Enhancing the oral drug delivery through hot melt extrusion techniques

Hot melt extrusion has been developed as a fresh technique for taste masking, in recent years. This method provides many aids as compared to traditional methods like avoiding the use of solvents, continuous manufacturing, ease to scale up, and adaptability to meet the goals of FDA for quality products. This method is useful for various applications like solubility enhancement, abuse deterrence, taste masking, transdermal dosage forms like films, immediate release oral dosage forms. In this work, This technique is explored for its applications using a novel polymer, Kollicoat® Smartseal 100P and its ability to be coupled with FDM 3D printing to manufacture oral solid dosage forms.

In the first chapter, attempt has been made to mask the bitter taste of Theophylline using Kollicoat® Smartseal 100P polymer. In the second chapter, same polymer was evaluated for its ability to enhance the solubility of poorly soluble drug, Efavirenz by forming Amorphous Solid Dispersions. This study proves that Kollicoat® Smartseal 100P could be considered as a potential alternative for taste masking of bitter drugs to improve pediatric patient compliance and for improving solubility and dissolution of poorly soluble drugs via Hot melt extrusion. In the third chapter, this hot melt extrusion technique was coupled with FDM 3d Printing to formulate tablets of Nifedipine Amorphous solid dispersions with increased solubility and dissolution.

This study showed that 3D printing speed, build plate temperature, and design /shape of the printed tablets effect on printability/adhesion of Kollicoat® IR based filaments. Increase in the build plate temperature and printing temperature improves adhesion between the consecutive layers. Moreover, adhesion or printability of the Kollicoat® IR filaments was found to be better with oval shape design as compared to round shape. Addition of Kollidon® VA 64 enhanced the printing properties as well as the dissolution profile. Thus, in this work, Hot melt extrusion was applied successfully to enhance the oral drug delivery.

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Komanduri, Neeraja, “Enhancing the oral drug delivery through hot melt extrusion techniques” (2022). Electronic Theses and Dissertations. 2441. https://egrove.olemiss.edu/etd/2441

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