HOT MELT EXTRUSION SYSTEM

For pharmaceutical application

Hot Melt Extrusion[HME] has emerged as a novel processing technology in developing molecular dispersions of Active Pharmaceutical Ingredients[APIs] into various polymer and lipid matrices. Currently, this technology is extensively used in pharmaceutical research and development for solubility enhancement, time controlled, modified, extended and targeted drug delivery.

 

STEER H.M.E.S is a complete system with its core unit ‘Hot Melt Extruder’ having the STEER EPZ products like screw elements & barrels. Appropriate with both up-stream and down-stream components like micro feeder, split and side feeder, refill silo and its associated platform, chill roll unit, chill air conveyor unit, pelletizer and flaker complete the system.  The system is modular, comprehensive and scalable.

 

Pharmaceutical Compounding using Hot Melt Extrusion(HME) involves achieving a homogenous solid dispersion or solution by mixing and/or melting API with one or more excipients such as polymers, lipids, surfactants, diluents, lubricants, glidants, plasticizers and other modifiers for the purpose of stabilization, bioavailability enhancement, controlled release or taste masking and improved delivery especially in oral and trans-dermal systems.

STEER HMES OMICRON 10 [MINI] offers the best platform for Universities and Pharmaceutical Companies doing hard core research on hot melt extrusion on NCE and/or applications requiring high potent API. OMICRON 10 is designed to handle very low volumes. The option of changing process section with four different Do/Di (1.27,1.42,1.55,1.71) ratios to vary the shear rate makes OMICRON 10 the best extruder platform for pharmaceutical research.

STEER HMES OMICRON 12 is an excellent extruder for conducing feasibility/proof of concept studies in pharmaceutical research. With micro feeder and combinational downstream ancillaries, OMICRON 12 is a complete solution for scale up studies for the drug development. OMICRON 12 is well-known to process most of the excipients used in pharma research.

Key features

  • Minimum quantity- 40gm
  • Flexibility of feeding in any zone/liquid injection
  • Module/configurable screw elements
  • Length -42D
  • 8 Heating and cooling zones with vent ports
  • STEER EPZ Products

Advantages

  • Easy cleaning and changeover
  • Low material loss
  • Inline process control
  • Easy scale up
  • Processing of temperature sensitive API

Applications

  • Hot Melt Extrusion formulations
  • Research & Development projects

STEER H.M.E.S OMega 20

FOR PILOT PRODUCTION

STEER HMES OMEGA 20 is the most suitable pilot scale extruder for Scale-up studies, Exhibit/Clinical batches. OMEGA 20 is designed to comply with GMP requirement of automation, contact surface and cleaning.

Key features

  • Pilot scale
  • Conforms to GMP
  • Option of Clam Shell and Segmented Jiffy Clamp Barrel Design
  • Upstream: Split/Side Feeding
  • Downstream: Chill Roll Unit, Cool Air Conveyor, and Pelletizer
  • Liquid/Gas injection
  • Skid mounted
  • Degassing

Applications

  • Exhibition batches
  • Clinical batches
  • Scale-up studies
  • Solid Molecular dispersions
  • Bio-availabiity Enhancement
  • Taste Masking
  • Sustained Release

 

 

 

Advantage

  • Scalablity
  • Process Flexibility
  • Easy Cleaning and dismantling
  • Inline Process Control(PAT)
  • Better mixing capability
  • Shorter residence time
  • Reliable data logging

STEER H.M.E.S OMega 30

FOR COMMERCIAL LARGE SCALE

STEER H.M.E.S OMega 40

FOR COMMERCIAL LARGE SCALE

STEER’s OMEGA PHARMA twin-screw extruder created for pharmaceutical applications is modular in design. The HOT MELT EXTRUSION SYSTEM consists of co-rotating fully wiping twin-screws and clamshell barrel. The key tasks of the extruder are mixing, homogenizing and degassing. Its modular design offers a choice of screw elements which allow altering the configuration of the intake, mixing and metering zones with respect to different applications. Flexibility, continuous operation process capability and higher energy efficiency make the OMEGA PHARMA HOT EXTRUSION SYSTEM the ideal Pharma extruder.

Key features

  • Conforms to GMP standards
  • Clamshell or Segmented Barrel Jiiffy Clamp design for easy cleaning
  • Precise temperature control
  • Custom upstream: Split/Side feeding, Refill Silos, Platforms
  • Application based custom downstream: Chill Roll, Cool Air Conveyor, and Pelletizer
  • Complete Validation support
  • 21 CFR part 11 compliance

 

 

Advantages

  • High throughput
  • Plant engineering support
  • Easy Cleaning and dismantling
  • Inline Process Control(PAT)
  • Better mixing capability
  • Shorter residence time
  • Reliable data logging

 

 

Applications

  • Hot Melt extrusion formulations
  • Solid Molecular dispersions
  • Bio-availability Enhancement
  • Taste Masking
  • Sustained Release