Journal articles: 'Hot-melt ram extrusion printing'

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Musazzi, Umberto M., Francesca Selmin, Marco A. Ortenzi, Garba Khalid Mohammed, Silvia Franzé, Paola Minghetti, and Francesco Cilurzo. "Personalized orodispersible films by hot melt ram extrusion 3D printing." International Journal of Pharmaceutics 551, no. 1-2 (November 2018): 52–59. http://dx.doi.org/10.1016/j.ijpharm.2018.09.013.

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Gupta, Maram, Devegowda Gowda, Tegginamath Kumar, and Jessica Rosenholm. "A Comprehensive Review of Patented Technologies to Fabricate Orodispersible Films: Proof of Patent Analysis (2000–2020)." Pharmaceutics 14, no. 4 (April 8, 2022): 820. http://dx.doi.org/10.3390/pharmaceutics14040820.

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Orodispersible films (ODFs)are ultra-thin, stamp-sized, rapidly disintegrating, and attractive oral drug delivery dosage forms best suited for the pediatric and geriatric patient populations. They can be fabricated by different techniques, but the most popular, simple, and industrially applicable technique is the solvent casting method (SCM). In addition, they can also be fabricated by extrusion, printing, electrospinning, and by a combination of these technologies (e.g., SCM + printing). The present review is aimed to provide a comprehensive overview of patented technologies of the last two decades to fabricate ODFs. Through this review, we present evidence to adamantly confirm that SCM is the most popular method while electrospinning is the most recent and upcoming method to fabricate ODFs. We also speculate around the more patent-protected technologies especially in the domain of printing (two or three-dimensional), extrusion (ram or hot-melt extrusion), and electrospinning, or a combination of the methods thereof.

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Than, Yee Mon, Sarisa Suriyarak, and Varin Titapiwatanakun. "Rheological Investigation of Hydroxypropyl Cellulose–Based Filaments for Material Extrusion 3D Printing." Polymers 14, no. 6 (March 10, 2022): 1108. http://dx.doi.org/10.3390/polym14061108.

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The rheological properties of drug–polymer mixtures have a significant influence on their processability when using transformative techniques, such as hot-melt-extrusion and material-extrusion 3D printing; however, there has been limited data on printable systems. This study investigated the rheological properties of 17 formulations of successful printed tablets for both immediate and controlled release. Hydroxypropyl cellulose was used in various ratios to obtain printable filaments in combination with various drugs (indomethacin or theophylline), polymers and disintegrants. The complex viscosity, shear thinning behavior and viscoelastic properties were affected by the drug load, polymer composite, disintegrant type, temperature and shear rate applied. Larger windows of processing viscosity were revealed. The viscosity of the printable blends could be as low as the range 10–1000 Pa·s at 100 rad/s angular frequency. All formulations showed shear thinning behavior with a broad slope of complex viscosity from −0.28 to −0.74. The addition of 30–60% drug or disintegrant tended to have greater viscosity values. While microcrystalline cellulose was found to be an alternative additive to lower the storage and loss modulus among disintegrants. This rheological data could be useful for the preformulation and further development of material-extrusion 3D-printing medicines.

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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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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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Liu, Boshi, Xiaolu Han, Zengming Wang, Hui Zhang, Nan Liu, Xiang Gao, Jing Gao, and Aiping Zheng. "Three-dimensional printing personalized acetaminophen sustained-release tablets using hot melt extrusion." Journal of Drug Delivery Science and Technology 66 (December 2021): 102855. http://dx.doi.org/10.1016/j.jddst.2021.102855.

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Zhang, Jiaxiang, Xin Feng, Hemlata Patil, Roshan V. Tiwari, and Michael A. Repka. "Coupling 3D printing with hot-melt extrusion to produce controlled-release tablets." International Journal of Pharmaceutics 519, no. 1-2 (March 2017): 186–97. http://dx.doi.org/10.1016/j.ijpharm.2016.12.049.

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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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Janczura, Magdalena, Szymon Sip, and Judyta Cielecka-Piontek. "The Development of Innovative Dosage Forms of the Fixed-Dose Combination of Active Pharmaceutical Ingredients." Pharmaceutics 14, no. 4 (April 11, 2022): 834. http://dx.doi.org/10.3390/pharmaceutics14040834.

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The development of innovative forms of combination drugs is closely related to the invention of the multilayer tablet press, polymers for pharmaceutical applications, the hot-melt extrusion process, and 3D printing in the pharmaceutical industry. However, combining multiple drugs within the same dosage form can bring many physicochemical and pharmacodynamic interactions. More and more new forms of fixed-dose combinations (FDCs) have been developed due to work to overcome the incompatibility of active substances or to obtain different drug release profiles in the same dosage form. This review provides discussions of the application of various innovation formulation technologies of FDC drugs such as bilayer system, multilayer tablet, active film coating, hot-melt extrusion, and 3D printing, taking into account the characteristics of the key ingredients in the FDC formulation and presenting technological problems and challenges related to the development of combination drugs. Moreover, the article summarizes the range of dosage forms that have been made using these technologies over the past 30 years.

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Reddy Dumpa, Nagi, Suresh Bandari, and Michael A. Repka. "Novel Gastroretentive Floating Pulsatile Drug Delivery System Produced via Hot-Melt Extrusion and Fused Deposition Modeling 3D Printing." Pharmaceutics 12, no. 1 (January 8, 2020): 52. http://dx.doi.org/10.3390/pharmaceutics12010052.

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This study was performed to develop novel core-shell gastroretentive floating pulsatile drug delivery systems using a hot-melt extrusion-paired fused deposition modeling (FDM) 3D printing and direct compression method. Hydroxypropyl cellulose (HPC) and ethyl cellulose (EC)-based filaments were fabricated using hot-melt extrusion technology and were utilized as feedstock material for printing shells in FDM 3D printing. The directly compressed theophylline tablet was used as the core. The tablet shell to form pulsatile floating dosage forms with different geometries (shell thickness: 0.8, 1.2, 1.6, and 2.0 mm; wall thickness: 0, 0.8, and 1.6 mm; and % infill density: 50, 75, and 100) were designed, printed, and evaluated. All core-shell tablets floated without any lag time and exhibited good floating behavior throughout the dissolution study. The lag time for the pulsatile release of the drug was 30 min to 6 h. The proportion of ethyl cellulose in the filament composition had a significant (p < 0.05) effect on the lag time. The formulation (2 mm shell thickness, 1.6 mm wall thickness, 100% infill density, 0.5% EC) with the desired lag time of 6 h was selected as an optimized formulation. Thus, FDM 3D printing is a potential technique for the development of complex customized drug delivery systems for personalized pharmacotherapy.

