Pharma Hot Melt Extrusion-Drug Formulation-Manufacturing

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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.

creating novel drug formulations, and in the transition from inefficient batch processing to continuous manufacturing.

 Featured drug formulation and manufacturing technologies

Hot Melt ExtrusionHot Melt Extrusion

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.

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

Pharmaceutical manufacturers are using conical and twin-screw extruders to mix drug molecules with bioactive polymers in situations where drug ingredients are poorly soluble or unstable during processing. Extruders are also useful in preparing enteric dosages, sustained release dosages, in taste-masking, and to create forms such as films.