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Journal articles on the topic 'Hot melt extrusion'

Author: Grafiati

Published: 4 June 2021

Last updated: 11 March 2023

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1

Hengsawas Surasarang, Soraya, Justin M. Keen, Siyuan Huang, Feng Zhang, James W. McGinity, and Robert O. Williams. "Hot melt extrusion versus spray drying: hot melt extrusion degrades albendazole." Drug Development and Industrial Pharmacy 43, no. 5 (October 20, 2016): 797–811. http://dx.doi.org/10.1080/03639045.2016.1220577.

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2

NEUB. "Pharmaceutical Hot Melt Extrusion." Scientia Pharmaceutica 78, no. 3 (2010): 585. http://dx.doi.org/10.3797/scipharm.cespt.8.lppt05.

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3

Enose, Arno A., Priya K. Dasan, H. Sivaramakrishnan, and Sanket M. Shah. "Formulation and Characterization of Solid Dispersion Prepared by Hot Melt Mixing: A Fast Screening Approach for Polymer Selection." Journal of Pharmaceutics 2014 (March 12, 2014): 1–13. http://dx.doi.org/10.1155/2014/105382.

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Solid dispersion is molecular dispersion of drug in a polymer matrix which leads to improved solubility and hence better bioavailability. Solvent evaporation technique was employed to prepare films of different combinations of polymers, plasticizer, and a modal drug sulindac to narrow down on a few polymer-plasticizer-sulindac combinations. The sulindac-polymer-plasticizer combination that was stable with good film forming properties was processed by hot melt mixing, a technique close to hot melt extrusion, to predict its behavior in a hot melt extrusion process. Hot melt mixing is not a substitute to hot melt extrusion but is an aid in predicting the formation of molecularly dispersed form of a given set of drug-polymer-plasticizer combination in a hot melt extrusion process. The formulations were characterized by advanced techniques like optical microscopy, differential scanning calorimetry, hot stage microscopy, dynamic vapor sorption, and X-ray diffraction. Subsequently, the best drug-polymer-plasticizer combination obtained by hot melt mixing was subjected to hot melt extrusion process to validate the usefulness of hot melt mixing as a predictive tool in hot melt extrusion process.

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4

Gottschalk, Tobias, Cihangir Özbay, Tim Feuerbach, and Markus Thommes. "Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion." Pharmaceutics 14, no. 9 (August 23, 2022): 1757. http://dx.doi.org/10.3390/pharmaceutics14091757.

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Even though hot melt extrusion (HME) is a commonly applied process in the pharmaceutical area, determination of the optimal process parameters is demanding. The goal of this study was to find a rational approach for predetermining suitable extrusion parameters, with a focus on material temperature and throughput. A two-step optimization procedure, called scale-independent optimization strategy (SIOS), was applied and developed further, including the use of an autogenic extrusion mode. Three different polymers (Plasdone S-630, Soluplus, and Eudragit EPO) were considered, and different optimal process parameters were assessed. The maximum barrel load was dependent on the polymers’ bulk density and the extruder size. The melt temperature was influenced by the screw speed and the rheological behavior of the polymer. The melt viscosity depended mainly on the screw speed and was self-adjusted in the autogenic extrusion. A new approach, called SIOS 2.0, was suggested for calculating the extrusion process parameters (screw speed, melt temperature and throughput) based on the material data and a few extrusion experiments.

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5

Alshetaili, Abdullah, Saad M. Alshahrani, Bjad K. Almutairy, and Michael A. Repka. "Hot Melt Extrusion Processing Parameters Optimization." Processes 8, no. 11 (November 22, 2020): 1516. http://dx.doi.org/10.3390/pr8111516.

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The aim of this study was to demonstrate the impact of processing parameters of the hot-melt extrusion (HME) on the pharmaceutical formulation properties. Carbamazepine (CBZ) was selected as a model water-insoluble drug. It was incorporated into Soluplus®, which was used as the polymeric carrier, to produce a solid dispersion model system. The following HME-independent parameters were investigated at different levels: extrusion temperature, screw speed and screw configuration. Design of experiment (DOE) concept was applied to find the most significant factor with minimum numbers of experimental runs. A full two-level factorial design was applied to assess the main effects, parameter interactions and total error. The extrudates’ CBZ content and the in vitro dissolution rate were selected as response variables. Material properties, including melting point, glass transition, and thermal stability, and polymorphs changes were used to set the processing range. In addition, the extruder torque and pressure were used to find the simplest DOE model. Each change of the parameter showed a unique pattern of dissolution profile, indicating that processing parameters have an influence on formulation properties. A simple, novel and two-level factorial design was able to evaluate each parameter effect and find the optimized formulation. Screw configuration and extrusion temperature were the most affecting parameters in this study.

