hot melt extrusion technology twin screw granulator

about the extruder

Xinda Hot Melt Extruder : Clamshell Barrel

Hot-melt extrusion is a proven manufacturing process that complies with FDA Process Analytical Technology (PAT) goals for designing, analyzing and controlling manufacturing process programs.

This technology can be used to produce granules, pellets, immediate-release tablets, controlled-release tablets, and Pellicle. At present, many drugs have been approved for marketing in foreign countries using HME technology

hot melt extruder video

 split barrel design easy to disassemble and clean

Multi-stage temperature
control system

Modular screw
combination mechanism

Comply with GMP, FDA, EU and other industry regulations

Customized Software complies with 21 CFR Part 11 standards

Statistics show that 40% of the drugs sold globally are poorly soluble drugs, and the proportion of poorly soluble drugs among the drugs under research is as high as 90%. Solubility has become a key factor affecting the development and application of such drugs. With the upgrading of the industry and the advancement of production technology, the “serial production” method may be gradually replaced by the “continuous production”. Have her cake, and eat it, too — a technology that can not only improve the solubility of poorly soluble drugs but also realize continuous production mode – hot melt extrusion technology, has emerged.

Various models and sizes of accessories are available

Feeder

Volumetric feeder/Gravimetric feeder/Forced volumetric feeder

Conveyor belt

water cooling/air cooling laboratory/production

 

Cutter

Compact size customized to meet different granulation requirements

Model PSHJ-11 PSHJ-16 PSHJ-20 PSHJ-35 PSHJ-50
Capacity(kg/h) 0.02~2 0.02-5 2-10 5-20 40-150
Screw diameter(mm) 11 16 21.7 35 50
Length/Diameter(L/D) 30~40 30~42 30~42 30~42 30~42
Maximum
Screw Speed(rpm)
1000 600 600 600 600
Single shaft Output Torque(Nm) 7 16 32~43 147~294 438~875
Total Power(kw) 1.5 2 4~5.5 18.5~37 55~110
Power Supply 380/50HZ
Three-phase five-wire
380/50HZ
Three-phase five-wire
380/50HZ
Three-phase five-wire
380/50HZ
Three-phase five-wire
380/50HZ
Three-phase five-wire
Total Weight(≈kg) 200 ≈300 ≈800 ≈900 ≈1200

Product Quality Index

Energy Generation

pharma extruder product

Working Principle

Hot-melt extrusion is a technology that mixes drugs and polymers and other excipients in a molten state, and extrudes them at a certain pressure, speed, and shape to form products.

After the powder raw materials and auxiliary materials are fully mixed, they are evenly transported to the feed port through the feeding system, and then the API and drug carrier are evenly transported to the temperature-controlled barrel by the twin screw. The barrel is equipped with threaded elements, which perform different unit operations from the feeding position to the die head in sequence. The material moves forward under the conveying action of the threaded elements and melts or softens in the melting section. The melt is evenly mixed under the action of the mixing elements and finally extruded from the die at a certain pressure, speed and shape.

Feeding

 Feed the API and polymer into extruder

Melting

Under the mechanical force of the extruder and the heating of the barrel, the material melts or softens in a certain temperature range

Mix

Through the action of strong shearing and mixing by the screw, the multi-phase material undergoes symmetrical exchange and infiltration during the period, and finally it is highly uniformly dispersed in a single-phase

Devolatilization

 Remove moisture or other solvents from the material

Extrusion

 Through screw conveying and pressurization, and further mixing at the same time, the final material is smoothly extruded through the die. According to the requirements of the dosage form, the shape of the extrudate can be changed arbitrarily through the die

Processing after extrusion

After the material is extruded from the extruder, it can be cooled and shaped by air cooling, water cooling, cooling rolls, etc., and finally crushed, pelletized, or rolled according to requirements

Equipment

There are two main types of hot melt extrusion equipment, plunger type and screw type. Plunger extruders are gradually eliminated due to their weak mixing ability. Screw extruders are divided into single-screw, twin-screw and multi-screw. At present, single-screw and twin-screw extruders are most widely used in the formulation field.

The single-screw extruder is an integral structure, which consists of cooling hopper area, solid conveying area, melting area, and melt conveying area. The twin-screw extruder is a combined structure, which consists of five parts: solid conveying zone, melting zone, mixing zone, exhaust zone and melt conveying zone.

Advantages

Hot-melt extrusion technology provides sufficient mixing and shearing. The shearing force comes from the meshing elements, and the drug can be highly mixed and uniformly dispersed in the carrier material. The dissolution rate of the drug is greatly improved, and a highly mixed and uniformly dispersed shaped product can be obtained, which can also improve the release of the drug in vivo. In order to meet the needs of different compounds and preparations, hot melt extrusion technology has many advantages:

> Use a twin-screw feeder to ensure uniform and stable feeding;

> Use segmented electric heating to ensure uniform and stable heating without temperature contamination;

> Combined twin-screw design allows you to freely select thread elements and thread lengths according to material characteristics;

> The extrusion die aperture can be selected with different apertures and different shapes of die heads according to needs;

> Cooling and crushing devices of different structures can be configured according to different material characteristics;

> Quick design, simple installation and disassembly, easy to clean;

> Customized services can be provided according to customer needs;

> Comply with industry regulations such as GMP, FDA, and EU;

> High-quality DQ, IQ, and OQ verification document system.

Application

Hot-melt extrusion is a validated manufacturing process that meets the FDA’s Process Analytical Technology (PAT) goals for designing, analyzing, and controlling manufacturing process programs. This technology can be used to prepare granules, pellets, immediate-release tablets, controlled-release tablets and films, etc. At present, many drugs have been approved for marketing in foreign countries using HME technology.

  Everolimus Tablets
  Lynparza
  Nirvadipine
  Sporanox
  Tacrolimus
  Zithromax
  Vlekira Pak
  Isoptin

  Nimodipine
  Fenoglide
  Ibuprofen
  Clotrimazole
  Eucreas
  Belsonara
  Palladone
  Zoladex

  Kaletra
  Norvir
  Cesamet
  Fenoglide
  Onmel
  Ozurdex
  NuvaRing
  Opana ER

Latest Articles

hot melt extrusion process

Hot Melt Extrusion Process Now has be Used In the Pharmaceuticals Industry

June 28th, 2024

The hot melt extrusion process is a versatile technology, originally used for polymers, now essential in pharmaceuticals.

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Xinda participated in the 2024 ACHEMA with 11mm hot melt exruder

June 07th, 2024

The 2024 ACHEMA With manufacturers and service providers from over 50 countries presenting their chemical and pharmaceutical products.

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Learning from pharmaceutical blenders: some neglected twin-screw extrusion process

May 17th, 2024

This article explores integrating the twin-screw extrusion process into pharmaceutical manufacturing, emphasizing TSE’s efficiency.

Exhibition

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