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AAPS PharmSciTech

, 20:209 | Cite as

A Thermodynamic Balance Model for Liquid Film Drying Kinetics of a Tablet Film Coating and Drying Process

  • Bumjoon Cha
  • Shaun C. Galbraith
  • Huolong Liu
  • Seo-Young Park
  • Zhuangrong Huang
  • Thomas O’Connor
  • Sau Lee
  • Seongkyu YoonEmail author
Research Article
  • 126 Downloads

Abstract

A tablet film coating and drying process was assessed by an experimentally validated thermodynamic balance model. Mass conservation equations were derived for the process air and the aqueous coating solution. Thermodynamic behavior of the solution was described by evaporation at the tablet surface and penetration into the tablet. Energy balance equations including heat loss to the atmosphere were coupled to the mass conservation equation. Experimental data using the ConsiGma™ coater (GEA, Belgium) were used for both parameter estimation and model validation. The results showed the proposed model can investigate primitive outlet variables and further internal variables representing evaporation and penetration. A sensitivity analysis revealed that evaporation depended more on the input parameters while penetration hinges on the tablet properties, particularly on the tablet volume affecting the tablet porosity.

KEY WORDS

tablet film coating and drying thermodynamic balance model evaporation and penetration parameter estimation sensitivity analysis 

Nomenclature

A

surface area (m2)

Cp

heat capacity (J/kg·K)

D

diffusion coefficient (m2/s)

d

diameter (m)

E

energy (J)

EI

elasticity index (−)

\( \hat{H} \)

specific enthalpy (J/kg).

\( \Delta {H}_{\mathrm{eva}}^0 \)

latent heat of vaporization at T = 0°C (J/kg)

h

thickness (m)

K

heat loss factor (W/K)

k

heat transfer coefficient (W/m2·K)

M

molecular weight (g/mol)

m

mass (kg)

\( \dot{m} \)

mass flowrate (kg/s)

N

number of tablet (−)

n

number of coating runs (−)

P

pressure (Pa)

p

pressure (mbar)

psat

saturation vapor pressure (mbar)

\( \dot{Q} \)

heat flowrate (J/s)

R

gas constant (m3·Pa/K·mol)

Rep

particle Reynolds number (−)

RH

relative humidity (%)

Sc

Schmidt number (−)

SI

sensitivity index (−)

SH

specific humidity (kg/kg)

Sh

Sherwood number (−)

T

temperature (°C)

u

speed (m/s)

\( \overline{u} \)

relative speed (m3/s).

\( \dot{V} \)

volumetric flowrate (m3/s).

Greek Letter

α

evaporation coefficient (m/s)

β

penetration coefficient (1/m)

ρ

density (kg/m3)

κ

perimeter (m)

η

viscosity (kg/m·s)

γ

surface tension (N/m)

φ

evaporative ratio (%)

ψ

drying efficiency (%)

ω

rotating speed (rpm)

ζ

input parameter.

Ω

response output variable

Subscriptions

a

humid air

cal

calculated variable

cs

coating spray

E

(evaporation)

est

estimated variable

d

dry air

f

liquid film

i

in, out, kand k2

in

(inlet)

k1

air knife 1

k2

air knife 2

mea

measured variable

loss

heat loss

out

(outlet)

P

(penetration)

surr

ambient surroundings

T

(tablet)

v

water vapor

w

liquid water

wheel

coating wheel

Notes

Acknowledgements

The authors wish to thank Dr. HaeWoo Lee for insightful conversations. A license for the gSOLIDS process modeling software (4.1.0) has also been provided by Process Systems Enterprise Ltd. (London, UK) for the modeling and simulation. The project is also partially supported by Merck & Co., Inc., Kenilworth, NJ, USA, who shared the dataset used in this work. The dataset was originally collected by GEA, GmBH, Dusseldorf, Germany. The authors extend their thanks to Merck & Co and GEA for the data making this work possible.

Funding Information

This study was financially supported by the U.S. FDA (grant number 5U01FD005294).