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6

Bhairav, Bhushan A., Prajakta A. Kokane, and Ravindra B. Saudagar. "Hot Melt Extrusion Technique-A Review." Research Journal of Science and Technology 8, no. 3 (2016): 155. http://dx.doi.org/10.5958/2349-2988.2016.00022.x.

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7

Andrews, Gavin P., and David S. Jones. "Hot melt extrusion - processing solid solutions?" Journal of Pharmacy and Pharmacology 66, no. 2 (January 17, 2014): 145–47. http://dx.doi.org/10.1111/jphp.12202.

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8

Kothawade, Sagar, Rutuja Wakure, Shubham Biyani, Vijay Thalapally, and Bhagwan Bukya. "Hot Melt Extrusion an Emerging Pharmaceutical Technology." Scholars Academic Journal of Pharmacy 9, no. 6 (June 6, 2020): 175–82. http://dx.doi.org/10.36347/sajp.2020.v09i06.002.

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9

Wilson, Matthew, Marcia A. Williams, David S. Jones, and Gavin P. Andrews. "Hot-melt extrusion technology and pharmaceutical application." Therapeutic Delivery 3, no. 6 (June 2012): 787–97. http://dx.doi.org/10.4155/tde.12.26.

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10

Yeung, Chi-Wah, and Hubert Rein. "Hot-melt extrusion of sugar-starch-pellets." International Journal of Pharmaceutics 493, no. 1-2 (September 2015): 390–403. http://dx.doi.org/10.1016/j.ijpharm.2015.07.079.

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11

Censi, Roberta, Maria Gigliobianco, Cristina Casadidio, and Piera Di Martino. "Hot Melt Extrusion: Highlighting Physicochemical Factors to Be Investigated While Designing and Optimizing a Hot Melt Extrusion Process." Pharmaceutics 10, no. 3 (July 11, 2018): 89. http://dx.doi.org/10.3390/pharmaceutics10030089.

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12

Kavinkumar Sakthivel, Krishnanand Anilkumar, Jawahar Natarajan, and Senthil Venkatachalam. "A promising method to enhance the solubility of poorly water soluble drug by using hot-melt extrusion technique." International Journal of Research in Pharmaceutical Sciences 11, no. 3 (July 18, 2020): 3657–66. http://dx.doi.org/10.26452/ijrps.v11i3.2526.

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More than 40% of new chemicals are of poor solubility, it causes poor bioavailability. Several techniques are available to increase the solubility of drugs, such as converting the drug into salt form, complexion, co-solvency, particle size reduction, nano-suspension, cryogenic technique, modification of crystal habit etc. Hot melt extrusion has increased wide acknowledgment in the recent past. Over the past recent three decades modern flexibility has permitted hot melt extrusion (HME) is to increase wide acknowledgment and has just settled its place in the wide range of assembling activities and pharmaceutical research advancements. HME has just been exhibited as a vigorous, novel system to cause strong scatterings so as to give time controlled, changed, broadened, and focused on medicate conveyance bringing about improved bioavailability just as taste covering of bitter Active Pharmaceutical Ingredients (APIs). Hot melt extrusion is one of the efficient technique for improving the solubility of hydrophobic drugs by forming solid dispersion. It is a solventfree process and time taken for the production is less. The process involved in this technique include, weighing/feeding, Melting, Mixing, Venting, Extrusion, Cooling, Pelletizing. Solubility of many drugs have improved by utilizing hot melt-extrusion technology. In this review, a detailed overview about Solubility enhancement of drugs by hot-melt extrusion and its applications are discussed. This review summarizes the importance and uses of solid dispersion technique for improving the solubility of poorly soluble drugs

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13

Lang, Bo, James W. McGinity, and Robert O. Williams. "Hot-melt extrusion – basic principles and pharmaceutical applications." Drug Development and Industrial Pharmacy 40, no. 9 (February 13, 2014): 1133–55. http://dx.doi.org/10.3109/03639045.2013.838577.

