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Insulin Formulations: Types and Delivery01:27

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Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Nanoparticle-Based Oral Insulin Delivery: Challenges, Advances, and Future Directions.

Gianluca Fontana1, Giulio Innamorati1, Luca Giacomello1

  • 1Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of Verona, 37134 Verona, Italy.

Pharmaceutics
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Summary

Oral insulin nanocarriers offer a better alternative to injections for diabetes management. However, challenges in preclinical models and regulatory hurdles hinder their clinical translation, requiring improved strategies for development.

Keywords:
clinical translationdiabetesdrug deliveryinsulinnanomaterialsoral delivery

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Area of Science:

  • Biomedical Engineering
  • Nanotechnology
  • Pharmacology

Background:

  • Subcutaneous insulin injections for diabetes management cause discomfort and non-physiological insulin distribution.
  • Oral insulin delivery via nanocarriers promises improved bioavailability and physiological mimicry but faces significant barriers.

Purpose of the Study:

  • To review the non-clinical and regulatory challenges impeding the clinical translation of oral insulin nanocarriers.
  • To highlight limitations in current preclinical models and regulatory frameworks for nanomedicines.

Main Methods:

  • Review of existing literature on oral insulin nanocarriers.
  • Analysis of physicochemical attributes, biocompatibility, and pharmacokinetic challenges.
  • Evaluation of preclinical models and regulatory considerations for nanomedicine development.

Main Results:

  • Nanoparticle carriers show promise in protecting insulin and enhancing absorption in preclinical studies.
  • Clinical translation is limited due to inadequate animal models and regulatory frameworks for nanomedicines.
  • Challenges include controlling nanocarrier attributes, ensuring biocompatibility, and evaluating complex pharmacokinetic profiles.

Conclusions:

  • Bridging the translational gap requires more rigorous and predictive preclinical and regulatory strategies.
  • Addressing limitations in current models is crucial for advancing oral insulin nanocarrier technology.
  • Successful development necessitates a deeper understanding of nanocarrier-drug interactions and long-term safety.