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Nagata, Ryotaro, Yasuhiro Uetani, Hidetoshi Takagi, Kenji Matsuda, and Susumu Ikeno. "Rheo-Extrusion of A7075 Aluminium Alloy Utilizing Semi-Solid Slurry Manufactured by Simple Method." Materials Science Forum 519-521 (July 2006): 1847–52. http://dx.doi.org/10.4028/www.scientific.net/msf.519-521.1847.

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In order to extrude A7075 aluminum alloy soundly from melt without using feed stock billet, rheo-extrusion was tried by utilizing semi-solid slurry with fine solid granules made by employing cooling tube. When the melt moving down inside thin tube was adequately cooled in different ways and introduced into an extrusion container kept at semi-solid temperature of 873K, structure of solidified slurries were granular and mean grain sizes of about 60 to 120μm could be obtained. Subsequently, these slurries were extruded to round bars at various extrusion ratios (28 to 64) and press ram speed of 10mm/s, just after cooling to 833K. The newly developed slurries could easily be extruded to bars with smooth surfaces at lower forces. Although every tensile strength of extruded bars were lower than that of hot-extruded one, there was a tendency that finer the solid granules in slurry, higher the tensile strength of extruded bar.

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Pereira, Gabriela G., Sara Figueiredo, Ana Isabel Fernandes, and João F. Pinto. "Polymer Selection for Hot-Melt Extrusion Coupled to Fused Deposition Modelling in Pharmaceutics." Pharmaceutics 12, no. 9 (August 22, 2020): 795. http://dx.doi.org/10.3390/pharmaceutics12090795.

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Three-dimensional (3D) printing offers the greatest potential to revolutionize the future of pharmaceutical manufacturing by overcoming challenges of conventional pharmaceutical operations and focusing design and production of dosage forms on the patient’s needs. Of the many technologies available, fusion deposition modelling (FDM) is considered of the lowest cost and higher reproducibility and accessibility, offering clear advantages in drug delivery. FDM requires in-house production of filaments of drug-containing thermoplastic polymers by hot-melt extrusion (HME), and the prospect of connecting the two technologies has been under investigation. The ability to integrate HME and FDM and predict and tailor the filaments’ properties will extend the range of printable polymers/formulations. Hence, this work revises the properties of the most common pharmaceutical-grade polymers used and their effect on extrudability, printability, and printing outcome, providing suitable processing windows for different raw materials. As a result, formulation selection will be more straightforward (considering the characteristics of drug and desired dosage form or release profile) and the processes setup will be more expedite (avoiding or mitigating typical processing issues), thus guaranteeing the success of both HME and FDM. Relevant techniques used to characterize filaments and 3D-printed dosage forms as an essential component for the evaluation of the quality output are also presented.

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Venâncio, Nuno, Gabriela Pereira, João Pinto, and Ana Fernandes. "Influence of the Infill Geometry of 3D-Printed Tablets on Drug Dissolution." Medical Sciences Forum 5, no. 1 (July 20, 2021): 15. http://dx.doi.org/10.3390/msf2021005015.

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Patient-centric therapy is especially important in pediatrics and may be attained by three-dimensional printing. Filaments containing 30% w/w of theophylline were produced by hot-melt extrusion and printed using fused deposition modelling to produce tablets. Here, preliminary results evaluating the effect of infill geometry (cross, star, grid) on drug content and release are reported.

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Pflieger, Thomas, Rakesh Venkatesh, Markus Dachtler, Karin Eggenreich, Stefan Laufer, and Dominique Lunter. "Novel Approach to Pharmaceutical 3D-Printing Omitting the Need for Filament—Investigation of Materials, Process, and Product Characteristics." Pharmaceutics 14, no. 11 (November 17, 2022): 2488. http://dx.doi.org/10.3390/pharmaceutics14112488.

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The utilized 3D printhead employs an innovative hot-melt extrusion (HME) design approach being fed by drug-loaded polymer granules and making filament strands obsolete. Oscillatory rheology is a key tool for understanding the behavior of a polymer melt in extrusion processes. In this study, small amplitude shear oscillatory (SAOS) rheology was applied to investigate formulations of model antihypertensive drug Metoprolol Succinate (MSN) in two carrier polymers for pharmaceutical three-dimensional printing (3DP). For a standardized printing process, the feeding polymers viscosity results were correlated to their printability and a better understanding of the 3DP extrudability of a pharmaceutical formulation was developed. It was found that the printing temperature is of fundamental importance, although it is limited by process parameters and the decomposition of the active pharmaceutical ingredients (API). Material characterization including differential scanning calorimetry (DSC) and thermogravimetric analyses (TGA) of the formulations were performed to evaluate component miscibility and ensure thermal durability. To assure the development of a printing process eligible for approval, all print runs were investigated for uniformity of mass and uniformity of dosage in accordance with the European Pharmacopoeia (Ph. Eur.).

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Lee, Soo Hwan, Young Ho Cho, and Gye Won Lee. "The Development of Gastro-Retentive Tablet using Hot Melt Extrusion and 3D Printing Technology." Yakhak Hoeji 66, no. 2 (April 30, 2022): 76–89. http://dx.doi.org/10.17480/psk.2022.66.2.76.

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Zhang, Jiaxiang, Anqi Lu, Rishi Thakkar, Yu Zhang, and Mohammed Maniruzzaman. "Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies." Pharmaceutics 13, no. 10 (October 3, 2021): 1613. http://dx.doi.org/10.3390/pharmaceutics13101613.

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Conventional oral dosage forms may not always be optimal especially for those patients suffering from dysphasia or difficulty swallowing. Development of suitable oral thin films (OTFs), therefore, can be an excellent alternative to conventional dosage forms for these patient groups. Hence, the main objective of the current investigation is to develop oral thin film (OTF) formulations using novel solvent-free approaches, including additive manufacturing (AM), hot-melt extrusion, and melt casting. AM, popularly recognized as 3D printing, has been widely utilized for on-demand and personalized formulation development in the pharmaceutical industry. Additionally, in general active pharmaceutical ingredients (APIs) are dissolved or dispersed in polymeric matrices to form amorphous solid dispersions (ASDs). In this study, acetaminophen (APAP) was selected as the model drug, and Klucel™ hydroxypropyl cellulose (HPC) E5 and Soluplus® were used as carrier matrices to form the OTFs. Amorphous OTFs were successfully manufactured by hot-melt extrusion and 3D printing technologies followed by comprehensive studies on the physico-chemical properties of the drug and developed OTFs. Advanced physico-chemical characterizations revealed the presence of amorphous drug in both HME and 3D printed films whereas some crystalline traces were visible in solvent and melt cast films. Moreover, advanced surface analysis conducted by Raman mapping confirmed a more homogenous distribution of amorphous drugs in 3D printed films compared to those prepared by other methods. A series of mathematical models were also used to describe drug release mechanisms from the developed OTFs. Moreover, the in vitro dissolution studies of the 3D printed films demonstrated an improved drug release performance compared to the melt cast or extruded films. This study suggested that HME combined with 3D printing can potentially improve the physical properties of formulations and produce OTFs with preferred qualities such as faster dissolution rate of drugs.

