Colour stability of tetracycline hydrochloride capsules.
Rakwatin, Churairat; Tanunkat, Orapin; Wongnopara-tlaudt, Saowanee.
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| IMSEAR | ID: sea-137760
In a preliminary study of various excipients that could stabilize the colour of tetracycline hydrochloride (TC), it was found that sodium metabisulfite yielded the maximum stability and it was then chosen for a further study. Comparative studies of the colour and chemical stability of TC powder in capsules in different of colour capsule shells, different types of containers, as well as the omission and addition of 0.1% sodium metabisulfite were then made. The results showed that, after 36 months at ambient temperature, there was no significant difference in colour of the drug powder in each formula resulting from the type of container or colour of the capsule shell. At ambient temperature, the addition of sodium metabisulfite prolonged shelf life from 3 to 9 mnths in colour stability aspect, but the rate constant of 4-epianhydrotetracycline production (Zero order reaction) increased from 0.0012-0.0056% to 0.0052-0.0093% per month. The tentative shelf life of TC with and without sodium metabisulfite at 95% confidence were then more than 5 years. However, storage in refrigerator (14-15oC) for 36 months, TC preparation with and without sodium metabisulfite gave good colour stability (yellow powder) and a shelf life longer than 36 months.
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