Characterisation and modelling of the thermorheological properties of pharmaceutical polymers and their blends using capillary rheometry: Implications for hot melt processing of dosage forms

Jones, David S.; Margetson, Daniel N.; McAllister, Mark; Andrews, Gavin

doi:10.1016/j.ijpharm.2015.07.024

Cited by 12 publications

(4 citation statements)

References 46 publications

(47 reference statements)

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“…For both processes, the rheological properties of the molten material are very important to enable extrusion through the extruder die or printer nozzle. Thus, a capillary rheometer was chosen to characterize the melt flow behaviour of materials through viscosity measurements at a range of shear conditions and process-relevant temperatures (Jones, Margetson et al, 2015).…”

Section: Rheology Studies Of Molten Materials To Understand Its Behav...mentioning

confidence: 99%

3D printing of pharmaceutical oral solid dosage forms by fused deposition: The enhancement of printability using plasticised HPMCAS

Oladeji

Mohylyuk

Andrews

2022

International Journal of Pharmaceutics

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Section: Rheology Studies Of Molten Materials To Understand Its Behav...mentioning

confidence: 99%

3D printing of pharmaceutical oral solid dosage forms by fused deposition: The enhancement of printability using plasticised HPMCAS

Oladeji

Mohylyuk

Andrews

2022

International Journal of Pharmaceutics

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“…Hot‐melt extrusion (HME) has been successfully exploited for the manufacturing of oral thin films or strips due to its unique advantages . HME is a solvent‐free green technology, easy to scale up and operates in a continuous mode . Another key advantage of HME is that robust extruded films/strips can be obtained in a single processing step making the process economically viable.…”

Section: Introductionmentioning

confidence: 99%

“…[8] HME is a solvent-free green technology, easy to scale up and operates in a continuous mode. [9][10][11] Another key advantage of HME is that robust extruded films/strips can be obtained in a single processing step making the process economically viable. In a HME process, melt extruded strips are produced via feeding the blends of appropriate amounts of the relevant polymer(s), drug, plasticiser and other excipients into the preheated extruder barrel and conveying them with rotating screws into homogenous sheets.…”

Section: Introductionmentioning

confidence: 99%

Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing

Maniruzzaman

Farias

Slipper

et al. 2016

Journal of Pharmacy and Pharmacology

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Abstract:Objectives The aim of this study was to develop mucoadhesive oral strips using hot-melt extrusion as a continuous manufacturing process. Methods Powder blends of ketoconazole, a water insoluble drug; either hydroxypropyl methylcellulose (HPMC) or soluplus (SOL), sorbitol (SRB) and magnesium aluminometasilicate (MAS) were extruded to manufacture thin strips with 0.5 mm thickness. The presence of the inorganic metasilicate facilitated smooth processing of the extruded strips as it worked as an absorbent directly impacting on the extensive mixing of the drug/excipients inside the extruder barrel. Key findings The use of MAS also favoured the rapid hydration, swelling and eventual disintegration of the strips. Differential scanning calorimetry (DSC) and transmission X-ray diffraction (TXRD) analysis revealed the existence of the amorphous drug within the extruded strips. Scanning electron microscopy (SEM) and energy dispersive X-Ray (EDS) undertaken on the formulations showed a homogeneous drug distribution within the extruded strips. Conclusion The strips produced via continuous HME processing showed significantly faster release of KTZ compared to the bulk drug substance. Journal of Pharmacy and Key findingsThe use of MAS also favoured the rapid hydration, swelling and eventual disintegration of the strips. Differential scanning calorimetry (DSC) and transmission X-ray diffraction (TXRD) analysis revealed the existence of the amorphous drug within the extruded strips. Scanning electron microscopy (SEM) and energy dispersive X-Ray (EDS) undertaken on the formulations showed a homogeneous drug distribution within the extruded strips. ConclusionThe strips produced via continuous HME processing showed significantly faster release of KTZ compared to the bulk drug substance.

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“…Jones et al [54] determined the thermorheological properties of Eudragit E100 and hydroxypropylcellulose and their blends by implementing advanced capillary rheometry. The study was conducted either in the presence or absence of the drug.…”

Section: Applications Via Hmementioning

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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Characterisation and modelling of the thermorheological properties of pharmaceutical polymers and their blends using capillary rheometry: Implications for hot melt processing of dosage forms

Cited by 12 publications

References 46 publications

3D printing of pharmaceutical oral solid dosage forms by fused deposition: The enhancement of printability using plasticised HPMCAS

3D printing of pharmaceutical oral solid dosage forms by fused deposition: The enhancement of printability using plasticised HPMCAS

Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing

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

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