Drug Formulation & Evaluation

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Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect.

Pre-formulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation. In dealing with protein pre-formulation, the important aspect is to understand the solution behaviour of a given protein under a variety of stress conditions such as freeze/thaw, temperature, shear stress among others to identify mechanisms of degradation and therefore its mitigation.

Applications and various formulations for which contract manufacturing, research and packaging are widely used are also discussed separately in the report. The report also takes into account various new developments and regulatory aspects in this industry. The report also covers significant patents in each category. Analysis of global market trends, with data from 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.The North American market is estimated to reach nearly $73 billion in 2011 and is expected to increase at a 7.9% compound annual growth rate to reach nearly $107 billion in 2016.

  • Biopharmaceutics
  • Compatibility Study
  • Quality by Design (QbD)
  • Design Of Experiments (DOE)
  • Early Phase Formulations
  • Optimization
  • Stability Study
  • Feasibility Testing
  • Process Validation
  • Packaging
  • Technology Transfer
  • Pre-formulation Studies

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