Modeling film-coat non-uniformity in polymer coated pellets: A stochastic approach

Nahor Haddish-Berhane, Seong Hoon Jeong, Kamyar Haghighi, Kinam Park

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

The objective of the present study is to include coating thickness non-uniformity in the development of a drug release model using coated ion-exchange pellets through the use of stochastic approaches. Drug release from ion-exchange resins was described using a Nernst-Plank model. Complexes of a model drug (dextromethorphan) and Dowex® 50WX4-200 were prepared using a modified batch method and coated with Kollicoat® SR 30D polymer. The deterministic model, validated using experimental drug release profiles for different coating thicknesses at 0%, 10%, 15%, 20% (w/w), was in agreement with the experimental data with a maximum root mean square error (RMSE) of 2.4%. An arbitrary Lagrangian-Eulerian approach was pursued to develop models of spherical pellets with non-uniform coating thicknesses. The Monte Carlo method was used to simulate the effect of the level of coating deformity on the cumulative drug release profile. Considering the co-existence of equal percentages of deformed and undeformed pellets in a batch, the cumulative release profile can vary by approximately ±6% as a result of coating non-uniformity. The release profile obtained for a model of an arbitrary pellet with an actual non-uniform coating profile was in good agreement with the average release profile for the models of the theoretical randomly deformed pellets. The developed mathematical model is a useful tool to evaluate and predict release profiles of polymer coated ion-exchange resin complexes.

Original languageEnglish
Pages (from-to)64-71
Number of pages8
JournalInternational Journal of Pharmaceutics
Volume323
Issue number1-2
DOIs
StatePublished - 12 Oct 2006

Keywords

  • Coated pellets
  • Coating non-uniformity
  • Ion-exchange
  • Mathematical modeling
  • Numerical methods
  • Sustained release

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