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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2013)

Evolution of a Revolution: An Autobiographical Account on Formulation by Design (FbD)

Bhupinder Singh Bhoop

Introduction: Design and development of an impeccable drug product or pharmaceutical process usually involves multiple objectives under its ambit. For decades, this task had been endeavored through trial and error, supplemented with the previous knowledge, wisdom and experience of the formulator. This traditional short-gun approach of formulation development essentially involves studying the influence of Changing One Factor at a Time (OFAT), has shown to suffer from numerous pitfalls, e.g., utilization of greater magnitude of resources viz. time, money and experimental efforts, in conduciveness to detect and plug errors, inability to reveal interactions, and plausibility of rigidity. Using this methodology, the solution of a specific problematic formulation characteristic can certainly be achieved, but attainment of the true optimal composition can never be warranted. This may primarily be ascribed to the presence of interactions, i.e., the influence of one or more factors on each other or with the associated process(es). The final product, thus, may be satisfactory but mostly sub-optimal, as a better optimal formulation might still exist for the studied conditions. As one cannot establish “cause-effect” relationships using OFAT, the technique becomes futile when several variables tend to have differential impact on the final product. 

 

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