Formulation development

For dosage forms to be truly user-friendly, they must be easy to take and pleasant to taste. This means selecting the most appropriate dosage form for a given active pharmaceutical ingredient (API) or nutrient, and also considering the needs and preferences of the intended target (patient) group. It also means drawing on specialist knowledge and technologies to create a formulation that ensures a positive user experience. These are areas where we are truly global experts.

Both taste and mouthfeel are important factors when developing user-friendly oral dosage forms. For example, as many APIs are bitter, sour, sulfuric, astringent or salty, taste masking is often required to make the final product palatable. This is particularly important for user-friendly dosage forms, as they tend to spend more time in the mouth and are tasted more thoroughly than conventional tablets and capsules.

Our formulation experts know how to best mask the unpleasant taste of your API or nutrient. Based on many years of experience, we know which flavors work well together and to which indications they are best suited. For example, lemon flavorings work well for cold and flu remedies, while chocolate flavorings have proven popular among patients suffering from sleep disorders. We also have access to unique flavors, providing you with another avenue to differentiate your products in the marketplace.

At HERMES PHARMA, we use coating technologies to prevent the intense flavor of poor-tasting components coming through in the mouth. Such taste-masking strategies include coating API particles with a physical barrier composed of lipid excipients.

Hot melt coating (HMC) is an advanced coating method that is ideal for the production of orally disintegrating granules (ODGs), for example. HMC is faster than conventional fluid-bed coating and eliminates the need for potentially toxic, flammable and expensive solvents. As HMC allows us to alter the release profile, we also use it for immediate and extended-release formulations.

TOPO granulation is a unique, patented granulation technology that is ideal for improving the stability of effervescent products. Chemically-sensitive APIs and ingredients can be formulated into effervescent products with a long shelf life in this way.

TOPO granulation passivates the surfaces of the effervescent components, reducing their sensitivity to moisture and reactivity under normal, dry conditions (during storage, for example). Furthermore, the process is ideal for downstream blending and compression. For large-volume products, we have further developed TOPO technology into our Continuous Flow (CF) granulation technology. Read more about our patended granulation technologies or watch video:

Working in cooperation with our manufacturing teams, our formulation experts ensure that products can be scaled up and that the manufacturing process is quickly optimized and validated.

Our teams work quickly. We are usually able to create the first formulation samples in a few weeks and the stability of the formulations can be demonstrated by early stress tests. We can handle minute amounts of API and still ensure content uniformity. For example, a cough and cold remedy recently developed for one of our customers contained 5 mg of phenylephrine in a 3,200 mg effervescent tablet – a ratio of 1:640. To ensure equal distribution of the API molecules under such conditions requires specific blending steps and ongoing process monitoring.