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.
Being active for 25 years in formulation development has learned us that the limited information on an 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 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 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.
Our experience in 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 :
– 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 that are encountering challenges such as:
Compatibility of 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.