Amorphous nanoparticles of cefuroxime axetil (CFA), a poorly water-soluble drug, were produced by the controlled nanoprecipitation method without any surfactants at room temperature. The influence of the operation parameters, such as the types of solvent and anti-solvent, the stirring speed, the solvent/anti-solvent (S/AS) volume ratio, the drug concentration and the precipitation temperature, were experimentally investigated. The results indicated that increasing the stirring speed and the S/AS volume, decreasing the drug concentration and the temperature favored to decrease the particle size from 700 to 900 nm to approximately 300 nm. The XRD analyses confirmed that the as-prepared CFA was amorphous nanoparticles. Furthermore, the amorphous CFA nanoparticles exhibited significantly enhanced dissolution property when compared to the commercial spray-dried product. The results demonstrated that the controlled nanoprecipitation method is a direct and feasible technology which could be utilized for preparation of the poorly water-soluble pharmaceutical nanoparticles.
A double-blind placebo-controlled randomized multicentric study conducted with two treatment arms including 310 patients has demonstrated that pristinamycin, 2 g/d for 8 days, has a clinical efficacy equivalent to cefuroxime axetil, 500 mg/d.
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Computerized pharmacodynamic simulations were performed against strains with penicillin/amoxicillin/cefuroxime/cefditoren minimum inhibitory concentrations (MICs, microg/ml) and serotypes: strain 1 (0.25/0.12/1/0.12; serotype 6A), strain 2 (2/4/ 2/0.25; serotype 6B), strain 3 (4/16/4/0.5; serotype 14), and strain 4 (4/16/8/1; serotype 14).
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To compare the efficacy and safety of azithromycin dihydrate monotherapy with those of a combination of cefuroxime axetil plus erythromycin as empirical therapy for community-acquired pneumonia in hospitalized patients.
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In 94/121 (77.7%) patients Borrelia was detected in skin samples by PCR testing and 65/118 (55.1%) patients had positive skin culture result (96.8% B. afzelii, 3.2% B. garinii). Borrelia culture and PCR results correlated significantly with the presence of central clearing and EM size, while Borrelia burden correlated significantly with central clearing, EM size, and presence of newly developed or worsened symptoms since EM onset, with no other known medical explanation (new or increased symptoms, NOIS). In addition, the logistic regression model for repeated measurements adjusted for time from inclusion, indicated higher Borrelia burden was a risk factor for incomplete response (defined as NOIS and/or persistence of EM beyond 14 days and/or occurrence of new objective signs of Lyme borreliosis). The estimated association between PCR positivity and unfavorable outcome was large but not statistically significant, while no corresponding relationship was observed for culture positivity.
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Bacteriologic response to cefuroxime axetil and cefaclor administered for 10 days was evaluated in acute otitis media (AOM) in patients aged 6-36 months. Middle ear fluid culture was obtained by tympanocentesis before treatment, on day 4 or 5 after initiation of treatment, and if clinical relapse occurred before day 17. Bacteriologic failure was observed in 32% of patients receiving cefaclor versus 15% of patients receiving cefuroxime axetil (P = .009). Failure rates increased with increasing MIC: For Streptococcus pneumoniae, 0.5 microg/mL (established as cutoff value for cefuroxime by the National Committee for Clinical Laboratory Standards [NCCLS]) discriminated between success and failure. For Haemophilus influenzae, high failure rates were observed for cefaclor, even with low MICs (< or = 1.0 microg/mL), and with both drugs they tended to increase with increasing MIC, even for values below the cutoff suggested by the NCCLS (8.0 and 4.0 microg/mL for cefaclor and cefuroxime, respectively). Thus, for AOM caused by H. influenzae, lower susceptibility cutoff levels for MICs should be established.
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A combination of fusion and surface adsorption techniques was used to enhance the dissolution rate of cefuroxime axetil. Solid dispersions of cefuroxime axetil were prepared by two methods, namely fusion method using poloxamer 188 alone and combination of poloxamer 188 and Neusilin US2 by fusion and surface adsorption method. Solid dispersions were evaluated for solubility, phase solubility, flowability, compressibility, Kawakita analysis, Fourier transform-infrared spectra, differential scanning calorimetry, powder X-ray diffraction study, in vitro drug release, and stability study. Solubility studies showed 12- and 14-fold increase in solubility for solid dispersions by fusion method, and fusion and surface adsorption method, respectively. Phase solubility studies showed negative ΔG (0) tr values for poloxamer 188 at various concentrations (0, 0.25, 0.5, 0.75 and 1%) indicating spontaneous nature of solubilisation. Fourier transform-infrared spectra and differential scanning calorimetry spectra showed that drug and excipients are compatible with each other. Powder X-ray diffraction study studies indicated that presence of Neusilin US2 is less likely to promote the reversion of the amorphous cefuroxime axetil to crystalline state. in vitro dissolution studies, T50% and mean dissolution time have shown better dissolution rate for solid dispersions by fusion and surface adsorption method. Cefuroxime axetil release at 15 min (Q15) and DE15 exhibited 23- and 20-fold improvement in dissolution rate. The optimized solid dispersion formulation was stable for 6 months of stability study as per ICH guidelines. The stability was ascertained from drug content, in vitro dissolution, Fourier transform-infrared spectra and differential scanning calorimetry study. Hence, this combined approach of fusion and surface adsorption can be used successfully to improve the dissolution rate of poorly soluble biopharmaceutical classification system class II drug cefuroxime axetil.
