Capsugel is uniquely differentiated in having industry-leading expertise in innovative taste and odor masking approaches and enabling technologies that are used to create optimal solutions for our customers’ drug delivery needs. A full range of specialized capsule technologies complements this formulation capability, providing additional taste masking and dosing functionality / flexibility (e.g. sprinkle-capsules).
Taste masking is typically accomplished in one of three ways:
Capsugel uses all three of these approaches depending on the application, but the third method is often the most effective in our experience. During formulation, a risk-based approach is used to select the necessary excipients, evaluating market-accepted materials with established safety data at levels that achieve the desired dosage form performance and stability. The initial quality control metrics are:
Armed with the initial characterization data and the target product profile, the optimal taste masking strategy and dosage form are selected. Multiple approaches (e.g. lipid multiparticulates with functional coatings) may be required. The ultimate goal is to select a formulation that is stable, ideally preservative-free, and amenable to flexible, uniform dosing for a broad range of patient populations.
Capsugel uses a wide range of taste masking and modified release coating technologies, with definition of the optimal approach based on specific API characteristics and the target product profile:
The key to a successful formulation design is a rational technology and dosage form selection process. The perception of taste is dependent on multiple factors, including texture or mouth-feel, odor, taste and after-taste. We evaluate the need for taste masking as a first step. For example, we have found that multiparticulates below 250 microns in diameter typically have good mouth-feel for patients and can therefore facilitate good taste experience. Ideally, taste issues are identified early in clinical development using sensory information that helps determine the compliance risk for patient populations. A thorough characterization of the active ingredients is conducted in an initial screening process.
Capsugel works closely with our customer to identify key components of the target product profile, addressing such issues as:
Armed with this information, Capsugel works with the customer to select the most promising approaches to investigate and develop.
In our experience, we have found that the combination of multiparticulate formulations, functional coatings, and – in many cases – functional capsules serves as a powerful toolbox for meeting target product profiles. This includes taste masking of bitter compounds – especially for specialized patient populations.