Hot-Melt Extrusion (HME): From Process to Pharmaceutical Applications

Maniruzzaman, Mohammed; Douroumis, Dennis; Boateng, Joshua; Snowden, Martin J.

doi:10.5772/51582

Cited by 6 publications

(9 citation statements)

References 51 publications

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“…TSE holds many advantages for the pharmaceutical industry, as highlighted by Andrews et al [48] and Maniruzzaman et al [43,44] These include solvent-free, continuous processing, access to several screw profiles, and, particularly, the improvement in component uniformity, which is a result of the intense mixing possible with TSE. [48] Also, APIs do not undergo significant compression during extrusion, and so the API is unlikely to undergo polymorphic change as a result of compressive forces.…”

Section: Extrusion In Pharmaceutical Manufacturingmentioning

confidence: 99%

“…[43] This involves simply carrying out the extrusion (TSE) process at elevated temperatures, such that one or more components is in the melt phase. The U.S. Food and Drug Administration (FDA) established the process analytical technology (PAT) scheme, [44] which encourages, supports, and regulates the use of extrusion in the pharmaceutical industry. More recently, HME has been used for taste masking.…”

Section: Extrusion In Pharmaceutical Manufacturingmentioning

confidence: 99%

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Recent Developments in Mechanochemical Materials Synthesis by Extrusion

Crawford¹,

Casabán

2016

Advanced Materials

128

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Mechanochemical synthesis, i.e., reactions conducted by grinding solid reactants together with no or minimal solvent, has been demonstrated as an excellent technique for the formation of both organic and inorganic compounds. Mechanochemistry is viewed as an alternative approach to chemical synthesis and is not always considered when developing manufacturing processes of fine chemicals. Here, recent advances are highlighted regarding mechanochemical synthesis, by utilizing a well-developed continuous technique - extrusion, and the advantages it offers to further support its use in the manufacturing of these chemicals. To put this work into context, it is shown how extrusion plays a vital role for manufacturing in the food, polymer, and pharmaceutical industries, and how the research carried out by these respective industrialists provides great insight and understanding of the technique, with the results being applicable in the chemical industry. The synthesis of metal-organic frameworks (MOFs) is highlighted herein as an excellent example showcasing the advantages that extrusion provides to the manufacture of these materials, one advantage being the exceptional space time yields (STYs) reported for these processes, at three orders of magnitude greater than conventional (solvothermal) synthesis.

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Section: Extrusion In Pharmaceutical Manufacturingmentioning

confidence: 99%

Section: Extrusion In Pharmaceutical Manufacturingmentioning

confidence: 99%

Recent Developments in Mechanochemical Materials Synthesis by Extrusion

Crawford¹,

Casabán

2016

Advanced Materials

128

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“…The excipients and the API are heated and homogenised by a screw extruder until they are fully blended. The blend is passed through a flat extrusion die which presses the extrudate into the desired film shape, cooled and cut to the required size and packaged [96].…”

Section: Figure 2: the Hot Melt Extrusion Processmentioning

confidence: 99%

Oral Thin Films As a Remedy for Noncompliance in Pediatric and Geriatric Patients

et al. 2019

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Paediatric and geriatric patients experience swallowing difficulties for traditional oral dosage forms, such as tablets. Further, microbial contamination, chemical stability, unpleasant taste and swallowing large volumes of fluids have led to low therapeutic efficacy and patient noncompliance. The emergence of oral thin films has resulted in dramatic improvements in compliance and drug therapy outcomes in paediatric and geriatric patients. Oral thin films do not require water for administration, are readily hydrated upon contact with saliva, adhere to the mucosa and disintegrate ideally under one minute. This article provides an overview of oral thin films, modern trends in their formulation and characterisation, available commercial products, information to fill knowledge gaps and future potential and economic prospects of oral thin film technology, with emphasis on their use in the paediatric and geriatric patient groups.

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“…Since its introduction during the late 1970s, HME has been utilized successfully in manufacturing pharmaceutical products for multiple drug delivery strategies [1][2][3][4][5][6][7][8][9][25][26][27][28]. HME can be adopted as a CM platform by optimizing a suitable set of instrumentations (Figure 1).…”

Section: And Hme Processing Technologymentioning

confidence: 99%

“…HME has been successfully applied to develop multiple drug delivery systems for various applications (e.g., solubility enhancement, sustained release, taste masking, implants and films and/or strips) since the early 1970s [1][2][3][4][5]. HME-based applications for pharmaceutical manufacturing date back to 1930s where HME was started mainly for its commercial exploitation in the plastics [6,7] and food industry [8,9]. HME has emerged as a complementary pharmaceutical manufacturing technology to develop solid dispersions of challenging drug candidates to enhance their physicochemical properties [1].…”

Section: Introductionmentioning

confidence: 99%

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

Maniruzzaman

Nokhodchi

2017

Drug Discovery Today

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A c c e p t e d M a n u s c r i p t Highlights  HME can be exploited in a broad range of applications for advanced drug delivery  Unique advantages to be utilised in a solvent free manufacturing platform  A means to explore the potential of continuous manufacture of pharmaceuticals  Scale-up issue considerations, from an FDA compliance point of view  HME regulatory guidelines for the manufacture of novel drug delivery systems Ali NokhodchiAli Nokhodchi is a professor of pharmaceutics and drug delivery at the University of Sussex. He has supervised over 120 Mpharm, PharmD, and MSc students and 15 PhD postgraduate students at several institutions in various fields of pharmaceutical formulations and drug delivery. He is an editorial board member of over 20 peer-reviewed international journals. Ali has published over 185 research articles in various fields of pharmaceutics, including tableting, particle engineering, inhalation, nanoparticles, dissolution, skin delivery, and controlled-release formulations. In addition, he has published five book chapters on skin, controlled-release formulations, particle engineering, and inhalation products. Ali has also been the editor of a book on pulmonary delivery published by Wiley in 2015. He has been the recipient of several prizes in pharmaceutical sciences and has been listed by Essential Science Indicators in the top 1% scientists in the field of pharmacology and toxicology.Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.

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Hot-Melt Extrusion (HME): From Process to Pharmaceutical Applications

Cited by 6 publications

References 51 publications

Recent Developments in Mechanochemical Materials Synthesis by Extrusion

Recent Developments in Mechanochemical Materials Synthesis by Extrusion

Oral Thin Films As a Remedy for Noncompliance in Pediatric and Geriatric Patients

Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

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