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14

Crowley, Michael M., Feng Zhang, Michael A. Repka, Sridhar Thumma, Sampada B. Upadhye, Sunil Kumar Battu, James W. McGinity, and Charles Martin. "Pharmaceutical Applications of Hot-Melt Extrusion: Part I." Drug Development and Industrial Pharmacy 33, no. 9 (January 2007): 909–26. http://dx.doi.org/10.1080/03639040701498759.

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15

Repka, Michael A., Sunil Kumar Battu, Sampada B. Upadhye, Sridhar Thumma, Michael M. Crowley, Feng Zhang, Charles Martin, and James W. McGinity. "Pharmaceutical Applications of Hot-Melt Extrusion: Part II." Drug Development and Industrial Pharmacy 33, no. 10 (January 2007): 1043–57. http://dx.doi.org/10.1080/03639040701525627.

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16

Repka, Michael A., Soumyajit Majumdar, Sunil Kumar Battu, Ramesh Srirangam, and Sampada B. Upadhye. "Applications of hot-melt extrusion for drug delivery." Expert Opinion on Drug Delivery 5, no. 12 (December 2008): 1357–76. http://dx.doi.org/10.1517/17425240802583421.

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17

Smith-Goettler, Brandye, Colleen M. Gendron, and Robert F. Meyer. "Understanding Hot Melt Extrusion via near Infrared Spectroscopy." NIR news 25, no. 7 (November 2014): 10–12. http://dx.doi.org/10.1255/nirn.1481.

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18

Alshahrani, Saad M., Joseph T. Morott, Abdullah S. Alshetaili, Roshan V. Tiwari, Soumyajit Majumdar, and Michael A. Repka. "Influence of degassing on hot-melt extrusion process." European Journal of Pharmaceutical Sciences 80 (December 2015): 43–52. http://dx.doi.org/10.1016/j.ejps.2015.08.008.

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19

Reitz, Elena, Helmut Podhaisky, David Ely, and Markus Thommes. "Residence time modeling of hot melt extrusion processes." European Journal of Pharmaceutics and Biopharmaceutics 85, no. 3 (November 2013): 1200–1205. http://dx.doi.org/10.1016/j.ejpb.2013.07.019.

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20

Dhumal, Ravindra S., Adrian L. Kelly, Peter York, Phil D. Coates, and Anant Paradkar. "Cocrystalization and Simultaneous Agglomeration Using Hot Melt Extrusion." Pharmaceutical Research 27, no. 12 (September 25, 2010): 2725–33. http://dx.doi.org/10.1007/s11095-010-0273-9.

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21

Radl, Stefan, Thomas Tritthart, and Johannes G. Khinast. "A novel design for hot-melt extrusion pelletizers." Chemical Engineering Science 65, no. 6 (March 2010): 1976–88. http://dx.doi.org/10.1016/j.ces.2009.11.034.

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22

Lu, Jiannan, Sakae Obara, Nicolas Ioannidis, John Suwardie, Costas Gogos, and Shingo Kikuchi. "Understanding the Processing Window of Hypromellose Acetate Succinate for Hot-Melt Extrusion, Part I: Polymer Characterization and Hot-Melt Extrusion." Advances in Polymer Technology 37, no. 1 (February 10, 2016): 154–66. http://dx.doi.org/10.1002/adv.21652.

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23

Matić, Josip, Carolina Alva, Andreas Witschnigg, Simone Eder, Kathrin Reusch, Amrit Paudel, and Johannes Khinast. "Towards predicting the product quality in hot-melt extrusion: Small scale extrusion." International Journal of Pharmaceutics: X 2 (December 2020): 100062. http://dx.doi.org/10.1016/j.ijpx.2020.100062.

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24

Bochmann, Esther, Andreas Gryczke, and Karl Wagner. "Validation of Model-Based Melt Viscosity in Hot-Melt Extrusion Numerical Simulation." Pharmaceutics 10, no. 3 (August 18, 2018): 132. http://dx.doi.org/10.3390/pharmaceutics10030132.

