Excipia is, 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.
Excipia is, 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.
Pharma excipients, also called inactive ingredients, 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 Functionality Related Characteristics (FRCs) of excipient materials in order to achieve safe, robust and stable products.
Being active for 25 years in pharmaceutical formulation development has learned us that the limited information on an pharma excipient Certificate of Analysis often falls short in explaining observed formulation characteristics or in appointing product specific FRCs. So there must be more to it,….
In the past 15 years analytical scientists of Excipia have worked hard to set up unique analytical and physicochemical methods with ingenious sample preparation techniques and successfully filled this knowledge gap for a broad variety of pharma excipients. For some excipients, up to one hundred unique batches of different grades and suppliers were analyzed to compile a knowledge database.
With all this, Excipia can help your company to identify critical FRCs of pharmaceutical excipients and combinations of inactive ingredients in a formulation, or investigate batch to batch variability, select specific excipient batches or set in-house specifications for customized product properties.
Our experience in pharma excipient characterization enables us not only
to identify and quantify individual excipients / inactive ingredients in any drug product (deformulation)
but also to investigate excipient reactivity and reveal hidden excipient properties like :
Why is excipient characterization important?
Excipient characterization is crucial for understanding and optimizing the performance of pharmaceutical formulations. It ensures product quality, stability, and compliance with regulatory standards.
How long does the excipient characterization process take?
The timeline varies based on the specific services required. Contact us for a personalized estimate based on your project.
Do you offer customized excipient characterization packages?
Absolutely! We tailor our services to meet the unique needs of each client. Discuss your requirements with our team for a customized solution.
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:
Excipia, all about excipients
Polysaccharides
– Cellulose
– Starch
– Alginate
– Xanthan gum
– Carrageenan
– Pullulan
– Chitosan
…..
Cellulose derivatives
– 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
– Organic acids
– Peroxides
– Hemicellulose
– Solvents
– Monomers
– Lignin
…..
Excipia
Novio Tech Campus – M-building
Transistorweg 5
6534 AT Nijmegen, The Netherlands
Email : Excipia @ avivia.nl
