ABSTRACT
A hanseníase, doença crônica, granulomatosa, infecto-contagiosa, transmitida pelo Mycobacterium leprae, ainda se mantém prevalente nos dias atuais, principalmente em países subdesenvolvidos e a sua forma paucibacilar com lesão única, vem sendo tratada através da administração de rifampicina (600mg), ofloxacina (400mg) e minociclina (100mg), em dose única (esquema ROM). Assim, o objetivo deste trabalho foi investigar a correlação dose/concentração plasmática versus alterações bioquímicas na administração da rifampicina, ofloxacina e minociclina a ratos machos Wistar, em regime de dose única em mono e politerapia. Concluímos que a rifampicina e a ofloxacina sofreram um aumento na concentração plasmática quando administrados em politerapia, enquanto que a minociclina sofreu uma redução, provavelmente por interferências na biotransformação e excreção. Constatamos através das análises bioquímicas que a rifampicina provavelmente é a responsável por alterações hepáticas e renais, e que as interações medicamentosas envolvendo o fármaco exigem estudos individualizados principalmente quando o fármaco é usado associado a ofloxacina e minociclina.
Subject(s)
Animals , Male , Rats , Anti-Bacterial Agents/administration & dosage , Kidney/drug effects , Leprostatic Agents/administration & dosage , Leprosy/drug therapy , Liver/drug effects , Minocycline/administration & dosage , Ofloxacin/administration & dosage , Rifampin/administration & dosage , Anti-Bacterial Agents/blood , Clinical Protocols , Drug Therapy, Combination , Kidney/chemistry , Leprosy/blood , Liver/chemistry , Minocycline/blood , Ofloxacin/blood , Rats, Wistar , Rifampin/bloodABSTRACT
Bioequivalence study was performed for Levofloxacin Tablets 250mg. For this purpose one reference formulation manufactured in Pakistan, by a local Pharmaceutical Company which is also a brand leader, was compared with test formulation manufactured by another Pharmaceutical Industry. The study was formated in accordance to the draft guidance provided by FDA [CDER] for biovailability and bioequivalence studies. The test formulation was administered orally, in fasting state, to 7 healthy volunteers and the blood samoles were drawn at appropriate intervals upto 30hrs, Reference product [Cravit] was administered to the same group of volunteer after a wash out period of one week. Samples were analysed on HPLC for the determination of drug conncentrations. The Pharmacokinetic parameter such as Cmax, Tmax and AUC were calculated. The data generated was analysed statistically by ANOVA and paired t test. Results of Pharmacokinetic parameter indicated that both products Test [A] and Reference [B] are bioequivalent. Statisyical analysis supports this conclusion