Laboratory extruder RES-2PM 2x20 mm-Pharma

Laboratory modular extruders for extruding new pharmaceutical products RES-2PN 2x20mm-Pharma

Laboratory pharmaceutical extruders are small versions of production extruders. However, there are many differences between laboratory and production extruders. Laboratory extruders are more extensively equipped with functions that allow testing many materials, which makes them very versatile devices. They have functionalities that facilitate and accelerate the research process. Laboratory pharmaceutical extruders are equipped with a rich set of precise measuring sensors .

• Lab extruders are ideal for short delivery and response times for low volume batches or pilot trials. They can be tailored to suit all applications.

• They are designed to enable the efficient development of new products and the testing of new extrusion processes can be critical for a manufacturing company or research laboratoriesLaboratory extruders can be used to reduce the time to market of new pharmaceutical products.

• Pharmaceutical extrusion laboratory extruders can test active drugs (APIs) Different formulations can be tested to find out how they behave during extrusion The amount of extruded samples is usually sufficient to be easily made for testing and evaluation of a newly developed product.

• Continuous research and development ensure continuous improvement and optimization of final products. Final products require quality control. This is most easily done on a laboratory scale.

• Universal laboratory extruders designed for small batches of product, with the possibility of a quick change of the research process, can be effectively used in the training process. They allow you to effectively use time and maximize the effectiveness of training.Laboratory extruders are ideal devices for practical acquisition of new knowledge and experience.

Construction elements of the pharmaceutical extruder:

• Feeding tank (gravimetric or volumetric feeding).

• Extruder cylinder with precise temperature control (heating and/or cooling).

• Die forming the extruded product (different die configurations available).

Additional equipment of the pharmaceutical extruder:

• Process analysis technology - saves all measurement data.

• Vacuum pumps for degassing the plasticizing system of the extruder.

• Pumps for feeding fluids into the extruder barrel.

• Pharmaceutical granulators for cutting extruded material.

• Calendering rollers for forming tapes or films.

• Cooling tubs.

• Gravimetric feeders.

• Side dispensers.

The pharmaceutical extruder provides measurement and monitoring of the following parameters in the extrusion process using standard instrumentation:

• Melt pressure

• Melt temperature

• Axial force acting on the screws

• Temperature of the extruder barrel zones

• Torque of the extruder screws

• Electricity consumption

• Die temperature

• Rotational speed of the extruder screws

• Ambient temperature

• Ambient relative humidity

• Vent vacuum level (if applicable)

By monitoring these parameters, it is possible to effectively conduct research on the extrusion process. The condition must be met that the measurements made are reliable and the operation of the regulators is reliable and repeatable. In this way, the research process can be maintained and optimized and can be characterized by important aspects. Extrusion system parameters, such as specific energy, can be determined by these parameters.
The extruder instrumentation mentioned above allows the operator to control the extruder in an optimal way. Some critical quality attributes can be combined using the parameters of the extrusion system with values monitored by the extruder instrumentation. It is important that changes in the operating parameters of the extruder are reliable.
Zamak Mercator lab extruders are modular in design to facilitate configuration changes. In particular, the configuration of the extruder screws has a significant impact on the extrusion process and can be designed to achieve high or low shear.

Parameters defining the screws of the pharmaceutical extruder:

(Di) is the internal diameter of the extruder screw and (D0) is the diameter of the extruder barrel The ratio D0/D is very important and indicates the available free volume of the extruder screws The length of the extruder barrel is given as a multiple of the diameter of the extruder barrel [Do] This means that an extruder of length 40 L/D has a length equal to 40 times the outer diameter of the extruder screws. For scaling purposes, it is important to keep the functional length and D0/D ratio constant.

