Fully dedicated to Excipient Characterization
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.
Complementary to a Certificate of Analysis
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 fifteen 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.
Reverse Engineering and Beyond
Our experience in excipient characterization enable us not only to identify and quantify individual excipients in a drug product (deformulation) but also 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.
Hands-on troubleshooting services and solutions
Excipia offers fast and flexible hands-on solutions and troubleshooting services to pharmaceutical drug companies and excipient manufacturers that are encountering challenges such as:
• Competitor research and analysis
• Deformulation or reverse engineering
• Selection of excipient or feedstock
• Batch to batch product performance variation, e.g. manufacturability, stability, release, etc.
• Identifying functionality related characteristics and setting product specific (in house) specifications
• Implementing a Quality by Design approach
• Manufacturing process or site changes
• • • •
Feel free to get in touch with our experts to see how we can help you in making your products safe, robust and stable.
Be in control of your product!
VARIABILITY OF EXCIPIENTS: Xylose in microcrystalline cellulose
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.
Furfural is a degradation product of pentoses like xylose and often found to unfavorably affect the stability of medicines.Download full article HERE