Experts in excipient analysis

for safe robust stable pharmaceutical products​

Excipient Quality Testing and Selection Services

Discover and compare the concealed composition and properties of excipients.

Reverse Engineering / Deformulation Services

Identify, confirm and quantify individual excipients in a product.

Formulation Development Support

Identify and control unknown Functionality Related Characteristics of excipients in your drug formulation.

Welcome to Excipia, a service platform dedicated to excipient composition and quality.

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, Excipia.

Fully dedicated to Excipient Characterization

 

Pharma 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 Functionality Related Characteristics (FRCs) of excipient materials in order to achieve safe, robust and stable products.

Excipia.eu Deformulation, Reverse engineering services and excipient characterization

Complementary to a Certificate of Analysis

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 combination of excipients in a formulation, or investigate batch to batch variability, select specific excipient batches or set in-house specifications for customized product properties.

Reverse Engineering of Pharmaceutical Formulations and Beyond

Our experience in pharma excipient characterization enables us not only
to identify and quantify individual excipients in any drug product (deformulation)
but also to investigate excipient reactivity and reveal hidden excipient properties like :

Formulation Development and Deformulation

– 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

Hands-on troubleshooting services and solutions

Excipia offers fast and flexible hands-on solutions and troubleshooting services to pharmaceutical drug companies and excipient manufacturers interested in:                                          

Excipient Case Study

VARIABILITY OF EXCIPIENTS: Xylose in microcrystalline cellulose

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.
www.Excipia.eu- Furfural and Xylose in MCC

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, a division of Avivia BV

 Excipia as dedicated excipient knowledge platform is a division of Avivia BV, a Dutch independent specialized pharmaceutical development company that operates a hybrid business model combining CRO service activities with internal product development programs. The other complementary platforms of Avivia are Pharmaceutical R&D, Analytical R&D, and Biorelevant Dissolution Testing. For more information about Avivia and its pharmaceutical development CRO services, please visit the Avivia website.