Control Strategy Considerations for Continuous Manufacturing Using Hot Melt Extrusion

Just found this chapter of the 2nd Edition of "Pharmaceutical Extrusion Technology" which can be of interest in the field of continuous manufacturing.


Hot melt extrusion (HME) is a continuous process operation that has been successfully applied to the manufacture of quality drug products over the last decade [1–4]. 54HME achieves the molecular mixing of active pharmaceutical ingredients (API) and excipients at temperatures above their glass transition temperatures (T g) and/or melting temperatures (T m) [5,6]. The excipients in HME can be broadly classified as matrix carriers, release-modifying agents, fillers, thermal lubricants, stabilizing agents, plasticizers, antioxidants, and miscellaneous additives. Most commonly, the objective of the HME process is to enhance the dissolution profile of poorly water-soluble drugs by converting the formulation components into a single-phase amorphous product with uniform content, size, and shape. Several other applications of HME include taste masking [5,6]; microencapsulation [7]; films [8,9]; abuse deterrence [10,11]; implants for drug delivery via oral [12], transdermal, and transmucosal routes [9]; and nanoparticulate systems [2]. Additionally, HME is a solvent-free process with high throughput, which is an advantage over other processes used to achieve the same products and dosage properties. Several research articles and patents have been reported based on HME technology in pharmaceutical applications [2,13–18]. Some of the commercially available products based on HME (Table 3.1) show how the technology can enable versatility in product design and quality attributes.

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Book Cover of "Pharmaceutical Extrusion Technology"
Chapter of the book: Pharmaceutical Extrusion Technology

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