NDLI: Development of a Material Sparing Bulk Density Test Comparable to a Standard USP Method for Use in Early Development of API’s

Content Provider	Springer Nature Link
Author	Hughes, Helen Leane, Michael M. Tobyn, Michael Gamble, John F. Muz, Santiago Musembi, Pauline
Copyright Year	2014
Abstract	Bulk density can be a key indicator of performance, and may influence choice of formulation route of materials in pharmaceutical development. During early development, the cost of API’s can be expensive and the availability of material for powder property analysis is limited. The aim of this work was to investigate a suitable small-scale, low material requirement, bulk density test which would provide comparable data to the recommended large volume USP test. Materials with a range of morphological characteristics typically seen in the pharmaceutical industry were assessed to ensure that methods were suitably robust. It was found that the USP II “low volume” test does not give equivalent results to other tests in the USP, across the range of materials. An alternative test based on the FT4 powder rheometer at a scale of 25 mL gave results equivalent to the large volume USP I standard test. The use of smaller 10-mL methods was also found to give acceptable results for materials that were considered well-behaved but were more variable with difficult to handle materials with low bulk density.
Starting Page	165
Ending Page	170
Page Count	6
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	16
Issue Number	1
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2014-09-19
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Biotechnology Biochemistry Pharmacy
Content Type	Text
Resource Type	Article

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