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Tan, Deck, Mohammed Maniruzzaman, and Ali Nokhodchi. "Advanced Pharmaceutical Applications of Hot-Melt Extrusion Coupled with Fused Deposition Modelling (FDM) 3D Printing for Personalised Drug Delivery." Pharmaceutics 10, no. 4 (October 24, 2018): 203. http://dx.doi.org/10.3390/pharmaceutics10040203.

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Three-dimensional printing, also known as additive manufacturing, is a fabrication process whereby a 3D object is created layer-by-layer by depositing a feedstock material such as thermoplastic polymer. The 3D printing technology has been widely used for rapid prototyping and its interest as a fabrication method has grown significantly across many disciplines. The most common 3D printing technology is called the Fused Deposition Modelling (FDM) which utilises thermoplastic filaments as a starting material, then extrudes the material in sequential layers above its melting temperature to create a 3D object. These filaments can be fabricated using the Hot-Melt Extrusion (HME) technology. The advantage of using HME to manufacture polymer filaments for FDM printing is that a homogenous solid dispersion of two or more pharmaceutical excipients i.e., polymers can be made and a thermostable drug can even be introduced in the filament composition, which is otherwise impractical with any other techniques. By introducing HME techniques for 3D printing filament development can improve the bioavailability and solubility of drugs as well as sustain the drug release for a prolonged period of time. The latter is of particular interest when medical implants are considered via 3D printing. In recent years, there has been increasing interest in implementing a continuous manufacturing method on pharmaceutical products development and manufacture, in order to ensure high quality and efficacy with less batch-to-batch variations of the pharmaceutical products. The HME and FDM technology can be combined into one integrated continuous processing platform. This article reviews the working principle of Hot Melt Extrusion and Fused Deposition Modelling, and how these two technologies can be combined for the use of advanced pharmaceutical applications.

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dos Santos, Juliana, Guilherme Silveira da Silva, Maiara Callegaro Velho, and Ruy Carlos Ruver Beck. "Eudragit®: A Versatile Family of Polymers for Hot Melt Extrusion and 3D Printing Processes in Pharmaceutics." Pharmaceutics 13, no. 9 (September 8, 2021): 1424. http://dx.doi.org/10.3390/pharmaceutics13091424.

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Eudragit® polymers are polymethacrylates highly used in pharmaceutics for the development of modified drug delivery systems. They are widely known due to their versatility with regards to chemical composition, solubility, and swelling properties. Moreover, Eudragit polymers are thermoplastic, and their use has been boosted in some production processes, such as hot melt extrusion (HME) and fused deposition modelling 3D printing, among other 3D printing techniques. Therefore, this review covers the studies using Eudragit polymers in the development of drug delivery systems produced by HME and 3D printing techniques over the last 10 years. Eudragit E has been the most used among them, mostly to formulate immediate release systems or as a taste-masker agent. On the other hand, Eudragit RS and Eudragit L100-55 have mainly been used to produce controlled and delayed release systems, respectively. The use of Eudragit polymers in these processes has frequently been devoted to producing solid dispersions and/or to prepare filaments to be 3D printed in different dosage forms. In this review, we highlight the countless possibilities offered by Eudragit polymers in HME and 3D printing, whether alone or in blends, discussing their prominence in the development of innovative modified drug release systems.

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Muldoon, Kirsty, Zeeshan Ahmad, Yu-Chuan Su, Fan-Gang Tseng, Xing Chen, James A. D. McLaughlin, and Ming-Wei Chang. "A Refined Hot Melt Printing Technique with Real-Time CT Imaging Capability." Micromachines 13, no. 10 (October 21, 2022): 1794. http://dx.doi.org/10.3390/mi13101794.

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Personalised drug delivery systems with the ability to offer real-time imaging and control release are an advancement in diagnostic and therapeutic applications. This allows for a tailored drug dosage specific to the patient with a release profile that offers the optimum therapeutic effect. Coupling this application with medical imaging capabilities, real-time contrast can be viewed to display the interaction with the host. Current approaches towards such novelty produce a drug burst release profile and contrasting agents associated with side effects as a result of poor encapsulation of these components. In this study, a 3D-printed drug delivery matrix with real-time imaging is engineered. Polycaprolactone (PCL) forms the bulk structure and encapsulates tetracycline hydrochloride (TH), an antibiotic drug and Iron Oxide Nanoparticles (IONP, Fe3O4), a superparamagnetic contrasting agent. Hot melt extrusion (HME) coupled with fused deposition modelling (FDM) is utilised to promote the encapsulation of TH and IONP. The effect of additives on the formation of micropores (10–20 µm) on the 3D-printed surface was investigated. The high-resolution process demonstrated successful encapsulation of both bioactive and nano components to present promising applications in drug delivery systems, medical imaging and targeted therapy.

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Cho, Hui-Won, Seung-Hoon Baek, Beom-Jin Lee, and Hyo-Eon Jin. "Orodispersible Polymer Films with the Poorly Water-Soluble Drug, Olanzapine: Hot-Melt Pneumatic Extrusion for Single-Process 3D Printing." Pharmaceutics 12, no. 8 (July 22, 2020): 692. http://dx.doi.org/10.3390/pharmaceutics12080692.

