CONTINUOUS MELT GRANULATION FOR TASTE-MASKING OF ACTIVE PHARMACEUTICAL INGREDIENTS
|Melt granulation is a versatile process that is underutilized in the pharmaceutical industry. Most pharmaceutical wet granulation and twin-screw extruders can be adapted for melt granulation. Twin-screw melt granulation (TSMG) is of interest since is a continuous process and allows for flexible process design and a high degree of control. TSMG can be used to produce formulations for oral immediate or sustained release. This research focuses on the use of TSMG to taste-mask APIs. Many APIs are bitter or unpleasant tasting. Taste-masking may be required, particularly for products intended for pediatric patients. Taste-masking has been achieved with many different techniques, but a simple, cost-effective method that can be applied to many different APIs is not currently available. A matrix encapsulation approach using continuous twin-screw melt granulation was attempted with three different APIs. The resulting granule properties, particularly particle size, are related to the granulation process parameters. Prediction of taste-masking based on in vitro assessments is challenging and generally clinical evaluation is required. A small-volume dissolution method was developed as a screening test the melt granules. It is not clear if this technique is predictive of clinical taste-masking performance, but it is expected to be an improvement over discrete sampling or typical quality control dissolution methods. The dissolution rate was estimated using the Noyes-Whitney equation and correlated to the mean granule particle size. From this, a simple model for time to a taste threshold could be used to define a design space around the granulation process.
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|CONTINUOUS MELT GRANULATION FOR TASTE-MASKING OF ACTIVE PHARMACEUTICAL INGREDIENTS
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