Short-Stability Study of Rifaximin-Based Samples.

BACKGROUND

Rifaximin is an oral antimicrobial with a daily dose ranging from 600 to 800 mg. It is classified as Class IV in the Biopharmaceutic Classification System. Thus, rifaximin-based samples were developed by complexation to β-cyclodextrin using a phase solubility diagram, and malaxation and decreasing particle size using wet milling.

OBJECTIVE

Concomitant to the pharmaceutical technology, a stability studywas undertaken with the objective of verifying the integrity of the drug.

METHODS

The stability of the new samples were studied for 6 months, without interruption, under controlled conditions of temperature and humidity in a climatic chamber. They were analyzed simultaneously by HPLC and microbiological turbidimetry at zero, 3, and 6 months.

RESULTS

Two of the samples follow second reaction order and one follows zero reaction order. Microbiological analysis proved to be important in assessing the potency of rifaximin in one of the samples, and its results were more consistent than the results by HPLC.

CONCLUSIONS

The rifaximin-based samples were stable under controlled temperature and humidity conditions and the physical-chemical and microbiological methods were able to evaluate their behavior during the 6-month study.

HIGHLIGHTS: It is worth considering the development of these products, since the design process of formulation and pharmaceutical technology is financially more attractive than the development of new drugs that require high levels of investment in research and development, innovation of public policies, and regulatory actions.