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In Vitro Drug Dissolution: Compendial Testing Models II01:09

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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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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...
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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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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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Author Spotlight: Shear Assay Protocol for the Determination of Single-Cell Material Properties
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Flow characterization of a pharmaceutical excipient using the shear cell method.

Paulo José Salústio1, Cláudia Inácio1, Telmo Nunes2

  • 1Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), University of Lisbon. Av. Prof. Gama Pinto, Lisbon, Portugal.

Pharmaceutical Development and Technology
|November 14, 2019
PubMed
Summary

Microcrystalline Cellulose (MCC) powder flowability unexpectedly decreased at high stress due to increased cohesion. Homogeneous particle sizes and narrower distributions improve powder flow for solid dosage forms.

Keywords:
Flowingexcipientflow indexshear cellsieving

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Powder flow is crucial for industrial solid dosage form manufacturing.
  • Microcrystalline Cellulose (MCC) is a common excipient with typically predictable flow properties.
  • Unexpected flow behaviors were observed for MCC in this study.

Purpose of the Study:

  • To investigate the non-ideal flow behaviors of Microcrystalline Cellulose (MCC).
  • To analyze the impact of particle size and consolidation stress on MCC flowability.
  • To understand the underlying mechanisms causing deviations in flow properties.

Main Methods:

  • Fractionation of MCC by sieving to obtain different particle size fractions.
  • Analysis of powder flow behavior using shear cell methods.
  • Evaluation of flowability index (ff) under varying consolidation stress levels.

Main Results:

  • Flowability index (ff) increased with particle size and consolidation stress, up to a point.
  • A decrease in ff was observed above 2000-4000 N/m² consolidation stress, attributed to increased cohesion.
  • Fractions of 125-180 µm exhibited higher ff than bulk powder at similar median particle sizes (Dv50).

Conclusions:

  • Powder flowability is significantly influenced by particle size and distribution.
  • High consolidation stress can negatively impact MCC flow due to increased cohesion.
  • Optimizing particle size homogeneity and distribution is key to achieving better powder flowability in pharmaceutical production.