Excipient Quantification and Identification Services for Pharmaceutical Formulations
What is pharmaceutical deformulation?
Excipient quantification and Identification
Deformulation is the analytical process of breaking down pharmaceutical formulations into their individual components to identify and quantify each ingredient, including excipients. This essential analysis provides insights into formulation composition, functionality, and performance, ensuring products meet regulatory standards and market demands.
At our advanced analytical laboratory, we specialize in excipient quantification and identification using state-of-the-art facilities and proven methodologies. Our expertise enables us to deliver precise results for pharmaceutical companies aiming to optimize formulations, ensure bioequivalence, and meet compliance requirements.
Why Choose Our Deformulation Services?
Pharmaceutical companies and researchers approach us for excipient analysis and deformulation for various reasons, including:
- Biowaiver Bioequivalence (BE) Strategies: For Q1/Q2 (qualitative/quantitative equivalence) and Q3 (physical equivalence) compliance, deformulation is crucial for developing generic drugs that exactly replicate reference or comparator products.
- Competitive Analysis: Investigate and understand the composition of competitive or reference formulations to gain a competitive edge.
- Patent Evaluation: Identify potential patent infringements or protect intellectual property by analyzing formulation details.
- Formulation Enhancement: Improve the performance, stability, or manufacturability of underperforming products by analyzing excipient interactions and contributions.
- Regulatory Compliance: Ensure formulations meet regulatory requirements by identifying and addressing inconsistencies or deviations in excipient composition.
Benefits of Our Excipient Quantification and Identification Services
- Accurate identification of individual excipients in pharmaceutical formulations.
- Comprehensive analysis tailored to specific client objectives, such as formulation optimization or regulatory submission.
- Enhanced formulation performance and compliance with industry standards.
- Support for intellectual property claims and competitive product development.
Partner with us to leverage expert deformulation services and achieve your pharmaceutical development goals. Contact us today to learn more about our excipient quantification and identification solutions.
Pharmaceutical Deformulation Services: Determination of Excipient Grade, Quality, and Source
Our extensive expertise in excipient characterization and pharmaceutical deformulation enables us to go beyond simple identification and quantification of excipients in complex formulations. We can often determine the excipient grade, assess excipient quality, and, in some cases, identify the source of the excipients used in the formulation.
By offering deeper insights into excipient properties and origins, our deformulation services provide valuable data for improving formulation performance, ensuring regulatory compliance, and optimizing manufacturing processes.
Looking to delve even deeper? Learn more about our complementary reverse engineering services, designed to provide a comprehensive understanding of pharmaceutical formulations.
Bioequivalence, essential similarity, and Q1/Q2 formulation Assessments
Excipia’s pharmaceutical deformulation services have been successfully applied in biowaiver bioequivalence (BE) strategies for complex generics, to provide Q1/Q2 formulation assessment data or proof essential similarity to a reference product. For certain types of products, FDA’s regulations generally require that proposed Q1/Q2 products be qualitatively (Q1) and quantitatively (Q2) the same as the reference listed drug (RLD) with respect to inactive ingredients.
Similarly, the EMA defines in extended pharmaceutical equivalence acceptance criteria that the nominal quantitative composition of excipients should be the same or differences not greater than ±5% or 10% with respect to comparator medicinal 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 Q1/Q2 product biowaiver approach can be considered acceptable, provided there is no significant difference between the 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).
Excipia’s pharmaceutical deformulation services and techniques can quickly provide solid and precise Q1/Q2 data. Our experiences employees have years of experience and know-how to extract, identify and quantify all components of pharmaceutical formulations.
Combined Deformulation, 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 deformulated and the exact formulation composition, both excipient quality and excipient amount, is revealed. Decoding the quantitative details will drastically reduce the number of experiments required to reach the optimal formulation.
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.
Case study deformulation services: bioequivalent product development
Fixed dose combination product (example)
Avivia colleagues were approached by a client to develop a discriminatory dissolution method for a complex fixed dose combination product after failed bioequivalence studies.
A CDA was put in place and information was exchanged. After evaluation of the product formulation and (bio)analytical data by an internal multidisciplinary expert team, the team made a proposal to the customer to first deformulate the reference product and possibly adapt the formulation of the test product accordingly.
After complete deformulation of the pharmaceutical reference product, qualitative sameness was confirmed, however important differences in quantitative composition were revealed.
The formulation was modified, confirmed improved delivery of the active pharmaceutical ingredients through dissolution testing, and then successfully passed the following bioequivalence study.
Read more about our reverse engineering services.
Fixed dose combination product (example)
Avivia colleagues were approached by a client to develop a discriminatory dissolution method for a complex fixed dose combination product after failed bioequivalence studies.
A CDA was put in place and information was exchanged. After evaluation of the product formulation and (bio)analytical data by an internal multidisciplinary expert team, the team made a proposal to the customer to first deformulate the reference product and possibly adapt the formulation of the test product accordingly.
After complete deformulation of the pharmaceutical reference product, qualitative sameness was confirmed, however important differences in quantitative composition were revealed.
The formulation was modified, confirmed improved delivery of the active pharmaceutical ingredients through dissolution testing, and then successfully passed the following bioequivalence study.
Read more about our reverse engineering services.
Welcome to Excipia, a service platform of Avivia, dedicated to the composition, quality and quantity of excipients in medicinal products.
Discover our unique services such as quantitative excipient analysis, identification, selection or specific formulation development support. Don’t forget to check out our case studies.
Feel free to contact us using the “Contact” button or by sending a message to Excipia@avivia.nl.
Menno Wiltink
Founder of Excipia.
