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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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The enteral drug administration involves three primary routes: oral, sublingual, and buccal. Oral ingestion is the most prevalent, safe, economical, and convenient method for drug administration. However, it has certain drawbacks, including limited absorption due to the drug's low water solubility or poor membrane permeability, possible emesis from GI mucosa irritation, destruction of drugs by digestive enzymes or low gastric pH, and irregular absorption along with food or other drugs.
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Repaglinide (Prandin) and Nateglinide (Starlix), known as glinides, are oral insulin secretagogues that stimulate insulin release from pancreatic β cells by closing the ATP-sensitive potassium channels (KATP channel). Repaglinide controls insulin release from pancreatic β cells by managing potassium efflux. It shares two binding sites with sulfonylureas and also has a unique site, indicating overlapping mechanisms of action. With a rapid onset and a 4-7 hour duration, it effectively...
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Permeation Enhancer-based Ionogel Shows Remarkable Potential for Oral Insulin Delivery.

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A novel choline decanoate ionic liquid (IL) formulation significantly enhances oral insulin bioavailability. This peptide delivery system shows sustained absorption and minimal intestinal damage, offering a promising alternative to current methods.

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Area of Science:

  • Pharmaceutical Sciences
  • Biomaterials Science
  • Drug Delivery Systems

Background:

  • Oral administration of peptide therapeutics faces challenges due to poor absorption and enzymatic degradation.
  • Permeation enhancers like sodium decanoate are used, but their efficacy and safety profiles require improvement.
  • Ionic liquids (ILs) show potential for enhancing drug absorption.

Purpose of the Study:

  • To develop and evaluate a decanoate-based ionic liquid (IL) for oral insulin delivery.
  • To investigate the physicochemical properties and in vivo performance of the novel IL formulation.
  • To assess the safety and efficacy of the IL compared to existing enhancers.

Main Methods:

  • Formulation of a choline decanoate-based ionic liquid (chC10 1:2) loaded with insulin.
  • In vitro characterization of rheological properties and dissolution.
  • In vivo assessment of oral insulin bioavailability and pharmacokinetic profiles.
  • Histological examination of intestinal villi morphology post-administration.

Main Results:

  • The optimized chC10 1:2 formulation exhibited gel-like properties with high viscosity and hydrophobicity, leading to slow in vitro dissolution.
  • In vivo studies demonstrated a 7-fold and 13-fold increase in oral insulin bioavailability compared to choline geranate (CAGE) and sodium decanoate, respectively (6.5% vs 0.9% and 0.5%).
  • Histological analysis showed no adverse effects on villi morphology with chC10 1:2, unlike CAGE which caused significant villi height reduction.

Conclusions:

  • The developed decanoate-based ionic liquid (chC10 1:2) is a promising oral drug delivery vehicle for insulin.
  • This IL formulation offers superior bioavailability enhancement and improved safety profile compared to CAGE and sodium decanoate.
  • Further research into ILs for oral peptide delivery is warranted.