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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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...
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

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...
Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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 employed to...
Bioavailability Enhancement: Drug Solubility Enhancement01:16

Bioavailability Enhancement: Drug Solubility Enhancement

Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

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Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Solution-mediated phase transformation of different roxithromycin solid-state forms: Implications on dissolution and

Marique Aucamp1, Nicole Stieger, Neil Barnard

  • 1Center of Excellence for Pharmaceutical Sciences, Faculty of Health Sciences, North-West University, Potchefstroom Campus, 2520, South Africa. Marique.Aucamp@nwu.ac.za

International Journal of Pharmaceutics
|April 13, 2013
PubMed
Summary

Roxithromycin exists in multiple solid-state forms, including previously unreported anhydrous and mixed forms. These forms undergo transformations affecting drug solubility and dissolution, impacting bioavailability.

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Last Updated: May 12, 2026

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Drug Delivery

Background:

  • Roxithromycin exhibits various solid-state forms, influencing its pharmaceutical properties.
  • Understanding these forms is crucial for consistent drug performance and bioavailability.

Purpose of the Study:

  • To characterize the solid-state forms of roxithromycin.
  • To investigate the impact of solution-mediated phase transformations on dissolution and solubility.
  • To evaluate current identification methods and propose improvements for assessing drug performance.

Main Methods:

  • X-ray powder diffraction (XRPD) for phase quantification.
  • Dissolution studies to monitor transformations over time.
  • Analysis of solid-state forms including monohydrate, amorphous, and anhydrous states.

Main Results:

  • Identified four solid-state forms of roxithromycin: Form I (monohydrate), Form II (amorphous), Form III (anhydrate), and a mixture of Forms I and III.
  • Demonstrated solution-mediated phase transformations of amorphous and anhydrous forms to the stable monohydrate.
  • Showed that standard pharmacopoeial methods fail to accurately identify these distinct solid-state forms.
  • Observed significant differences in dissolution profiles among the various forms.

Conclusions:

  • Roxithromycin's solid-state forms and their transformations critically affect dissolution, solubility, and bioavailability.
  • Current identification methods are inadequate for differentiating roxithromycin's solid forms.
  • Peak dissolution concentrations offer a more precise measure of solubility enhancement for metastable active pharmaceutical ingredients (APIs).