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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Extraction of Plant-based Capsules for Microencapsulation Applications
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Sustained-release capsules coated via thermoforming techniques.

Lian Shen1, Xiaohong Yu2, Hui Fu1

  • 1College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou, China.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|November 10, 2021
PubMed
Summary

This study introduces thermoforming coating techniques for capsules, offering a solvent-free method for drug delivery. Both vacuum forming coating (VFC) and centrifugal forming coating (CFC) achieved 24-hour sustained drug release.

Keywords:
Capsule coatingCentrifugal forming coatingSustained-releaseThickness distributionVacuum forming coating

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Drug Delivery Systems

Background:

  • Capsule coatings protect active pharmaceutical ingredients but are limited by gelatin shell sensitivity to heat and solvents.
  • Few studies have explored capsule coating techniques due to these material constraints.

Purpose of the Study:

  • To investigate and compare two thermoforming coating techniques: vacuum forming coating (VFC) and centrifugal forming coating (CFC).
  • To elucidate the underlying processes and mechanisms of VFC and CFC through rheological and mechanical property analysis.
  • To characterize and compare coating integrity and drug release behavior for both techniques.

Main Methods:

  • Utilized vacuum forming coating (VFC) and centrifugal forming coating (CFC) for capsule coating.
  • Investigated rheological and mechanical properties of the coating materials.
  • Characterized coating integrity, film thickness distribution, and drug release profiles.
  • Analyzed drug release data in relation to Fick's diffusion law.

Main Results:

  • A lower temperature was found to be more suitable for VFC compared to CFC.
  • Increased film thickness led to a decreased drug release rate.
  • Both VFC and CFC techniques produced capsules with a 24-hour sustained-release profile.
  • VFC resulted in a more homogeneous coating thickness distribution than CFC.

Conclusions:

  • Thermoforming coating techniques (VFC and CFC) provide convenient and efficient solvent-free solutions for capsule coating.
  • These methods are suitable for small-scale personalized coating of oral solid preparations.
  • The study demonstrates the potential of VFC and CFC for developing controlled-release drug delivery systems.