American Elements pharmaceutical production facility in Bluffdale, Utah operates under fully documented GMP standards. It has been fully audited by Bristol Myers Squibb, Pfizer and many other important pharma customers.
Several key pharmaceutical, nutritional and cosmetic additives have been developed by or in cooperation with American Elements. For example, we co-developed a new class of excipient powder now in common use in such drugs as Abilify™.
#21: American Elements Invents New Rapid Dissolve Pharmaceutical Powder for Psychiatric Patients
The Challenge
Formulating new innovations in drugs often requires the development of two separate materials-the performing “Active Ingredient” and the “Excipient” which determines in which region(s) and how quickly the active ingredient will be absorbed in the patient’s body. Bristol Myers Squibb sought a new ultra quick dissolving powder that could easily pack into a pill using existing equipment for its new schizophrenia drug, Abilify™.
The Innovation
To meet this gap in excipient technology, American Elements invented a new class of micronized crystalline powder that both dissolved in the mouth instantly and exhibited excellent packing density. Once approved by BMS, we scaled the process to full scale production at our Murray, Utah facility.
The Result
Bristol Myers Squibb received FDA approval in 2002 for use of Abilify to treat schizophrenia. The drug is now in wide use. The excipient developed by American Elements can now be found in numerous other drugs as well. In 2012, American Elements transferred this technology to the Engineered Materials division of the JM Huber Corporation which markets the powder under the trade name RxCIPIENTS® FM1000.
American Elements Pharmaceuticals & Cosmetics Industry Customers Include:
