Pharmaceutical Deformulation Services
Excipient identification, quantification and Q1/Q2 formulation assessment for pharmaceutical products
What is pharmaceutical deformulation?
Excipient quantification and Identification
Deformulation is the analytical process of breaking down a pharmaceutical formulation into its individual components to identify and quantify the active and inactive ingredients.
Excipia supports pharmaceutical companies with deformulation of finished drug products, including excipient identification, excipient quantification and Q1/Q2 formulation assessment. This can help reveal what a formulation contains, how much of each excipient is present, and which formulation differences may be relevant for generic development, bioequivalence strategy, troubleshooting or competitive analysis.
Our expertise in excipient characterization allows us to go beyond simple identification. Depending on the formulation, we can often assess excipient grade, quality and functionality-related properties, and connect the findings with Avivia’s formulation, analytical and dissolution expertise.
When is deformulation used?
Pharmaceutical companies and researchers approach us for excipient analysis and deformulation for various reasons, including:
- Q1/Q2 formulation assessment for generic development and selected bioequivalence or biowaiver strategies
- Reference product characterization to support formulation matching or product development
- Excipient identification and quantification in complex or poorly documented formulations
- Excipient grade, quality or source investigation, where analytically feasible
- Competitive product analysis and IP-supporting formulation evaluation
- Troubleshooting of stability, manufacturability, dissolution or product performance issues
- Support for Q3/physical characterization, where composition alone is not sufficient
| Client question | Typical deformulation output |
|---|---|
| Which excipients are present? | Qualitative excipient identification |
| How much of each excipient is present? | Quantitative excipient profile / Q1/Q2 composition |
| Is the same excipient grade likely used? | Grade or quality assessment, where feasible |
| Are there relevant excipient markers or variability? | Excipient characterization and impurity/quality indicators |
| Does the formulation match the reference product? | Comparative formulation assessment |
| Could differences affect performance? | Recommendation for dissolution, release, stability or formulation follow-up |
Why choose Excipia for deformulation?
- Focused expertise in excipient identification and quantification
- Experience with complex and poorly documented formulations
- Ability to assess excipient grade, quality and functionality-related properties where feasible
- Direct connection with Avivia’s analytical, formulation and dissolution capabilities
- Practical interpretation of findings for development, troubleshooting and Q1/Q2 assessment
Pharmaceutical Deformulation Services: Excipient grade, quality and source assessment
Excipia’s deformulation and excipient characterization expertise can go beyond simple identification and quantification. Depending on the excipient and formulation matrix, we may be able to assess excipient grade, quality and functionality-related properties, and in some cases identify markers that indicate likely excipient source or variability.
These insights can be important when formulation performance, manufacturability, stability or product matching depends on more than the nominal excipient name alone.
Looking to dive even deeper? Learn more about our complementary reverse engineering services, designed to provide a comprehensive understanding of pharmaceutical formulations.
Regulatory context: Q1/Q2 assessment in the US and EU
In generic drug development, formulation sameness or similarity can be an important part of the bioequivalence strategy, depending on dosage form, route of administration and product-specific expectations.
Deformulation and Q1/Q2 assessment can help development teams to:
- identify which excipients are present in the reference product;
- quantify excipient levels and compare them with the test formulation;
- assess whether the formulation is aligned with Q1/Q2 expectations;
- identify excipient differences that may create regulatory or development risk;
- determine whether further Q3 or performance characterization may be needed;
- support discussions on bioequivalence strategy, product-specific guidance and formulation risk.
In the United States, FDA product-specific guidances describe the Agency’s current thinking on the evidence recommended to support ANDA approval for specific products. These guidances are issued and revised over time, so Q1/Q2 expectations should always be checked against the relevant product-specific guidance and current FDA requirements.
For some dosage forms, US regulations include specific inactive-ingredient requirements. For example, 21 CFR 314.94 states that ophthalmic or otic drug products generally must contain the same inactive ingredients in the same concentration as the reference listed drug. It also includes specific provisions for parenteral drug products.
In Europe, EMA publishes product-specific bioequivalence guidance after public consultation and CHMP adoption. EMA states that product-specific guidance should be considered together with relevant clinical pharmacology and pharmacokinetics guidance and Q&As.
For complex or locally acting products, formulation composition alone may not be sufficient. FDA’s final Q3 guidance for topical drug products describes how physicochemical and structural characterization can be used to identify dosage form properties that may be critical to product performance and support a bioequivalence demonstration.
