Instigator helped a small pharma company develop an effective manufacturing process for an orally dissolvable tablet with strict production requirements.
With a bitter active ingredient, the creation of an orally dissolvable tablet proved to be a challenge for the pharmaceutical company manufacturing it. Additionally, the tablets needed to comply with a strict set of specifications: they needed to disintegrate in 6-10 minutes, contain exclusively natural ingredients, and be compressed to a specific size and shape in order to fit in between a patient’s cheek and gum. To overcome these constraints, the company turned to Instigator to develop a valid and effective tablet manufacturing process.
Our experts headed to the lab to observe the tablets in production. After studying the company’s current process and identifying the problems, our experts used design-of-experiments (DOE) to develop the optimal tablet formulation by co-processing with variable particle size alcohol sugars and varying degrees of pre-gelatinized starch.
Our research and development completed, we developed a scalable formulation and process.
The combination of menthol and spearmint flavor minimized the bitter taste of the active ingredient while optimizing the tablet’s flavor and mouth feel.
Thanks to Instigator’s expertise during the development process, the client was able to launch a validated product that was put on the market.