Drug Formulation and Manufacturing

Solutions for scale-up and continuous processing

Addressing challenges in pharmaceuticals where API solubility and processing stability, taste-masking, enterics, and specialized dosage forms are critical projects, Thermo Scientific extruders and related analytical instrumentation provide the shortest path from feasibility studies to production in drug formulation and manufacturing.

Compounding and extrusion technologies have been used in manufacturing for centuries and have become a valuable tool in creating novel drug formulations, and in the transition from inefficient batch processing to continuous manufacturing.

Quick links

Featured drug formulation and manufacturing technologies

Hot melt extrusion (HME) is a key technology that can produce alternative drug delivery systems such as subcutaneous, solid implants for controlled-release treatment in ophthamology and cancer (e.g., hormone) as well as extrusion of biocompatible or biodegradable polymer/drug formulations.

HME can be configured to create a fully-automated implant production line with small tolerances in diameter and length. This continuous manufacturing process is an ideal solution, offering high-precision control of implant dimensions, a small footprint for full containment and simple cleaning for aseptic requirements of FDA approved materials.

Rheometry and spectroscopy play important roles in developing and implementing extruder-centered drug formulations. The use of near infrared (NIR) spectroscopy for the analysis of active ingredients in pharmaceutical formulations is well known. The technique is nondestructive, has excellent signal-to-noise ratios and can use fiber optics to take sampling to the process. NIR spectroscopy is an ideal choice to monitor the output of a hot melt extruder. Complementary to NIR in bulk and in-line sampling, Raman spectroscopy adds microscopic imaging to analyze tablet homogeneity and the analysis of co-extrusions.

Hot Melt Extrusion: A Continuous Process for Pharmaceutical Production


ODFs made easy with HME

Orally disintegrating films (ODFs) allow safe, easy and exact dosage of active pharmaceutical ingredients (APIs). They also improve bioavailability of the API and help avoid the first pass effect. Hot-melt extrusion (HME) works well for manufacturing ODFs; it’s well-established, provides reproducible results, and doesn’t require solvents. Produce high-quality ODFs at lab- or production-scale.

Read application note ›

Continuous granulation

Hints to optimize pharma processes via continuous granulation

The switch from batch processing to continuous manufacturing of pharmaceuticals can really pay off with efficiencies and other savings. But how to set up a successful new continuous process - that's a challenge for everyone. We teamed up with Innopharma Technology to help.

Unique Advantages of Process Analytical Technology in Twin-Screw Granulation describes an experiment combining Thermo Scientific Twin-Screw Granulation (TSG) technology and Innopharma Process Analytical Technology (PAT). Read the results to learn which extruder parameters to adjust for the most impact on the continuous granulation process.

Download the application note ›

Improve pharma and biotech manufacturing processes and help ensure patient safety

Save time, improve processes, protect brand integrity, and ensure patient safety, from raw material identification through the pharmaceutical manufacturing process, to finished and packaged pharmaceutical product inspection.

Learn more