Pharmaceutical

Superior quality and purity makes Croda a supplier of choice in the global pharmaceutical market. Our proprietary manufacturing and purification technology yields high quality products that meet the exacting requirements of international pharmacopoeia. Croda offers a complete range of products for topical dosage forms as well as high-purity multi-compendial solvents and surfactants suitable for parenteral, oral, ophthalmic, nasal, vaginal and suppository formulations. Our dedicated R&D teams pioneer new product developments for various therapeutic areas, including high purity lipids and surfactants for enhanced drug delivery.

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.