Assessment of segregation potential of powder blends.
Pharmaceutical blends consist of several components each with its own unique characteristics, with different size, shape, density, and particle-particle interactions. With so many degrees of complexity, prediction of segregation behavior becomes intractable. The objective of this study was to develop a segregation test method or a segregation tool that would assess the segregation potential of blends. Literature reports generally seek to predict the segregation behavior based on only one mechanism by which the segregation occurs, primarily sifting or fluidization. This study makes an attempt to combine both of these mechanisms by which segregation occurs. A test is developed and used to assess the segregation behavior of blends at large scale and compare the content uniformity results of tablets with the results of the segregation test. The segregation testing model was successful in predicting the segregation tendency of the formulation and also in rank ordering large scale formulation blends based on their segregation potential. A segregation risk classification system is proposed to assess the potential of segregation at large scale.
Shah
Keyur R
KR
Bristol-Myers Squibb Pharmaceutical Research Institute, New Brunswick, NJ 08903, USA. keyur.shah@bms.com
Badawy
Sherif I Farag
SI
Szemraj
Marta M
MM
Gray
David B
DB
Hussain
Munir A
MA
D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011208:Powders / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry
D004364:Pharmaceutical Preparations; D011208:Powders; D013607:Tablets