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Amorphous solid dispersions (ASDs) improve the oral delivery of poorly water-soluble drugs. ASDs of olanzapine (OLZ), which have a high melting point and low solubility, are performed using a complicated process. Three-dimensional (3D) printing based on hot-melt pneumatic extrusion (HMPE) is a simplified method for producing ASDs. Unlike general 3D printing, printlet extrusion is possible without the preparation of drug-loaded filaments. By heating powder blends, direct fused deposition modeling (FDM) printing through a nozzle is possible, and this step produces ASDs of drugs. In this study, we developed orodispersible films (ODFs) loaded with OLZ as a poorly water-soluble drug. Various ratios of film-forming polymers and plasticizers were investigated to enhance the printability and optimize the printing temperature. Scanning electron microscopy (SEM) showed the surface morphology of the film for the optimization of the polymer carrier ratios. Differential scanning calorimetry (DSC) was used to evaluate thermal properties. Powder X-ray diffraction (PXRD) confirmed the physical form of the drug during printing. The 3D printed ODF formulations successfully loaded ASDs of OLZ using HMPE. Our ODFs showed fast disintegration patterns within 22 s, and rapidly dissolved and reached up to 88% dissolution within 5 min in the dissolution test. ODFs fabricated using HMPE in a single process of 3D printing increased the dissolution rates of the poorly water-soluble drug, which could be a suitable formulation for fast drug absorption. Moreover, this new technology showed prompt fabrication feasibility of various formulations and ASD formation of poorly water-soluble drugs as a single process. The immediate dissolution within a few minutes of ODFs with OLZ, an atypical antipsychotic, is preferred for drug compliance and administration convenience.

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Uetani, Yasuhiro, Ryotaro Nagata, Hidetoshi Takagi, Kenji Matsuda, and Susumu Ikeno. "Simple Manufacturing Method for A7075 Aluminum Alloy Slurry with Fine Granules and Application to Rheo-Extrusion." Solid State Phenomena 116-117 (October 2006): 746–49. http://dx.doi.org/10.4028/www.scientific.net/ssp.116-117.746.

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Semi-solid slurry of A7075 aluminum alloy with fine solid granules was tried simply to make by passing the melt through upright tube followed by inclined water-cooled tube. Structures of solidified slurries were granular and mean grain sizes of about 0.06 to 0.11mm could be obtained. When the slurries introduced into an extrusion container kept at semi-solid temperature 873K were extruded to round bars at various extrusion ratios and press ram speed of 10mm/s, just after cooling to 833K, they could easily be extruded to bars with smooth surfaces at lower forces. Although every tensile strength of extruded bars were lower than that of hot-extruded one, there was a tendency that finer the solid granules in slurry, higher the tensile strength of extruded bar.

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Al-Gawhari, Fatima Jalal, and Ali A. Mohammed Ali. "Types of 3D Printers Applied in Industrial Pharmacy and Drug Delivery." Technium BioChemMed 3, no. 2 (April 7, 2022): 1–14. http://dx.doi.org/10.47577/biochemmed.v3i2.6064.

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The promising technology depend on using 3D printers' machines (3DPs) might be considered a modern approach in drug industry and delivery. A 3D printer may define as a machine which fabricates 3D models or products using computer aided design (CAD) software programs. These printers can create a single copy of an item that is too complicated and very difficult to produce by using traditional manufacturing methods. Moreover, it has ability to make products with complex internal structure geometries with lower cost and time. Recently, 3D printers have been involved into printing bio-products, custom pills and organs for transplant. This review presents the types of 3DPs suitable for drug industry and delivery. There are several types of 3DPs are used in pharmaceutical fields including inkjet (IK) printers, fused filament (FF) type printers, extrusion and hot melt extrusion 3D printing, sintering by selective kind of laser (SLS), Stereolithography (SLA), melting by micro selective laser (SLM), binder applied jetting printing (BJ) and the laminated object engineering manufacturing (LOM).

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Dumpa, Nagireddy, Arun Butreddy, Honghe Wang, Neeraja Komanduri, Suresh Bandari, and Michael A. Repka. "3D printing in personalized drug delivery: An overview of hot-melt extrusion-based fused deposition modeling." International Journal of Pharmaceutics 600 (May 2021): 120501. http://dx.doi.org/10.1016/j.ijpharm.2021.120501.

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Zhang, Peilun, Pengchong Xu, Sooyeon Chung, Suresh Bandari, and Michael A. Repka. "Fabrication of bilayer tablets using hot melt extrusion-based dual-nozzle fused deposition modeling 3D printing." International Journal of Pharmaceutics 624 (August 2022): 121972. http://dx.doi.org/10.1016/j.ijpharm.2022.121972.

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Song, Eon Soo, Youngjun Seo, and Dong Wuk Kim. "Fabrication of Theophylline-loaded Sustained Release Tablet via Coupling of Hot Melt Extrusion and 3D Printing." Yakhak Hoeji 63, no. 5 (October 31, 2019): 297–302. http://dx.doi.org/10.17480/psk.2019.63.5.297.

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Abbas, Nasir, Nadia Qamar, Amjad Hussain, Sumera Latif, Muhammad Sohail Arshad, Qazi Amir Ijaz, Faisal Mahmood, and Nadeem Irfan Bukhari. "Fabrication of modified-release custom-designed ciprofloxacin tablets via fused deposition modeling 3D printing." Journal of 3D Printing in Medicine 4, no. 1 (March 2020): 17–27. http://dx.doi.org/10.2217/3dp-2019-0024.

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Aim: The aim of the present work was to fabricate customized tablets of ciprofloxacin hydrochloride through 3D printing for optimized dosing. Materials & methods: A hot melt extrusion technique was employed to produce polyvinyl alcohol filaments with differing strengths of ciprofloxacin hydrochloride. Drug-loaded filaments were characterized for mechanical strength, thermal behavior and structural characteristics prior to printing of tablets by varying the infill percentage. Final formulations were evaluated for drug release profiles. Results: The prepared formulations contained 15–20% drug. The drug release patterns of different formulations were found to be reliant on infill percentage. Differential scanning calorimetry and thermo-gravimetric analysis confirmed that degradation temperature of drug is way above the printing temperature. Conclusion: This work is potentially significant for optimized antibiotic dosing, which in turn leads to enhanced clinical outcome.

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Ponsar, Hanna, Raphael Wiedey, and Julian Quodbach. "Hot-Melt Extrusion Process Fluctuations and Their Impact on Critical Quality Attributes of Filaments and 3D-Printed Dosage Forms." Pharmaceutics 12, no. 6 (June 3, 2020): 511. http://dx.doi.org/10.3390/pharmaceutics12060511.

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Fused deposition modeling (FDMTM) is a 3D-printing technology of rising interest for the manufacturing of customizable solid dosage forms. The coupling of hot-melt extrusion with FDMTM is favored to allow the production of pharma-grade filaments for the printing of medicines. Filament diameter consistency is a quality of great importance to ensure printability and content uniformity of 3D-printed drug delivery systems. A systematical process analysis referring to filament diameter variations has not been described in the literature. The presented study aimed at a process setup optimization and rational process analysis for filament fabrication related to influencing parameters on diameter inhomogeneity. In addition, the impact of diameter variation on the critical quality attributes of filaments (mechanical properties) and uniformity of mass of printed drug-free dosage forms was investigated. Process optimization by implementing a winder with a special haul-off unit was necessary to obtain reliable filament diameters. Subsequently, the optimized setup was used for conduction of rational extrusion analysis. The results revealed that an increased screw speed led to diameter fluctuations with a decisive influence on the mechanical resilience of filaments and mass uniformity of printed dosage forms. The specific feed load was identified as a key parameter for filament diameter consistency.