Compliance with Ethical Standards

Disclaimer

Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

References

  1. 1.
    Oshlack B, Chasin M, Pedi Jr. F. Controlled release formulations coated with aqueous dispersions of acrylic polymers. U.S.; 5,639,476, 1997.Google Scholar
  2. 2.
    Bayraktar O, Malay Ö, Özgarip Y, Batıgün A. Silk fibroin as a novel coating material for controlled release of theophylline. Eur J Pharm Biopharm. 2005;60(3):373–81.PubMedCrossRefGoogle Scholar
  3. 3.
    Behzadi SS, Toegel S, Viernstein H. Innovations in coating technology. Recent Pat Drug Deliv Formul. 2008;2(3):209–30.PubMedCrossRefGoogle Scholar
  4. 4.
    Felton LA, Timmins GS. A nondestructive technique to determine the rate of oxygen permeation into solid dosage forms. Pharm Dev Technol. 2006;11(1):141–7.PubMedCrossRefGoogle Scholar
  5. 5.
    Rege BD, Gawel J, Kou JH. Identification of critical process variables for coating actives onto tablets via statistically designed experiments. Int J Pharm. 2002;237(1–2):87–94.PubMedCrossRefGoogle Scholar
  6. 6.
    Teckoe J, Mascaro T, Farrell TP, Rajabi-Siahboomi AR. Process optimization of a novel immediate release film coating system using QbD principles. AAPS PharmSciTech. 2013;14(2):531–40.PubMedPubMedCentralCrossRefGoogle Scholar
  7. 7.
    Suzzi D, Radl S, Khinast JG. Local analysis of the tablet coating process: impact of operation conditions on film quality. Chem Eng Sci. 2010;65(21):5699–715.CrossRefGoogle Scholar
  8. 8.
    Wilson KE, Crossman E. The influence of tablet shape and pan speed on intra-tablet film coating uniformity. Drug Dev Ind Pharm. 1997;23(12):1239–43.CrossRefGoogle Scholar
  9. 9.
    Rowe RC. Defects in aqueous film-coated tablets. In: McGinity JW, Felton LA, editors. Aqueous polymeric coatings for pharmaceutical dosage forms. 3rd ed. Boca Raton: CRC Press; 2008. p. 129–49. (Drugs and the Pharmaceutical Sciences).Google Scholar
  10. 10.
    Pandey P, Bindra D, Felton L. Influence of process parameters on tablet bed microenvironmental factors during pan coating. AAPS PharmSciTech. 2014;15(2):296–305.PubMedCrossRefGoogle Scholar
  11. 11.
    Just S, Toschkoff G, Funke A, Djuric D, Scharrer G, Khinast J, et al. Optimization of the inter-tablet coating uniformity for an active coating process at lab and pilot scale. Int J Pharm. 2013;457(1):1–8.PubMedCrossRefGoogle Scholar
  12. 12.
    Niblett D, Porter S, Reynolds G, Morgan T, Greenamoyer J, Hach R, et al. Development and evaluation of a dimensionless mechanistic pan coating model for the prediction of coated tablet appearance. Int J Pharm. 2017;528(1–2):180–201.PubMedCrossRefGoogle Scholar
  13. 13.
    Thoma K, Bechtold K. Influence of aqueous coatings on the stability of enteric coated pellets and tablets. Eur J Pharm Biopharm. 1999;47(1):39–50.PubMedCrossRefGoogle Scholar
  14. 14.
    Römer M, Heinämäki J, Strachan C, Sandler N, Yliruusi J. Prediction of tablet film-coating thickness using a rotating plate coating system and NIR spectroscopy. AAPS PharmSciTech. 2008;9(4):1047–53.PubMedPubMedCentralCrossRefGoogle Scholar
  15. 15.
    Ruotsalainen M, Heinämäki J, Guo H, Laitinen N, Yliruusi J. A novel technique for imaging film coating defects in the film-core interface and surface of coated tablets. Eur J Pharm Biopharm. 2003;56(3):381–8.PubMedCrossRefGoogle Scholar
