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Physico-chemical and solid-state characterization of secnidazole
A B Rivera1, R G Hernández, H Novoa de Armas
1Center of Pharmaceutical Chemistry, Playa, Havana, Cuba.
Farmaco (Societa Chimica Italiana : 1989)
|February 24, 2001
Summary
Secnidazole, an antimicrobial agent, exhibits basic properties and instability at high humidity. Preformulation studies revealed poor rheological characteristics but no drug-excipient interactions.
Area of Science:
- Pharmaceutical Sciences
- Medicinal Chemistry
Background:
- Secnidazole is an antimicrobial agent effective against amebiasis, giardiasis, and trichomoniasis.
- Preformulation studies are crucial for understanding drug properties before formulation.
Purpose of the Study:
- To characterize physicochemical properties of secnidazole during preformulation.
- To develop and validate a spectrophotometric method for secnidazole assay.
- To assess drug-excipient compatibility.
Main Methods:
- Determination of apparent partition coefficient and pH-dependent solubility.
- Spectrophotometric assay method validation (linearity, sensitivity, precision, accuracy, selectivity).
- Hygroscopicity evaluation, rheological property assessment (density, compressibility), and Differential Scanning Calorimetry (DSC) for compatibility.
Main Results:
- Secnidazole exhibits basic characteristics and is unstable above 54% relative humidity.
- A validated spectrophotometric method was established for secnidazole assay.
- The drug displayed poor rheological characteristics, but DSC indicated no physical interactions with excipients.
Conclusions:
- Secnidazole's physicochemical profile presents challenges for formulation, particularly regarding humidity and rheology.
- The validated analytical method is suitable for quality control of bulk secnidazole.
- Further formulation strategies are needed to address the identified stability and rheological issues.