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Enhancing the Dissolution Stability of Hard Gelatin Capsules Using Activated Carbon as a Packaging Component.

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Summary

Activated carbon (AC) packaging components prevent hard gelatin capsule (HGC) cross-linking, improving drug dissolution stability. This innovative approach enhances HGC product performance in various packaging systems.

Keywords:
dissolutionmoisture sorptionoral drug deliverysolid dosage form(s)stability

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Drug Delivery Systems

Background:

  • Hard gelatin capsules (HGCs) are susceptible to gelatin cross-linking, impacting in vitro drug dissolution.
  • Proteolytic enzymes in dissolution media can mitigate cross-linking but complicate testing and face regulatory limitations.

Purpose of the Study:

  • To evaluate activated carbon (AC) canisters and AC-embedded polymeric films as packaging solutions.
  • To assess the ability of AC packaging to attenuate gelatin cross-linking and improve dissolution stability of HGCs.

Main Methods:

  • Acetaminophen and diphenhydramine HCl HGCs were packaged with or without AC canisters in HDPE bottles and with or without AC films in glass vials.
  • Samples were stored under accelerated International Council for Harmonisation conditions (50°C/75% RH for 3 months; 40°C/75% RH for 6 months).
  • In vitro dissolution rates were compared between HGCs packaged with and without AC components.

Main Results:

  • HGCs packaged with AC canisters or AC films exhibited more rapid dissolution compared to controls when differences were observed.
  • AC packaging demonstrated a protective effect against gelatin cross-linking under accelerated storage conditions.
  • The efficacy of AC was shown in both bottle and vial packaging systems.

Conclusions:

  • Activated carbon in various formats (canisters, films) effectively enhances the dissolution stability of hard gelatin-encapsulated products.
  • AC packaging offers a promising alternative to mitigate cross-linking issues in HGCs.
  • This strategy is applicable to diverse packaging systems, including bottles and blister cards.