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Related Concept Videos

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...
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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...
Drug Dissolution: Requirements and Profile Comparison01:14

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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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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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Characterizing Dissipative Elastic Metamaterials Produced by Additive Manufacturing
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Rheological Modeling and Torque-Based Processability Prediction for Celecoxib/PVPVA Hot-Melt Extruded Amorphous Solid

Paula Kaufelde1, Rita Maria Soares1, Oxana Brante1

  • 1Riga Stradins University, Latvia.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|June 29, 2026
PubMed
Summary
This summary is machine-generated.

Melt viscosity predicts hot-melt extrusion torque for amorphous solid dispersions (ASDs). This viscosity-to-torque framework guides formulation selection and process optimization, ensuring drug stability and processability.

Keywords:
Amorphous solid dispersionsCross and Carreau constitutive modelingcelecoxib – PVPVA 64extruder torque predictionviscosity extrapolation

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Predicting amorphous solid dispersion (ASD) processability during hot-melt extrusion (HME) is crucial for pharmaceutical development.
  • Understanding the relationship between material properties and process parameters is key to successful HME formulation.

Purpose of the Study:

  • To demonstrate that melt apparent viscosity data from rotational rheology, combined with constitutive modeling, can predict in-process extruder torque for ASDs.
  • To guide formulation and process selection for HME using a viscosity-to-torque framework.

Main Methods:

  • Quantified composition- and temperature-dependent melt rheology of celecoxib-PVPVA 64 ASDs at various drug-to-polymer ratios (30/70, 50/50, 70/30 w/w) between 130-160°C.
  • Fitted steady-shear viscosity data to Cross and Carreau models and extrapolated to process-relevant shear rates.
  • Converted extrapolated viscosities to torque using shear stress relationships and applied empirical calibration for HME conditions.

Main Results:

  • Polymer-rich formulations (30/70) exhibited higher viscosity and torque demand, while drug-rich systems (70/30) showed lower viscosity due to plasticization, impacting the amorphous processing window.
  • The Cross model provided superior viscosity fits and torque predictions compared to the Carreau model.
  • Transparent filaments confirmed amorphization for 30/70 and 50/50 formulations; 70/30 showed heterogeneity. The 30:70 formulation at 150°C offered the best balance of properties.

Conclusions:

  • The viscosity-to-torque framework provides a material-sparing approach to anticipate HME processability for ASDs.
  • This method aids in defining composition- and temperature-dependent processing windows, optimizing formulation and process selection.
  • The study identified the 30:70 celecoxib-PVPVA ASD at 150°C as the optimal condition for VCM preparation, balancing dispersion, amorphization, and processability.