Fully dedicated to Excipient Characterization
Excipia is an independent contract R&D platform that focusses on the physicochemical characterization of pharmaceutical excipients and food ingredients; as a pure substance, as a raw material or when processed into products.
Being active for more than 25 years in pharmaceutical formulation development has learned us that the limited information on an excipient Certificate of Analysis (CoA) often falls short in explaining observed excipient or product characteristics and that more profound knowledge about the actual chemical composition is essential to meet and understand specific challenges.
In the past 15 years analytical scientists of Excipia have spent tens of thousands of hours to set up unique dedicated analytical and physicochemical methods with ingenious sample preparation techniques to characterize excipients.
In these years we have gained a lot of knowledge about many excipients, about their properties and exact composition, the difference between batches, grades and manufacturers, how to quantify them in medicines and how they can best be used in a formulation. The science and experience of Excipia can support you in areas such as, but not limited to:
Quality of excipients
Excipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases they are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.
Besides differences in process technology, conditions and parameters, these raw materials required to produce the excipient are an important source of variability in the composition of excipients. For example, one of the most important components of cellulose ethers is the cellulose raw material itself. No two trees are alike, so there will be inherent variability from batch to batch of cellulose raw material.
Excipia offers fast and flexible hands-on solutions and troubleshooting services to reveal and compare hidden excipient properties like the presence of potential reactive impurities or functional groups, degradation products and related substances, just like molecular weight distributions, degree of substitution, substituent distribution, monomer ratio and many other featured characteristics.
With this in-depth knowledge we can guide excipient manufacturers to select and control their feedstock, production processes and optimize product reliability and consistency.
In addition, we can help users of excipients to pick the most appropriate excipient manufacturer, select the most suitable grade for their finished dosage form, or define customized specifications to control product performance, quality and safety.
– Xanthan gum
– 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
– Polyethylene glycol
– Polypropylene glycol
– Citric acid
– Magnesium stearate
– Polyoxyl castor oil
– Organic acids
Though excipients were at one time assumed to be “inactive” ingredients, it is now understood that excipients can have an important impact on the pharmaceutical and chemical performance of a drug product formulation. It’s therefore important to identify and control unknown FRCs of excipient materials, to manage their effects on pharmacodynamics and pharmacokinetics and achieve safe, robust and stable products.
Our extensive experience in formulation development and excipient characterization enables us to explain observed formulation characteristics or to appoint product specific FRCs.
Excipia can help your company to identify critical FRCs and (combinations of) excipients in a formulation, investigate batch-to-batch variability, select specific excipient batches or set in-house specifications for customized product properties.
Deformulation, Reverse Engineering and Beyond
The knowledge about excipient characteristics and the available analytical methodologies and procedures enable us to identify and quantify individual excipients in a drug product. The process of analytically breaking down a material or product’s formulation into separate components and determine the specific identity and exact quantity of constituent components is called deformulation or chemical reverse engineering.
Our experience in excipient characterization enables us not only to identify and quantify individual excipients in a complex product, but often also confirm the grade, quality and sometimes even the source of the ingredients.
Thanks to the unique combination with a pharmaceutical development and enhanced dissolution testing platform within Avivia, we can offer additional insight into other product characteristics, such as detailed release performance or insight into the applied production techniques or processes. If desired, we can reconstruct a copy of the product.
Excipia, a division of Avivia BV
For more information about Avivia and its pharmaceutical development CRO services, please visit the Avivia website.