dissolution is one such known critical quality attribute to be affected by tablet hardness, which can be controlled by varying the compression force, typically in a directly proportional relationship.  Beyond a certain threshold of compression force value, however, hardness reaches a maximum value and plateaus.  Continuing to increase compression force after this threshold value could lead to loss in tablet cohesion due to high internal stresses or eventually tooling and equipment damage.  Near the plateau threshold, there is a space over which tablet hardness may not adequately capture the tablet properties controlling its dissolution.  This work explores this space for a polymer matrix extended release tablet where improved dissolution release robustness is desired.  A parameter of weight/thickness ratio is suggested as a density surrogate to fine tune dissolution performance near and within the hardness plateau region.

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