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A validation for the use of model-based melt viscosity in hot-melt extrusion numerical simulations was presented. Here, the melt viscosity of an amorphous solid dispersion (ASD) was calculated by using its glass transition temperature (Tg) and the rheological flow profile of the pure polymeric matrix. All further required physical properties were taken from the pure polymer. For forming the ASDs, four active pharmaceutical ingredients (APIs), that had not been considered in first place to establish the correlation between Tg and melt viscosity were examined. The ASDs were characterized in terms of density, specific heat capacity, melt rheology, API solubility in the polymeric matrix, and deviation from the Couchman–Karasz fit to, identify the influencing factors of the accuracy of the simulation using model-based melt viscosity. Furthermore, the energy consumption of the hot-melt extrusion (HME) experiments, conventional simulation, and simulation using model-based melt viscosity were compared. It was shown, with few exceptions, that the use of model-based melt viscosity in terms of the HME simulation did not reduce the accuracy of the computation outcome. The commercial one-dimensional (1D) simulation software Ludovic® was used to conduct all of the numerical computation. As model excipients, vinylpyrrolidone-vinyl acetate copolymer (COP) in combination with four APIs (celecoxib, loratadine, naproxen, and praziquantel) were investigated to form the ASDs.

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25

S. Abdul Jabbar, Ahmed. "Dissolution Enhancement of Raltegravir by Hot Melt Extrusion Technique." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512) 27, no. 1 (June 4, 2018): 20–29. http://dx.doi.org/10.31351/vol27iss1pp20-29a.

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The objective of the study to develop an amorphous solid dispersion for poorly soluble raltegravir by hot melt extrusion (HME) technique. A novel solubility improving agent plasdone s630 was utilized. The HME raltegravir was formulated into tablet by direct compression method. The prepared tablets were assessed for all pre and post-compression parameters. The drug- excipients interaction was examined by FTIR and DSC. All formulas displayed complying with pharmacopoeial measures. The study reveals that formula prepared by utilizing drug and plasdone S630 at 1:1.5 proportion and span 20 at concentration about 30mg (trail-6) has given highest dissolution rate than contrasted with various formulas of raltegravir. Keywords: Hot melt extrusion, Raltegravir, Plasdone S630.

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26

Yan, Guangming, Zhi Cao, Declan Devine, Manfred Penning, and Noel M. Gately. "Physical Properties of Shellac Material Used for Hot Melt Extrusion with Potential Application in the Pharmaceutical Industry." Polymers 13, no. 21 (October 28, 2021): 3723. http://dx.doi.org/10.3390/polym13213723.

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Hot melt extrusion offers an efficient way of increasing the solubility of a poorly soluble drug. Shellac has potential as a pharmaceutical matrix polymer that can be used in this extrusion process, with further advantages for use in enteric drug delivery systems. The rheological property of a material affects the extrusion process conditions. However, the literature does not refer to any published work that investigates the processability of various shellac materials. This work explores various types of shellac and explores their physicochemical and thermal properties along with their processability in the hot melt extrusion application. Physicochemical characterization of the materials was achieved using differential scanning calorimetry, Fourier transform infrared spectroscopy, scanning electron microscopy and energy-dispersive X-ray spectroscopy. Additional processability characterization was achieved using melt flow index and rheology analysis. The results indicated that there was no chemical difference between the various shellac types compared in this study. However, the extrudable temperature ranges and rheological properties of different shellac types varied; SSB 55 Pharma FL had the lowest processing temperature and glass transition temperatures. Due to the shear-thinning behaviours, shellac can be extruded at lower temperatures. This study provides necessary data to determine the processing conditions in hot melt extrusion applications for the range of shellac materials.

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27

Rosenbaum, Christoph, Linus Großmann, Ellen Neumann, Petra Jungfleisch, Emre Türeli, and Werner Weitschies. "Development of a Hot-Melt-Extrusion-Based Spinning Process to Produce Pharmaceutical Fibers and Yarns." Pharmaceutics 14, no. 6 (June 10, 2022): 1229. http://dx.doi.org/10.3390/pharmaceutics14061229.