Excipia supports this process by providing excipient identification, excipient quantification and Q1/Q2 formulation assessment data. Where needed, deformulation findings can be combined with Avivia’s formulation, analytical and dissolution expertise to support follow-up development decisions.
Recent developments and expectations for Q1/Q2 assessments
Recent regulatory expectations increasingly emphasize a science-based link between composition, structure and performance. For complex generics, FDA continues to publish and update product-specific guidances and provides resources on Q1/Q2 sameness, formulation assessment and complex generic development.
In Europe, EMA also continues to develop and publish product-specific bioequivalence guidance after public consultation and CHMP adoption. These product-specific guidances should be considered together with relevant EMA clinical pharmacology/pharmacokinetics guidance and Q&As.
For topical and other locally acting products, the role of deformulation is particularly important. In these products, small differences in excipient composition, grade, microstructure, viscosity, rheology, particle size, pH, osmolality or release behaviour can affect local availability and product performance. Regulatory expectations therefore often go beyond simple Q1/Q2 composition and may require Q3 physicochemical/structural characterization, in vitro release or permeation testing, and product-specific justification.
This is especially relevant for products such as topical semisolids, ophthalmic and otic products, nasal products, inhaled products, locally acting gastrointestinal products, suspensions and emulsions. FDA’s Q3 guidance for topical ANDA products and EMA’s guidance on quality and equivalence of locally applied, locally acting cutaneous products both reflect this broader focus on linking product composition and structure to performance.
For developers, this means that deformulation is most useful when combined with formulation expertise, analytical method development and, where relevant, dissolution, release, permeation, rheology or other performance testing. This is where Excipia’s deformulation work can connect directly with Avivia’s formulation, analytical and dissolution platforms.
Connecting deformulation data to formulation performance
Deformulation provides the composition and excipient profile. Where needed, Avivia’s formulation, analytical and dissolution teams can help interpret what those findings mean for product performance.
Follow-up work may include dissolution or release testing, formulation screening, excipient compatibility assessment, stability studies or formulation optimization.
Where appropriate, deformulation findings can support formulation redevelopment or prototype reconstruction.
Case study: deformulation support after failed bioequivalence
Fixed dose combination product (example)
A client approached Avivia after failed bioequivalence studies for a complex fixed-dose combination product. After reviewing the formulation and bioanalytical data, the project team recommended deformulation of the reference product and comparison with the test formulation.
Deformulation confirmed qualitative sameness but revealed quantitative differences in excipient composition. The formulation was adjusted, improved release was confirmed through dissolution testing, and the following bioequivalence study was successful.
Read more about our reverse engineering services.
Fixed dose combination product (example)
A client approached Avivia after failed bioequivalence studies for a complex fixed-dose combination product. After reviewing the formulation and bioanalytical data, the project team recommended deformulation of the reference product and comparison with the test formulation.
Deformulation confirmed qualitative sameness but revealed quantitative differences in excipient composition. The formulation was adjusted, improved release was confirmed through dissolution testing, and the following bioequivalence study was successful.
Read more about our reverse engineering services.
Deformulation vs reverse engineering
Deformulation focuses on identifying and quantifying formulation components: what is present, how much is present, and whether excipient grade or quality may be relevant.
Reverse engineering is broader. It uses deformulation data together with formulation science, product performance testing and development experience to understand how the product works and how it may be reproduced, improved or differentiated.
For broader product understanding, see our reverse engineering services.
FAQ
What is pharmaceutical deformulation?
Pharmaceutical deformulation is the analytical process of identifying and quantifying the components of a drug product, including excipients. It is used to understand formulation composition, support generic development, compare reference products and investigate performance.
What is Q1/Q2 formulation assessment?
Q1 refers to qualitative sameness of inactive ingredients. Q2 refers to quantitative sameness or similarity, meaning the levels of inactive ingredients are aligned with the reference product according to applicable regulatory expectations.
Does Q1/Q2 sameness replace a bioequivalence study?
Not automatically. Q1/Q2 data can support a bioequivalence strategy, but requirements depend on dosage form, route, product-specific guidance and regulatory expectations. Additional Q3 characterization, in vitro testing or in vivo studies may be needed.
What is the difference between deformulation and reverse engineering?
Deformulation identifies and quantifies formulation components. Reverse engineering uses deformulation data together with formulation science and product performance testing to understand how the formulation works.
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.
