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RIFAMPICIN AND ISONIAZID MICROCAPSULES FOR TREATMENT OF TUBERCULOSIS  [PDF]
A. Bajaj et al.
International Journal of Pharmaceutical Sciences and Research , 2012,
Abstract: Rifampicin and Isoniazid microcapsules were prepared by phase seperation coacervation method for inclusion in suspension formulations. Ethyl cellulose was used as the coating material for microencapsulation. Developed microcapsules were characterized for visual appearance, photomicrography, sieve analysis, drug content, bulk density, ethyl cellulose content and drug release studies. Microcapsules were found to be irregular in shape, free flowing with wide particle distribution in the range of 178-422 μm with 75 % drug content. Both Rifampicin and Isoniazid microcapsules exhibited prolonged release with first order kinetics. Rifampicin and Isoniazid microcapsule suspension formulation was characterized for pH, viscosity, sedimentation rate and drug content. The developed suspension was found to be uniform with drug content between 99-100%. Stability studies indicated that Rifampicin and Isoniazid suspension formulation exhibited greater stability as compared to pure drug suspensions. Hence, Rifampicin and Isoniazid suspension exhibits a potential to be developed as controlled release paediatric and geriatric formulation.
Damage of testicular cell macromolecules and reproductive capacity of male rats following co-administration of ethambutol, rifampicin, isoniazid and pyrazinamide
Ganna Mykhailivna Shayakhmetova, Larysa Borysivna Bondarenko, Valentina Mykolaivna Kovalenko
Interdisciplinary Toxicology , 2012, DOI: 10.2478/v10102-012-0002-9
Abstract: The necessity to minimize adverse effects of tuberculosis chemotherapy requires a comprehensive evaluation of the effects of antituberculosis drugs on the reproductive system and testicular cell macromolecules. The epidemiological situation of tuberculosis in Central and Eastern Europe is getting worse. Data on adverse effects of antituberculosis drugs are scare concerning particularly their effects on the reproductive system. The aim of the present study was to investigate the potential effect of ethambutol, rifampicin, isoniazid and pyrazinamide co-administration on lipid peroxidation, glutathione content and protein SH-groups, DNA fragmentation levels, the reproductive capacity of Wistar male rats and the antenatal development of their posterity. The rats (150-170 g) were divided into two groups: group I - received antituberculosis drugs suspended in 1% starch gel per os: ethambutol - 155 mg/kg b.w./day, rifampicin - 74.4 mg/kg b.w./day, isoniazid - 62 mg/kg b.w./day, pyrazinamide - 217 mg/kg b.w./day, group II (control) - received only starch gel in corresponding volumes. The contents of TBA-active compounds, glutathione and protein SH-groups in testis and sperm were determined spectrophotometrically, the DNA-fragmentation was determined using an UV transilluminator (BIORAD, USA), reproductive system indices were measured by standard methods. The co-administration of therapeutic doses of ethambutol, isoniazid, rifampicin and pyrazinamide to male rats during the period of spermatogenesis caused an increase in the rate of thiobarbituric acid reactive substances formation in testis and sperm, decrease of testis glutathione and protein SH-group contents, significant changes in DNA fragmentation, fatal decrease of male fertilizing capacity and fertility, and increase of pre- and post-implantation embryo lethality. The changes in reproductive indices could be the result of direct or indirect effects of one or more drugs investigated.
Development and validation of an electroanalytical methodology for determination of isoniazid and rifampicin content in pharmaceutical formulations
Leandro, Katia Christina;Carvalho, Juliana Machado de;Giovanelli, Luiz Fernando;Moreira, Josino Costa;
Brazilian Journal of Pharmaceutical Sciences , 2009, DOI: 10.1590/S1984-82502009000200019
Abstract: tuberculosis remains a major public health problem, especially in developing countries. brazil presents the largest number of cases in latin america and is among the 22 countries considered priorities by the world health organization (who). the rio de janeiro state has the largest number of cases registered in the country. the treatment of patients, commonly, makes use of the drugs isoniazid and rifampicin for six months. this study aimed to develop and validate an electroanalytical methodology, using the technique of differential pulse voltammetry for the determination of these drugs in the associated form, in order to evaluate the quality of medicines distributed in the state of rio de janeiro. the potential reduction for the isoniazid and rifampicin were -1.10 and -0.90 v. the developed and validated electroanalytical method presented a linear range of 0.25 to 1.25 mg/l to isoniazid, limits of detection and quantification of 0.05 and 0.14 mg/l, and recovery of 98.2 ± 0.4%; a tracking linear of 0.40 to 2.00 mg/l for rifampicin, with limits of detection and quantification of 0.07 and 0.19 mg/l and recovery of 95.8 ± 0.6%. six lots of medicines from two pharmaceutical companies were analyzed. only one of the samples showed unsatisfactory levels of rifampicin.