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Figueiredo, Sara, João Pinto, Fátima Carvalho, and Ana Fernandes. "Tuning of Paroxetine 3D-Printable Formulations for Fused Deposition Modelling." Medical Sciences Forum 5, no. 1 (July 20, 2021): 17. http://dx.doi.org/10.3390/msf2021005017.

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This work reports the preliminary development of paroxetine-containing formulations amenable to hot-melt extrusion coupled to fused deposition modelling-based 3D printing. Polymeric matrices were used alone, or added with processing enhancers (e.g., plasticizer and filler). The polymeric formulation containing paroxetine (30% w/w), hydroxypropylcellulose (54% w/w) and excipients (16% w/w of dicalcium dihydrate phosphate, magnesium stearate and triethylcitrate; 10:1:5 ratio) exhibited the most suitable behaviour to be extruded and 3D printed, proving that adjuvants are critical to ensure processing of the formulations.

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Siddharatha Dhoppalapudi and Narmada Illa. "A review of hot melt extrusion paired fused deposition modeling three-dimensional printing for developing patient centric dosage forms." GSC Biological and Pharmaceutical Sciences 21, no. 2 (November 30, 2022): 065–79. http://dx.doi.org/10.30574/gscbps.2022.21.2.0428.

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In recent years, the demand for developing patient-centric dosage forms is increasing enormously with the increasing patient population. Much research is ongoing exploring various additive manufacturing techniques for developing pharmaceutical medications. Poor solubility of drug substances and underdeveloped manufacturing strategies are majorly affecting the pharmaceutical industry's revenue. Developing intravenous dosage forms for drug substances with poor solubility will affect the revenue of the pharmaceutical industries. Thus, improving solubility remains to be the major prerequisite for the developmental scientist. In addition to improving solubility, establishing a robust manufacturing process with commercial viability is also essential. In recent years hot melt extrusion (HME) has been most widely investigated for developing amorphous solid dispersions (ASDs) over other techniques such as spray drying and KinetisolÒ. The process of HME can be coupled with the fused deposition modeling (FDM) three-dimensional (3D) printing technique which is capable of fabricating on-demand patient-centric dosage forms. A continuous manufacturing line can be established by painting HME and FDM 3D printing processes. The quality of the product can be controlled and monitored by employing suitable process analytical technology (PAT) tools. Though the process of the HME-paired FDM 3D printing process has resulted in various advantages compared to the conventional manufacturing process, still many limitations, such as the limited number of polymers, reproducibility, and stability, need to be addressed.

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Xu, Han, Farnoosh Ebrahimi, Ke Gong, Zhi Cao, Evert Fuenmayor, and Ian Major. "Hybrid Manufacturing of Oral Solid Dosage Forms via Overprinting of Injection-Molded Tablet Substrates." Pharmaceutics 15, no. 2 (February 3, 2023): 507. http://dx.doi.org/10.3390/pharmaceutics15020507.

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Since 3D printing allows for patient-specific dosage forms, it has become a major focus in pharmaceutical research. However, it is difficult to scale up drug product manufacturing. Injection molding has been used in conjunction with hot-melt extrusion to mass produce drug products, but making tailored solid dosage forms with this technology is neither cost-effective nor simple. This study explored the use of a combination of fused filament fabrication and injection molding to create patient-specific solid dosage forms. A tablet fixation and location template was used to overprint directly on injection-molded tablet bases, and theophylline was combined with polycaprolactone and Kollidon® VA64 via hot-melt extrusion to produce the filament. Dynamic mechanical analysis was used to evaluate the brittleness of the filament, and differential scanning calorimetry was used to analyze the thermal results. The results showed that theophylline had a flow promoting effect on the polymer blend and that overprinted tablets were manufactured faster than 3D-printed tablets. Drug release studies also showed that overprinted tablets released faster than injection-molded tablets. This method demonstrates the potential of hybrid manufacturing for the pharmaceutical industry as a means of bridging the gap between personalized dosage forms and mass production.

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Abdulkhaleq, Nuha Mohammed, and Mowafaq M. Ghareeb. "Combination of FDM 3D Printing and Compressed Tablet for Preparation of Baclofen as Gastro-Floating Drug Delivery System (Conference Paper )#." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN 1683 - 3597 E-ISSN 2521 - 3512) 31, Suppl. (February 16, 2023): 18–24. http://dx.doi.org/10.31351/vol31isssuppl.pp18-24.

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This study aimed to develop an oral drug delivery system for gastro-retentive sustained drug release of baclofen by using a 3D printed capsular device since baclofen has a short half-life of 2.5 to 4 hours and has a narrow absorption window. Firstly sustained-release tablets of baclofen were formulated through the hot-melt extrusion of various thermoplastic polymers and direct compression of the extrudate, then a capsular device was designed and 3D printed to contain two air pockets to enable floating of the device and has four windows for drug release. 3D printing of the capsular device was done by an FDM printer using biodegradable PLA filament, and the sustained release tablets were inserted into the device to allow the medicine to be released into the stomach over a longer period. An in vitro buoyance test and an in vitro dissolution test were used to examine the buoyancy and sustained-release features of the formulated gastro-floating system. Five sustained release formulas were developed using different thermoplastic polymers in hot-melt extrusion. Produced tablets were assayed for drug content, hardness, and friability while a DSC study was done on the selected formula. F 5 which contains 20% baclofen, 55% Eudragit RS-100, 20% ethylcellulose, and 5% PEG 4000 showed sustained release where the complete dissolution of the drug occurred in 12 hours, and the gastro-floating device remained floating all the time. This method has a great potential for developing various floating drug delivery systems with the required release profile.

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Chansatidkosol, Siraprapa, Chutima Limmatvapirat, Suchada Piriyaprasarth, Vipaluk Patomchaiviwat, and Sontaya Limmatvapirat. "Assessment of Shellac as Alternative Material for Preparation of Fused Deposition Modeling (FDM) 3D Printing Filaments." Key Engineering Materials 914 (March 21, 2022): 53–62. http://dx.doi.org/10.4028/p-fz3v68.

