Reverse Engineering of Pharmaceuticals
EAG’s chemists have performed reverse engineering studies for hundreds of pharmaceuticals and medical devices. Information from these projects help companies accelerate their R&D efforts, resolve supply chain issues and investigate product quality challenges.
This strategic technical investigation known as deformulation is the separation, identification and quantitation of ingredients in a formulation. Reverse engineering projects yield valuable data regarding a pharmaceutical’s active (API) ingredient and excipient ingredients, and may be used for competitive product comparisons, patent infringement investigations, or the development of generic formulations.
Our scientists offer RLD (Reference Listed Drug) reverse engineering services for Q1 (qualitative) and Q2 (quantitative) equivalency of topical products, including lotions, creams and ointments. We also deformulate tablets, capsules and controlled release products, as well as transdermal patch delivery systems and ophthalmic solutions/creams to demonstrate equivalency.
EAG knows how to perform quantitation of excipients, including hydrocarbon based ingredients, polymers, modified cellulose, surfactants, emulsifiers and polyols. Part of this process is identifying the grade of material used as the excipient and then obtaining reference standards of this material to use for quantitation. We can also procure the RLD, if necessary, and some clients prefer to prepare their own formulations for our scientists to compare side-by-side with the RLD.
Our clients receive a full report with supporting data and analysis details. Each deformulation project has a designated Project Manager, providing regular updates and meetings. EAG scientists have the skills and tools to successfully reverse engineer the most difficult pharmaceutical and medical device products.
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