About Technology

HOT MELT EXTRUSION

Hot melt extrusion (HME) is a unique technology that enhances bioavailability of poorly soluble Active Pharmaceutical Ingredients (API). Hot Melt Extrusion is increasingly being adopted in the Pharmaceutical industry as more and more drug ingredients, in particular Pharmaceutical APIs, are either poorly soluble or unstable during traditional processing. By dispersing and mixing APIs with thermoplastic binders and/or polymers at the molecular level a solid solution (mono-phase matrix) or solid dispersion (multi-phase matrix)  is formed, thereby enhancing the bioavailability of poorly water-soluble or lipophilic APIs.

Advantages of Hot Melt Extrusion:

• HME is a solvent free process in comparison to spray drying
• High drug loading is possible in comparison to spray drying process
• It is an economical and efficient process that reduces production time as there is shorter material residence time
• The process is scalable with tighter process control
• HME has a smaller footprint compared to conventional systems
• It can be used to overcome solubility limitations, which will improve bioavailability by creating controlled release extrudates.
• Material exposure to the temperature and shear is very low (few seconds) 
• HME is a contained system and hence Low dust formation so safe for handling of high potent drugs
• Possibility of Patent circumventing is possible
• Being continuous system, the process is predictable through in-line or online monitoring
• HME is a scalable process 

TWIN SCREW PROCESSING

Pharmaceutical industry has faced increasing pressure to reduce costs due to the competition raised from generics production also to reduce the batch-to-batch variability. Shifting from batch to continuous manufacturing because of several advantages..

Advantage of Twin Screw Processing

• Reduction in development and processing time
• Reduction in equipment size
• Reduction in manufacturing space
• Reduction in costs
• Reduction in quality control steps
• Reduction of scale-up problems
• Increased control and ability to integrate process analytical tools

Several initiatives are undertaken by regulatory agencies and pharmaceutical companies and accordingly new guidelines by USFDA and ICH have been introduced for Continuous Manufacturing. 

Twin screw based continuous manufacturing has emerged as an alternative to conventional batch process. Twin Screw is used for continuous wet or melt granulation.