Twin screw hot melt extrusion granulator

1Introduction to Hot Melt Extrusion Process

Originally developed by the plastic industry, hot melt extrusion technology is becoming a new type of drug delivery technology, creatively combining processing technology with pharmacy for drug delivery research. This technology can treat polymer materials above their glass transition temperature, promoting effective mixing of thermoplastic adhesives and/or polymers and active ingredients at the molecular level.

Hot melt extrusion technology combines many advantages of solid dispersion technology and mechanical preparation, achieving dust-free, continuous operation, good reproducibility, andhigh-energyThe production efficiency. This technology can not only promote the dissolution of insoluble active ingredients to improve their bioavailability, but also be used to delay the dissolution of water-soluble active ingredients and prepare sustained-release or enteric coated formulations; In addition, it can also be applied to the preparation of taste masking microspheres or other special shaped formulations, such as film agents, stick agents, etc. Due to the short duration of the entire extrusion process and the absence of water or organic solvents, there is no need for heating and drying, making it less prone to hydrolysis and other issues.

IITechnical characteristics of twin-screw hot melt granulator

1. Develop stable solid solutions

1.1.Improve the bioavailability of poorly soluble drugs;

1.2.Reduce the demand for solvents;

2. Novel dosage form

2.1.Production of implantable drug delivery formulations;

2.2.Directly extruding transdermal absorption products;

2.3.Co extruded slow-release products

3. Continuous process

3.1.Steady-state process ---Whether produced on a small or large scale, continuous hot melt extrusion can provide products of consistent quality；

3.2.Using online analysis technology (PAT) to monitor the machining process；

3、 Working principle of hot melt extrusion equipment - twin-screw mixed extrusion

Conveying (feeding)→Mixing (melt mixing)→Squeezing (Exhaust Boosting)

4、 The advantages of twin-screw hot melt extrusion technology

Easy to add materials: It is fed quantitatively by the matching feeder.

Scale up: can be scaled up to specified batch production equipment.

Small inventory: The inventory of products in processing is low.

Open type material barrel: easy to disassemble parts that come into contact with the product, ensuring cleanliness.

Modular design: The screw and barrel adopt modular design, which can be flexibly used for new product development.

Formula storage: Provides reliable and reproducible operating conditions.

Integrated data recording: can accurately record process data used for product review.

5Twin screw hot melt extrusion granulatorParallel twin-screw extruder screw unit

1. Conveyor unit:

• Use an open mesh screw cavity shape:

-In the feeding section

-Used for melt exchange (longitudinal mixing)

-Used as exhaust

• Use a closed mesh screw cavity shape:

-Used to increase pressure

-Placed in the meshing unit

2. Mesh unit:

The meshing unit is used to introduce shear energy into the extruded material

The screw teeth are arranged at different deflection angles and can be used for:

-Plasticization

-Mixed

-Disperse

Twin screw mixing process

The material flows in a horizontal 8-shaped path, continuously transferring from one screw to another through interlocking threads. The function of mixing is to utilize the drag effect between screws and between screws and barrels for compression and extension.

In addition to heating, the energy of molten polymer comes from the mechanical energy driven by the motor to rotate the screw. Rapid melting caused by internal particle friction, as well as high shear experienced during the transition from solid to high viscosity melt.

3. Distributed flow unit:

Distributed flow units are special mixing units used for dispersing small amounts of additives and shear sensitive materials.

The shear energy applied to the polymer is much lower than that of the meshing unit.

Twin screw hot melt extrusion granulatorEquipment parameters for the entire line