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Ophthalmic Drug Delivery Systems01:23

Ophthalmic Drug Delivery Systems

Ophthalmic drug delivery faces major limitations due to poor absorption across the corneal membrane. This process is primarily driven by diffusion and is influenced by two main factors: the physicochemical properties of the drug and tear drainage. Most ophthalmic drugs, such as pilocarpine, epinephrine, atropine, and local anesthetics, are weak bases. They are typically formulated at an acidic pH to enhance chemical stability. However, this leads to high ionization, reducing their ability to...

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Optimisation of Backing Layer Formulations via Rational Polymer Selection to Improve the Insertion of Dissolving Microneedles Into Skin.

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Glassy Drug Microneedle Array Design: Drug Glass-Forming Ability and Stability.

Mohamed Elkhashab1, Ziad Sartawi2, Waleed Faisal2

  • 1SSPC, the Research Ireland Centre for Pharmaceuticals, School of Pharmacy, University College Cork, Cork T12 K8AF, Ireland.

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Summary

Drug-only glassy microneedles offer high drug loading for intradermal delivery. Their stability depends on drug glass-forming ability and storage conditions, especially avoiding moisture to maintain structure.

Keywords:
glass transition temperatureglass-forming abilityglassy microneedleshumidityhygroscopicitystability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Glassy microneedles offer a drug-only alternative for intradermal delivery, surpassing drug-polymer systems in drug loading and mechanical strength.
  • Microneedle structural integrity and mechanical properties are contingent upon the stability of the drug's glassy state.

Purpose of the Study:

  • To investigate the relationship between drug glass-forming ability (GFA) and the glass stability of drug-only microneedles.
  • To evaluate the impact of various storage conditions on the physical stability of glassy microneedles.

Main Methods:

  • Fabrication of drug-only microneedles from six different drugs.
  • Assessment of microneedle stability under varying conditions: 2-8 °C (nitrogen), 25 °C/60% RH, and 40 °C/75% RH for 3 months.
  • Analysis using differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and visual inspection.

Main Results:

  • All glassy microneedles maintained structural integrity when stored at 2-8 °C under nitrogen for 3 months.
  • Drug GFA predicted glass stability in dry conditions below the glass transition temperature (Tg).
  • Exposure to humidity caused crystallization in most microneedles, except itraconazole, due to water absorption and plasticization. Itraconazole's stability was linked to interactions with liquid crystalline phases.

Conclusions:

  • Glassy microneedle stability is influenced by storage below Tg and interactions with moisture.
  • Selecting appropriate storage conditions, particularly controlling humidity, is crucial for maintaining microneedle integrity and skin penetration efficiency.
  • Drug GFA is a useful predictor of stability in dry environments but does not fully account for behavior under humid conditions.