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Related Experiment Videos

[Dosage problems in suspension eyedrops]

K A Kwon1, M Diestelhorst, R Süverkrüp

  • 1Pharmazeutisches Institut, Universität Bonn, Pharmazeutische Technologie.

Klinische Monatsblatter Fur Augenheilkunde
|August 1, 1996
PubMed
Summary

Ophthalmic suspension eyedrops require effective shaking for uniform dosing. A new automated shaker test reveals incomplete redispersion in some products, leading to inaccurate drug delivery and potential therapeutic issues.

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Area of Science:

  • Pharmaceutical Technology
  • Ophthalmic Drug Delivery
  • Rheology

Context:

  • Ophthalmic suspensions are prone to particle sedimentation during storage.
  • Uniform dosing of suspension eyedrops is critical for therapeutic efficacy.
  • Current pharmacopoeial standards lack a standardized test for assessing redispersion properties.

Purpose:

  • To develop and validate a reproducible test method for assessing the dose uniformity of ophthalmic suspension eyedrops.
  • To establish the experimental and theoretical basis for a reliable test of redispersibility.
  • To evaluate the performance of a computer-controlled pneumatic shaker and sampler for this purpose.

Summary:

  • Shaking profiles of patients and healthy subjects were recorded using acceleration sensors and compared to a pneumatic shaker.
  • Drug content in single drops of three ophthalmic suspensions (dexamethasone, indomethacin, prednisolone acetate) was analyzed.
  • The automated shaker demonstrated reproducible testing conditions for evaluating dose uniformity after sedimentation.

Impact:

  • Identified incomplete redispersion in Isopto-dex, resulting in significantly lower doses.
  • Demonstrated variable dosing for Chibro-Amuno 3 and satisfactory results for Inflanefran-forte.
  • The developed apparatus provides a standardized method for ensuring the quality and efficacy of ophthalmic suspension eyedrops.

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