Excipient Analysis
For what is not on your CoA!
Excipients can influence drug product manufacturability, stability, dissolution and overall product performance. Many excipients are natural products or derived from natural sources, leading to potential natural variation in their properties. Materials that comply with the same pharmacopoeial specification or Certificate of Analysis may nevertheless differ between grades, suppliers or batches in properties that are relevant to a particular formulation.
Avivia uses its experience and proprietary expertise to integrate excipient analysis and characterization into pharmaceutical formulation development and troubleshooting through Excipia, its specialized excipient characterization platform. Beyond routine pharmacopoeial testing, we investigate excipient composition, variability, chemical reactivity and Functionality Related Characteristics (FRCs) to understand how an excipient may influence the drug product.
Avivia provides integrated pharmaceutical R&D services in formulation, analytical development, dissolution and excipient analysis.
When Can Excipient Analysis Help?
- Unexpected drug product stability or degradation
- Differences in performance between excipient suppliers, grades or batches
- Changes in dissolution, disintegration or drug release
- API–excipient compatibility concerns
- Manufacturing or processing variability
- Excipient supplier, grade, site or process changes
- Selection of excipients during formulation development
- Identification or quantification of excipients in a reference product
- Generic or hybrid drug product development
- Investigation of reactive components or impurities not adequately described by the CoA
Beyond the Certificate of Analysis
Pharmacopoeial specifications and Certificates of Analysis are essential for confirming excipient quality, but they do not necessarily describe every material property that may be relevant to a specific drug product.
Depending on the excipient and formulation, differences may occur in molecular-weight distribution, substitution or composition, particle or surface properties, residual components, degradation products, reactive impurities and other Functionality Related Characteristics (FRCs). Such differences can influence processing, API compatibility, stability or product performance even when both excipient batches comply with specification.
Advanced excipient characterization can therefore complement routine quality testing when conventional specifications do not explain an observed formulation or product-performance difference.
Connecting Excipient Properties to Drug Product Performance
At Avivia, excipient characterization can be directly connected with formulation development, analytical R&D and dissolution testing. This allows differences identified in an excipient to be evaluated in relation to the behaviour of the actual drug product.
For example, an investigation may compare excipient batches or suppliers, characterize potentially relevant differences and then evaluate whether those differences correlate with formulation stability, dissolution, processing or other product-performance characteristics.
This integrated approach helps distinguish whether an observed problem originates from the API, excipient, formulation, manufacturing process or analytical method and supports rational formulation or material-selection decisions.
Specialized Excipient Characterization Through Excipia
Excipia is Avivia’s specialized pharmaceutical excipient analysis and characterization platform. It originated from practical formulation-development experience where differences in excipient behaviour could not be explained by the limited information available from routine specifications or Certificates of Analysis.
Over more than 25 years, specialized analytical approaches and knowledge have been developed to investigate the composition, variability, functionality and chemical reactivity of pharmaceutical excipients. Excipia supports pharmaceutical companies, excipient manufacturers and drug product developers with advanced characterization, supplier and batch comparison, troubleshooting, deformulation and reverse engineering.
Excipient Characterization & Quality
Composition, variability, FRCs, supplier/grade/batch comparison.
Excipient Reactivity & Stability
Reactive components, degradation pathways and API–excipient compatibility.
Identification and quantification of excipients and Q1/Q2 assessment.
Understanding composition, formulation design and factors controlling reference-product performance.
Excipient Characterization and Quality by Design
Characterization of relevant excipient FRCs can also support Quality by Design (QbD) approaches by helping identify material attributes that may affect drug product performance and defining appropriate controls where routine pharmacopoeial specifications are insufficient.
Excipient Characterization in Practice
In a controlled-release formulation development project, dissolution testing showed that drug release and HPMC release from the matrix did not behave as initially expected. Further investigation indicated that product performance was sensitive to HPMC properties. Specialized excipient characterization through Excipia was subsequently used to identify relevant material characteristics and support the definition of appropriate in-house excipient specifications.
Frequently Asked Questions
Why can two excipient batches that meet the same specification behave differently?
Pharmacopoeial specifications and Certificates of Analysis define important quality attributes, but they do not necessarily describe every property relevant to drug product performance. Differences in composition, molecular-weight distribution, substitution, particle or surface properties, residual components, reactive impurities or other material characteristics may occur between suppliers, grades or batches while the excipient remains within specification.
What are Functionality Related Characteristics (FRCs) of pharmaceutical excipients?
Functionality Related Characteristics (FRCs) are physical or chemical properties of an excipient that can influence its functionality in a pharmaceutical formulation. Relevant FRCs depend on the excipient and its intended function and may affect processing, stability, dissolution, drug release or other aspects of drug product performance. Characterizing relevant FRCs can also support Quality by Design (QbD) and the development of appropriate material controls.
Can Avivia investigate whether an excipient is causing a drug product stability problem?
Yes. Avivia can combine formulation knowledge, analytical R&D and specialized excipient characterization through Excipia to investigate excipient-related stability problems. Depending on the product, this may include evaluating excipient variability, chemical reactivity, reactive components, degradation products and potential interactions with the API.
Can excipients from different suppliers, grades or batches be compared?
Yes. Excipia can characterize and compare pharmaceutical excipients beyond routine pharmacopoeial specifications. Supplier, grade and batch comparisons can help identify material differences that may explain changes in manufacturing behaviour, stability, dissolution or other drug product characteristics and can support excipient selection or supplier changes.
Can Avivia investigate API–excipient compatibility?
Yes. API–excipient compatibility can be investigated as part of formulation development, stability assessment or troubleshooting. Analytical studies can be combined with specialized characterization of the excipient to investigate whether its composition, reactive components or other properties contribute to API degradation or changes in product performance.
Can Avivia identify and quantify excipients in a reference drug product?
Yes. Through Excipia, Avivia can support the identification and quantification of excipients in pharmaceutical drug products. This deformulation work can be combined with formulation development, analytical characterization and comparative dissolution to support generic and hybrid drug product development.
What is the difference between excipient analysis, deformulation and reverse engineering?
Excipient analysis and characterization investigates the composition, variability, reactivity and relevant properties of an excipient itself. Deformulation focuses on identifying and, where possible, quantifying the components of a finished drug product. Reverse engineering has a broader objective and combines information about composition, formulation design and product performance to understand how a reference or existing drug product works.