  16. 16.
    Prpich A, am Ende MT, Katzschner T, Lubczyk V, Weyhers H, Bernhard G. Drug product modeling predictions for scale-up of tablet film coating—a quality by design approach. Comput Chem Eng. 2010;34(7):1092–7.CrossRefGoogle Scholar
  17. 17.
    Sahni E, Chaudhuri B. Experiments and numerical modeling to estimate the coating variability in a pan coater. Int J Pharm. 2011;418(2):286–96.PubMedCrossRefGoogle Scholar
  18. 18.
    Cahyadi C, Heng PWS, Chan LW. Optimization of process parameters for a quasi-continuous tablet coating system using design of experiments. AAPS PharmSciTech. 2011;12(1):119–31.PubMedCrossRefGoogle Scholar
  19. 19.
    Dincer I, Sahin AZ. A new model for thermodynamic analysis of a drying process. Int J Heat Mass Transf. 2004;47(4):645–52.CrossRefGoogle Scholar
  20. 20.
    Turton R. Challenges in the modeling and prediction of coating of pharmaceutical dosage forms. Powder Technol. 2008;181(2):186–94.CrossRefGoogle Scholar
  21. 21.
    Ebey GC. A thermodynamic model for aqueous film-coating. Pharm Technol. 1987;11(4):40–50.Google Scholar
  22. 22.
    Am Ende MT, Berchielli A. A thermodynamic model for organic and aqueous tablet film coating. Pharm Dev Technol. 2005;10(1):47–58.PubMedCrossRefGoogle Scholar
  23. 23.
    Page S, Baumann K-H, Kleinebudde P. Mathematical modeling of an aqueous film coating process in a Bohle lab-coater, part 1: development of the model. AAPS PharmSciTech. 2006;7(2):E79–86.PubMedCentralCrossRefGoogle Scholar
  24. 24.
    Strong JC. Psychrometric analysis of the environmental equivalency factor for aqueous tablet coating. AAPS PharmSciTech. 2009;10(1):303–9.PubMedPubMedCentralCrossRefGoogle Scholar
  25. 25.
    Pourkavoos N, Peck GE. Evaluation of moisture sorption by tablet cores containing superdisintegrants during the aqueous film coating process. Pharm Res An Off J Am Assoc Pharm Sci. 1993;10(8):1212–8.Google Scholar
  26. 26.
    Ruotsalainen M, Heinämäki J, Taipale K, Yliruusi J. Influence of the aqueous film coating process on the properties and stability of tablets containing a moisture-labile drug. Pharm Dev Technol. 2003;8(4):443–51.PubMedCrossRefGoogle Scholar
  27. 27.
    Kestur U, Pandey P, Badawy S, Lin J, Desai D. Controlling the chemical stability of a moisture-sensitive drug product through monitoring and identification of coating process microenvironment. Int J Pharm. 2014;476(1):93–8.PubMedCrossRefGoogle Scholar
  28. 28.
    Page S, Baumann K-H, Kleinebudde P. Mathematical modeling of an aqueous film coating process in a Bohle lab-coater, part 2: application of the model. AAPS PharmSciTech. 2006;7(2):E87–94.PubMedCentralCrossRefGoogle Scholar
  29. 29.
    Kemp IC, Iler L, Waldron M, Turnbull N. Modeling, experimental trials, and design space determination for the GEA ConsiGma™ coater. Dry Technol. 2018;37(4):475-85.CrossRefGoogle Scholar
  30. 30.
    Cunningham CR, Birkmire A, Rajabi-Siahboomi AR. Application of a developmental, high productivity film coating in the GEA ConsiGmaTM coater. In: AAPS 2016 poster. American Association of Pharmaceutical Scientists; 2015:W4177.Google Scholar
  31. 31.
    Cunningham CR, Birkmire A, Gilliam S. Examination of coating process adaptability using opadry qx in the GEA ConsiGmaTM coater. In: AAPS 2016 poster. American Association of Pharmaceutical Scientists; 2016. p. 22T0130.Google Scholar
