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Oxygen diffusion coefficients in commonly used topical semisolid creams.
1Pharmaceutical Research & Development Division, Bristol-Myers Co., Buffalo, New York 14213.
Pharmaceutical Research
|February 1, 1988
Summary
This study measured oxygen diffusion in topical creams. Oxygen diffusion coefficients decrease as petrolatum concentration increases in oil-in-water creams.
Area of Science:
- Pharmaceutics
- Physical Chemistry
- Materials Science
Background:
- Oxygen sensitivity is a critical factor in formulating drugs for topical, ophthalmic, and parenteral use.
- Understanding oxygen diffusion in semisolid dosage forms is crucial for drug stability and efficacy.
- Topical ointments and creams require specific formulation considerations to protect oxygen-sensitive ingredients.
Purpose of the Study:
- To determine oxygen diffusion coefficients, permeabilities, and solubilities in oil-in-water (o/w) topical ointments and commercial anthralin creams.
- To investigate the impact of petrolatum concentration on oxygen diffusion in o/w creams.
- To provide data for optimizing the formulation of oxygen-sensitive drugs in semisolid dosage forms.
Main Methods:
- A novel coupled steady-state and unsteady-state analysis for oxygen diffusion was employed.
- Oxygen diffusion through a thin layer of test material on a membrane-covered polarographic oxygen electrode was measured.
- The method, developed by Ju and Ho (1986), was applied to a USP XXI hydrophilic ointment and four 1% anthralin creams.
Main Results:
- Oxygen diffusion coefficients were found to decrease with increasing petrolatum concentration in o/w topical creams.
- The study successfully determined oxygen diffusion coefficients for four commercial 1% anthralin creams.
- Permeability and solubility data were also obtained, contributing to a comprehensive understanding of oxygen transport.
Conclusions:
- The formulation of topical creams significantly influences oxygen diffusion rates.
- Increased petrolatum concentration in o/w creams acts as a barrier to oxygen diffusion.
- This research provides valuable insights for designing stable and effective topical formulations for oxygen-sensitive pharmaceuticals.