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Fibers and yarns are part of everyday life. So far, fibers that are also used pharmaceutically have mainly been produced by electrospinning. The common use of spinning oils and the excipients they contain, in connection with production by melt extrusion, poses a regulatory challenge for pharmaceutically usable fibers. In this publication, a newly developed small-scale direct-spinning melt extrusion system is described, and the pharmaceutically useful polyvinyl filaments produced with it are characterized. The major parts of the system were newly developed or extensively modified and manufactured cost-effectively within a short time using rapid prototyping (3D printing) from various materials. For example, a stainless-steel spinneret was developed in a splice design for a table-top melt extrusion system that can be used in the pharmaceutical industry. The direct processing of the extruded fibers was made possible by a spinning system developed called Spinning-Rosi, which operates continuously and directly in the extrusion process and eliminates the need for spinning oils. In order to prevent instabilities in the product, further modifications were also made to the process, such as a the moisture encapsulation of the melt extrusion line at certain points, which resulted in a bubble-free extrudate with high tensile strength, even in a melt extrusion line without built-in venting.

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28

Thommes, Markus, Lieven Baert, and Jan Rosier. "800 mg Darunavir tablets prepared by hot melt extrusion." Pharmaceutical Development and Technology 16, no. 6 (August 23, 2010): 645–50. http://dx.doi.org/10.3109/10837450.2010.508077.

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29

Naaz, Shaik, and Vamshi Krishna Tippavajhala. "Hot-Melt Extrusion Technology in the Emerging Pharma Field." Research Journal of Pharmacy and Technology 11, no. 4 (2018): 1619. http://dx.doi.org/10.5958/0974-360x.2018.00301.3.

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30

Shetty, Rakshith, Vaishnavi Tallapaneni, Sreenivasa Reddy M, Nayanabhirama Udupa, Srinivas Mutalik, Vijay Kulkarni, Vinay Rao, and Aravind Kumar Gurram. "Solubility Enhancement of Lumefantrine by Hot Melt Extrusion Process." Research Journal of Pharmacy and Technology 12, no. 6 (2019): 2929. http://dx.doi.org/10.5958/0974-360x.2019.00493.1.

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31

Tambe, Srushti, Divya Jain, Yashvi Agarwal, and Purnima Amin. "Hot-melt extrusion: Highlighting recent advances in pharmaceutical applications." Journal of Drug Delivery Science and Technology 63 (June 2021): 102452. http://dx.doi.org/10.1016/j.jddst.2021.102452.

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32

Grimard, Jonathan, Laurent Dewasme, and Alain Vande Wouwer. "A Review of Dynamic Models of Hot-Melt Extrusion." Processes 4, no. 2 (June 6, 2016): 19. http://dx.doi.org/10.3390/pr4020019.

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33

Shuwisitkul, Duangratana. "Hot melt extrusion: An application for enhancing drug solubility." Asian Journal of Pharmaceutical Sciences 11, no. 1 (February 2016): 45–46. http://dx.doi.org/10.1016/j.ajps.2015.10.032.

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34

Khor, Chia Miang, Wai Kiong Ng, Parijat Kanaujia, Kok Ping Chan, and Yuancai Dong. "Hot-melt extrusion microencapsulation of quercetin for taste-masking." Journal of Microencapsulation 34, no. 1 (January 2, 2017): 29–37. http://dx.doi.org/10.1080/02652048.2017.1280095.

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35

Li, Yongcheng, Huishi Pang, Zhefei Guo, Ling Lin, Yixuan Dong, Ge Li, Ming Lu, and Chuangbin Wu. "Interactions between drugs and polymers influencing hot melt extrusion." Journal of Pharmacy and Pharmacology 66, no. 2 (December 11, 2013): 148–66. http://dx.doi.org/10.1111/jphp.12183.

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36

Kate, Laxman, Vinod Gokarna, Vivek Borhade, Priyanka Prabhu, Vinita Deshpande, Sulabha Pathak, Shobhona Sharma, and Vandana Patravale. "Bioavailability enhancement of atovaquone using hot melt extrusion technology." European Journal of Pharmaceutical Sciences 86 (April 2016): 103–14. http://dx.doi.org/10.1016/j.ejps.2016.03.005.

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37

Bialleck, Sebastian, and Hubert Rein. "Preparation of starch-based pellets by hot-melt extrusion." European Journal of Pharmaceutics and Biopharmaceutics 79, no. 2 (October 2011): 440–48. http://dx.doi.org/10.1016/j.ejpb.2011.04.007.

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38

Hwang, Ilhwan, Chin-Yang Kang, and Jun-Bom Park. "Advances in hot-melt extrusion technology toward pharmaceutical objectives." Journal of Pharmaceutical Investigation 47, no. 2 (February 17, 2017): 123–32. http://dx.doi.org/10.1007/s40005-017-0309-9.