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The objective of this study was to assess feasibility of applying shellac as a biopolymer filament for using in fused deposition modeling (FDM) 3D printing. The shellac matrices were prepared through hot melt process by heating the ground shellac samples at 80°C in a silicone oil bath under continuous stirring for 15 min. Accelerated stability testing (annealing process) was also performed in order to evaluated thermal stability by re-heating shellac matrices at 80 °C for 12 h and 24 h in a hot air oven. The shellac matrices and annealed shellac matrices were then comparatively characterized. In the present study, all shellac matrices were investigated for physical appearance, acid value, insoluble solid, moisture content and also characterized by instrument analysis including Fourier-transform infrared (FTIR) spectroscopy, powder X-ray diffractometry (PXRD) and thermal analysis. The results demonstrated that shellac with initial heat (80°C, 15 min) and annealed at 80°C for 12 h had similar properties except the annealed shellac at 80°C for 24 h which shown the lower acid value and formed insoluble solid. The melting temperature, decomposition temperature and melting enthalpy of shellac were around 63-64°C, over than 200°C and 23 J/g, respectively. Furthermore, the extruded filament based on shellac was achieved by hot melt extrusion (HME) technique. The findings revealed that the shellac properties might be suitable to fabricate FDM filaments.

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Chung, Sooyeon, Priyanka Srinivasan, Peilun Zhang, Suresh Bandari, and Michael A. Repka. "Development of ibuprofen tablet with polyethylene oxide using fused deposition modeling 3D-printing coupled with hot-melt extrusion." Journal of Drug Delivery Science and Technology 76 (October 2022): 103716. http://dx.doi.org/10.1016/j.jddst.2022.103716.

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Cunha-Filho, Marcilio, Maísa RP Araújo, Guilherme M. Gelfuso, and Tais Gratieri. "FDM 3D printing of modified drug-delivery systems using hot melt extrusion: a new approach for individualized therapy." Therapeutic Delivery 8, no. 11 (November 2017): 957–66. http://dx.doi.org/10.4155/tde-2017-0067.

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Vo, Anh Q., Jiaxiang Zhang, Dinesh Nyavanandi, Suresh Bandari, and Michael A. Repka. "Hot melt extrusion paired fused deposition modeling 3D printing to develop hydroxypropyl cellulose based floating tablets of cinnarizine." Carbohydrate Polymers 246 (October 2020): 116519. http://dx.doi.org/10.1016/j.carbpol.2020.116519.

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Zhang, Ziru, Sheng Feng, Ahmed Almotairy, Suresh Bandari, and Michael A. Repka. "Development of multifunctional drug delivery system via hot-melt extrusion paired with fused deposition modeling 3D printing techniques." European Journal of Pharmaceutics and Biopharmaceutics 183 (February 2023): 102–11. http://dx.doi.org/10.1016/j.ejpb.2023.01.004.

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Tan, Deck Khong, Mohammed Maniruzzaman, and Ali Nokhodchi. "Development and Optimisation of Novel Polymeric Compositions for Sustained Release Theophylline Caplets (PrintCap) via FDM 3D Printing." Polymers 12, no. 1 (December 21, 2019): 27. http://dx.doi.org/10.3390/polym12010027.

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This study reports a thorough investigation combining hot-melt extrusion technology (HME) and a low-cost fused deposition modelling (FDM) 3D printer as a continuous fabrication process for a sustained release drug delivery system. The successful implementation of such an approach presented herein allows local hospitals to manufacture their own medical and pharmaceutical products on-site according to their patients’ needs. This will help save time from waiting for suitable products to be manufactured off-site or using traditional manufacturing processes. The filaments were produced by optimising various compositions of pharmaceutical-grade polymers, such as hydroxypropyl cellulose (HPC), Eudragit® (RL PO), and polyethylene glycol (PEG), whereas theophylline was used as a model thermally stable drug. For the purpose of the study, twin-screw hot-melt extrusion (HME) was implemented from the view that it would result in the formation of solid dispersion of drug in the polymeric carrier matrices by means of high shear mixing inside the heated barrel. Four filament compositions consisting of different ratios of polymers were produced and their properties were assessed. The mechanical characterisation of the filaments revealed quite robust properties of the filaments suitable for FDM 3D printing of caplets (PrintCap), whereas the solid-state analyses conducted via DSC and XRD showed amorphous nature of the crystalline drug dispersed in the polymeric matrices. Moreover, the surface analysis conducted via SEM showed a smooth surface of the produced filaments as well as caplets where no drug crystals were visible. The in vitro drug release study showed a sustained release profile over 10 h where about 80% of the drug was released from the printed dosage forms. This indicates that our optimised 3D printed caplets could be suitable for the development of sustained release on-demand drug delivery systems.

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Giri, Bhupendra, Eon Song, Jaewook Kwon, Ju-Hyun Lee, Jun-Bom Park, and Dong Kim. "Fabrication of Intragastric Floating, Controlled Release 3D Printed Theophylline Tablets Using Hot-Melt Extrusion and Fused Deposition Modeling." Pharmaceutics 12, no. 1 (January 17, 2020): 77. http://dx.doi.org/10.3390/pharmaceutics12010077.

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This work presents a novel approach for producing gastro-retentive floating tablets (GRFT) by coupling hot-melt extrusion (HME) and fused deposition three-dimensional printing (3DP). Filaments containing theophylline (THEO) within a hydroxypropyl cellulose (HPC) matrix were prepared using HME. 3DP tablets with different infill percentages and shell thickness were developed and evaluated to determine their drug content, floating behavior, dissolution, and physicochemical properties. The dissolution studies revealed a relationship between the infill percentage/shell thickness and the drug release behavior of the 3DP tablets. All the developed GRFTs possessed the ability to float for 10 h and exhibited zero-order release kinetics. The drug release could be described by the Peppas–Sahlin model, as a combination of Fickian diffusion and swelling mechanism. Drug crystallinity was found unaltered throughout the process. 3DP coupled with HME, could be an effective blueprint to produce controlled-release GRFTs, providing the advantage of simplicity and versatility compared to the conventional methods.

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Korte, Carolin, and Julian Quodbach. "Formulation development and process analysis of drug-loaded filaments manufactured via hot-melt extrusion for 3D-printing of medicines." Pharmaceutical Development and Technology 23, no. 10 (February 9, 2018): 1117–27. http://dx.doi.org/10.1080/10837450.2018.1433208.

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Chivate, Amit, Atul Garkal, Namdev Dhas, and Tejal Mehta. "Three Dimensional Printing by Hot-Melt Extrusion; New Era for Development of Personalized Medicines and Continuous Manufacturing of Pharmaceuticals." International Journal of Pharmaceutical Investigation 10, no. 3 (October 10, 2020): 233–36. http://dx.doi.org/10.5530/ijpi.2020.3.43.

