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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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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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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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Factors Influencing Drug Absorption: Physicochemical Parameters01:22

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The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
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Effervescence-induced amorphous solid dispersions with improved drug solubility and dissolution.

Muralidhar Pisay1, Dani Lakshman Yarlagadda2, Sai Krishna Anand Vullendula2

  • 1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.

Pharmaceutical Development and Technology
|January 23, 2023
PubMed
Summary

This study explored drug carrier miscibility in amorphous solid dispersions (ASDs) and effervescent-induced amorphous solid dispersions (ESDs) to improve Glibenclamide solubility. ESDs enhanced solubility, dissolution, and ex-vivo intestinal absorption, indicating improved drug delivery and potential bioavailability.

Keywords:
Flory-Huggins miscibilityGibb’s free energyGlibenclamideeffervescencein-silico molecular dynamics simulationsolubility parameter

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Poor water solubility of drugs like Glibenclamide (GLB) limits their bioavailability.
  • Solid dispersions (SDs) are a promising approach to enhance drug solubility and dissolution.
  • Effervescence-induced amorphous solid dispersions (ESDs) offer a novel strategy for drug delivery.

Purpose of the Study:

  • To investigate drug carrier miscibility in pharmaceutical solid dispersions (SDs) and effervescent-induced amorphous solid dispersions (ESDs).
  • To enhance the solubility and dissolution of poorly water-soluble Glibenclamide (GLB) using these systems.
  • To evaluate the impact of ESDs on drug delivery and bioavailability.

Main Methods:

  • In-silico prediction of drug-carrier miscibility using molecular dynamics simulation, Hansen solubility parameters, Flory-Huggins theory, and Gibb's free energy.
  • Preparation of solid dispersions (SDs) and ESDs using microwave, solvent evaporation, lyophilization, and Hot Melt Extrusion (HME).
  • Characterization of solid dispersions using FTIR, 1H NMR, DSC, PXRD, microscopy, solubility, in-vitro dissolution, and ex-vivo intestinal absorption studies.

Main Results:

  • In-silico and theoretical methods predicted good miscibility between GLB and selected carriers (Kollidon VA 64, PEG-3350, Gelucire-50/13).
  • FTIR and 1H NMR confirmed intermolecular hydrogen bonding, with higher levels in ESDs.
  • DSC, PXRD, and microscopy demonstrated enhanced amorphization of GLB in ESDs compared to SDs.
  • Optimized ESDs prepared via HME showed significantly improved solubility, dissolution, and ex-vivo intestinal absorption compared to pure GLB.

Conclusions:

  • Drug-carrier miscibility was successfully studied in GLB solid dispersions.
  • The addition of an effervescent agent in ESDs significantly enhanced GLB solubility and dissolution.
  • ESDs, particularly those prepared by HME, show potential for improved drug delivery and bioavailability.