Advantages of pharmaceutical hot extrusion [HME].In the pharmaceutical industry, hot melt extrusion has been used for a variety of purposes, such as:

• Increasing the rate of dissolution and bioavailability of the drug

• Controlling or modifying drug release

• Masking the taste of the product

• Stabilizing the interface of the active substance API

• Parenteral storage and topical drug delivery systems

• Modification or addition of a functional group

• Controlled degradation and cross-linking of polymers to produce a product with a controlled molecular weight distribution

• Reactive blending which involves the extrusion of two or more compatible polymer blends leading to the formation of a polymer-polymer complex

Increasing the dissolution rate and bioavailability of APIs that are poorly soluble in water are important challenges in the development of dosage forms. One approach is to form a solid dispersion solution of the drug with hydrophilic excipients. thermodynamic barrier to dissolution Once formulated, hot extrusion is a reliable and robust process offering cost-effectiveness advantagesCompared to other solid solution manufacturing processes, the extrusion process is much less complex The production of such dosage forms requires only a few steps and avoids the use of organic solvents.

Hot extrusion also has advantages over solid solution/dispersion forming methods using solvent methods:

• There is no need to handle flammable solvents

• No residual solvents

• Possibility of continuous processing

• Fewer process steps

• High product density

• Non-dusty granules

• Pharmaceutical extrusion equipment takes up little space

• The extrusion process does not require water

In addition to oral medicinal preparations, the hot extrusion technique can be used to produce parenteral depots such as implants and stents, and topical delivery systems such as dermal or transdermal patches. For these applications, the extrusion process is often combined with a shaping or injection molding step.

A look into the future of HME pharmaceutical hot extrusion.

The value of 'continuous processing' in the pharmaceutical industry is recognized Hot extrusion (HME) is a manufacturing process widely used in the plastics industry and has considerable potential as a continuous pharmaceutical process.

New chemical entities that exhibit poor bioavailability due to solubility problems are prime candidates for hot extrusion. This technology can be used to disperse such drugs in a given matrix at the molecular level by forming a solid solution. Combined with the use of dispersed, amorphous and molecularly dissolved systems, it can be apply a range of other formulation techniques using a melt extrusion approach. HME has also been shown to provide many different advantages in the production of thin films for both drug delivery and wound care. Hot extrusion technologies can offer numerous advantages over traditional methods. Shorter and more efficient lead times to the final product.Environmental benefits of eliminating solvents in processing (including recyclability) Increased drug delivery efficiency to the patient makes hot extrusion an exciting challenge for pharmaceutical scientists.

A wide range of dosage forms and applications from oral to topical can be prepared Solid dispersions or solid dissolutions of drug embedded in carrier matrices can allow for sustained release and improved dissolution rates A wide range of functional excipients are available Potential drug and matrix degradation may be hampered by high process temperatures and shear forces. However, these challenges can be overcome through formulation and equipment design and engineering approaches. Selection of low melt media or use of compatible plasticizers can reduce

Zamak Mercator is a manufacturer of pharmaceutical twin-screw extruders with screw diameters of 2 x 12 mm and 2 x 16 mm.
Pharmaceutical research twin-screw extruders designed for larger tasks [applications] with screw diameters: 2 x 20 mm and 2 x 24 mm.

• The extruders can work as co-rotating and, after changing the operating mode, as counter-rotating with the L/D range up to 48, with a modular and non-modular structure.

• The key factor determining the quality and credibility of research on the pharmaceutical extrusion process is the control and reliable measurement of the melt temperature in each zone of the extruder.

• The cylinder of the pharmaceutical extruder is divided along the longitudinal axis in order to obtain the possibility of optical control of the process of plasticizing and mixing the melt.

• The extruder cylinder is equipped with ports for side feeders and ports in the top of the cylinder for dispensing liquids or gases. The heaters are arranged so that the heat is evenly distributed in each heating and cooling zone of the pharmaceutical extruder cylinder.

• The temperature measuring sensors are arranged in such a way as to ensure reliable temperature measurement and limit measurement interference from heaters operating at a higher temperature than the plasticizing system.

• In order to avoid uncontrolled temperature rises, each zone of the cylinder is equipped with an efficient and fast cooling system that cooperates with the heating system of the pharmaceutical extruder cylinder.

• Precise temperature control of the plasticizing system of the extruder is ensured by a multi-zone temperature controller designed by our company.

• The temperature control system has the ability to calibrate and shape the heating and cooling characteristics of the plasticizing system by the researcher.

