Doxycycline is an antibiotic of the tetracycline group with a broad spectrum of action.
Doxycycline hyclate is provided in solution to be administered orally. Such products traditionally present a series of problems of stability: forming coordination complexes (due to water hardness in case that it is used as an excipient), photo oxidation (as doxycycline becomes a quinone, responsible for discolouration), hydrolysis (basic pH more easily hydrolyzed) epimerization and precipitation.
Once known all these possible form of degradation of doxycycline hyclate, deep galenic study is necessary to find a combination of solvents, stabilizers, pH buffers, etc … thereby offering the user a doxycycline hyclate solution which not present any of these possible reactions.
Finally it has been found, by a combination series of galenic doxycycline hyclate technological factors in one solution that ensures product stability for two years.
The results obtained are shown in the following tables:
|TIME (months)||CONCENTRATION OF DOCYCYCLINE HYCLATE (mg/ ml)||APPEARANCE||REFRACTIVE INDEX||CONTROL pH|
|0||150.9 ± 0.2||Correct||1.4615||4.8|
|3||150.8 ± 0.2||Correct||1.4615||4.9|
|6||150.8 ± 0.2||Correct||1.4615||4.9|
|9||150.8 ± 0.2||Correct||1.4615||4.9|
|12||150.7 ± 0.2||Correct||1.4615||5.0|
|15||150.7 ± 0.2||Correct||1.4615||5.0|
|18||150.7 ± 0.1||Correct||1.4615||5.0|
|21||150.7 ± 0.2||Correct||1.4615||5.0|
|22||150.7 ± 0.2||Correct||1.4615||5.1|
|23||150.7 ± 0.1||Correct||1.4615||5.0|
|24||150.7 ± 0.2||Correct||1.4615||5.1|
|25||150.5 ± 0.1||Correct||1.4615||5.1|
The product proves stability since there is no degradation in the concentration of the active ingredient.
This product is commercially available under the name ALQUERPLUS Doxycycline.