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Pandey, B., and A. B. Khan. "Technological Advancements in Oral Films." International Journal of Drug Delivery Technology 9, no. 01 (January 9, 2019): 15–20. http://dx.doi.org/10.25258/ijddt.9.1.3.

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The aim of the review was to explore the necessity, advantages and different techniques of oral films for enhancing solubility of poorly soluble drugs with an emphasis on the newer, state-of the art technologies, such as 3D printing and hot-melt extrusion (HME). The historical background of oral films is presented along with the regularly used techniques. The modern approach of quality-by-design (QbD) is unravelled, identifying appropriate critical process parameters (CPP) and applied to oral films. A section is devoted modern technologies such as 3D printing and HME of oral films. Oral films are innovative formulations by which poorly soluble drugs have been founds to give positive results in enhancing their solubility and dissolution characteristics. With modern sophisticated techniques, precise mass production of oral films has been given a thrust. Oral films have better patient compliance, improved biopharmaceutical properties, improved efficacy, and better safety. By applying QbD and implementation of modern technologies the newer generation of oral films are yielding promising results

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Hoffmann, Lena, Jörg Breitkreutz, and Julian Quodbach. "Fused Deposition Modeling (FDM) 3D Printing of the Thermo-Sensitive Peptidomimetic Drug Enalapril Maleate." Pharmaceutics 14, no. 11 (November 8, 2022): 2411. http://dx.doi.org/10.3390/pharmaceutics14112411.

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Fused deposition modeling (FDM) 3D printing was used to produce 3D printed tablets with the thermo-sensitive model peptidomimetic drug enalapril maleate (EM). Two different formulations were prepared to investigate the degradation of enalapril maleate during the FDM 3D printing process. Soluplus® and Eudragit® E PO were chosen as polymers. After hot-melt extrusion (HME) and FDM 3D printing, both formulations were characterised regarding their solid-state properties using DSC and XRD. The degradation of the drug was analysed by determination of the content in the extrudates and 3D printed tablets, and dissolution was assessed. Various approaches have been attempted to prevent degradation of enalapril maleate, including utilization of a larger nozzle diameter and higher printing speeds to reduce heat exposition. None of these approaches were successful in preventing drug degradation. However, significant differences in the amount of degradation between the two formulations with different polymers could be observed. Thus, the FDM 3D printing process was not feasible without any degradation for the thermo-sensitive drug enalapril maleate. A maximum of 85.55 ± 1.48% enalapril was recovered in Eudragit® E PO tablets printed with a 0.4 mm nozzle at a temperature of 180 °C and with a speed of 30 mm/s.

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Kavimughil, M., M. Maria Leena, J. A. Moses, and C. Anandharamakrishnan. "Effect of material composition and 3D printing temperature on hot-melt extrusion of ethyl cellulose based medium chain triglyceride oleogel." Journal of Food Engineering 329 (September 2022): 111055. http://dx.doi.org/10.1016/j.jfoodeng.2022.111055.

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Nashed, Nour, Matthew Lam, and Ali Nokhodchi. "A comprehensive overview of extended release oral dosage forms manufactured through hot melt extrusion and its combination with 3D printing." International Journal of Pharmaceutics 596 (March 2021): 120237. http://dx.doi.org/10.1016/j.ijpharm.2021.120237.

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Terenteva, O. A., K. A. Gusev, V. V. Tikhonova, D. N. Maimistov, G. A. Shandryuk, and E. V. Flisyuk. "Three-dimensional printing of ramipril tablets by fused deposition modeling." Drug development & registration 10, no. 4 (December 24, 2021): 79–87. http://dx.doi.org/10.33380/2305-2066-2021-10-4(1)-79-87.

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Introduction. Arterial hypertension is one of the main risk factors for the development of cardiovascular diseases. Drug treatment of arterial hypertension is associated with a number of difficulties: often requires combination therapy, also a possible change in either dosages or drugs during treatment during the patient's life. Three-dimensional printing allows to create individual medicines on-demand.Aim. Study suitability of Kollidon® VA 64 as a matrix-polymer for the preparation of immediate release ramipril printing tablets.Materials and methods. Substance: ramipril; excipients: Kollidon® VA 64, Kollidon® CL-F, Soluplus®, PEG 1500, sodium carbonate anhydrous, Poloxamer 188, sodium stearyl fumarate, mannitol; reagents: hydrochloric acid, acetonitrile for ultra-HPLC, sodium octanesulfonate for HPLC, orthophosphoric acid 85 %, sodium perchlorate analytical grade, triethylamine, standard: ramipril USP (№1598303). Ramipril filaments were prepared by hot melt extrusion on the extruder Haake™ miniCTW (Thermo Fisher Scientific). The tablets were printed on a hand-made 3D printer. The printlets were studied for friability and hardness. Uniformity and quantitative determination of ramipril and impurities in tablets and filaments were determined by high performance liquid chromatography on a Shimadzu Prominence LC liquid chromatograph. Stability of ramipril was studied on a DSC 3+ Mettler Toledo by differential scanning calorimetry. Also, the stability of ramipril was determined by the Raman spectroscopy on an analytical system ORTES-785TRS-2700.Results and discussion. Ramipril filaments with a diameter of 1.75 mm were obtained by melt extrusion at a temperature of 105 °C. They were homogeneous in quantitative content of the active substance. From the resulting filaments, tablets were printed in five configurations with three filling densities: 30 %, 50 % and 100 %. Degradation of ramipril in filaments and tablets is not observed. The melting point of the selected mixture is lower than the melting point of matrix-polymer. It makes possible to lower the processing temperature. Tablets with 100 % filling provide an immediate release of ramipril.Conclusion. Kollidon® VA 64 is suitable as a matrix-polymer for the development of immediate release ramipril printlets. Kollidon® VA 64 provides the necessary physical and processing properties of the filament required for FDM printing.

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Kim, Chang Geun, Kyung Seok Han, Sol Lee, Min Cheol Kim, Soo Young Kim, and Junghyo Nah. "Fabrication of Biocompatible Polycaprolactone–Hydroxyapatite Composite Filaments for the FDM 3D Printing of Bone Scaffolds." Applied Sciences 11, no. 14 (July 9, 2021): 6351. http://dx.doi.org/10.3390/app11146351.

