Reverse Engineering of Pharmaceutical Formulations

Reverse engineering of pharmaceutical formulations may be required for a variety of reasons:

  • Intellectual property issues (viz. patent infringement)
  • Analytical issues (viz. matrix extraction)
  • Stability issues
  • Safety issues
  • Generic formulation design and development

Reverse engineering of a formulation can be done using public domain information about the composition of a drug product, and applying knowledge and experience of formulation science to develop an approximation to the quantitative formula and likely manufacturing process.

It is possible to estimate the quantitative formulation from the qualitative formulation using the knowledge and understanding of:

  • Formulation science
  • The implications of chemical structure for the stability of the API
  • Excipients; understanding their function, their limitations, and typical levels of use
  • Pharmaceutical unit processes
  • How these different facets of the product interact with each other

Reverse engineering at this level is not an exact process but provides a reasonable estimate.

FinnBrit Consulting has many years of practical experience of reverse engineering of pharmaceutical formulations and can assist with such work.

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All information published throughout is intended for information only, and does not contain any warranties, implied or otherwise.

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