• We have designed cylinders with exchangeable inserts constituting the working surface of the extruder cylinder. In practice, this means that we can adapt the extruder to work with other materials in a short time by replacing the cylinder inserts. Interchangeable inserts allow for quick and relatively cheap regeneration of the plasticizing system. In principle, inserts can be made of any material and technology that is suitable for this purpose. A set of screws is easy to replace with another. You can conduct research on virtually all materials in the medical and pharmaceutical industries.

• The Vertex II geared extruders replace two extruders, expanding your research capabilities.Our extruders are equipped with torque dividing gears that can work as co-rotating and counter-rotating, the direction of rotation is changed automatically from the operator's panel.

• Zamak Mercator research extruders can be equipped with a precise tensometric measurement of the force acting on the screws lengthwise, this mechanism additionally extends the possibilities of conducting research.

• The Vertex II geared extruders replace two extruders, expanding your research capabilities. Our extruders are equipped with torque dividing gears that can work as co-rotating and counter-rotating, the direction of rotation is changed automatically from the operator's panel.

Drive modules for laboratory extruders.

Drive modules, Extruder Blue Power contain the main drive of extruders and other devices with a maximum power of up to 26.4 KW and a torque of up to 1100 Nm, a cooling system for hoppers, a degassing system and a complete digital control system for attached devices, which it recognizes and configures automatically.

Drive Modules are the basic element of the system of research equipment for the plastics and rubber processing industry, manufactured by ZAMAK MERCATOR. In cooperation with executive modules, they allow for the mapping of industrial processes in laboratory conditions.

• Main drive
  The source of the module's power are modern AC motors made in 120 Hz technology in the power range up to 22 KW and 87 Hz in the range of higher power. the motors are practically maintenance-free and the costs of their use are lowFrequency converter [inverter] is an important element of the driveThe inverter allows you to control the rotational speed and torqueWe use inverters from reputable manufacturersThe optional module for measuring the consumed energy and controlling its quality allows you to control the costs and quality of the consumed energy on an ongoing basis, which increases research opportunities.

• Precision torque converter.
  The applied strain gauge torque transducer allows for continuous measurement, it is useful in the process of conducting research on polymer extrusion.

• Extruder feed cooling system
  It ensures that the feed temperature of the attached extruders is maintained at a sufficiently low temperature. Due to the use of an efficient cooler and pump, it enables cooling of other devices in the line or e.g. crushers. The cooler is supported by an efficient fan with automatically adjustable rotational speed.

• Controlling attached devices
  All testing devices in the line are controlled from a colourful, user-friendly, touch-screen operator panel All set and measured parameters [temperature in working zones, engine speed, pressure in zones and heads, torques, forces, electrical network parameters and many others ] are displayed on one control panel and can be saved to an external USB drive.

• Vacuum degassing system
  The modules can be equipped with a degassing system, one or two vacuum pumps can be used. Degassing takes place through ports in the upper part of the cylinder.Vacuum at the level of 150 mbar, allowing the removal of volatile components generated during polymer processing processes. The system is equipped with a replaceable filter.

• Modular connector
  The drive is equipped with a connector that allows you to easily connect mechanically and electrically cooperating devices. The connection transmits torque, power supply, all control and measurement signals, including Ethernet Power Link and Open Safety bus signals. After connecting the devices, the mechanism is mechanically secured before disconnection Smaller and lighter equipment [single screw extruders, crushers] can be attached directly to the module. The mechanism is easy to operate.

• Digital control system
  Because we cannot imagine research and production processes without their automation, our automation and electrical department, based on many years of experience, has developed software to manage extruders and entire research lines. Our software allows you to steer, control and manage extrusion processes.
  Continuous control of extrusion parameters such as: pressure, temperature, revolutions, torque, force, energy consumption allow you to have control over the process and device. You can add to this the ability to save parameters to the database for later analysis and archiving, displaying graphs on-line and working in the plant and even global networkThanks to our software, we can conduct research and transmit the process and video image via Ethernet to any place with computers, tablets, etc.
  Our software can be adapted to the expectations of our customers. The process can be controlled from the touch screen on the device console or in the Ethernet network.
  To implement our solutions in the field of automation and drives, we use our own programs and devices from Bernecker + Rainer Industrie Elektronik GmbH and Lenze Drives GmbH, we also cooperate with many other renowned companies. It is possible to integrate our devices with control systems of devices from other manufacturers