Pharmaceutical Excipient Analysis and Characterization Services
Excipia provides specialized pharmaceutical excipient analysis, characterization and custom problem-solving services for pharmaceutical companies and excipient manufacturers. We investigate excipient composition, quantity, quality, variability, functionality and chemical reactivity to understand how excipients may influence drug product development, manufacturing, stability and performance.
Our work goes beyond routine pharmacopoeial testing. Depending on the pharmaceutical question, we can identify and quantify excipients in finished drug products, compare excipient grades, batches and suppliers, investigate functionality-related characteristics and reactive components, and determine which excipient attributes may be relevant to an observed drug product problem.
Rather than applying a fixed analytical package, Excipia develops a tailored characterization strategy based on the excipient, formulation and development question. Projects can range from deformulation and pharmaceutical reverse engineering to excipient supplier or grade comparison, stability investigations, formulation troubleshooting and excipient selection. Analytical characterization can be combined with Avivia’s formulation development and dissolution expertise when the impact of excipient differences on drug product performance needs to be investigated experimentally.
Pharmaceutical Deformulation
Identify and quantify the components of a finished pharmaceutical product. Deformulation can provide Q1/Q2 composition information, support reference product characterization and help identify formulation differences relevant to generic, hybrid or reformulated drug product development. Explore Pharmaceutical Deformulation
Pharmaceutical Reverse Engineering
Understand not only what a pharmaceutical product contains, but how its formulation is designed and which attributes contribute to its performance. Reverse engineering combines compositional, physical and performance characterization to support reference product understanding, formulation development and troubleshooting. Explore Pharmaceutical Reverse Engineering
Excipient Quality Testing and Characterization
Investigate differences between excipient grades, batches or suppliers that may not be apparent from routine pharmacopoeial specifications. Characterization can include composition, molecular properties, functionality-related characteristics, residual components and reactive impurities potentially relevant to drug product performance or stability. Explore Excipient Quality Testing and Characterization
Excipient Support for Formulation Development
Determine which excipient properties are important to a particular formulation. Excipia can support excipient selection, grade and supplier comparison, formulation troubleshooting and the identification of functionality-related characteristics relevant to manufacturing and drug product performance. Explore Excipient Support for Formulation Development
From Excipient Characterization to Drug Product Performance
Characterizing an excipient is most valuable when the analytical findings can be related to the pharmaceutical question being investigated. A difference between two excipient materials is not necessarily relevant simply because it can be measured; the important question is whether that difference can influence the formulation, manufacturing process, stability or performance of the drug product.
Through the combination of Excipia’s excipient expertise with Avivia‘s analytical, formulation and dissolution capabilities, identified material differences can be investigated in the context of the finished drug product. This can include comparative formulation studies, compatibility investigations, small-scale formulation experiments and dissolution or release testing.
This integrated approach is particularly useful when investigating unexpected stability behaviour, batch-to-batch product variability, differences between test and reference products, failed formulation performance or changes following an excipient grade or supplier change.
Why Can Excipient Characterization Beyond the Pharmacopoeia Be Necessary?
Pharmacopoeial compliance establishes important quality requirements for pharmaceutical excipients, but a pharmacopoeial monograph does not necessarily characterize every material attribute relevant to a particular drug product.
Two excipient materials that comply with the same monograph may still differ in molecular characteristics, composition, particle properties, residual components, reactive impurities or other functionality-related characteristics. Depending on the excipient and formulation, these differences may influence manufacturability, drug release, API stability or other aspects of product performance.
Additional characterization can therefore be valuable when qualifying an alternative supplier, comparing nominally equivalent grades, investigating batch-to-batch variability or troubleshooting an unexplained drug product problem.
The appropriate analytical strategy should be based on the excipient, its function in the formulation and the pharmaceutical problem being investigated. The objective is not to measure every possible excipient property, but to identify which material attributes are relevant to the performance of the specific drug product.
A Problem-Oriented Approach to Excipient Analysis
Excipient investigations at Excipia start with the pharmaceutical question rather than with a predefined analytical test package. Available information about the excipient, API, formulation, manufacturing process and observed product behaviour is reviewed to identify the most plausible material attributes and mechanisms.
Analytical methods can then be selected or developed specifically to investigate those hypotheses. Depending on the project, this may involve comparison of multiple excipient batches, grades or suppliers, characterization of molecular or chemical properties, analysis of reactive components, or determination of excipient content in the finished drug product.
Where necessary, analytical findings can subsequently be tested through formulation, compatibility, stability, dissolution or other performance studies. See also the Avivia website.
When Can Advanced Excipient Characterization Help?
Advanced excipient characterization can be valuable when a pharmaceutical product shows unexplained stability, dissolution or manufacturing behaviour; when product performance changes between excipient batches; when changing excipient grade or supplier; when qualifying a second source; when developing a generic or reformulated product; or when routine pharmacopoeial testing does not explain an observed difference.
It can also support investigations of API–excipient compatibility, reactive impurities, functionality-related characteristics and the establishment of product-specific excipient specifications where tighter control of particular material attributes is required.
Frequently Asked Questions About Pharmaceutical Excipient Characterization
What is pharmaceutical excipient characterization?
Pharmaceutical excipient characterization is the analysis of physical, chemical or molecular properties of an excipient to understand its composition, variability, functionality or potential interaction with a drug product. It can extend beyond routine pharmacopoeial testing when additional material attributes are relevant to a specific formulation.
Why can pharmacopoeially compliant excipients perform differently?
Excipient monographs define important quality requirements but do not necessarily control every functionality-related or chemically relevant material attribute. Materials complying with the same monograph can therefore differ in properties that may affect manufacturing, stability or drug product performance.
Can Excipia compare excipients from different suppliers?
Yes. Comparative characterization can be used to identify differences between excipient suppliers, grades or batches and assess which differences may be relevant to a particular pharmaceutical formulation or manufacturing process.
Can Excipia investigate whether an excipient is causing a stability problem?
Yes. The investigation can be designed around the API degradation pathway and may include characterization of reactive components, residual impurities, moisture-related properties or other excipient attributes potentially associated with the observed stability behaviour.
Be in control of your product!
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.
Try us. Feel free to contact us using the “Contact” button or by sending a message to Excipia@avivia.nl.
Menno Wiltink
Founder of Excipia.