Systematic screening of pharmaceutical polymers for hot melt extrusion processing: a comprehensive review
Pharmaceutical research, whether industrial or academic, has attempted to adopt approaches most efficient for the development of innovations.
With the abundance of literature and growth of modern techniques available to minimize the number of trials, research is becoming more systematic by the day. Screening and selection of polymers for a pharmaceutical formulation can be challenging, considering the variety of polymers available and under development. Multiple considerations and experimentations are required to select a polymer to attain the target product profile. In this review, a stepwise discussion of techniques useful to screen and select polymers suitable for hot melt extrusion processing are explored and reported.
First of all, selecting a range of polymers available for certain formulation types, for example, immediate release or modified release. Secondly, the screening of these selected polymers based on their physical and chemical properties as these properties should be in line with the active pharmaceutical ingredients (APIs) and the processing limitations of the equipment.
Finally, selecting polymers using theoretical models such as solubility parameters and Flory Huggins modeling. Utilization of these three steps before proceeding to experimental methods will minimize the use of resources and provide a higher degree of accuracy towards the development of efficient, stable, and consistent products.
See the article on Systematic screening of pharmaceutical polymers for hot melt extrusion
Author links open overlay panelRishiThakkar, RuchiThakkar, AmitPillai, Eman A.Ashour, Michael A.Repka
https://doi.org/10.1016/j.ijpharm.2019.118989
Easy cleaning of hot melt extrusion
More than half of New Chemical Entities (NCEs), which were developed recently, tend to show high crystallinity and poor solubility in water. Solid dispersion is a technique to improve the solubility and bioavailability of these NCEs. Hot-melt extrusion (HME) is one of the main methods to prepare solid dispersions.Enteric Polymers (e.g. AQOAT®, EUDRAGIT®, Kollicoat® etc.), which are widely used as an enteric coating agent, are useful carriers for solid dispersions and applicable for HME. However, these polymers are insoluble in water and usersoften have difficulties cleaning their extruder after processing.A purge compound for hot melt extrusion can terminate difficulties to clean the extruder after processing. There are special water-soluble purge compounds with a micro-cleansing effect available. By using such cleaners the difficulties of screw cleaning after the HME process can be minimized. For example, the HME Cleaner Plus (GMP) offers effective cleaning in pharma quality due to its high cleaning power and low residues.
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