Two open-label, randomized, crossover studies assessing the bioequivalence of ofloxacin administered as immediateand extended-release formulations in healthy subjects

Marier, Jean‐François; Ducharme, Murray P.; DiMarco, Marika; Spirito, Mike Di; Morelli, Gaetano; Tippabhotla, Sudhakar Koundinya; Badri, Nima; Rampal, Ashok; Monif, Tausif

doi:10.1016/j.clinthera.2006.12.018

Cited by 10 publications

(9 citation statements)

References 11 publications

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“…One RCT randomized 298 persons, of which 76 received moxifloxacin [37]. In 15 of 22 study arms (68%) the volunteers were treated for seven days [32]–[38],[41],[42],[46],[47] and in seven (32%) for 8 to 13 days [33],[39],[40],[44],[45].…”

Section: Resultsmentioning

confidence: 99%

“…Only two of the 14 included RCTs reported having applied random sequence generation for randomly assigning treatments [39],[42] whereas allocation concealment was not described in any of the other trials. Six trials were at high risk of bias because of lack of blinding of study staff and/or participants [32],[36],[37],[42],[44],[45].…”

Section: Resultsmentioning

confidence: 99%

“…Six trials were at high risk of bias because of lack of blinding of study staff and/or participants [32],[36],[37],[42],[44],[45]. These were all actively controlled trials.…”

Section: Resultsmentioning

confidence: 99%

“…Ofloxacin: Marier and colleagues reported that two of 40 participants were withdrawn from the study because they needed treatment of an adverse event; one of these had completed the 7-day 200 mg daily regimen and was on the second day of the 400 mg daily regimen when withdrawn because of repeated vomiting, whereas the other one needed treatment for dizziness and headache of increasing severity halfway the second period of treatment (order of regimens not stated) [42]. Adverse events leading to discontinuation of intravenous administration of 200 mg ofloxacin per day occurred in two out of 12 participants because of rash, respectively dizziness and tachycardia [41].…”

Section: Resultsmentioning

confidence: 99%

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Adverse Events in Healthy Individuals and MDR-TB Contacts Treated with Anti-Tuberculosis Drugs Potentially Effective for Preventing Development of MDR-TB: A Systematic Review

et al. 2013

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A recent systematic review concluded that there is insufficient evidence on the effectiveness to support or reject preventive therapy for treatment of contacts of patients with multidrug resistant tuberculosis (MDR-TB). Whether preventive therapy is favorable depends both on the effectiveness and the adverse events of the drugs used. We performed a systematic review to assess adverse events in healthy individuals and MDR-TB contacts treated with anti-tuberculosis drugs potentially effective for preventing development of MDR-TB. We searched MEDLINE, EMBASE, and other databases (August 2011). Record selection, data extraction, and study quality assessment were done in duplicate. The quality of evidence was assessed using the GRADE approach. Of 6,901 identified references, 20 studies were eligible. Among the 16 studies in healthy volunteers (a total of 87 persons on either levofloxacin, moxifloxacin, ofloxacin, or rifabutin, mostly for 1 week), serious adverse events and treatment discontinuation due to adverse events were rare (<1 and <5%, respectively), but mild adverse events frequently occurred. Due to small sample sizes of the levofloxacin and ofloxacin studies an increased frequency of mild adverse events compared to placebo could not be demonstrated or excluded. For moxifloxacin the comparative results were inconsistent. In four studies describing preventive therapy of MDR-TB contacts, therapy was stopped for 58–100% of the included persons because of the occurrence of adverse events ranging from mild adverse events such as nausea and dizziness to serious events requiring treatment. The quality of the evidence was very low. Although the number of publications and quality of evidence are low, the available evidence suggests that shortly after starting treatment the occurrence of serious adverse events is rare. Mild adverse events occur more frequently and may be of importance because these may provoke treatment interruption.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Six trials were at high risk of bias because of lack of blinding of study staff and/or participants [32],[36],[37],[42],[44],[45]. These were all actively controlled trials.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Adverse Events in Healthy Individuals and MDR-TB Contacts Treated with Anti-Tuberculosis Drugs Potentially Effective for Preventing Development of MDR-TB: A Systematic Review

et al. 2013

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“…[7][8][9] The repeated oral doses of ofloxacin over long time could result in nervous system and gastrointestinal system disorders. 10,11 Efforts have been made to develop alternative formulations of ofloxacin to improve therapeutic efficacy and reduce frequency of administration. [12][13][14][15][16] Ofloxacin-loaded liposomes produced higher intracellular drug concentrations and antimicrobial activities.…”

Section: Introductionmentioning

confidence: 99%

Preparation and evaluation of ofloxacin-loaded palmitic acid solid lipid nanoparticles

Xie¹,

Zhu²,

Zhao³

et al. 2011

IJN

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The purpose of this study was to use solid lipid nanoparticles (SLN) to improve the pharmacological activity of ofloxacin. Ofloxacin-loaded SLN were prepared using palmitic acid as lipid matrix and poly vinyl alcohol (PVA) as emulsifier by a hot homogenization and ultrasonication method. The physicochemical characteristics of SLN were investigated by optical microscope, scanning electron microscopy, and photon correlation spectroscopy. Pharmacokinetics was studied after oral administration in mice. In vitro antibacterial activity and in vivo antibacterial efficacy of the SLN were investigated using minimal inhibitory concentrations (MIC) and a mouse protection model. The results demonstrated that the encapsulation efficiency, loading capacity, diameter, polydispersivity index, and zeta potential of the nanoparticles were 41.36% ± 1.50%, 4.40% ± 0.16%, 156.33 ± 7.51 nm, 0.26 ± 0.04, and −22.70 ± 1.40 mv, respectively. The SLN showed sustained release and enhanced antibacterial activity in vitro. Pharmacokinetic results demonstrated that SLN increased the bioavailability of ofloxacin by 2.27-fold, and extended the mean residence time of the drug from 10.50 to 43.44 hours. Single oral administrations of ofloxacin-loaded nanoparticles at 3 drug doses, 5 mg/kg, 10 mg/kg, and 20 mg/kg, all produced higher survival rates of lethal infected mice compared with native ofloxacin. These results indicate that SLN might be a promising delivery system to enhance the pharmacological activity of ofloxacin.

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In vitro and in vivo evaluation of ofloxacin sustained release pellets

Cui

Zhang

Tang

2008

International Journal of Pharmaceutics

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Two open-label, randomized, crossover studies assessing the bioequivalence of ofloxacin administered as immediateand extended-release formulations in healthy subjects

Cited by 10 publications

References 11 publications

Adverse Events in Healthy Individuals and MDR-TB Contacts Treated with Anti-Tuberculosis Drugs Potentially Effective for Preventing Development of MDR-TB: A Systematic Review

Adverse Events in Healthy Individuals and MDR-TB Contacts Treated with Anti-Tuberculosis Drugs Potentially Effective for Preventing Development of MDR-TB: A Systematic Review

Preparation and evaluation of ofloxacin-loaded palmitic acid solid lipid nanoparticles

In vitro and in vivo evaluation of ofloxacin sustained release pellets

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