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Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations.

A Vervaeck1, T Monteyne2, L Saerens2

  • 1Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|July 11, 2014
PubMed
Summary

Prilling successfully created multiparticulate dosage forms for fixed-dose combinations. This technique allows tailored drug release for both controlled (metoprolol tartrate) and immediate (hydrochlorothiazide) release profiles, enhancing bioavailability.

Keywords:
Controlled releaseFatty acidsFixed-dose combinationImmediate releaseMultiparticulate dosage formsPolyethylene glycolPrilling

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Multiparticulate dosage forms offer advantages in drug release modulation.
  • Fixed-dose combinations require careful formulation to ensure appropriate drug release profiles.
  • Prilling is an under-explored technique for manufacturing advanced drug delivery systems.

Purpose of the Study:

  • To evaluate prilling as a manufacturing technique for multiparticulate dosage forms.
  • To develop a fixed-dose combination using prills with tailored drug release profiles.
  • To investigate the impact of formulation variables on drug release from prills.

Main Methods:

  • Prilling of metoprolol tartrate (controlled release) and hydrochlorothiazide (immediate release) into fatty acid/polyethylene glycol (PEG) matrices.
  • Systematic variation of fatty acid type, PEG molecular weight, and fatty acid/PEG ratio.
  • Solid-state characterization of drug-loaded prills.
  • In vitro drug release studies and in vivo pharmacokinetic evaluation in dogs.

Main Results:

  • Prilling enabled the creation of distinct controlled and immediate release profiles for metoprolol tartrate and hydrochlorothiazide, respectively.
  • Metoprolol tartrate release was successfully tailored by varying PEG molecular weight (4000, 6000, 10,000).
  • Hydrochlorothiazide release was immediate and independent of PEG molecular weight when high PEG content was used.
  • Solid-state analysis showed decreased metoprolol tartrate crystallinity and molecular dispersion of hydrochlorothiazide.
  • Drug release from prills remained stable during storage.
  • In vivo studies demonstrated similar bioavailability for hydrochlorothiazide prills and significantly higher bioavailability for metoprolol tartrate prills compared to a reference.

Conclusions:

  • Prilling is a viable technique for manufacturing multiparticulate dosage forms for fixed-dose combinations.
  • Formulation parameters, including fatty acid type and PEG characteristics, effectively control drug release kinetics.
  • The developed prills offer a promising approach for improving drug bioavailability and achieving desired release profiles.