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Recently, three-dimensional printing (3DP) technology has been widely adopted in biology and biomedical applications, thanks to its capacity to readily construct complex 3D features. Using hot-melt extrusion 3DP, scaffolds for bone tissue engineering were fabricated using a composite of biodegradable polycaprolactone (PCL) and hydroxyapatite (HA). However, there are hardly any published reports on the application of the fused deposition modeling (FDM) method using feed filaments, which is the most common 3D printing method. In this study, we report on the fabrication and characterization of biocompatible filaments made of polycaprolactone (PCL)/hydroxyapatite (HA), a raw material mainly used for bone scaffolds, using FDM 3D printing. A series of filaments with varying HA content, from 5 to 25 wt.%, were fabricated. The mechanical and electrical properties of the various structures, printed using a commercially available 3D printer, were examined. Specifically, mechanical tensile tests were performed on the 3D-printed filaments and specimens. In addition, the electrical dielectric properties of the 3D-printed structures were investigated. Our method facilitates the fabrication of biocompatible structures using FDM-type 3DP, creating not only bone scaffolds but also testbeds for mimicking bone structure that may be useful in various fields of study.

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Buyukgoz, Guluzar Gorkem, Christopher Gordon Kossor, and Rajesh N. Davé. "Enhanced Supersaturation via Fusion-Assisted Amorphization during FDM 3D Printing of Crystalline Poorly Soluble Drug Loaded Filaments." Pharmaceutics 13, no. 11 (November 4, 2021): 1857. http://dx.doi.org/10.3390/pharmaceutics13111857.

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Filaments loaded with griseofulvin (GF), a model poorly water-soluble drug, were prepared and used for 3D printing via fused deposition modeling (FDM). GF was selected due to its high melting temperature, enabling lower temperature hot-melt extrusion (HME) keeping GF largely crystalline in the filaments, which could help mitigate the disadvantages of high HME processing temperatures such as filament quality, important for printability and the adverse effects of GF recrystallization on tablet properties. Novel aspects include single-step fusion-assisted ASDs generation during FDM 3D printing and examining the impact of tablet surface areas (SA) through printing multi-mini and square-pattern perforated tablets to further enhance drug supersaturation during dissolution. Kollicoat protect and hydroxypropyl cellulose were selected due to their low miscibility with GF, necessary to produce crystalline filaments. The drug solid-state was assessed via XRPD, DSC and FT-IR. At 165 °C HME processing temperature, the filaments containing ~80% crystalline GF were printable. Fusion-assisted 3D printing led to GF supersaturation of ~153% for cylindrical tablets and ~293% with the square-pattern perforated tablets, indicating strong monotonous impact of tablet SA. Dissolution kinetics of drug release profiles indicated Fickian transport for tablets with higher SA, demonstrating greater SA-induced drug supersaturation for well-designed 3D printed tablets.

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Chamberlain, Rebecca, Hellen Windolf, Simon Geissler, Julian Quodbach, and Jörg Breitkreutz. "Precise Dosing of Pramipexole for Low-Dosed Filament Production by Hot Melt Extrusion Applying Various Feeding Methods." Pharmaceutics 14, no. 1 (January 17, 2022): 216. http://dx.doi.org/10.3390/pharmaceutics14010216.

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The aim of this research was the production of low-dosed filaments via hot-melt extrusion (HME) with the model drug pramipexole for the treatment of Parkinson’s disease. The active pharmaceutical ingredient (API) and one of the polymers polyvinyl alcohol (PVA) or basic butylated methacrylate copolymer (bPMMA) were fed by various dosing techniques with the aim of achieving the smallest deviation (RSD) from the target concentration of 0.1% (w/w) pramipexole. It was found that deviation from target pramipexole concentration occurred due to degradation products in bPMMA formulations. Additionally, material temperature above 120 °C led to the formation of the anhydrous form of pramipexole within the extruded filaments and need to be considered in the calculation of the recovered API. This study clearly shows that even if equilibrium state of the extrusion parameters was reached, equilibrium condition for drug content was reached relatively late in the process. In addition, the RSD calculated by the Stange–Poole equation was proposed by us to predict the final content uniformity considering the sample size of the analyzed filament. The calculated RSD, depending on sample size and drug load, can serve as upper and lower limits of variation from target concentration and can be used to evaluate the deviations of drug content in equilibrium conditions of the HME process. The lowest deviations from target concentration in equilibrium condition for drug content were obtained in filaments extruded from previously prepared granule mixtures (RSD = 6.00%, acceptance value = 12.2). These promising results can be transferred to other API–excipient combinations to produce low-dosed filaments, which can be used for, e.g., fused filament 3D printing. The introduced calculation of the RSD by Stange–Poole equation can be used for precise determination of the homogeneity of an extruded batch.

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Boniatti, Janine, Patricija Januskaite, Laís B. da Fonseca, Alessandra L. Viçosa, Fábio C. Amendoeira, Catherine Tuleu, Abdul W. Basit, Alvaro Goyanes, and Maria-Inês Ré. "Direct Powder Extrusion 3D Printing of Praziquantel to Overcome Neglected Disease Formulation Challenges in Paediatric Populations." Pharmaceutics 13, no. 8 (July 21, 2021): 1114. http://dx.doi.org/10.3390/pharmaceutics13081114.

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For the last 40 years, praziquantel has been the standard treatment for schistosomiasis, a neglected parasitic disease affecting more than 250 million people worldwide. However, there is no suitable paediatric formulation on the market, leading to off-label use and the splitting of commercial tablets for adults. In this study, we use a recently available technology, direct powder extrusion (DPE) three-dimensional printing (3DP), to prepare paediatric Printlets™ (3D printed tablets) of amorphous solid dispersions of praziquantel with Kollidon® VA 64 and surfactants (Span™ 20 or Kolliphor® SLS). Printlets were successfully printed from both pellets and powders obtained from extrudates by hot melt extrusion (HME). In vitro dissolution studies showed a greater than four-fold increase in praziquantel release, due to the formation of amorphous solid dispersions. In vitro palatability data indicated that the printlets were in the range of praziquantel tolerability, highlighting the taste masking capabilities of this technology without the need for additional taste masking excipients. This work has demonstrated the possibility of 3D printing tablets using pellets or powder forms obtained by HME, avoiding the use of filaments in fused deposition modelling 3DP. Moreover, the main formulation hurdles of praziquantel, such as low drug solubility, inadequate taste, and high and variable dose requirements, can be overcome using this technology.

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Hu, Zhiqing, Pengchong Xu, Jiaxiang Zhang, Suresh Bandari, and Michael A. Repka. "Development of controlled release oral dosages by density gradient modification via three-dimensional (3D) printing and hot-melt extrusion (HME) technology." Journal of Drug Delivery Science and Technology 71 (May 2022): 103355. http://dx.doi.org/10.1016/j.jddst.2022.103355.

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Journal articles on the topic 'Hot-melt ram extrusion printing'

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