Fumed silica has become one of the most important and frequently used pharmaceutical excipients in the drug industry so AEROSIL R 972, Degussa's new excipient, is the latest in a range of the company's products that seek to enhance the manufacturing as well as properties of various dosage forms.
The surface treatment applied to AEROSIL R 972 Pharma greatly reduces agglomeration and self-adhesion, allowing for easier and more efficient incorporation, even under gentle mixing conditions.
Due to its improved dispersion and hydrophobic treatment, the excipient delivers superior flow properties to the precursor powders used to make tablets and fill capsules.
It can also be used to thicken pharmaceutical oils to gels, keeping insoluble active ingredients well suspended and adjusting their release behaviour.
The excipient is a fine white amorphous powder that is made up of highly pure colloidal silicon dioxide that is post-treated to bind methyl groups to the surface via stable siloxane bonds.
AEROSIL R 972 Pharma complies to European Pharmacopoeia (EP) monongraph [2208] for hydrophobic colloidal anhydrous silica that was published in Supplement 5.5 of the EP in January 2006 and that has been implemented as of July 1, 2006.
With the approval of the EP monograph listing now complete, Degussa has submitted an application for approval by the United States Pharmacopoeia / National Formulary.
No animal or vegetable raw materials or solvents are used to manufacture AEROSIL R 972 Pharma, made exclusively by chemical synthesis.
AEROSIL R 972 Pharma supplied in multiple layer 10kg bags and should be used within two years after production.