Stability of Split Tablets

  • Vilayat A. Sayeed
  • Abhay Gupta
  • Mansoor A. Khan
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)


The current pharmacy practice of splitting tablets has grown exponentially in the last few years to contain the ever growing cost of health care. At present, there is no scientific evidence in the public domain to demonstrate that the random splitting of tablets would not pose any safety concerns by compromising the quality of the product. The presentation would addresses the quality risk associated with the tablet splitting and the need for generating adequate scientific data before recommending a tablet splitting.


Drug Product Weight Variation Dissolution Profile Public Standard Validate HPLC Method 
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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • Vilayat A. Sayeed
    • 1
  • Abhay Gupta
    • 2
  • Mansoor A. Khan
    • 3
  1. 1.Division of Chemistry IIIU.S. Food and Drug AdministrationRockvilleUSA
  2. 2.Division of Product Quality ResearchU.S. Food and Drug AdministrationSilver SpringUSA
  3. 3.Division of Product Quality Research, Center for Drug Evaluation and ResearchU.S. Food and Drug AdministrationSilver SpringUSA

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