High Isoniazid Resistance Rates in Rifampicin Susceptible Mycobacterium tuberculosis Pulmonary Isolates from Pakistan  [PDF]
Naima Fasih, Yasraba Rafiq, Kausar Jabeen, Rumina Hasan
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0050551
Abstract: Background Rapid new diagnostic methods (including Xpert MTB/RIF assay) use rifampicin resistance as a surrogate marker for multidrug resistant tuberculosis. Patients infected with rifampicin susceptible strains are prescribed first line anti-tuberculosis therapy. The roll out of such methods raises a concern that strains with resistance to other first line anti-tuberculosis drugs including isoniazid will be missed and inappropriate treatment given. To evaluate implications of using such methods review of resistance data from high burden settings such as ours is essential. Objective To determine resistance to first line anti-tuberculosis drugs amongst rifampicin susceptible pulmonary Mycobacterium tuberculosis (MTB) isolates from Pakistan. Materials and Methods Data of pulmonary Mycobacterium tuberculosis strains isolated in Aga Khan University Hospital (AKUH) laboratory (2009–2011) was retrospectively analyzed. Antimicrobial susceptibility profile of rifampicin susceptible isolates was evaluated for resistance to isoniazid, pyrazinamide, ethambutol, and streptomycin. Results Pulmonary specimens submitted to AKUH from 2009 to 2011 yielded 7738 strains of Mycobacterium tuberculosis. These included 54% (n 4183) rifampicin susceptible and 46% (n: 3555) rifampicin resistant strains. Analysis of rifampicin susceptible strains showed resistance to at least one of the first line drugs in 27% (n:1133) of isolates. Overall isoniazid resistance was 15.5% (n: 649), with an isoniazid mono-resistance rate of 4% (n: 174). Combined resistance to isoniazid, pyrazinamide, and ethambutol was noted in 1% (n: 40), while resistance to isoniazid, pyrazinamide, ethambutol, and streptomycin was observed in 1.7% (n: 70) of strains. Conclusions Our data suggests that techniques (including Xpert MTB/RIF assay) relying on rifampicin susceptibility as an indicator for initiating first line therapy will not detect patients infected with MTB strains resistant to other first line drugs (including isoniazid). The roll out of these techniques must therefore be accompanied by strict monitoring ensuring early resistance detection to increase chances of improved patient outcomes.
Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine + Sulfadoxine- Pyrimethamine for Malaria: A Randomized Trial  [PDF]
Blaise Genton, Ivo Mueller, Inoni Betuela, Gerard Casey, Meza Ginny, Michael P Alpers, John C Reeder
PLOS ONE , 2006, DOI: 10.1371/journal.pctr.0010038
Abstract: Objectives Previous studies of a fixed combination including cotrimoxazole, rifampicin, and isoniazid (Cotrifazid) showed efficacy against resistant strains of Plasmodium falciparum in animal models and in small-scale human studies. We conducted a multicentric noninferiority trial to assess the safety and efficacy of Cotrifazid against drug-resistant malaria in Papua New Guinea. Design The trial design was open-label, block-randomised, comparative, and multicentric. Setting The trial was conducted in four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea. Participants Patients of all ages with recurrent uncomplicated malaria were included. Interventions Patients were randomly assigned to receive Cotrifazid, mefloquine, or the standard treatment of quinine with sulfadoxine–pyrimethamine (SP). Outcome Measures Incidence of clinical and laboratory adverse events and rate of clinical and/or parasitological failure at day 14 were recorded. Results The safety analysis population included 123 patients assigned to Cotrifazid, 123 to mefloquine, and 123 to quinine + SP. The Cotrifazid group experienced lower overall incidence of adverse events than the other groups. Among the efficacy analysis population (72 Cotrifazid, 71 mefloquine, and 75 quinine + SP), clinical failure rate (symptoms and parasite load) on day 14 was equivalent for the three groups (0% for Cotrifazid and mefloquine; 1% for quinine + SP), but parasitological failure rate (P. falciparum asexual blood-stage) was higher for Cotrifazid than for mefloquine or quinine + SP (9% [PCR corrected 8%] versus 0% and 3%, respectively [p = 0.02]). Conclusion Despite what appears to be short-term clinical equivalence, the notable parasitological failure at day 14 in both P. falciparum and P. vivax makes Cotrifazid in its current formulation and regimen a poor alternative combination therapy for malaria. Trial Registration ClinicalTrials.gov NCT00322907
Combined drug medium with isoniazid and rifampicin for identification of multi-drug resistant Mycobacterium tuberculosis  [cached]
Nalini S,Lakshmi R,Devika K,Ravikumar D
Indian Journal of Medical Microbiology , 2010,
Abstract: A low-cost method of detecting multi-drug resistant Mycobacterium tuberculosis (MDR-TB) with the possibility of quick adoption in a resource limited setting is urgently required. We conducted a study combining isoniazid and rifampicin in a single LJ medium, to detect MDR-TB strains. Combined and individual drug media showed 100% concordance for the detection of MDR-TB and susceptible strains by proportion method. Considering the results, combined isoniazid and rifampicin containing medium could be considered for use in settings where the sole detection of MDR-TB strains is justified.
Protective Effects of Metallothionein on Isoniazid and Rifampicin-Induced Hepatotoxicity in Mice  [PDF]
Yong Lian, Jing Zhao, Peiyu Xu, Yimei Wang, Jun Zhao, Li Jia, Ze Fu, Li Jing, Gang Liu, Shuangqing Peng
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0072058
Abstract: Isoniazid (INH) and Rifampicin (RFP) are widely used in the world for the treatment of tuberculosis, but the hepatotoxicity is a major concern during clinical therapy. Previous studies showed that these drugs induced oxidative stress in liver, and several antioxidants abated this effect. Metallothionein (MT), a member of cysteine-rich protein, has been proposed as a potent antioxidant. This study attempts to determine whether endogenous expression of MT protects against INH and RFP-induced hepatic oxidative stress in mice. Wild type (MT+/+) and MT-null (MT?/?) mice were treated intragastrically with INH (150 mg/kg), RFP (300 mg/kg), or the combination (150 mg/kg INH +300 mg/kg RFP) for 21 days. The results showed that MT?/? mice were more sensitive than MT+/+ mice to INH and RFP-induced hepatic injuries as evidenced by hepatic histopathological alterations, increased serum AST levels and liver index, and hepatic oxidative stress as evidenced by the increase of MDA production and the change of liver antioxidant status. Furthermore, INH increased the protein expression of hepatic CYP2E1 and INH/RFP (alone or in combination) decreased the expression of hepatic CYP1A2. These findings clearly demonstrate that basal MT provides protection against INH and RFP-induced toxicity in hepatocytes. The CYP2E1 and CYP1A2 were involved in the pathogenesis of INH and RFP-induced hepatotoxicity.
