Drug formulation development processes
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.
Drug formulation development methods
Melt extrusion has been used in the plastics and polymers industry for decades. Advances in formulation enable poorly soluble drug molecules to be incorporated into solid dispersions using a polymeric carrier. Hot melt extrusion is an alternative to wet agglomeration, a good carrier for sustained release forms and taste-masked dosages. Extrusion processes can also create films for oral strips or dermal patches in a solvent-free process.
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.
According to the US FDA, the continuous manufacturing process reduces human errors caused by starts and stops during the batch process. Continuous granulation is also safer and more reliable. In a continuous process, ingredients are fed and mixtures sent to downstream production. Extruders have been used in wet granulation processes for many years; twin-screw extruders are now playing a central role in pharmaceutical manufacturing.
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
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.
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.
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.
Lab ideas for people – like yourself– in analytical labs making medicines, directed by topics, ideas and thoughts from your fellow medicine makers. Each month, a new theme addresses challenges and solutions around technology and workflows.