Laboratory extruder RES-2PN 2x16 mm-Pharma

Laboratory extruders for extruding new pharmaceutical products RES-2PN 2x16mm-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. 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 laboratory 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 provided 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.