Hot-Melt Extrusion as an Advantageous Technology to Obtain Effervescent Drug Products.

ABSTRACT: Here, we assessed the feasibility of hot-melt extrusion (HME) to obtain effervescent drug products for the first time. For this, a combined mixture design was employed using paracetamol as a model drug. Extrudates were obtained under reduced torque (up to 0.3 Nm) at 100 °C to preserve the stability of the effervescent salts. Formulations showed vigorous and rapid effervescent disintegration (<3 min), adequate flow characteristics, and complete solubilization of paracetamol instantly after the effervescent reaction. Formulations containing PVPVA in the concentration range of 15-20% m/m were demonstrated to be sensitive to accelerated aging conditions, undergoing marked microstructural changes, since the capture of water led to the agglomeration and loss of their functional characteristics.

SUBMITTER: Lima AL 

PROVIDER: S-EPMC7464369 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature