Excipia is a specialized pharmaceutical excipient analysis and characterization platform supporting pharmaceutical companies with questions that extend beyond routine pharmacopoeial testing.
We investigate excipient composition, quantity, variability, functionality and chemical reactivity, and help determine whether differences between excipient grades, batches or suppliers may be relevant to formulation behaviour, manufacturing, API–excipient compatibility or drug product stability.
Excipia combines specialized excipient analytics with extensive pharmaceutical formulation experience. Our services include excipient characterization and quantification, supplier and grade comparison, pharmaceutical deformulation, reverse engineering and formulation troubleshooting.
Excipients are often described by compendial identity, grade and basic quality specifications. For pharmaceutical development, however, additional material characteristics can sometimes determine whether an excipient performs as expected in a particular formulation.
Excipia specializes in identifying these differences. Depending on the pharmaceutical question, we can investigate chemical composition, molecular characteristics, functionality-related properties, residual components, reactive impurities and differences between excipient grades, batches or suppliers.
The objective is not simply to generate additional analytical data. It is to determine which excipient characteristics are relevant to the formulation, API or drug product problem being investigated.
Menno Wiltink
Founder of Excipia.
Excipients are often described by compendial identity, grade and basic quality specifications. For pharmaceutical development, however, additional material characteristics can sometimes determine whether an excipient performs as expected in a particular formulation.
Excipia specializes in identifying these differences. Depending on the pharmaceutical question, we can investigate chemical composition, molecular characteristics, functionality-related properties, residual components, reactive impurities and differences between excipient grades, batches or suppliers.
The objective is not simply to generate additional analytical data. It is to determine which excipient characteristics are relevant to the formulation, API or drug product problem being investigated.
Menno Wiltink
Founder of Excipia.
Pharmaceutical excipients, although often described as inactive ingredients, can have an important influence on the manufacturing, stability, dissolution and overall performance of a drug product. Functionality Related Characteristics (FRCs) are physical or chemical properties of an excipient that may influence its functionality in a particular formulation. Identifying and understanding relevant FRCs can therefore be important when selecting excipients, comparing suppliers or grades, investigating batch-to-batch variability and establishing product-specific excipient controls.
A Certificate of Analysis and pharmacopoeial testing provide essential information about excipient quality, but they do not necessarily describe every material attribute relevant to a specific pharmaceutical formulation.
During more than 25 years of pharmaceutical formulation development, we have encountered situations where nominally equivalent excipient materials produced different manufacturing, stability or product-performance outcomes. Excipia was established to investigate these differences analytically.
Our scientists have developed specialized analytical and physicochemical methods for a broad range of pharmaceutical excipients. For selected excipients, up to approximately 100 batches across different grades and suppliers have been characterized, creating an extensive knowledge base on excipient composition and variability.
This experience can support supplier and grade comparison, batch selection, root-cause investigations and the identification of material attributes that may require product-specific control.
The appropriate characterization strategy depends on the excipient and pharmaceutical question. Depending on the material, Excipia can investigate characteristics including excipient composition and quantity, molecular-weight distribution, degree and distribution of substitution, monomer or carbohydrate composition, residual components, degradation products, organic acids, aldehydes, peroxides and other reactive or functionality-related characteristics.
Characterization can be performed on excipient raw materials or, where analytically feasible, within finished pharmaceutical products. Comparative analysis of multiple grades, batches or suppliers can help identify which material differences correlate with observed changes in formulation behaviour.
Why can pharmacopoeially compliant excipients perform differently?
Pharmacopoeial monographs define important quality requirements but do not necessarily control every material attribute relevant to a particular formulation. Excipient grades, batches or suppliers complying with the same monograph may therefore differ in characteristics that influence manufacturing, stability or drug product performance.
Can Excipia compare excipients from different suppliers or batches?
Yes. Comparative characterization can identify chemical, molecular, physical or functionality-related differences between excipient suppliers, grades and batches and help determine which differences may be relevant to a specific drug product.
Can excipient variability contribute to API stability problems?
Yes. Depending on the API and excipient, differences in residual components, reactive impurities, moisture behaviour, surface chemistry or other material characteristics can potentially influence drug product stability. The investigation should be designed around the API degradation pathway and formulation.
Can Excipia quantify excipients in finished drug products?
Yes. Excipia develops analytical approaches to identify and quantify excipients in pharmaceutical formulations where analytically feasible. This can support deformulation, Q1/Q2 assessment, reference-product characterization and formulation comparison.
Does Excipia manufacture or supply pharmaceutical excipients?
No. Excipia is an independent pharmaceutical excipient analysis and characterization platform. We analyze excipients and finished drug products and support pharmaceutical companies with supplier comparison, material selection, deformulation, reverse engineering and formulation-related investigations.
Compatibility of pharmaceutical excipients in drug products is demonstrated in accelerated and real-time stability programs, but too often batch-to-batch variability of excipients is ignored. Many excipients are derived through processing of natural animal, vegetable or mineral sources. Variability is introduced not only by process technology or process parameters, but also by inadequate specifications of starting materials; species of crop, different regional and seasonal provenance may contribute to batch-to-batch inconsistency. Excipia analyzed about 100 Microcrystalline Cellulose (MCC) samples from various manufacturers and grades for properties like molecular weight distribution, chemical composition, purity and chemical reactivity. We identified, amongst other things, a relation between the content of xylose and the reactive aldehyde furfural in MCC.
More excipients:
Explore Our Excipient Knowledge
– Cellulose
– Starch
– Alginate
– Xanthan gum
– Carrageenan
– Pullulan
– Chitosan
…..
– Microcrystalline cellulose MCC
– Hydroxyethyl cellulose HEC
– Hydroxymethyl cellulose HMC
– Hydroxypropyl methyl cellulose HPMC
– Hydroxypropyl cellulose HPC
– Methyl cellulose MC
– Ethyl cellulose EC
– Carboxymethyl cellulose CMC
– Hydroxyethylmethyl cellulose HEMC
– Hydroxypropyl methyl cellulose acetate succinate HPMCAS
Polyols
– Glucose
– Galactose
– Fructose
– Mannitol
– Sorbitol
– Xylitol
– Lactose
– Sucrose
– Maltitol
Other excipients
– Polyethylene glycol PEG
– Polysorbate
– Citric acid
– Magnesium stearate
– Polyoxyl castor oil
– Polyvinylpyrrolidone PVP
– Poloxamer
– Mint
– Silica
– Talc
Related substances
– Furans
– Aldehydes
– Nitrite and nitrate
– Organic acids
– Peroxides
– Hemicellulose
– Solvents
– Monomers
– Lignin
