| Processing challenges with solid dosage formulations containing vitamin E TPGS. | |
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MedLine Citation:
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PMID: 23136832 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The 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. |
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Authors:
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Preetanshu Pandey; Patrick D Sinko; Dilbir S Bindra; Rhye Hamey; Shruti Gour; Chandra Vema-Varapu |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-11-9 |
Journal Detail:
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Title: Pharmaceutical development and technology Volume: - ISSN: 1097-9867 ISO Abbreviation: Pharm Dev Technol Publication Date: 2012 Nov |
Date Detail:
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Created Date: 2012-11-9 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9610932 Medline TA: Pharm Dev Technol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Drug Product Science and Technology, Bristol-Myers Squibb , 1 Squibb Drive, New Brunswick, NJ 08901 , USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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