Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater, Part 1: Development of the model

Page, Susanne; Baumann, Karl-Heinrich; Kleinebudde, Peter

doi:10.1208/pt070242

Cited by 13 publications

(16 citation statements)

References 6 publications

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“…A number of approaches have been developed to model bed humidity during fluid bed granulation and spray coating operations based on heat and mass balances [30,43,44]. Figure 4 displays one possible approach that has been used in Janssen development and manufacturing to convert the functionalities and characteristic features of the real FBG into a model of the equipment.…”

Section: A Practical Fluid Bed Granulation Moisture and Heat Balance mentioning

confidence: 99%

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

Lyngberg

Bijnens

Geens

et al. 2016

Methods in Pharmacology and Toxicology

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Historically application of mechanistic modeling approaches to processing steps in pharmaceutical oral solid dosage form manufacturing have been limited compared to similar efforts for small molecule synthesis. One plausible explanation may be that there has been a lack of fundamental governing equations for drug product processes. The general similarity of oral solid dosage form processes from product to product make models in this area highly reusable and they can be used for purposes such as reducing scale-up and technology transfer times as well as reducing material usage for these activities. In this chapter we describe three mechanistic models used in oral solid dosage form process development and manufacturing from the perspective of how they are developed, used, and linked with supporting empirical data. The three models cover fluid bed granulation, tablet coating, and spray drying. The focus of the chapter is to illustrate the importance of embedding the models into existing development, scale-up, and manufacturing workstreams such as to create a model enhanced workstream that is more efficient, faster, and better routed in science than the fully empirical approach. Such workstreams require verification of their performance before being fully operational which is also discussed.

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Section: A Practical Fluid Bed Granulation Moisture and Heat Balance mentioning

confidence: 99%

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

Lyngberg

Bijnens

Geens

et al. 2016

Methods in Pharmacology and Toxicology

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“…The coating process involves a large number of parameters convoluted with each other, and without a theoretical framework in which to understand these parameters, a purely empirical approach would tend to be cumbersome, laborious, and ultimately unreliable. A number of first-principles thermodynamic coating models have been reported in the literature as being useful for understanding and predicting the performance and scale-up of aqueous tablet coating and the key parameters 1 Global Formulation Sciences, Global Pharmaceutical Research and Development, Abbott Laboratories, 200 Abbott Park Road, Dept. R4P7, Abbott Park, IL 60064-6199, USA.…”

Section: Introductionmentioning

confidence: 99%

“…Subscripts: 1, point 1; 2, point 2; ∞, free stream; a, dry air; a+w, moist air; amb, ambient; B, tablet bed; ex, exhaust conditions; film, film conditions; h, heat transfer; i, species i; in, inlet conditions; m, mass transfer; na, nozzle air; pa, process air; w, water; wb, wet bulb conditions. which impact the quality of the film coating (1)(2)(3)(4)(5). It has been reported (5) that the Environmental Equivalency (EE) model proposed by Ebey (6) is the most widely used aqueous coating model and has also been incorporated into the TAAC computer program published by Thomas Engineering (7).…”

Section: Introductionmentioning

confidence: 99%

“…It has been reported (5) that the Environmental Equivalency (EE) model proposed by Ebey (6) is the most widely used aqueous coating model and has also been incorporated into the TAAC computer program published by Thomas Engineering (7). The EE model has been frequently cited in recent papers and texts on aqueous tablet coating (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

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Psychrometric Analysis of the Environmental Equivalency Factor for Aqueous Tablet Coating

Strong

2009

AAPS PharmSciTech

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Abstract. Process control of aqueous tablet coating depends on a number of thermodynamic and psychrometric variables. Since many of these variables are interdependent, the choice of parameters by which to control the process or designate a design space is not necessarily obvious. Several mass or heat conservation models for aqueous tablet coating can be found in the literature, varying in approach and proposed method for controlling the coating process. A commonly used first-principles model built upon the coupled heat and mass transfer in evaporative mass transfer derives an "Environmental Equivalency" (EE) factor as an indicator of the relative rate of water evaporation from the tablet bed surface and as a relevant scaling factor for aqueous coating. The EE factor is expressed by an equation involving ten individual parameters; however, if the derivation of EE is extended further under the context of an adiabatic process, a much-simplified yet equivalent expression for EE emerges consisting of only three parameters, each directly measurable or obtainable from a psychrometric chart and which bear direct significance to the gross thermodynamic conditions of the coating. The psychrometric model herein is presented as a more physically evocative description of the coating process, enhancing process understanding and potentially playing a key role in a Quality by Design approach to defining an aqueous coating design space.