Evaluation of Biochip System in Determining Isoniazid and Rifampicin Resistances of Mycobacterium Tuberculosis in Sputum Samples  [PDF]
Wei Lu, Cheng Chen, Yan Shao, Jinyan Shi, Chongqiao Zhong, Dandan Yang, Honghuan Song, Guoli Li, Xiaoyan Ding, Hong Peng, Linyang Zhu, Yang Zhou, Limei Zhu
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0052953
Abstract: Objective To evaluate a biochip system in determining isoniazid and rifampicin resistances of Mycobacterium tuberculosis in sputum samples in a Chinese population. Methods We assembled 907 sputum smeared positive specimens of tuberculosis patients in total. Each sample would be separated into two parts for culture and biochip assay simultaneously. And those cultured positive and having full drug resistance results would be used as reference. The McNemar χ2 test was adopted for evaluating the paired 2×2 table. Results Compared with drug sensitivity test, the agreement rates of the two methods in detecting rifampicin and isoniazid resistances were 93.37% and 94.49%, respectively. The sensitivity and specificity of biochip in detecting isoniazid were 74.31% and 96.92%, respectively. Meanwhile, the sensitivity and specificity for rifampicin were 79.76% and 96.53%, respectively. For multi-drug resistance, the sensitivity and specificity were 64.62% and 97.75%, respectively. Conclusions The biochip system is a rapid and accurate method for drug resistant tuberculosis diagnosis using sputum samples directly, especially for rifampicin resistance detection.
Protective role of Ficus benghalensis against isoniazid-rifampicin induced oxidative liver injury in rat
Parameswari, S. Angala;Saleem, T. S. Mohamed;Chandrasekar, K. B;Chetty, C. Madhusudhana;
Revista Brasileira de Farmacognosia , 2012, DOI: 10.1590/S0102-695X2012005000009
Abstract: the present study was made to investigate the protective effect of methanolic extract of ficus benghalensis l., moraceae, on isoniazid-rifampicin-induced hepatotoxicity in rats. rats were divided into six different groups; group 1 served as a control, group 2 received isoniazid and rifampicin (100 mg/kg, i.p.), in sterile water, groups 3, 4 and 5 received 100, 200 & 300 mg/kg bw, p.o. methanolic extract of f. benghalensis and group 6 received liv 52. all the treatment protocols followed 21 days and after rats were sacrificed blood and liver were used for biochemical and histological studies, respectively. administration of isoniazid and rifampicin caused a significant elevation in the levels of liver marker enzymes (p<0.05 and p<0.01) and thiobarbituric acid reactive substances (p<0.001) in experimental rats. administration of methanolic extracts of f. benghalensis significantly prevented isoniazid-rifampicin-induced elevation in the levels of serum diagnostic liver marker enzymes and tbars level in experimental groups of rats. morever, total protein and reduced glutathione levels were significantly (p<0.001) increased in treatment group. the effect of extract was compared with a standard drug, liv 52. the changes in biochemical parameters were supported by histological profile. it is to be concluded that the methanolic extract of f. benghalensis protects against isoniazid and rifampicin-induced oxidative liver injury in rats.
Protective role of Ficus benghalensis against isoniazid-rifampicin induced oxidative liver injury in rat  [cached]
S. Angala Parameswari,T. S. Mohamed Saleem,K. B Chandrasekar,C. Madhusudhana Chetty
Revista Brasileira de Farmacognosia , 2012,
Abstract: The present study was made to investigate the protective effect of methanolic extract of Ficus benghalensis L., Moraceae, on isoniazid-rifampicin-induced hepatotoxicity in rats. Rats were divided into six different groups; group 1 served as a control, group 2 received isoniazid and rifampicin (100 mg/kg, i.p.), in sterile water, groups 3, 4 and 5 received 100, 200 & 300 mg/kg bw, p.o. methanolic extract of F. benghalensis and group 6 received Liv 52. All the treatment protocols followed 21 days and after rats were sacrificed blood and liver were used for biochemical and histological studies, respectively. Administration of isoniazid and rifampicin caused a significant elevation in the levels of liver marker enzymes (p<0.05 and p<0.01) and thiobarbituric acid reactive substances (p<0.001) in experimental rats. Administration of methanolic extracts of F. benghalensis significantly prevented isoniazid-rifampicin-induced elevation in the levels of serum diagnostic liver marker enzymes and TBARS level in experimental groups of rats. Morever, total protein and reduced glutathione levels were significantly (p<0.001) increased in treatment group. The effect of extract was compared with a standard drug, Liv 52. The changes in biochemical parameters were supported by histological profile. It is to be concluded that the methanolic extract of F. benghalensis protects against isoniazid and rifampicin-induced oxidative liver injury in rats.
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