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Dosage uniformity in hydrocortisone ointment B.P.
The Journal of Pharmacy and Pharmacology
|November 1, 1980
Summary
Hydrocortisone ointment content uniformity varied significantly across brands. Agglomerated particles, not individual ones, led to non-uniform drug distribution, potentially causing localized toxicity and variable absorption.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Quality Control
Background:
- Content uniformity is critical for topical drug efficacy and safety.
- Hydrocortisone ointments are widely used, necessitating consistent drug delivery.
- Particle agglomeration in ointments can significantly impact drug distribution.
Purpose of the Study:
- To investigate the content uniformity of hydrocortisone in commercially available 1% ointments.
- To correlate drug content variability with particle/agglomerate distribution.
- To assess the implications of non-uniformity on drug absorption and potential toxicity.
Main Methods:
- Assay of 5 mg samples from seven hydrocortisone ointment brands using high-performance liquid chromatography (HPLC).
- Statistical analysis of drug content data to determine skewness and coefficients of variation (CE and CP).
- Comparison of experimental content uniformity with theoretical predictions based on particle distribution.
Main Results:
- Significant positive skewness in drug content was observed in six out of seven ointments.
- Experimental coefficients of variation (CE) often exceeded predicted values (CP) due to particle agglomeration.
- Some 5 mg samples contained more than double the labeled strength of hydrocortisone.
Conclusions:
- Hydrocortisone particle agglomeration hinders uniform drug distribution in ointments.
- Non-uniform content can lead to localized toxicity, increased systemic availability, and variable therapeutic effects.
- Regulatory control of content uniformity for topical steroids is recommended to prevent unintentional over-dosage.
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