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Related Concept Videos

In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
378
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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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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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Real time Raman imaging to understand dissolution performance of amorphous solid dispersions.

Francesco Tres1, Kevin Treacher2, Jonathan Booth2

  • 1School of Pharmacy, Boots Science Building, University of Nottingham, Nottingham NG7 2RD, United Kingdom.

Journal of Controlled Release : Official Journal of the Controlled Release Society
|June 10, 2014
PubMed
Summary

This study used Raman spectroscopic imaging and a novel dissolution method to investigate amorphous solid dispersions. Higher drug loadings in felodipine-copovidone dispersions led to drug recrystallization and slower dissolution rates.

Keywords:
Amorphous solid dispersionsIntrinsic dissolution rateMulti-variate curve resolution (MCR)Poorly soluble drugsRaman imagingSolid-state transformations

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance the solubility of poorly water-soluble drugs.
  • Understanding drug-release mechanisms from ASDs is crucial for drug formulation.
  • In-situ, real-time monitoring of dissolution processes remains challenging.

Purpose of the Study:

  • To investigate the in-situ, real-time dissolution mechanisms of amorphous solid dispersions.
  • To evaluate the effect of drug loading on the dissolution performance of felodipine-copovidone ASDs.
  • To elucidate the interplay between drug properties and polymer matrix during dissolution.

Main Methods:

  • Raman spectroscopic imaging combined with multivariate curve resolution (MCR) analysis for in-situ monitoring.
  • Novel rotating disk dissolution rate (RDDR) methodology coupled with high-performance liquid chromatography (HPLC).
  • Characterization using Raman and X-ray powder diffraction (XRPD).

Main Results:

  • At 5% drug loading, felodipine and copovidone dissolved as a single entity, dominated by the polymer's behavior.
  • At 50% drug loading, dissolution rates were significantly reduced, with drug recrystallization observed after polymer dissolution.
  • Raman imaging showed spatially heterogeneous amorphous-to-crystalline transitions of felodipine within the dosage form.

Conclusions:

  • Dissolution behavior of ASDs is highly dependent on drug loading and physicochemical properties.
  • The study highlights the utility of combined Raman imaging and RDDR for understanding complex dissolution dynamics.
  • Drug recrystallization at higher loadings impacts the release profile of poorly soluble drugs from ASDs.