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Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process with Kolliphor® P407
23 Jul 2024 | Contributor(s):: Pawar, Jaywant, Narkhede, Rajkiran, Amin, Purnima, Tawde, Vaishali
The aim of the present context was to develop and evaluate a Kolliphor® P407-based transdermal gel formulation of diclofenac sodium by hot melt extrusion (HME) technology; central composite design was used to optimize the formulation process. In this study, we have explored first time ever HME as...
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Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach
Peer-reviewed journal | 06 Sep 2023 | Contributor(s):: Siva Ram Munnangi, Ahmed Adel Ali Youssef, Nagarjuna Narala, Preethi Lakkala, Sateesh Kumar Vemula, Rohit Alluri, Feng Zhang, Micheal A. Repka
Conventional cyclodextrin complexation enhances the solubility of poorly soluble drugs but is solvent-intensive and environmentally unfavorable. This study evaluated solvent-free hot-melt extrusion (HME) for forming cyclodextrin inclusion complexes to improve the solubility and dissolution of...
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Towards a novel continuous HME-Tableting line: Process development and control concept
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Sacher, Stephan, Celikovic, Selma, Rehrl, Jakob, Poms, Johannes, Kirchengast, Martin, Kruisz, Julia, Sipek, Martin, Salar-Behzadi, Sharareh, Berger, Hannes, Stark, Gerald, Horn, Martin, Khinast, Johannes G.
The objective of this study was to develop a novel closed-loop controlled continuous tablet manufacturing line, which first uses hot melt extrusion (HME) to produce pellets based on API and a polymer matrix. Such systems can be used to make complex pharmaceutical formulations, e.g., amorphous...
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The optimization of process analytical technology for the inline quantification of multiple drugs in fixed dose combinations during continuous processing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Dadou, SM, Tian, YWLi, S, Jones, DS, Andrews, GP
Complications associated with uncontrolled hypertension are considered the major cause of premature death worldwide. Fixed-dose combinations (FDCs) offer an alternative approach to polypharmacy with the aim to improve patient compliance. Process Analytical Technology (PAT) is gaining momentum as...
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The development of an inline Raman spectroscopic analysis method as a quality control tool for hot melt extruded ramipril fixed-dose combination products
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Andres, G.P., Jones D.S., Senta-Loys Z., Almajaan A., Li S., Chevallier O., Elliot C., Healy A.M., Kelleher J.F., Madi A.M., Gilvary G.C., Tian Y.a
Currently in the pharmaceutical industry, continuous manufacturing is an area of significant interest. In particular, hot-melt extrusion (HME) offers many advantages and has been shown to significantly reduce the number of processing steps relative to a conventional product manufacturing line. To...
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The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Dadou, Suha, Senta-Loys, Zoe, Almajaan, Ammar, Li, Shu, Jones, David, Healy, Anne, Tian, Yiwei, Andrews, Gavin
Continuous processing is superseding conventional batch processing as a means of manufacturing within the pharmaceutical Research Article/industry. This paradigm shift has led to the implementation of Process Analytical Technology (PAT) as a semi-automatic, predictive tool offering real-time...
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Tablet coating by injection molding technology - Optimization of coating formulation attributes and coating process parameters
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Desai, Parind M., Puri, Vibha, Brancazio, David, Halkude, Bhakti S., Hartman, Jeremy E., Wahane, Aniket V., Martinez, Alexander R., Jensen, Keith D., Harinath, Eranda, Braatz, Richard D., Chun, Jung-Hoon, Trout, Bernhardt L.
We developed and evaluated a solvent-free injection molding (IM) coating technology that could be suitable for continuous manufacturing via incorporation with IM tableting. Coating formulations (coating polymers and plasticizers) were prepared using hot-melt extrusion and screened via...
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Recent progress in continuous and semi-continuous processing of solid oral dosage forms: a review
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Tezyk, Michal, Ernst, Andrzej, Milanowski, Bartlomiej, Lulek, Janina
Continuous processing is an innovative production concept well known and successfully used in other industries for many years. The modern pharmaceutical industry is facing the challenge of transition from a traditional manufacturing approach based on batch-wise production to a continuous...
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Process Design and Control of a Twin Screw Hot Melt Extrusion for Continuous Pharmaceutical Tamper-Resistant Tablet Production
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Baronsky-Probst, J., Möltgen, C.-V., Kessler, W., Kessler, R.W.
Hot melt extrusion (HME) is a well-known process within the plastic and food industries that has been utilized for the past several decades and is increasingly accepted by the pharmaceutical industry for continuous manufacturing. For tamper-resistant formulations of e.g. opioids, HME is the most...
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Pharmaceutical Applications of Hot-Melt Extrusion: Continuous Manufacturing, Twin-Screw Granulations, and 3D Printing
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Maniruzzaman , Mohammed
Recently, hot-melt extrusion (HME) techniques have been presented as innovative platforms to produce various pharmaceuticals. HME is an emerging processing technology used primarily for the manufacture of pharmaceutical solid dispersions. It also combines the advantages of a solvent-free process...
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Melt extrusion with poorly soluble drugs - An integrated review
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Repka, Michael A., Bandari, Suresh, Kallakunta, Venkata Raman, Vo, Anh Q., McFall, Haley, Pimparade, Manjeet B., Bhagurkar, Ajinkya M.
Over the last few decades, hot melt extrusion (HME) has emerged as a successful technology for a broad spectrum of applications in the pharmaceutical industry. As indicated by multiple publications and patents, HME is mainly used for the enhancement of solubility and bioavailability of poorly...
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Integrated hot-melt extrusion - injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Desai, Parind M, Hogan, Rachael C., Brancazio, David, Puri, Vibha, Jensen, Keith D., Chun, Jung-Hoon, Myerson, Allan S., Trout, Bernhardt L.
