Reverse Engineering of Pharmaceutical Formulations

Publications Presentations

Patent Preparation Expert Witness

New Product Acquisition Drug Delivery Systems

Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

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.

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

Site Map