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We studied 121 adult patients with EM in whom skin biopsy specimens were cultured and analyzed by quantitative PCR for the presence of Borreliae. Evaluation of clinical and microbiological findings were conducted at the baseline visit, and 14 days, 2, 6, and 12 months after treatment with either amoxicillin or cefuroxime axetil.
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Cefprozil is an orally active cephalosporin which has demonstrated activity against a wide range of organisms in vitro. It is particularly active against the Gram-positive organisms Streptococcus pyogenes, pneumoniae and agalactiae and against methicillin-susceptible Staphylococcus aureus. Strains of methicillin-resistant S. aureus are not susceptible to cefprozil. Cefprozil is also moderately active against Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, many Enterobacteriaceae and certain anaerobic organisms, and is relatively stable to hydrolysis by a number of beta-lactamases. In comparative trials, the clinical and bacteriological efficacy of cefprozil 500mg or 20 mg/kg administered once or twice daily has been comparable with multiple daily dosage regimens of erythromycin in patients with tonsillitis or pharyngitis, with cefaclor and amoxicillin/clavulanate in lower respiratory tract infections, with amoxicillin/clavulanate and erythromycin in skin and skin-structure infections and with cefaclor in acute uncomplicated urinary tract infections. The clinical efficacy of cefprozil is similar to that of cefaclor in patients with tonsillitis or pharyngitis but the bacteriological efficacy of cefprozil is significantly greater than that of cefaclor. Cefprozil is clinically more effective than cefuroxime axetil in the treatment of lower respiratory tract infections and demonstrated greater efficacy than cefaclor in one of 2 comparative studies when administered twice daily in patients with skin and skin-structure infections. In children with acute otitis media, cefprozil 15 mg/kg twice daily was as effective as cefaclor or amoxicillin/clavulanate 13.3 mg/kg 3 times daily and was as effective as cefixime 8 mg/kg once daily. The most frequently reported adverse effects associated with cefprozil, diarrhoea and nausea, are usually mild to moderate in severity and discontinuation of treatment is rarely necessary. Thus, cefprozil with its convenient administration regimen appears to be a suitable alternative to cefaclor, cefixime, amoxicillin/clavulanate or erythromycin for the treatment of upper and lower respiratory tract infections, skin and skin-structure infections, and otitis media in children. While cefprozil has shown similar efficacy to cefaclor in the treatment of uncomplicated urinary tract infections, well-controlled clinical trials comparing its efficacy with that of cotrimoxazole (trimethoprim+sulfamethoxazole) in this indication are required.
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Out of the 29436 emergencies studied on 30 days, 821 were diagnosed with acute otitis media. Fifteen point seven percent of the cases were already receiving antibiotics (22% amoxicillin clavulanate, 20% amoxicillin and 11% cefuroxime axetil). For the treatment, at discharge, of the 93% an antibiotic was prescribed (amoxicillin clavulanate in 41%, amoxicillin in 15%, cefuroxime axetil in 11%, cefaclor 6% and azithromycin 5%). Two point eight percent of the children were admitted. According to the guidelines of the panel of experts consulted, appropriateness was 61% for antibiotics of first choice, 12% for drugs of alternate use and 25% for inadequate treatment. The different hospitals presented significant variability in the type of antibiotic used and the appropriateness of such.
The influence of buffer composition on the release of cefuroxime axetil from stearic acid microspheres has been investigated, with particular emphasis on establishing the relationship between buffer composition and release at a single pH value. Studies of drug dissolution and release from spheres in pH 7.0 citrate phosphate buffer (CPB), boric acid buffer (BAB), phosphate buffer mixed (PBM) and Sorensens modified phosphate buffer (SMPB) indicated marked differences in release profile from the spheres, with an approximate rank order of SMPB > CPB approximately BAB > PBM. The role of added sodium was then investigated by examining the release profiles in SMPB and PBM to which sodium ions had been added. Increases in the sodium content from approximately 0.11 to 0.2 M were found to decrease the release rate for the SMPB, while increases from 0.007 to 1.0 M sodium in PBM resulted in a maximum release being seen for the systems containing 0.05 M sodium. Studies on surface disintegration, using scanning electron microscopy (SEM) and sodium uptake using flame emission spectroscopy, indicated an interrelationship between medium composition, disintegration and release. The data are discussed in terms of the possible mechanisms associated with drug release from these spheres.
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Development of resistance to available antimicrobial agents has been identified in every decade since the introduction of the sulfonamides in the 1930s. Current concerns for management of acute otitis media (AOM) are multi-drug resistant Streptococcus pneumoniae and beta-lactamase producing Haemophilus influenzae and Moraxella catarrhalis. In the USA, amoxicillin remains the drug for choice for AOM. Increasing the current dose to 80 mg/kg/day in two doses provides increased concentrations of drug in serum and middle ear fluid and captures additional resistant strains of S. pneumoniae. For children who fail initial therapy with amoxicillin an expert panel convened by the Centers for Disease Control and Prevention suggested amoxicillin-clavulanate, cefuroxime axetil or intramuscular ceftriaxone. To protect the therapeutic advantage of antimicrobial agents used for AOM, it is important to promote judicious use of antimicrobial agents and avoid uses if it is likely that viral infections are the likely cause of the disease, to implement programs for parent education and to increase the accuracy of diagnosis of AOM. Conjugate polysaccharide pneumococcal vaccines are currently in clinical trial; early results indicate protective levels of antibody can be achieved with a three dosage schedule beginning at 2 months of age. Finally, alternative medicine remedies may be of value for some infectious diseases including AOM; garlic extract is bactericidal for the major bacterial pathogens of AOM but is heat- and acid-labile and loose activity when cooked or taken by mouth.