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Journal of Pharmaceutical Research

Article

Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development
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Journal of Pharmaceutical Research

Year: 2016, Volume: 15, Issue: 3, Pages: 96-100

Original Article

Application of Design of Experiments for Optimizing Critical Quality Attributes (CQA) in Routine Pharmaceutical Product Development

Abstract

Purpose: QbD is a helpful tool in building quality products and to understand critical process parameters which affects the manufacturing of drug products. It helps to build control strategy which helps to maintain quality throughout its life cycle.Approaches: The major approach in QbD is through DOE which includes either screening or optimization done by various designs like plackett-Burmann, Box-Behnken design, Fractional Factorial design, Central Composite design, Mixture design etc.Findings: QbD approach helps in formulating and maintaining quality in the drug product. It helps to identify the critical quality attributes and process parameters which are likely to affect the quality of the drug product through screening design.Conclusions: Adopting QbD concepts into manufacturing of the drug product has its advantage of reducing development and marketing costs. It also helps in meeting regulatory requirements.

References

  • Guideline ICH. Pharmaceutical Development Q8 (R1). Current step.2009 Aug;4.
  • Kan S, Lu J, Liu J, Wang J, Zhao Y. A quality by design (QbD) case study on enteric-coated pellets: Screening of critical variables and establishment of design space at laboratory scale. Asian J. Pharm. sci. 2014;31;9(5):268-78.
  • Basalious EB, El-Sebaie W, El-Gazayerly O. Application of pharmaceutical QbD for enhancement of the solubility and dissolution of a class II BCS drug using polymeric surfactants and crystallization inhibitors: development of controlled-release tablets. AAPS Pharmscitech. 2011;12(3):799-810.
  • Louren�o V, Lochmann D, Reich G, Menezes JC, Herdling T, Schewitz J.A quality by design study applied to an industrial pharmaceutical fluid bed granulation. European J. Pharmaceutics and Biopharmaceutics. 2012;81(2):438-47.
  • Chowdary KP, Shankar KR, Kumar PS. Recent research on QbD approach in formulation development:A review. Int.J.Chem.Sci.& Tech.2014;4(1):282-92.
  • Ranga S, Jaimini M, Sharma SK, Chauhan BS, Kumar A. A review on Design of Experiments (DOE). Int. J. Pharm. Chem.Sci.2014;3(1):216-24.
  • Jain S. Quality by design (QBD): a comprehen-sive understanding of implementation and challenges in pharmaceuticals development. Int. J. Pharm. Pharm. Sci.2014; 6:29-35.
  • Telford JK.A brief introduction to design of experiments. Johns Hopkins apl technical digest.2007 Sep;27(3):224-32.
  • Simpson TW, Peplinski J, Koch PN, Allen JK.On the use of statistics in design and the implications for deterministic computer experiments. Design Theory and Methodo-logy-DTM'97.1997;Sep 14:14-7.
  • Garg RK, Singhvi I. Optimization Techniques: An Overview For Formulation Development.Asian J.Pharm. Res.Vol.2015;5(3):217-21.
  • Raman NV, Mallu UR, Bapatu HR. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry.2015 Jan 26;2015.
  • Bhoop BS. Quality by Design (QbD) for holistic pharma excellence and regulatory compliance. Pharm Times. 2014;46(8):26-33

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