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“…Proces raspršivanja tečnosti pod pritiskom široko se upotrebljava u farmaceutskoj industriji, prije svega za oblaganje tableta, kapsula, granula (195). Slično, ovaj proces je uspješno korišćen i za oblaganje čvrstih silikonskih mikroigala slojem karboksimetilceluloze (CMC) čija je debljina bila svega nekoliko mikrona (118).…”

Section: Izrada Rastvorljivih Mikroigala Procesom Atomizacije I Rasprunclassified

Formulation and characterization of dissolvable microneedles for controlled transdermal delivery of ketoprofen encapsulated in polymeric nanoparticles

Vučen¹

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Univerzitet u Beogradu -Tehnološko-metalurški fakultet Datum odbrane: Doktorska disertacija, Sonja VučenOva doktorska disertacija je urađena pod mentorstvom prof. dr Gordane Vuleta, kojoj istinski zahvaljujem na ukazanom povjerenju, bezrezervnoj podršci, velikom strpljenju i ličnom angažovanju tokom izrade ove doktorske disertacije, i mog cjelokupnog profesionalnog i naučno-istraživačkog rada do sada. Prva faza eksperimenata rađena je na Institutu tehničkih nauka SANU i Farmaceutskom fakultetu u Beogradu, dok su eksperimenti druge i treće faze rađeni u Irskoj, na Farmaceutskom fakultetu Univerziteta u Korku.Najiskrenu zahvalnost dugujem prof. dr Jeli Milić na ogromnom razumjevanju i podršci, uvijek korisnim savjetima i spremnosti da pomogne, od samih početaka, kada je i bilo najteže. Nesebično zalaganje i posebno veliki doprinos prof. Milić je, zajedno sa mentorom, pružila u toku pripremanja prve radne verzije disertacije, na čemu sam joj neizmjerno zahvalna.Prof. dr Nenadu Ignjatoviću veoma zahvaljujem na saradnji i značajnoj pomoći tokom dobijanja i interpretacije rezultata u okviru prve faze eksperimenata. Srdačno se zahvaljujem i prof. dr Snežani Savić na korektnoj dugogodišnjoj saradnji i spremnosti da prenese svoja iskustva, koja su mi pomogla u istraživanju. Prof. dr Slobodanu Petrović se iskreno zahvaljujem na korisnim sugestijama i savjetima tokom čitanja ove doktorske disertacije. Veliku zahvalnost dugujem i doc. dr Abina Crean i doc. dr Anne Moore, koje su mi pružile priliku i usmjeravale moje naučno usavršavanje tokom cijelog boravka u Irskoj.Veliko hvala upućujem i svim profesorima, stručnom osoblju i kolegama sa studijskog programa farmacija Medicinskog fakulteta u Banjoj Luci i Farmaceutskog fakulteta u Beogradu, kao i kolegama sa Instituta tehničkih nauka SANU i Farmaceutskog fakulteta Univerziteta u Korku, na podršci i konkrektnoj pomoći tokom mog rada i boravka u svim pomenutim institucijama. Najveću zahvalnost dugujem suprugu Dušanu na ogromnoj ljubavi, razumjevanju, bezrezervnoj podršci i konkretnoj pomoći tokom izrade ove doktorske disertacije.Neizmjerno se zahvaljujem svojim roditeljima, sestrama i najmlađim Nježićima, za svu ljubav i podršku koju mi pružaju. Tabela 1-4. Podjela, definicija i shematski prikaz nanosfera i nanokapsula.Tabela 1-6. Materijali i metode za izradu mikroigala.Tabela 1-7. Sistemi mikroigala koje se trenutno nalaze na tržištu ili su u fazi kliničkih ili prekliničkih ispitivanja.Tabela 1-8. Neki primjeri in vivo studija bezbjednosti primjene mikroigala.Tabela 3-1. Zavisni parametri u procesu dobijanja PDLLA-KET nanočestica.Tabela 3-2. Prikaz matematičkih modela korištenih za ispitivanje mehanizma oslobađanja ketoprofena inkapsuliranog u PDLLA nanočestice.Tabela 3-3. Vrijednosti kontrolisanih faktora procesa i njihovi nivoi. Ova tehnika je uspješno primjenjena za izradu nizova rastvorljivih mikroigala sa PDLLA-KET nanočesticama, koji su predstavljali vjernu reprodukciju originalnog silikonskog kalupa. Izrađene su mikroigle oštrih vrhova, sa rigidnom i nefleksibilnom ...

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Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater, Part 1: Development of the model

Cited by 13 publications

References 6 publications

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

Psychrometric Analysis of the Environmental Equivalency Factor for Aqueous Tablet Coating

Formulation and characterization of dissolvable microneedles for controlled transdermal delivery of ketoprofen encapsulated in polymeric nanoparticles

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