  32. 32.
    Pruppacher HR, Klett JD. Microphysics of clouds and precipitation. 2nd ed. New York: Springer; 2010.CrossRefGoogle Scholar
  33. 33.
    Felton LA. Mechanisms of polymeric film formation. Int J Pharm. 2013 Dec 5;457(2):423–7.PubMedCrossRefGoogle Scholar
  34. 34.
    Bolleddula DA, Berchielli A, Aliseda A. Impact of a heterogeneous liquid droplet on a dry surface: application to the pharmaceutical industry. In: Advances in Colloid and Interface Science, vol. 159. Amsterdam: Elsevier; 2010. p. 144–59.PubMedCrossRefGoogle Scholar
  35. 35.
    Ronsse F, Pieters JG, Dewettinck K. Combined population balance and thermodynamic modelling of the batch top-spray fluidised bed coating process. Part I—model development and validation. J Food Eng. 2007;78(1):296–307.CrossRefGoogle Scholar
  36. 36.
    Campbell GS, Norman JM. An introduction to environmental biophysics. 2nd ed. New York, NY: Springer New York; 1998.CrossRefGoogle Scholar
  37. 37.
    Skelland AHP, Cornish ARH. Mass transfer from spheroids to an air stream. AICHE J. 1963;9(1):73–6.CrossRefGoogle Scholar
  38. 38.
    Hottel HC, Noble JJ, Sarofim AF, Silcox GD, Wankat PC, Heat KKS. Mass transfer. In: Perry RH, Green DW, Maloney JO, editors. Perry’s chemical engineers’ handbook. 8th ed. New York: McGraw-Hill; 2015.Google Scholar
  39. 39.
    Dixon JC. The shock absorber handbook: second edition. The shock absorber handbook: second edition. Chichester, UK: John Wiley & Sons, Ltd; 2007. p. 1–415. p. (Wiley-Professional Engineering Publishing Series)Google Scholar
  40. 40.
    Marrero TR, Mason EA. Gaseous diffusion coefficients. J Phys Chem Ref Data. 1972;1(1):3–118.CrossRefGoogle Scholar
  41. 41.
    Coker AK, Ludwig EE. Ludwig’s applied process design for chemical and petrochemical plants, vol. 1. 4th ed. Amsterdam: Elsevier Gulf Professional Pub; 2007.Google Scholar
  42. 42.
    Faroongsarng D, Peck GE. The role of liquid water uptake by an insoluble tablet containing a disintegrant. Drug Dev Ind Pharm. 1994;20(10):1777–94.CrossRefGoogle Scholar
  43. 43.
    Fonteyne M, Gildemyn D, Peeters E, Mortier STFC, Vercruysse J, Gernaey KV, et al. Moisture and drug solid-state monitoring during a continuous drying process using empirical and mass balance models. Eur J Pharm Biopharm. 2014;87(3):616–28.PubMedCrossRefGoogle Scholar
  44. 44.
    Bacelos MS, Jesus CDF, Freire JT. Modeling and drying of carton packaging waste in a rotary dryer. Dry Technol. 2009 Aug 18;27(9):927–37.CrossRefGoogle Scholar
  45. 45.
    Loucks DP, van Beek E, Stedinger JR, Dijkman JPM, Villars MT. Water resources systems planning and management: an introduction to methods, models and applications. Paris: UNESCO; 2005. 680 p.Google Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  • Bumjoon Cha
    • 1
  • Shaun C. Galbraith
    • 1
  • Huolong Liu
    • 1
  • Seo-Young Park
    • 1
  • Zhuangrong Huang
    • 1
  • Thomas O’Connor
    • 2
  • Sau Lee
    • 2
  • Seongkyu Yoon
    • 1
    Email author
  1. 1.Department of Chemical EngineeringUniversity of MassachusettsLowellUSA
  2. 2.Office of Pharmaceutical Quality, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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