DEVELOPMENT OF AN INJECTABLE SOLUTION OF ENROFLOXACIN 10 %
Keywords:
enrofloxacin; injectable; drug development; veterinaryAbstract
Enrofloxacin is a fluoroquinolone for veterinary use only, with broad-spectrum
antimicrobial and mycoplasmicidal action. The objective of the work was to develop an
injectable solution of enrofloxacin 10 % for veterinary use. Two formulations were
prepared varying the use of solubilizer and cosolvents to achieve the solubility of the drug
and the one with the highest physical-chemical and microbiological stability was selected.
A long-term stability study was carried out on three pilot lots manufactured with the chosen
formulation for 18 months, as well as the stability in use of the product for 28 days.
Formulation variant two was selected for being the most stable. All batches met the quality
specifications established in the proposed storage conditions. The product is stable for 18
months and 28 days once the bottle is opened at room temperature and protected from light,
in 20 mL amber bulbs, so it can be used in veterinary medicine.
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Copyright (c) 2025 Lázara Sulin González-Ferre, Maybel Rosa González-Miraba, Yadira Aguado-Uribe, Rafael Francisco Semanat-Ferrer, Ylenia Piñero-Champagne
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