Twenty-Week Solid-State Stability Study of
Combined Doxycycline, Trimethoprim and Sulfamethoxypyridazine
Formulations after Extemporaneous Preparation for Veterinary Use
O Montejo1, P Modamio1, CF
Lastra1, I Segarra1, N Mestorino2
and EL Mariño1,*
1Clinical
Pharmacy and Pharmacotherapy Unit, Department of Pharmacy and
Pharmaceutical Technology, Faculty of Pharmacy, University of
Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain; 2Pharmacology
Department, Faculty of Veterinary Sciences, Universidad Nacional de
La Plata, CC 296, 1900 La Plata, Buenos Aires, Argentina;
*Corresponding author:emarino@ub.edu
Abstract
The solid-state stability of doxycycline,
trimethoprim and sulfamethoxypyridazine alone or in combination was evaluated
for 135 days (20 weeks). A validated HPLC assay was developed for their
simultaneous determination and applied to assess their solid-state stability
alone and in binary combinations upon extemporaneous preparation. The results
showed that the drugs are stable based on ICH Q1A (R2) protocol for at least 135
days at 25±2ºC and at 60±5% of relative humidity and protected from light.
Similarly, the solid-state stability of the combination mixtures of doxycycline
and sulfamethoxypyridazine, doxycycline and trimethoprim, and trimethoprim and
sulfamethoxypyridazine were also shown stable in the above conditions. These
findings provide evidence for the suitability of preparation of extemporaneous
formulations which might help for safe and efficacious treatments in veterinary
medicine.
Key words:
Doxycycline,
Solid-state stability, Sulfamethoxypyridazine,
Trimethoprim, Veterinary medicine