This study provides a framework for robust tablet development using an integrated hot-melt extrusion-injection molding (IM) continuous manufacturing platform. Griseofulvin, maltodextrin, xylitol and lactose were employed as drug, carrier, plasticizer and reinforcing agent respectively. A...
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Inline monitoring and a PAT strategy for pharmaceutical hot-melt extrusion
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Wahl, PR, Treffer, DMohr, S, Roblegg, E, Koscher, G, Khinast, JG
Implementation of continuous manufacturing in the pharmaceutical industry requires tight process control. This study focuses on a PAT strategy for hot melt extrusion of vegetable calcium stearate (CaSt) as matrix carrier and paracetamol as active pharmaceutical ingredient (API). The extrusion was...
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In-line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Schlindwein, Walkiria, Bezerra, Mariana, Almeida, Juan, Berghaus, Andreas, Owen, Martin, Muirhead, Gordon
This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing process and UV–Vis spectroscopy as an in-line...
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Improving Pellet Quality in a Pharmaceutical Hot Melt Extrusion Process via PID Control and LOLIMOT-Based MPC
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Rehrl, J, Kirchengast, MCelikovic, S, Sacher, S, Kruisz, J, Khinast, J, Horn, M
Purpose The aim of this paper is the development of a process control concept for a hot melt extrusion (HME) and pelletization process. The new concept should improve the particle size distribution of the pellets produced. Methods Production of pellets containing an active pharmaceutical...
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Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Patil, H, Tiwari, RV, Repka, MA
Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently...
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Formation of Ciprofloxacin-Isonicotinic Acid Cocrystal Using Mechanochemical Synthesis Routes-An Investigation into Critical Process Parameters
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Karimi-Jafari, M, Ziaee, AO'Reilly, E, Croker, D, Walker, G
The mechanochemical synthesis of cocrystals has been introduced as a promising approach of formulating poorly water-soluble active pharmaceutical ingredients (APIs). In this study, hot-melt extrusion (HME) as a continuous process and grinding and ball milling as batch processes were employed to...
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Development of Maltodextrin-Based Immediate-Release Tablets Using an Integrated Twin-Screw Hot-Melt Extrusion and Injection-Molding Continuous Manufacturing Process
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Puri, Vibha, Brancazio, Dave, Desai, Parind M., Jensen, Keith D., Chun, Jung-Hoon, Myerson, Allan S., Trout, Bernhardt L.
The combination of hot-melt extrusion and injection molding (HME-IM) is a promising process technology for continuous manufacturing of tablets. However, there has been limited Research Article on its application to formulate crystalline drug-containing immediate-release tablets. Furthermore,...
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Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Tiwari, RV, Patil, H, Repka, MA
Introduction: Hot-melt extrusion (HME) technology is applied successfully in the plastic, rubber and food industry. HME has also emerged as an important technology for drug delivery applications in pharmaceutical Research Article and manufacturing because of its process automation and low-cost...
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Continuous, one-step synthesis of pharmaceutical cocrystals via hot melt extrusion from neat to matrix-assisted processing - State of the art
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Gajda, Maciej, Nartowski, Karol P., Pluta, Janusz, Karolewicz, Bożena
Use of hot melt extrusion (HME) as continuous manufacturing process in the cocrystal synthesis is of increasing interest from both industrial and academic perspective and it is seen as a newly developing branch of mechanochemistry with possible broad application in single step synthesis and...
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Continuous manufacturing of co-crystals: challenges and prospects
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Chavan, Rahul, Thipparaboina, Rajesh, Yadav, Balvant, Shastri, Nalini
The last decade has witnessed extensive growth in the field of co-crystallization for mitigating the solubility and dissolutionrelated issues of poorly soluble drugs. This is largely because co-crystals can modify the physicochemical properties of drugs without any covalent modification in the...
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Continuous Manufacturing of Ketoprofen Delayed Release Pellets Using Melt Extrusion Technology: Application of QbD Design Space, Inline Near Infrared, and Inline Pellet Size Analysis
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Vo, Anh, Kutz, Gerd, He, Herman, Narala, Sagar, Bandari, Suresh, Repka, Michael A.
Delayed-release dosage forms are mainly manufactured as batch processes and include coated tablets, pellets, or particles with gastric resistant polymers. Authors propose a novel approach using the hot-melt extrusion technique to prepare delayed release dosage forms via a continuous manufacturing...
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Advanced methodologies for cocrystal synthesis
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Douroumis, D, Ross, SA, Nokhodchi, A
Pharmaceutical cocrystals are multicomponent systems composed of two or more molecules and held together by H-bonding. Currently, cocrystals provide exciting opportunities in the pharmaceutical industry for the development and manufacturing of new medicines by improving poor physical properties...
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A solution for low-dose feeding in continuous pharmaceutical processes
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Sacher, S, Heindl, NUrich, JAA, Kruisz, J, Khinast, JG
Continuous feeding of small quantities of powder is increasingly applied in pharmaceutical manufacturing. With that regard, what is crucial is not only the feasibility, but also the accuracy and stability. To enable stable processing, low amounts of various agents, e.g., lubricants, can be used....
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A review on the taste masking of bitter APIs: hot-melt extrusion (HME) evaluation
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Maniruzzaman, M, Boateng, JSChowdhry, BZ, Snowden, MJ, Douroumis, D
The majority of active pharmaceutical ingredients (APIs) found in oral dosage forms have a bitter taste. Masking the unpleasant taste of bitter, APIs is a major challenge in the development of such oral dosage forms. Taste assessment is an important quality-control parameter for evaluating...