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39

Miller, Dave A., Jason T. McConville, Wei Yang, Robert O. Williams, and James W. McGinity. "Hot-Melt Extrusion for Enhanced Delivery of Drug Particles." Journal of Pharmaceutical Sciences 96, no. 2 (February 2007): 361–76. http://dx.doi.org/10.1002/jps.20806.

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40

Tan, David Cheng Thiam, Jeremy Jianming Ong, Phan Thi Nam Mai, Rajeev Gokhale, and Paul Wan Sia Heng. "Application of hot melt extrusion process for taste masking." International Journal of Pharmaceutics 536, no. 2 (February 2018): 490–91. http://dx.doi.org/10.1016/j.ijpharm.2017.08.011.

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41

Lee, Soo Hwan, Geun Nyeong Lee, Young Jin Kim, Young Ho Cho, and Gye Won Lee. "Development and Evaluation of Implant using Hot-Melt Extrusion." Yakhak Hoeji 67, no. 1 (February 28, 2023): 32–44. http://dx.doi.org/10.17480/psk.2023.67.1.32.

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In this study, poly(lactic-co-glycolic acid) (PLGA)-based subcutaneous implant containing metformin HCl was prepared by hot-melt extrusion (HME). This study aimed to evaluate swelling and dissolution behavior for application as subcutaneous implant. Implants containing metformin HCl were fabricated successfully at 30 rpm, 90oC by HME. Drugexcipient compatibility studies through FT-IR and DSC revealed the absence of any interaction between the drug and polymers. Dissolution rate and swelling ratio of metformin HCl was significantly affected by the type of PLGA. Dissolution rate increased as the ratio of -COOH terminal group and GA. By the results, we could confirm that the mechanism of drug release from implants is Korsmeyer-Peppas model (n=0.14~0.71) by combination of non-fickian diffusion and erosion. The formulation F7 with 65% of RG 752H and 5% of RG 502 was showed excellent swelling ratio with drug release control. In this study, mixing 5~10% of RG 502 with RG 752H can be expected to develop optimal implants exhibiting diffusion-controlled release for 3 months without initial burst release.

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42

Hoffmann, Lena, Jörg Breitkreutz, and Julian Quodbach. "Hot-Melt Extrusion of the Thermo-Sensitive Peptidomimetic Drug Enalapril Maleate." Pharmaceutics 14, no. 10 (September 30, 2022): 2091. http://dx.doi.org/10.3390/pharmaceutics14102091.

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The aim of this research was the production of extrudates for the treatment of hypertension and heart failure and the investigation of the degradation of the peptidomimetic drug enalapril maleate (EM) during hot-melt extrusion (HME). A fast HPLC method was developed to quantify enalapril maleate and possible degradation products. Screening experiments revealed that the diketopiperazine derivative (Impurity D) was the main degradation product. Hot-melt extrusion of enalapril maleate with the polymer Soluplus® enabled extrusion at 100 °C, whereas a formulation with the polymer Eudragit® E PO could be extruded at only 70 °C. Extrusion at 70 °C prevented thermal degradation. A stabilizing molecular interaction between enalapril maleate and Eudragit® E PO was identified via FT-IR spectroscopy. Dissolution studies were carried out to study the influence of the formulation on the dissolution behavior of enalapril maleate. These promising results can be transferred to other thermo-sensitive and peptidomimetic drugs to produce extrudates which can be used, for instance, as feedstock material for the production of patient-specific dosage forms via Fused Deposition Modeling (FDM) 3D printing.

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43

Siddharatha Dhoppalapudi and Prashanth Parupathi. "Hot melt extrusion: A single-step continuous manufacturing process for developing amorphous solid dispersions of poorly soluble drug substances." GSC Advanced Research and Reviews 13, no. 2 (November 30, 2022): 126–35. http://dx.doi.org/10.30574/gscarr.2022.13.2.0311.

