Continuous & Semi-Continuous Applications

Pharma Extrusion

Solid dosage form manufacture via twin screw extrusion

The application of continuous extrusion via twin screw extruders for pharmaceutical solid dosage form production is growing in popularity as a preferred option to more traditional granulation techniques. Coperion's twin screw extruders offers several advantages including continuous processing with reproducibility and combination of a variety of unit operations within one piece of equipment, i.e. distributive and dispersive mixing, granulating and devolatilization. The production method provides gentle product handling at short residence time and low temperature.

Two methods in which the Coperion ZSK extruder is typically used for solid dosage form production are hot melt extrusion and wet granulation via wet extrusion. Coperion is one of the pioneers in the development of pharmaceutical extrusion. Coperion has references for pharmaceutical extruders in the sizes ZSK 18 to ZSK 70. The excellent mixing behavior and the devolailization possibilities of the co-rotating twin screws make this system particularly suitable for pharmaceutical extrusion.

During hot melt extrusion and wet extrusion powders and liquids must be fed accurately and continuously in order to ensure consistency of formulation, constant throughput, proper order of mixing ingredients and regulated mass transfer. Coperion K-Tron Pharmaceutical Loss-in-weight (LIW) feeders are used in conjunction with extruders in the pharmaceutical industry for both powder and liquid feeding. Typically, feed streams are introduced to the extruder in a “starve-fed” manner, where the rate is set by the feeders and is independent of the extruder screw speed.

Typical raw materials:

  • APIs of various potencies
  • Polymers including polyethylene glycol, polyethylene oxide, hydroxypropylcellulose, ethyl cellulose, hydroxymethyl cellulose (HPMC), polymethylacrylate, polyvinylpyrrolidone, polyvinylacetate, Povidone

Key benefits of pharma extrusion with Coperion technology

  • Coperion’s ZSK extruders and Coperion K-Tron’s pharma feeders are designed specifically for the pharmaceutical industry; all product contact parts are constructed to conform with strict cGMP standards and are standard in 316L stainless steel, designed with ease of cleaning in mind. Only tested, certified materials and FDA approved oils/lubricants are used.
  • ZSK extruders are designed for easy operation and easy access for cleaning and maintenance.
  • Coperion and Coperion K-Tron can provide detailed integrated controls including CFR 21 Part 11 based control platforms to ensure optimal performance and reliability.
  •  Coperion and Coperion K-Tron’s global systems engineering groups can provide complete systems including upstream material delivery, continuous LIW feeding and refill, extrusion and a variety of downstream processes including cooling conveyors and pelletizers/mills.
  • Coperion K-Tron´s P-Series line of pneumatic receivers is designed for cleanability and ease of access, with all materials of construction FDA approved.
  • Coperion K-Tron SFT weighing technology features a resolution of 1:4,000,000 in 80 ms, as well as built in immunity to plant vibration and fluctuations in temperatures.

Typical Areas of Application for Coperion Pharma Extruders

  • Pharmaceutical Hot Melt Extrusion
  • Solvent-free production of solid dispersions or solids solutions of APIs (also BCS class 2 & 4), thus enhancing their bioavailability
  • Hot Melt extrudates as basis for solid dosage forms with controlled / sustained release of APIs
  • Degassing of water to counteract API re-crystallisation
  • Encapsulation and taste masking
  • Wet Extrusion of  APIs as basis for granules for capsule filling
  • Extrusion of adhesives with APIs for transdermal plasters
  • Extrusion of adhesives for medical applications such as stoma
  • Extrusion of compounds for implants/biodegradable implants or contraceptive rings
  • Extrusion of medical plastics (wound plasters/butterfly closures)

Comprehensive product range

Coperion_ZSK_pharma_extruder_667x375px

Pharma extruders

Coperion’s custom designed ZSK extruders are pioneers in production technology for pharmaceutical formulations. Extruders are available in sizes for special applications on a laboratory scale and extend to industrial production systems. ZSK extruders have a modular design for maximum flexibility in product changes and machine modifications. The ZSK units are designed to produce an intensive mixing behavior with optimal blending characteristics and product quality. All pharma ZSK extruders are manufactured in cGMP design, with extensive control platforms.

Pharma Extruders

Feeders

The Coperion K-Tron line of pharmaceutical feeders are specifically designed to ensure the most accurate dispensing of pharmaceutical ingredients and blends to the extrusion process below. Our line of gravimetric screw feeders, liquid loss in weight feeders and vibratory feeders are all suited to handle even the most difficult flowing API’s, polymers and pharmaceutical excipients. All gravimetric feeders include our superior SFT digital weighing technology and state of the art controls for optimal extrusion performance.

Volumetric and gravimetric feeders
Coperion_Pharma_Pelletizer

Pelletizing solutions

Coperion Pelletizing Technology offers suitable pelletizers that are specifically designed for pharmaceutical applications. The systems are characterized by their high level of reliability and product quality and have proven themselves many times in practice. Appropriate materials and surfaces are used in order to meet the high requirements of the pharmaceutical industry. Special attention is paid to making the systems easy to access and to clean. Other features, such as pellet length adjustment, can also be realized.

Strand Pelletizers
B_P10-P30_Coperion_K-Tron

Material handling

The Coperion K-Tron line of pneumatic conveyors are ideally suited for the automated refill of LIW feeders in continuous pharmaceutical extrusion systems. A variety of pickup options are available, including from drums, IBCs and supersacks. All systems are completely integrated with Coperion K-Tron’s line of LIW feeders as well as Coperion’s line of ZSK pharmaceutical extruders to provide reliable and optimal performance, with product and process safety in mind.

Process Equipment

Service

Coperion offers a superior global service network to ensure 24-7 support and coverage of your pharma processing line.

Global Service

Solid dosage form manufacture via twin screw extrusion

Pharmaceutical Design Feeders

Play video
Coperion K-Tron pharmaceutical feeders are designed for easy cleaning

Downloads