Super Refined™ Excipient Taste Data
In many liquid formulations, the strong taste of a pharmaceutical excipient can often negatively impact the final drug product in such a way that can affect patient compliance. Croda’s proprietary chromatographic process known as Super Refining can greatly affect the taste impact of these excipients, thus making them more palatable. This process removes impurities that can contribute to unfavorable taste attributes thus aiding the drug formulator's creation of a final product that the consumer finds more agreeable.
To demonstrate that Super Refining can help minimise the taste impact of excipients, a range of Croda’s excipients were tested by a third party testing company (Sensory Spectrum, Inc.) to quantitatively identify the degree of difference in taste between our Super Refined products and their standard compendial counterparts. A taste panel of extensively trained taste specialists assigned a Degree of Difference to compare the Super Refined products to the controls. The Degree of Difference (DOD) scores ranged from 0-10, with 0 indicating no difference and a 10 indicating an extreme difference. A DOD of 5 or higher indicates that consumers will be able to perceive a difference in taste, while a DOD of 4-5 indicates a consumer might perceive a difference in taste. An example of this DOD designation is shown below.
As seen in the above chart, the DOD between Super Refined Polysorbate 80 and its Polysorbate 80 NF benchmark was assigned as 8. This indicates that through Super Refining, the Super Refined Polysorbate 80 has a consumer perceivable taste difference compared to its compendial grade.
The above graph shows the DOD for the remaining Croda excipients that were tested. The green dashed line represents the level at which consumers might notice a taste difference and the red line represents the level at which consumers will notice a taste difference. As indicated above, all of Croda’s Super Refined excipients exceed the level at which a taste difference is possibly perceivable and 7 of the 8 exceed the level at which a taste difference is definitely perceivable. Overall, this means that the Super Refined products shown above had lower taste impacts than their compendial counterparts. These products will therefore give formulators more flexibility when creating more palatable oral liquid dosage forms that can ultimately promote better patient compliance.