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In today’s world with increasing patient population, the demand for pharmaceutical medications is increasing enormously. However, poor solubility of drug substances and underdeveloped manufacturing process are affecting the revenue of the pharmaceutical industries. Improving the solubility and establishing a robust manufacturing process is the primary prerequisite of the developmental scientists. Among various approaches amorphous solid dispersion has gained a tremendous response for improving the solubility of the drug substances. In addition, the process of hot melt extrusion has attracted the investigators from regulatory agencies and industries. The process of hot melt extrusion involves application of thermal and mechanical energy on to the processing material. The process requires no solvent and is referred as “green technique.” Various factors need to be taken into consideration for developing amorph amorphous solid dispersions. The miscibility of drug and polymer, solubility of drug in polymer, drug-polymer interactions, glass transition temperature, storage conditions majorly influence the stability of the amorphous solid dispersions systems. Though hot melt extrusion is most widely employed for developing amorphous solid dispersions still a lot of research is warranted for developing strategies to formulate high drug loading medications with improved stability. This review article mainly focuses on the instrumentation, and process for developing amorphous solid dispersions by hot melt extrusion with a small note on the various advantages and limitations.

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44

Jung, Taek Kyun, T. J. Sung, Mok Soon Kim, and Won Yong Kim. "A Comparative Study of Mechanical Property in Al-8Fe-2Mo-2V-1Zr Bulk Alloys Fabricated from an Atomized Powder and a Melt Spun Ribbon." Materials Science Forum 534-536 (January 2007): 765–68. http://dx.doi.org/10.4028/www.scientific.net/msf.534-536.765.

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Al-8Fe-2Mo-2V-1Zr alloy powders were prepared by gas atomization and melt spinning method. In melt spinning technique, melt spun ribbons were pulverized by a speed rotor mill to make a powder shape. In order to produce a bulk form, powders were canned and hot extruded in the extrusion ratio of 25 to 1 at 693K. For the gas atomization and hot extrusion processed bulk material, equiaxed grains with the average size of 400 nm and finely distributed dispersoids with their particle sizes ranging from 50nm to 200nm were observed to display a characteristic nano-structured feature over the entire region. For the melt spun and hot extrusion processed alloy, a refined microstructural feature consisting of equiaxed grains with the average size of 200 nm and fine dispersoids with their particle sizes under 50 nm appeared to exhibit a difference in microstructure. Yield strength of the latter alloy was higher than that for the former alloy up to elevated temperatures. The maximum yield strength was measured to about 800 MPa at room temperature for the latter alloy.

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45

Matić, Josip, Carolina Alva, Simone Eder, Kathrin Reusch, Amrit Paudel, and Johannes Khinast. "Towards predicting the product quality in hot-melt extrusion: Pilot plant scale extrusion." International Journal of Pharmaceutics: X 3 (December 2021): 100084. http://dx.doi.org/10.1016/j.ijpx.2021.100084.

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Jung, Taek Kyun, Dong Suk Lee, Mok Soon Kim, and Won Yong Kim. "Fabrication and Properties of High Strength Al-8Fe-2Mo-2V-1Zr Alloy Produced by Melt Spinning Techniques." Materials Science Forum 510-511 (March 2006): 854–57. http://dx.doi.org/10.4028/www.scientific.net/msf.510-511.854.

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Abstract:

High strength Al-8Fe-2Mo-2V-1Zr (wt.%) alloys fabricated by a melt spinning and a hot extrusion process were produced to correlate the microstructure and mechanical property. Melt spun ribbon prepared by single roll melt spinner showed a cellular structure with an average size of 10nm and Al-Fe based intermetallic dispersoid of less than 10nm in particle size. The melt spun ribbon obtained was then pulverized to make a powder shape followed by hot extrusion at 648K, 673K, 723K and 773K in extrusion ratio of 5 to 1, respectively. Equiaxed grain structure containing Al-Fe based intermetallic phase was observed in all extruded specimens. According to increasing extrusion temperature, the grain size increased and particle size of intermetallic dispersoid. The lattice parameter increased from 0.4051nm to 0.4059 nm with increasing extrusion temperature from 648K to 773K, those values were larger than that obtained in pure Al (0.4049nm). Yield strength of the specimen extruded at 648K measured to 956MPa at room temperature, 501MPa at 573K and 83MPa at 773K, respectively. With increasing extrusion temperature yield strength decreased significantly at room temperature and even in the intermediate temperature range, while no noticeable difference in yield strength was observed at 773K.

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Koutsamanis, Ioannis, Martin Spoerk, Florian Arbeiter, Simone Eder, and Eva Roblegg. "Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion." Polymers 12, no. 12 (December 10, 2020): 2950. http://dx.doi.org/10.3390/polym12122950.

