Population Balance Models for Pharmaceutical Processes

Chaudhury, Anwesha; Sen, Maitraye; Barrasso, Dana; Ramachandran, Rohit

doi:10.1007/978-1-4939-2996-2_2

Cited by 3 publications

(3 citation statements)

References 90 publications

(129 reference statements)

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“…PBM can use a class of hyperbolic partial differential equations to describe a population of particles in a system over time. The most general form of PBM is written as eq 6 31 Ä…”

Section: Population Balance Model (Pbm)mentioning

confidence: 99%

“…PBM can use a class of hyperbolic partial differential equations to describe a population of particles in a system over time. The most general form of PBM is written as eq ∂ F ∂ t ( x , t ) + ∂ ∂ x [ F d x d t ] ( x , t ) = R ( x , t , F false( x , t false) ) where F is the number of particles, x is a vector of internal coordinates, t is time, ∂ ∂ x [ F d x d t ] ( x , t ) represents the continual growth or attrition of particle size in the internal coordinate x , and R ( x , t , F ( x t )) denotes all of the sources that are involved in changing the number of particles.…”

Section: Introduction To Numerical Models Used For Inhalable Dry Powd...mentioning

confidence: 99%

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Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

Lou,

Ding,

et al. 2023

Mol. Pharmaceutics

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Dry powder inhaler (DPI) products are commonly formulated as a mixture of micronized drug particles and large carrier particles, with or without additional fine particle excipients, followed by final powder filling into dose containment systems such as capsules, blisters, or reservoirs. DPI product manufacturing consists of a series of unit operations, including particle size reduction, blending, and filling. This review provides an overview of the relevant critical process parameters used for jet milling, highshear blending, and dosator/drum capsule filling operations across commonly utilized instruments. Further, this review describes the recent achievements regarding the application of empirical and mechanistic models, especially discrete element method (DEM) simulation, in DPI process development. Although to date only limited modeling/simulation work has been accomplished, in the authors' perspective, process design and development are destined to be more modeling/simulation driven with the emphasis on evaluating the impact of material attributes/process parameters on process performance. The advancement of computational power is expected to enable modeling/simulation approaches to tackle more complex problems with better accuracy when dealing with real-world DPI process operations.

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“…PBM can use a class of hyperbolic partial differential equations to describe a population of particles in a system over time. The most general form of PBM is written as eq 6 31 Ä…”

Section: Population Balance Model (Pbm)mentioning

confidence: 99%

Section: Introduction To Numerical Models Used For Inhalable Dry Powd...mentioning

confidence: 99%

Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

Lou,

Ding,

et al. 2023

Mol. Pharmaceutics

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“…To solve Eq. , several unknown parameters in the breakage rate kernel and in the breakage function must be evaluated, but due to their uncertain nature, they were estimated only empirically . Reynolds developed a mechanistic model of a conical screen mill using the population balance modeling, Eq.…”

Section: Introductionmentioning

confidence: 99%

DEM–PBM modeling of abrasion dominated ribbon breakage

Loreti

Reynolds

et al. 2017

AIChE Journal

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In dry granulation, fine cohesive powders are compacted into large multi‐particle entities, i.e., briquettes, flakes, or ribbons. The powder compaction is generally followed by milling, a size reduction process, which is crucial to obtain the desired granule size or properties. Abrasion and impact are two primary mechanisms of comminution in ribbon milling, but they are not completely understood. The aim of this article was hence to investigate numerically the fragmentation process induced by abrasion during ribbon milling. The discrete element method (DEM) was employed to simulate abrasion tests, for which three‐dimensional parallelepiped ribbons were generated using auto‐adhesive elastic spheres. The fragmentation rate, and the fragments size and number were determined for various surface energies and abrasive velocities. The DEM results showed that the mass‐equivalent fragment size distributions were bi‐modal, similar to the experimental observations and the numerical results for impact‐dominated ribbon milling reported in the literature. In addition, two quantities were determined from the DEM analysis, i.e., the number of large fragments and the fraction of fines, which was then integrated into the population balance models (PBM) so that a DEM–PBM multiscale modeling framework was developed to predict the granule size distribution during ribbon milling. The DEM–PBM results were compared with the experimental results reported in the literature, and a broad agreement was obtained, implying the proposed DEM–PBM can be used to analyse the ribbon milling behavior. © 2017 American Institute of Chemical Engineers AIChE J, 64: 1191–1204, 2018

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