Opioid misuse is a public health crisis in the United States. In response, the FDA has approved drug products with abuse-deterrent features to reduce the risk of prescription opioid abuse. Abuse-deterrent formulations (ADFs) typically…

Introduction Granulation of powder blends is a commonly applied technique for pharmaceutical formulations which have no suitable flowability or compactability or are inhomogeneous with regards to the API content. Mainly wet granulation is…

ConsiGmaTM-25 is a continuous production plant integrating a twin-screw granulation, fluid bed drying, granule conditioning, and a tableting unit. The particle size distribution (PSD), active pharmaceutical ingredient (API) content, and…

A recently developed process analytical technology (PAT) using artificial intelligence to form the framework of its model, combining frequency-domain acoustic emissions (AE) and elastic impact mechanics to accurately predict complex …

Continuous manufacturing is now considered as a well-established technique by pharmaceutical companies. However, the limited number of filed applications reflects the complexity to translate a science that has been described in many…

Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest from the pharmaceutical industry for its potential for the development of oral dosage forms. The technology has evolved rapidly due to the…

This study demonstrated the first case of combining a novel continuous granulation technique with powder-bed fusion-based selective laser sintering (SLS) process to enhance the dissolution rate and physical properties of a poorly…

Melt granules of DI-CAFOS® A12 and 15% (w/w) Kolliphor® P407 were manufactured in a twin-screw granulator (TSG) at five different conditions (screw speed and throughput varied) and compared to granules manufactured in a high-shear…

Granule structure has a key influence on tablet critical quality attributes. The ability to control this structure through excipient choice is an important part of formulation development. Mannitol is a popular diluent and the choice of…

In current study, it was investigated if the moisture-mediated polymorphic transition from δ- to β-mannitol during twin screw granulation (TSG) also took place in high drug loaded formulations and if the specific granule morphology…