Shanghai chooshin industrial CO.,Ltd
Hot Melt extrution/HME

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medical Production type hot melt extruder


HME is regarded as a technology to improve the solubility and bioavailability of insoluble API, and has a broad prospect.

When twin screw extruders are used, these challenging APIs can be dispersed in polymer carriers to

enhance their efficacy, making HME an effective technology in the pharmaceutical industry.

HME can be used to dissolve new prospective active ingredients that cannot be dissolved in other ways. The resulting polymer melt is suitable for directly forming tablets, spheres, implants, powders, films or patches.


Due to the high viscosity of extrudates, HME has been used to make various solid dosage forms in the past 25 years, such as:

*Controlled release drug

*Transdermal API patch

*Coextrusions and implants

*Flavor masking dosage form

*Fixed dose compound

*Curb abuse of dosage forms


Twin screw granulator - conversion to continuous production forming



Tablets account for more than half of the oral preparations widely used at present. In the process of tablet production, the agglomeration of powder formula is a very important step. The twin-screw extruder can apply shear force to the powder formulation and disperse the binder liquid to form the appropriate cohesion required for tablet pressing. The combined screw design can be used to produce particles with various expected particle sizes and characteristics.


With our extensive extrusion granulation and HME expertise, we can help you seamlessly integrate upstream (e.g. feeding device) and downstream (e.g. dryer, coating, molding) of equipment to build a complete and continuous production process from powder to tablet.


We have launched 8mm, 10mm, 16mm, 20mm, 30mm, 35mm, 50mm, 70mm90mm hot melt extruders to effectively develop drugs. The minimum amount of samples required each time is about 20g, and the maximum output can reach 1000kg/h.



characteristic:

1. comply with GMP standards: all parts in contact with materials are made of imported stainless steel

2. high flexibility: the thread elements of the extruder adopt a building block structure, which can be flexibly combined according to the process needs of HME

3. online data monitoring: advanced PLC system is used to online monitor data, meeting pat requirements

4. the integral cylinder is convenient for cleaning and material observation


Description of technical parameters

1. main technical parameters:

Screw diameter: 30mm, 35mm, 50mm, 70mm, 90mm

Length diameter ratio (l/d): 40:1, customizable

Screw speed: 300-1000rpm

Main motor power: 1.1kw

Bearing capacity coefficient of gearbox: above 8

Temperature control range: room temperature -300, customizable


2. structure diagram of core components

Split cylinder is adopted to meet rapid cleaning and disassembly

Customize various weighing and feeding systems to accurately and accurately measure and feed powder solids and liquids


The pharmaceutical twin-screw extruder is flexible in design.

You can choose to use different functional modules and plug ins to design and produce different

dosage forms, includingBut not limited to:


Powder for tablet pressing.

Transdermal patches or extruded sheets for oral therapy.

Subcutaneous or vaginal implants.

Capsule filled or directly injection molded small tablets.

No matter which dosage form you want to produce, you can customize the preparation process using a series of upstream and downstream accessories of the extruder, as shown in the table below.




Extrusion processenclosure

Upstream: before extrusion

The dried raw materials of HME and granulation process have Shape and flow characteristics.

For these powders Accurate and reproducible metering of particles and tablets and their loading into an extruder are critical to this process.

These key upstream accessories become pat (process analysis technology) tools, which affect the performance of the whole process.

Before extrusion

Dry material feeder

Select solid feeders with different volume and weight, and the feeding screw is consistent with the material characteristics.

The liquid feeding device selects the feeding device based on the high and low viscosity materials varying with temperature according to the specific process needs.


Midstream: during extrusion


Select the model design to make the dosage form expected by the downstream solid dosage form production.


During extrusion

The sheet model was designed to form a film, producing transdermal patches and oral lysis.

The coextrusion model was designed to form the coextrusion of implantable contraceptives and subcutaneous controlled-release preparations.

The extrusion and rounding die is designed to form segments for subsequent rounding.


Downstream:

The treatment of formable hot materials after extrusion is still an important part of manufacturing process. The model design produces various final shapes, such as film agent and coextrusion. The sample can also be shaped for further analysis.


Post extrusion

Cooling shaft

Accurately control the cooling rate, affect the amorphous properties of the drug or control the recrystallization.

Conveyor belt and stretch granulator

Effectively cool the extruded strip and cut it into balls of different sizes for direct use or further processing (such as grinding).



Post extrusion sampling

Direct molding of polymer melts injection molding systems prepare samples for analysis.