ABSTRACT
Ciprofloxacin, commonly used in India as an anti-microbial for prolonged use in chronic and non-specific indications, may affect the bioavailability of the drug. The drug prescribed is commonly taken with multivitamins, calcium and milk. A simple and reliable analytical methodology obtaining a correlation with in vivo urinary excretion studies using UV and HPLC and in vitro dissolution studies (IVIVC) has shown a significant increase in elimination rate of ciprofloxacin co-administered with multivitamins, calcium and milk. Appreciable IVIVC results proved that dissolution studies could serve as an alternative to in vivo bioavailability and also support bio-waivers.
ABSTRACT
India is facing an explosion of diabetes and related diseases. Health infrastructure in rural India is very poor. A large number of rural Indians are below poverty line. To overcome the problem of insulin resistance in rural India, the authors conducted studies with nutraceuticals and came across many sociocultural, socio-political and socioeconomic constraints to faithfully following ethical guidelines of Indian Council of Medical Research (ICMR). This paper deals with some of the constraints and it is strongly felt that the ICMR should review its guidelines in the context of the existing situation.