Technonews: Stability of Doxycycline Hyclate at 15%

INTRODUCTION:

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.

AIM:

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.

RESULTS:

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

CONCLUSIONS:

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.

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