An Evaluation of Wet Granulation Process Selection for API Prone to Polymorphic Form Conversion in the Presence of Moisture and Heat.

Purpose: Wet granulation (WG) is one of the most versatile processes to improve blend properties for processing. However, due to its need for moisture and heat, it is often considered not amenable to active pharmaceutical ingredients (APIs) prone to forming hydrates. Despite this claim, little literature exists evaluating the extent to which polymorphic form conversions occur for such API when processed with WG.

Continuous Feeding and Blending Demonstration with Co-Processed Drug Substance.

Continuous direct compression (CDC) of solid oral dosage forms requires materials exhibiting acceptable flow and compression properties. The desired active pharmaceutical ingredient (API) powder properties can be difficult to achieve through conventional particle engineering approaches, such as particle size and habit modification during crystallization. Co-processing of API with excipients can significantly improve the powder properties to overcome these difficulties.

Is a distinctive single Tg a reliable indicator for the homogeneity of amorphous solid dispersion?

For an amorphous drug-polymer solid dispersion, a distinctive single T(g) intermediate of the two T(g) values of the two components has been widely considered as an indication of the mixing uniformity, which is critical for the stability of the amorphous drug against crystallization. In this study, two batches of amorphous solid dispersions consisting of BMS-A, a poorly water-soluble drug, and PVP-VA, were made by a twin-screw hot-melt extruder using different processing conditions. Both batches displayed an identical distinctive single T(g) that is consistent with the prediction of Fox equation assuming homogeneous mixing of the two components.

Identification of critical process variables for coating actives onto tablets via statistically designed experiments.

The objective of this work was to identify, using a statistical experimental design, the critical processing variables that affect content uniformity and loading of active agent coated on tablets in a 24" Accela-Cota. United States Pharmacopeia (USP) specifies that the % relative standard deviation (RSD) of drug content within a batch should be less than 6%. A Plackett-Burman experimental design was used to identify the process variables that influence the content uniformity and loading efficiency of the drug in the aqueous-based film coat of the tablets.