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Working together to deliver your API
- Access specialised technical support to navigate your formulation development challenges
- Broad range of high purity compendial excipients listed by the FDA Inactive Ingredients Guide as suitable for parenteral administration
- Flexibility to develop specialised ingredients and formulation solutions supported by regulatory experience in new monograph development
Croda’s Super Refined products are a range of highly purified pharmaceutical excipients designed to reduce the risk of product degradation, improving the chances of successful formulation development. Super Refined polysorbates, PEGs, and oils add value to parenteral drug formulations by:
Reducing API costs
We have formulated a number of APIs with our Super Refined excipients and found that in many cases a significantly higher percentage of API is retained over time compared to formulation with standard pharmaceutical grade excipients. This decreases the minimum efficient concentration required to produce the desired pharmacological effect over the shelf life of the product, therefore requiring less API per dose.
Improving product safety profiles
The removal of polar impurities reduces API/excipient interactions, thus minimising the presence of potentially problematic API degradation products.
Lengthening product shelf lives
Super Refined excipients have been demonstrated to outperform their standard pharmaceutical equivalents with regard to the stabilisation of certain APIs over significantly longer periods of time and also with regard to the oxidative stability of the excipient itself, which has an effect on the overall stability of the drug formulation.
Improving patient comfort
Through minimising cellular irritation and allergenic reaction potential.
Can our range of vaccine adjuvants support your injectable formulation
Adjuvants can help to reach the same level of immune protection with fewer injections or a lower dose than when vaccinating with the non-adjuvanted antigen alone.