title: Development of a material sparing bulk density test comparable to a standard USP method for use in early development of API's.
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.
authors.affiliation: Drug Product Science and Technology, Bristol-Myers Squibb, Reeds Lane, Moreton, Wirral, CH46 1QW, UK, helen.hughes@bms.com.
authors.forename: Helen
authors.initials: H
authors.lastname: Hughes
authors.forename: Michael M
authors.initials: MM
authors.lastname: Leane
authors.forename: Michael
authors.initials: M
authors.lastname: Tobyn
authors.forename: John F
authors.initials: JF
authors.lastname: Gamble
authors.forename: Santiago
authors.initials: S
authors.lastname: Munoz
authors.forename: Pauline
authors.initials: P
authors.lastname: Musembi
mesh_terms: D003720:Densitometry / Q000592:standards*; D008422:Materials Testing / Q000592:standards*; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013678:Technology, Pharmaceutical / Q000592:standards*; D014481:United States
chemical_list: D004364:Pharmaceutical Preparations