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Implantable drug delivery systems (IDDSs) offer good patient compliance and allow the controlled delivery of drugs over prolonged times. However, their application is limited due to the scarce material selection and the limited technological possibilities to achieve extended drug release. Porous structures are an alternative strategy that can overcome these shortcomings. The present work focuses on the development of porous IDDS based on hydrophilic (HPL) and hydrophobic (HPB) polyurethanes and chemical pore formers (PFs) manufactured by hot-melt extrusion. Different PF types and concentrations were investigated to gain a sound understanding in terms of extrudate density, porosity, compressive behavior, pore morphology and liquid uptake. Based on the rheological analyses, a stable extrusion process guaranteed porosities of up to 40% using NaHCO3 as PF. The average pore diameter was between 140 and 600 µm and was indirectly proportional to the concentration of PF. The liquid uptake of HPB was determined by the open pores, while for HPL both open and closed pores influenced the uptake. In summary, through the rational selection of the polymer type, the PF type and concentration, porous carrier systems can be produced continuously via extrusion, whose properties can be adapted to the respective application site.

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Lee, Byoung Soo, Dae Heon Joo, Hoon Cho, Hyung Ho Jo, and Myung Ho Kim. "Aging Behavior of Al-Cu Alloys Produced by Melt Extrusion Process." Solid State Phenomena 116-117 (October 2006): 550–53. http://dx.doi.org/10.4028/www.scientific.net/ssp.116-117.550.

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Melt extrusion is a new fabrication process with the characteristics of both casting and extrusion. In this process, a metallic melt which is poured and solidified up to semisolid state in the container can be directly extruded through the die exit to form a product of bar shape without other intermediate processes. The aging behavior of Al-Cu alloys in the semisolid state was investigated. And the microstructure and mechanical properties of the melt extruded Al-Cu alloy bar were measured and its characteristics are compared with those of a hot extruded Al-Cu alloy bar. Al-Cu alloys were successfully extruded after squeezing out of liquid during melt extrusion with smaller force compared to the solid extrusion. Al-Cu alloys bar with the mean grain size of up to 200 μm was fabricated by melt extrusion process. And the mechanical properties of the melt extruded Al-Cu alloy bar were improved after the T6 treatment.

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Baru, Sarn-ii, Siobhan Matthews, Eric Marchese, Philip Walsh, and Austin Coffey. "The Effect of Sub- and Near-Critical Carbon Dioxide Assisted Manufacturing on Medical Thermoplastic Polyurethane." Polymers 15, no. 4 (February 7, 2023): 822. http://dx.doi.org/10.3390/polym15040822.

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Incorporating thermally labile active pharmaceutical ingredients for manufacturing multifunctional polymeric medical devices is restricted due to their tendency to degrade in the hot melt extrusion process. In this study, the potential of sub- and near-critical carbon dioxide (CO2) as a reversible plasticiser was explored by injecting it into a twin-screw hot melt extrusion process of Pellethane thermoplastic polyurethane to decrease its melt process temperature. Its morphological, throughput, thermal, rheological, and mechanical performances were also evaluated. The resultant extrudates were characterised using scanning electron microscopy, parallel plate rotational rheometer, differential scanning calorimetry, thermogravimetric analysis, and tensile testing. The process temperature decreased from 185 to 160 °C. The rheology indicated that the reduction in melt viscosity was from 690 Pa.s to 439 Pa.s (36%) and 414 Pa.s (40%) at 4.14 and 6.89 MPa, respectively. The tensile modulus in the elastomeric region is enhanced from 5.93 MPa, without CO2 to 7.71 MPa with CO2 at both 4.14 and 6.89 MPa. The results indicate that the employment of both sub- and near-critical CO2 as a processing aid is a viable addition to conventional hot melt extrusion and that they offer more opportunities for thermosensitive drugs to be more stable in the molten stream of Pellethane thermoplastic polyurethane.

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Maniruzzaman, Mohammed. "Pharmaceutical Applications of Hot-Melt Extrusion: Continuous Manufacturing, Twin-Screw Granulations, and 3D Printing." Pharmaceutics 11, no. 5 (May 7, 2019): 218. http://dx.doi.org/10.3390/pharmaceutics11050218.

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