Pharmaceutical Reverse Engineering Services
What is pharmaceutical reverse engineering?
Excipient Quantification, and Formulation Characterization
Reverse engineering of pharmaceutical formulations is a process or method of trying to understand how a formulation works, what exactly it is composed of and the decoding of an innovator product’s formulation parameters. The knowledge of excipient properties and Excipia’s in-house developed analytical procedures and methodologies allows us to offer excipient quantification and identification of individual excipients in pharmaceutical formulations.
Clients approach us for our reverse engineering services for a variety of reasons:
- To investigate a competitive or reference formulation
- For specific biowaiver bioequivalence (BE) strategies Q1/Q2(Q3) reverse engineering may be required to produce a generic product that exactly matches a drug on the reference list
- To determine if patents have been infringed
- To investigate and understand the principle of a formulation.
Reverse Engineering Services: Formulation Characterization
Experience in reverse engineering of pharmaceutical formulations, drug product characterization and formulation development, make it possible not only to quantify individual excipients in a complex pharmaceutical formulation, but also examine formulations in every detail and determine formulation optimization steps. To really understand how a formulation works, our pharmaceutical experts can evaluate the obtained product composition, and our dissolution team can investigate release, solubility and disintegration properties.
Our reverse engineering services go further than just quantifying excipients.
Reverse Engineering, Pharmaceutical & Dissolution Lab Services
The development of pharmaceutical formulations of a generic product can be accelerated if a reference product is well characterized. In solid dosage forms, the focus is often on release properties, but, in general, the formulation development can be speed up when the reference product is reverse-engineered and the exact composition and mechanisms of the formulation is revealed and the innovator product’s formulation parameters are decoded.
Due to the availability of in-house pharmaceutical development and dissolution testing services, we provide our clients comprehensive insight into various product properties, such as detailed release performance, product composition and principle or insight into the applied manufacturing techniques or processes.
If desired we can reconstruct a drug product in our pharmaceutical small scale facilities.