Deformulation lab Services, Reverse Engineering of Pharmaceutical Formulations and Beyond
Excipient quantification and Identification
The knowledge of excipient characteristics and the available analytical laboratory facilities, methodologies and procedures, enable us to offer excipient quantification and identification of individual excipients in a pharmaceutical formulation. The process of analytically breaking down a material or product’s formulation into separate components and determine the specific identity and exact quantity of constituent components is called deformulation or chemical reverse engineering of pharmaceutical formulations.
Determination of excipient grade and source
Our experience in excipient characterization and deformulation of pharmaceutical formulations gives us the opportunity not only to identify and quantify individual excipients in a complex pharmaceutical formulation, but often also confirm the excipient grade, excipient quality and sometimes even the excipient source of the ingredients.
Bioequivalence, essential similarity, and Q1/Q2 Assessments
Excipia’s deformulation and reverse engineering services have been successfully applied in biowaiver bioequivalence (BE) strategies for complex generics, to provide Q1/Q2 Assessment data or proof essential similarity to a reference product.
These specific BE approaches may be recommended in product-specific guidance for generic (Q1/Q2) formulations, like
- Parenteral suspension, emulsion, and liposome,
- Ophthalmic ointment, suspension and emulsion
- Otic suspension
- Orally inhaled and nasal drug products (OINDPs)
- Topical dermatological products
- Oral drug products
Such biowaiver approach can be considered acceptable, provided there is no significant difference between the reference products in terms of the qualitative and quantitative composition of excipients; Test (T) and Reference (R) contains the same active and inactive ingredients in the same concentration (Q1/Q2) as the RLD product. In this context, “sameness” refers to situations where the qualitative (Q1) and quantitative (Q2) properties, as well as the arrangement of matter (Q3) in the test and reference products, are considered to be the same.
Q1: Qualitative sameness; identity of an inactive ingredient.
- Means that the test product uses the same inactive ingredient(s) as the reference product. An applicant should provide detailed information on the chemistry and grade of each inactive ingredient, and characterization data, if needed for inactive ingredients.
Q2: Quantitative sameness; quantity of an inactive ingredient
- Means that concentrations of the inactive ingredient(s) used in the test product are within ±5% of those used in the reference product. An applicant should determine the difference (%) of an inactive ingredient in the Test (T) and Reference (R) products, i.e., [ (T-R)/R ] x 100).
Combined Analytical, Pharmaceutical and Dissolution lab Services
Often the development of pharmaceutical formulations of a generic product can be accelerated and improved if a reference product is well characterized. And then not only in terms of the release properties, but also when the product is reverse engineered and the exact formulation composition, both excipient quality and excipient amount, is revealed.
Thanks to the unique combination with a pharmaceutical development and dissolution testing services within Avivia, we can provide comprehensive insight into different product properties, such as detailed release performance, product composition or insight into the applied production techniques or processes.
If desired, we can reconstruct a copy of the product.
