Effect of material properties on the residence time distribution (RTD) characterization of powder blending unit operations. Part II of II: Application of models

Escotet‐Espinoza, M. Sebastian; Moghtadernejad, Sara; Oka, Sarang; Wang, Zilong; Wang, Yifan; Román-Ospino, Andrés D.; Schäfer, Elisabeth; Cappuyns, Philippe; Assche, Ivo Van; Futran, Mauricio; Muzzio, Fernando J.; Ierapetritou, Marianthi G.

doi:10.1016/j.powtec.2018.12.051

Cited by 41 publications

(16 citation statements)

References 45 publications

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“…An example of RTD applied to a DC CM process gives more details [ 53 ]. Two papers aim to focus thinking on the development of standard methods for conducting, interpreting and using RTD results in CM processes [ 54 , 55 ].…”

Section: Quality Considerations Of CM Processesmentioning

confidence: 99%

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Wahlich¹

2021

Pharmaceutics

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Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.

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Section: Quality Considerations Of CM Processesmentioning

confidence: 99%

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Wahlich¹

2021

Pharmaceutics

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“…where ω is the blade's angular speed in revolutions per minute. Given the linear correlation to the space time, the number of blade passes has been associated with a higher degree of mixing and with improved blend homogeneity (12,(24)(25)(26).…”

Section: Background Blender Metricsmentioning

confidence: 99%

Mixing Cell: a Device to Mimic Extent of Lubrication and Shear in Continuous Tubular Blenders

et al. 2019

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Continuous manufacturing (CM) has clear potential for manufacturing solid oral dosages. It provides several advantages that may aid the manufacturing and quality of drug products. However, one of the main challenges of this technology is the relatively large amount of knowledge required and the amounts of material needed to develop the process during the early stages of development. Early process development evaluations of continuous manufacturing equipment often require larger amounts of material compared with batch, which hinder CM prospect for drugs during the early stages of process development. In this work, a small-scale evaluation of the mixing process occurring in a continuous mixing system was performed. The evaluation involved the use of a small-scale "mixing cell" which was able to replicate the lubrication process of a continuous mixer. It is worth mentioning that we designed the mixing cell by reconfiguration of an existing continuous tubular blender. The extent of lubrication evaluation was performed for three example formulations and was done by mimicking the amount of shear provided to a formulation by means of matching the number of paddle-passes that a formulation experiences within a continuous blending process in the batch mixing cell. The evaluation showed that the small-scale mixing cell was able to replicate the extent of lubrication-evaluated by measuring the tensile strength of compacts being made with both the continuous and mixing cell experiments-occurring in the continuous mixer using a fraction of the amount of materials needed to perform the same evaluation in the continuous blending process.

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“…Ispitivanja raspodjele vremena zadržavanja primjenjuju se i za proučavanje problema u strujanju kao što su recirkulacija, promjena smjera ili stagnacija koji smanjuju učinkovitost procesne jedinice. 5,6 O načinu strujanja ovisi i prijenos tvari i topline unutar procesne jedinice, pa je tako u prehrambenoj industriji raspodjela temperature i vremena zadržavanja u cijevima važna za postizanje propisane kvalitete proizvoda. RVZ analize imaju široku primjenu u različitim granama industrije, poput petrokemijske gdje su nužne za optimizaciju destilacijskih kolona.…”

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“…Difuzijski je prijenos dan drugim Fickovim zakonom prikazanim jedn. (5), gdje je D e prosječni koeficijent difuzije ili koeficijent disperzije:…”

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Neidealno strujanje u modelnim cijevima

Kurt

Licht

Kosar³

2020

Kem. ind. (Online)

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Cilj ovog rada bio je istražiti strujanje kapljevine u trima različitim modelnim cijevima: ravnoj praznoj cijevi, cijevi ispunjenoj staklenim kuglicama i praznoj spiralnoj cijevi. Pri tome je osnovni koncept sadržan u pojmu raspodjele vremena zadržavanja kapljevine (RVZ). Kako bi se dobile RVZ krivulje, eksperimentalno je mjerena koncentracija inertne tvari (engl. <i>tracer</i>) na izlasku iz cijevi tijekom vremena. Kao inertna tvar upotrijebljena je otopina vodljive soli KCl. Pomoću modela aksijalne disperzije izračunate su vrijednosti srednjeg vremena zadržavanja i disperzijskog broja za različite protoke (100 – 600 ml min<sup>–1</sup>) i volumene inertne tvari (0,3 i 1 ml) te je dan kvantitativan opis odstupanja od idealnog strujanja.

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Effect of material properties on the residence time distribution (RTD) characterization of powder blending unit operations. Part II of II: Application of models

Cited by 41 publications

References 45 publications

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms

Mixing Cell: a Device to Mimic Extent of Lubrication and Shear in Continuous Tubular Blenders

Neidealno strujanje u modelnim cijevima

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