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Achieving gastroresistance without coating: Formulation of capsule shells from enteric polymers.

Joao A C Barbosa1, Maha M Al-Kauraishi1, Alan M Smith1

  • 1Department of Pharmacy, School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield HD1 3DH, United Kingdom.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|September 22, 2019
PubMed
Summary
This summary is machine-generated.

Researchers developed novel enteric capsule shells using common polymers, eliminating the need for extra coating steps. This simple method for gastroresistant capsules could significantly cut manufacturing costs for enteric-coated dosage forms.

Keywords:
CapsulesCoatingDelayed-releaseEntericEudragitHPMCModified-release

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Drug Delivery

Background:

  • Capsules are a preferred oral dosage form for pharmaceuticals and nutraceuticals due to manufacturing simplicity.
  • Existing capsules lack inherent gastroresistance, necessitating additional coating steps for enteric delivery.
  • Functional capsules with built-in gastroresistance offer significant value for drug delivery.

Purpose of the Study:

  • To investigate the use of common enteric polymers for producing gastroresistant hard-capsule shells.
  • To optimize capsule formulations for desirable physicochemical and gastroresistance properties.
  • To develop a simplified manufacturing process for enteric capsules.

Main Methods:

  • Evaluation of cellulose derivatives (HPMC AS-LF, HP-55) and acrylic/methacrylic acid derivatives (EUDRAGIT L100, S100) for capsule shell production.
  • Optimization of polymer and plasticizer concentrations to achieve desired characteristics.
  • Assessment of drug release from optimized capsules in compendial and physiological buffers.

Main Results:

  • Optimized capsule shells were successfully produced using HPMC AS-LF, HP-55, EUDRAGIT L100, and S100.
  • Drug release profiles from the novel enteric capsules matched those from conventional polymer-coated tablets.
  • The developed capsules demonstrated comparable gastroresistance to coated tablets.

Conclusions:

  • A simple method for producing enteric capsule shells without additional coating was successfully developed.
  • This approach can significantly reduce manufacturing costs for enteric-coated dosage forms.
  • The novel capsules may improve drug release consistency compared to conventional coated dosage forms.