Simplified, High Drug‐Loaded Formulations Containing Hydrochlorothiazide for Twin‐Screw Granulation

Abstract

Simplified, high drug loaded formulations for use in twin-screw granulation and tableting were introduced, using the plastically deforming drug ibuprofen. This concept was enlarged by application of hydrochlorothiazide, because opposed deformation behavior was expected to result in different product performances. In most instances the results differed. Critical quality attributes like granule size distribution, disintegration time, and tensile strength of tablets could be met. The study confirms the suitability of simplified formulation with differently behaving drugs for pharmaceutical product design in continuous manufacturing.

Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

“…Therefore, more research is required in the field of simplified formulations. This concept was originally studied by Meier et al for formulations containing 90% ibuprofen [ 22 ] and was later applied to a high-dosed hydrochlorothiazide formulation [ 106 ]. Recently, Vanhoorne et al demonstrated that delta mannitol could be used as a suitable filler and binder for granulating 75% paracetamol [ 60 ].…”

On-Demand Manufacturing of Direct Compressible Tablets: Can Formulation Be Simplified?

“…Compatibility studies such as screening drug-excipient incompatibilities are routinely required to identify (7). In continuous manufacturing, from a regulatory perspective, each batch of excipients and APIs needs to be tracked to know its contribution to each produced unit (8).…”