Read more about our services to mitigate and (re-)design drug product processes to prevent, reduce or eliminate nitrosamines.
Welcome to Excipia, a service platform dedicated to the composition of quality of excipients and quantity of inactive ingredients 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.
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 :
– the presence of potential reactive impurities or functional groups
– degradation products
– related substances
– molecular weight distributions
– degree of substitution
– substituent distribution
– monomer ratio
– other featured characteristics
Excipia offers fast and flexible hands-on solutions and troubleshooting services to pharmaceutical drug companies and excipient manufacturers interested in:
Excipia, all about excipients
– 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 PEG
– Citric acid
– Magnesium stearate
– Polyoxyl castor oil
– Polyvinylpyrrolidone PVP
– Organic acids