Formulation and Delivery
Zafar Iqbal, PhD, RPh, MBA
V.P. /Head of Pharmaceutical Development
Glatt Air Techniques, Inc. - Ramsey, NJ
Ramsey, New Jersey
Description: Amorphous solid dispersion (ASD) is one of the most frequently explored approaches in enhancing the solubility of poorly soluble drug substances formulated in solid pharmaceutical dosage forms as ASD retains its saturation in the gastrointestinal tract (GIT) and thus improves bioavailability.
Spray drying (SD), and hot-melt extrusion (HME) are among the most preferred options in pharmaceutical development of ASDs.
However, SD and HME has some limitations leading to production of low-density ASD powder which have poor flowability, further require an additional process step to densify the powder to improve its flowability.
FB process formulates ASD in free-flowing granules ready to be tableted or encapsulated or can be formulated directly into drug layered multi-particulate dosage forms (pellets) for both immediate (IR), extended (ER) or modified release (MR) for single as well as multi-drug combinations to achieve the desired dissolution and bioavailability.