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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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, maintaining...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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...
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,...
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
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...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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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Dynamic Light Scattering Analysis for the Determination of the Particle Size of Iron-Carbohydrate Complexes
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Correlation between compactibility values and excipient cluster size using an in silico approach.

Lizbeth Martínez1, Gabriele Betz, Rafael Villalobos

  • 1Tecnología Farmacéutica, División de Estudios de Posgrado, Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México, Cuautitlán Izcalli, Estado de México, Mexico.

Drug Development and Industrial Pharmacy
|May 10, 2012
PubMed
Summary

This study developed an in silico simulation for binary pharmaceutical compacts, correlating computational models with physical measurements. The simulation accurately predicts mechanical properties, aiding tablet formulation optimization.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Computational Chemistry

Background:

  • In silico simulation and percolation theory are crucial for understanding pharmaceutical compacts.
  • Existing methods lack detailed mechanical structure analysis for binary systems.

Purpose of the Study:

  • To develop a novel in silico simulation for binary compacts.
  • To describe the mechanical structure of compacts with varying excipient and drug ratios.
  • To correlate computational predictions with experimental data.

Main Methods:

  • Compressed paracetamol and microcrystalline cellulose powders at various pressures.
  • Measured indentation hardness and tensile strength, fitting data to Leuenberger's model.
  • Performed in silico simulations, identifying and quantifying excipient clusters using the Hoshen-Kopelman algorithm.

Main Results:

  • Leuenberger's model accurately fitted experimental data for excipient loads >40%.
  • High drug loads (≥0.8) resulted in poor compactibility.
  • The in silico excipient percolation threshold was determined to be 0.3395.

Conclusions:

  • Computational and physical measurements showed strong agreement.
  • The in silico approach can optimize pharmaceutical powder formulations for tablet compression.
  • The study identified a critical excipient fraction (0.3-0.4) for forming mechanically sound compacts.