Pharmaceutical industry begin to use HME for preparation of complex drugs.Compared with traditional batch
process,if adopte hot melt extrusion process ,there will be the following advantages:
*Product consistency is good
*High repeatability of the product
*The whole process can be monitored and recorded online
*Equipment investment and labor cost decrease
HME was first developed by the plastics industry, and its most basic purpose was to compress and mix the powder,converted into uniform density molding products.With the improvement of technical level, HME technology can reduce costs and form highly complex cross section, the importance of HME technology in the pharmaceutical field is improving.Both pharmaceutical and academic circles believe that HME is becoming an innovative drug delivery technology, and more and more attention has been paid to it,HME has now become a highly variable interdisciplinary problem.
The definition of hot melt extrusion is to process a variety of polymeric materials above the glass transition temperature, so that thermoplastic adhesives or polymers, active compounds can be effectively mixed at the molecular level.
HME advantage in pharmaceutical industry:
Active pharmaceutical ingredients (API) are usually mixed with various excipients or carriers to form the final drug product
Hot melt extrusion (HME) is a technique that uses a twin screw extruder to distribute API uniformly in polymer carriers
In twin screw continuous extrusion process, mixing mechanism and unit operation are the same for plastics industry and pharmaceutical industry
FDA encourages the continuous process of multi cell operation (PAT initiative) toincrease solubility of poorly soluble active drugs:
Structure of hot melt extruder:
Hot melt extrusion integrates various processes, including feeding, melting, mixing, reaction, extrusion
What type of screw feeder is customized to control the feeding time and quality, and the drug can be preliminarily crushed and mixed. According to the various application requirements, there are a variety of materials, screw size, motor controllable choice. And the twin screw feeding system which can meet the requirements of GMP is designed.
We can Customized liquid injection systems for drugs in the production process of feeding liquid or viscous fluid material , according to the pharmaceutical process, various types of customized liquid feed pump and tank, accurate weighing that control liquid feed rate, the temperature sensitive material also can be precise controlled and fed
Post treatment of hot melt extrusion：
Brace granulation:
After extrusion and cooling, according to different formulations, the choice is not the same, the most common mode is cooling conveyor belt, air cooling. IF the material allows access to water, can also be used in vertical or horizontal water tank. Cut by the cutter in the end .
Cooling roll
Another cooling method is extruded and the melt passes through the cooling roller. The processing temperature greater more than 100 degrees, in a relatively short period of time can achieve the temperature drop, the temperature of the cooling roller can be individually adjusted, after cooling can be used in primary crushing mill or jet mill. according to the final size requirement of different options.
Micro pelletizing
The melt can be cut into 0.5-3mm. in the molten state can be packed with capsules. The continuous production and particle size can be controlled by double screw extrusion and melt pump control . The dissolution curve can be realized by changing the diameter of the die and the cutter speed.
We can design accordin to customer requirement and the capacity for diffrent scew size:
