QUALITY by DESIGN (QbD)

QbD initiatives rely upon a better understanding of material science and critical to quality attributes of pharmaceutical ingredients.  Innovation in this area yields improved excipient functionality, robust formulations, efficient scale-up, and faster and more flexible NDA registrations.  FMC is poised to assist our customers’ efforts in QbD filings with:  1) specialized samples; 2) production capability data; and 3) highly functional excipients. 

Please contact us directly for more information or support on this topic.

Alternative dose form concepts

Gummies
Gummies is an example of only one of many unique dosage forms which can be developed using FMC's offering of carrageenans and alginates.  Using these materials, a broad range of unique, extremely attractive dosage forms are possible, including carrageenan based gummy chews, caramels, and fruit chews.  

Alginate Foam
The alginate foam concept is a newly patented technology by FMC BioPolymer.  Chemically, the material is a dry, flexible, hydrophilic, and porous matrix that allows high absorbency of liquids.  By adjusting certain processing parameters, we can control rate of absorption as well as tensile properties of the material.  Further, the foam can be formulated as an integral (e.g., long-lasting) or disintegrating matrix.  The open cell structure makes it ideal for incorporation of pharmaceutical actives.  Possible applications include:
Sugar Coating Systems
Sugar-coating delivers a finished-product which is unrivaled in appearance.  However, this formulation technique is both labor intensive and time consuming.  FMC offers an alternative, which achieves the benefits of sugar coating without the problems.  This new patent pending technology replaces the seal coat and build-up coat with LustreClear^TM LC-103 (a microcrystalline cellulose and carrageenan based coating) and LustreSugar, a proprietary combination of microcrystalline cellulose and sucrose. 

New excipient offerings

Avicel^® PH-200 LM is a low-moisture, large particle grade of microcrystalline cellulose.  This new product offering enables an economic processing alternative to wet granulation – Moisture Activated Dry Granulation (or “MADG”). 

Avicel^® HFE-102 is a patented, co-processed mixture of microcrystalline cellulose and mannitol.  This excipient offers a highly functional alternative to traditional MCC grades through: 1) improved flow; 2) accelerated disintegration; 3) better compaction; and 4) less lubricant sensitivity. 

For more information on these new excipients, click here.