The development of oral drugs presents several challenges, including low solubility, instability of the formulation and ineffective delivery of the IFA. The selection of the correct oral excipient during the initial stage of development is a critical step in achieving the success of the formulation.
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Croda's Super Refined™ technology produces high-purity excipients, which provide several benefits in a formulation for oral drugs. Among these benefits are increased stability of the drug, improved stability in gelatin capsules and less impact of taste, odor and color. As a result, they optimize the bioavailability of the drug and its shelf life, increase patient compliance and reduce the development, decreasing the time to market.
Taste of excipients can be a big problem in oral formulation. Do you do anything to mitigate this?
Super Refined excipients have minimal taste compared to their standard pharmaceutical equivalent grades, resulting in more palatable patient medicines. To demonstrate this, our Super Refined excipients and their standard pharmaceutical equivalent grades were tested by a panel of trained taste specialists (Sensory Spectrum, Inc.) to quantitatively identify the degree of difference in taste. The Degree of Difference (DOD) scores ranged from 0-10, with 0 indicating no difference and 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.
The chart shows that the DOD between Super Refined Polysorbate 80 and its Polysorbate 80 NF benchmark was assigned as 8, indicating that Super Refined Polysorbate 80 has a consumer perceivable taste difference compared to its compendial grade. This has also been shown to be the case with other Super Refined excipients, supporting their use in formulating more palatable oral liquid dosage forms in order to improve patient compliance and outcomes.
Super Refined Oral
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SEDDS and SMEDDS
SEDDS and SMEDDS drug delivery systems are mixtures of oils, surfactants, solvents, and drug substance that rapidly and spontaneously fine oil-in-water emulsions or microemulsions when introduced into aqueous phases under gentle agitation.Learn more
Achieving API solubility is one of the big challenges faced by formulators, with many APIs having low solubility. Our range of Super Refined pharmaceutical solvents can address this challenge, providing a range of polar and non-polar solvents that not only provide solubility, but also excellent stability for APIs.Learn more
Pharmaceutical solubility guide
As API solubility continues to present challenges for the pharmaceutical formulator, Croda has determined the solubility of a range of actives in a number of Croda’s high purity excipients.Learn more