Preetanshu Pandey, Patrick D Sinko, Dilbir S Bindra, Rhye Hamey, Shruti Gour, Chandra Vema-Varapu
Drug Product Science and Technology, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08901, USA. preetanshu.pandey@bms.com
Pharmaceutical development and technology 2013 FebThe objective of this study is to investigate processing challenges associated with the incorporation of Vitamin E TPGS (d-α tocopheryl polyethylene glycol 1000 succinate) into solid pharmaceutical dosage forms. For this work, a wet granulation process (high-shear and fluid bed) was used and Vitamin E TPGS was added as part of the binder solution during granulation. It was shown that Vitamin E TPGS can be incorporated into a prototype formulation at 10% w/w concentration without any significant processing challenges. However, the resulting granulations could only be compressed successfully at low tablet press speeds (dwell time ~100 ms). When compressed at low dwell times (<20 ms) representative of commercial tablet manufacturing, a significant loss in compactability was observed. In addition, several other tablet defects were observed. It was shown that intragranular incorporation of Aeroperl(®) 300, a granulated form of colloidal silicon dioxide, was able to overcome these compaction problems. The formulation consisting of Aeroperl(®) 300 showed significantly lower granule particle size, higher granule porosity and higher compactability as compared to the formulation without Aeroperl(®) 300.
Preetanshu Pandey, Patrick D Sinko, Dilbir S Bindra, Rhye Hamey, Shruti Gour, Chandra Vema-Varapu. Processing challenges with solid dosage formulations containing vitamin E TPGS. Pharmaceutical development and technology. 2013 Feb;18(1):296-304
PMID: 23136832
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