Super Refined™ Excipients
One of the main challenges in the pharmaceutical industry is the ability to produce stable drug formulations. This is especially demanding as many active pharmaceutical ingredients (APIs) respond unstably to oxidation, moisture or pH. Generally, excipients are the major component of any given drug formulation. In the past, pharmaceutical excipients have been viewed as ‘inert’ ingredients that played an insignificant role in the stability of formulations containing APIs. This view is now changing as pharmaceutical formulators have gained a greater awareness of the importance of excipient purity.
Excipient impurities can accelerate the degradation of the API as well as destabilizing emulsions, causing skin and cellular irritation and promoting gelatin cross-linking in both soft gelatin and hard gelatin capsules.
By chromatographically purifying our polar and non-polar excipients, it has been possible to eliminate many of the impurities that are normally present in pharmaceutical pharmacopoeia grade ingredients. Flash chromatography or ‘Super Refining™’ effectively removes or reduces polar and oxidative impurities, namely: moisture; residual catalyst; peroxide and aldehydes. The chromatographic process does not alter the chemical structure of the excipient in any way. The removal of polar impurities helps to reduce API interaction, maintaining both the stability of the drug and the finished formulation.