Abstract
Hot melt extrusion and prilling are gaining importance as solvent free and continuous techniques in the production of solid oral dosage forms with added value, by incorporating active compound in a molten carrier which is further solidified to form solid dispersion. This article reviews these two techniques in terms of understanding process basics, equipment characteristics, required properties of processed materials and application of the processes for development of solid oral dosage forms. Studies revealed that both hot-melt extrusion and prilling are regarded as simple, robust and continuous methods for processing different types of materials and production of solid dosage forms based on solid matrices. However, understanding of their concepts and requirements together with careful material selection is crucial for stable material processing and obtaining stable products of high-quality. Hot-melt extrusion proved to be a suitable method for production of modified release dosage forms, taste masked dosage forms and dosage forms offering improved drug dissolution rate and solubility. Prilling till now has been successfully applied just in the production of multiple unit drug delivery systems for immediate and sustained drug delivery. Further studies on product development and process understanding are required for full implementation of prilling in the pharmaceutical field.
Highlights
Contemporary pharmacy is facing many challenges, which demand increased investments in new ideas in terms of establishing new drug delivery platforms and implementation of new technologies coping with the principles of quality by design (QbD) and process analytical technology (PAT) (Qui et al, 2009)
This study showed that the incorporation of 1-10% PEG 10000 in a mixture containing metoprolol tartrate (MPT) and behenic acid affected the sustained release properties of the matrices, whereby the dissolution rate increased using a higher PEG content
Implementation of novel innovative technologies in the pharmaceutical field is essential in order to obtain medicines with added value and in terms of coping with the trends of continuous manufacturing based on PAT and Design space
Summary
Contemporary pharmacy is facing many challenges, which demand increased investments in new ideas in terms of establishing new drug delivery platforms and implementation of new technologies coping with the principles of quality by design (QbD) and process analytical technology (PAT) (Qui et al, 2009). By understanding and transferring this process from the plastic industry to the pharmaceutical field hot melt extrusion was successfully applied in the development of solid dosage forms, which offer improved drug dissolution rate and solubility, modified drug release or taste masking. This technique is increasingly implemented in the academic environment and in the industrial field (Repka et al, 2012). The aim of this article is to review hot-melt extrusion and prilling as contemporary modalities in the production of solid oral dosage forms. The aim is to reveal the multiple possibilities that these techniques offer, together with all the advantages and disadvantages that are introduced with their use
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