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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

Examination of the Intricacies Involved in Dissolution Test: A QbD Approach

Mukesh C. Gohel & Jayvadan K. Patel

Introduction: An active pharmaceutical ingredient (API) is transformed into a formulation considering the requirements of patient. The objective of drug formulation development is to develop a product with the correct amount of API in the right form, and to maintain its chemical and biological integrity for delivery at or over the proper time, at the proper rate, and in the desired location. A dosage form shall be efficacious in nature and it should not show any untoward clinical effects. Therefore, Food and Drugs Control Authority (FDA) puts the safety and efficacy at the top of the knowledge pile of the marketed products. Solid oral dosage forms meet most of the ideal requirements (cost, convenience, etc.). More than half of the marketed products account for tablets and capsules. 

 

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