Research progress of Cefpodoxime proxetil application in pediatrics / 中华实用儿科临床杂志

Cefpodoxime proxetil(CPDX-PR) is the third generation cephalosporin with high oral efficiency.It has strong anti-gram negative bacteria and-gram positive bacteria effects, with wide tissue distribution, long plasma half-time(T1/2), stable to lactamase, good tolerance, small therapeutic dose, few times of administration, definite cli-nical efficacy and other advantages.It is recommended for application in the treatment guidelines of foreign children with various infectious diseases.It is of great clinical significance to discuss the rational application of CPDX-PR oral preparation under the condition of severe bacterial drug resistance.This article reviews the pharmacological characteristics of CPDX-PR and the research progress in the treatment of common infectious diseases in pediatrics, so as to promote the research on the rational clinical application of CPDX-PR in China.

The rapeutic effect of Cefpodoxime proxetil granules in treatment of acute bronchitis in children / 中华实用儿科临床杂志

Objective@#To study the efficacy and safety of Cefpodoxime proxetil granules in the treatment of acute bronchitis in children.@*Methods@#One hundred and sixty children of the First People′s Hospital of Nanning from June to December 2018 with acute bronchitis were randomly divided into cefpodoxime group and cefaclor group, with 80 cases in each group.All patients received routine treatment.On this basis, 80 patients in the cefpodoxime group received oral Cefpodoxime proxetil granules 5 mg/kg (not more than 100 mg/time), twice a day; 80 patients in the cefaclor group received oral Cefaclor.The granules were 10 mg/kg (not more than 250 mg/time), 3 times a day, and the course of treatment was 5 days.The clinical efficacy and adverse reactions were observed.@*Results@#The cure rate and effective rate of Cefpodoxime group were 91.3% (73/80 cases) and 95.0% (76/80 cases), respectively, while the cure rate and effective rate of Cefaclor group were 66.3%(53/80 cases) and 81.3%(65/80 cases), respectively, and the differences between the 2 groups were statistically significant (χ2=14.94, 7.23, all P<0.05). Sixty-three strains of pathogenic bacteria and 66 strains of pathogenic bacteria were obtained in Cefpodoxine group and Cefaclor group, respectively, and the detection rates of bacteria in the 2 groups were 78.75% and 82.50%, respectively.There was no significant diffe-rence in the number of bacterial strains and strains detected in each group (χ2=0.36, P>0.05), but the total bacterial clearance rate in Cefpodoxine group was 88.9%(56/63 cases) while the bacterial Clearance rate in Cefaclor group was 74.2%(49/66 cases), and the difference between the 2 groups was statistically significant (χ2=4.57, P<0.05). In particular, the bacterial clearance rate in Cefpodoxine group to Streptococcus pneumoniae, Staphylococcus aureus and Klebsiella pneumoniae were significantly higher than those in Cefaclor group, while the bacterial Clearance rate of Proteus and Escherichia coli were lower than those in Cefaclor group.The incidence of adverse reactions in Cefpodoxine group and Cefaclor group were 5.0% and 3.8%, respectively, with no significant difference (P>0.05).@*Conclusions@#The clinical effect of Cefpodoxime pro-xetil granules in treating children with acute bronchitis is more significant than that of Cefaclor.It has high safety and no serious side effect.

The rapeutic effect of Cefpodoxime proxetil granules in treatment of acute bronchitis in children / 中华实用儿科临床杂志

Objective To study the efficacy and safety of Cefpodoxime proxetil granules in the treatment of acute bronchitis in children.Methods One hundred and sixty children of the First People's Hospital of Nanning from June to December 2018 with acute bronchitis were randomly divided into cefpodoxime group and cefaclor group,with 80 cases in each group.All patients received routine treatment.On this basis,80 patients in the cefpodoxime group received oral Cefpodoxime proxetil granules 5 mg/kg (not more than 100 mg/time),twice a day;80 patients in the cefaclor group received oral Cefaclor.The granules were 10 mg/kg (not more than 250 mg/time),3 times a day,and the course of treatment was 5 days.The clinical efficacy and adverse reactions were observed.Results The cure rate and effective rate of Cefpodoxime group were 91.3％ (73/80 cases) and 95.0％ (76/80 cases),respectively,while the cure rate and effective rate of Cefaclor group were 66.3 ％ (53/80 cases) and 81.3％ (65/80 cases),respectively,and the differences between the 2 groups were statistically significant (x2 =14.94,7.23,all P ＜ 0.05).Sixty-three strains of pathogenic bacteria and 66 strains of pathogenic bacteria were obtained in Cefpodoxine group and Cefaclor group,respectively,and the detection rates of bacteria in the 2 groups were 78.75％ and 82.50％,respectively.There was no significant difference in the number of bacterial strains and strains detected in each group (x2 =0.36,P ＞ 0.05),but the total bacterial clearance rate in Cefpodoxine group was 88.9％ (56/63 cases) while the bacterial Clearance rate in Cefaclor group was 74.2％ (49/66 cases),and the difference between the 2 groups was statistically significant (x2 =4.57,P ＜ 0.05).In particular,the bacterial clearance rate in Cefpodoxine group to Streptococcus pneumoniae,Staphylococcus aureus and Klebsiella pneumoniae were significantly higher than those in Cefaclor group,while the bacterial Clearance rate of Proteus and Escherichia coli were lower than those in Cefaclor group.The incidence of adverse reactions in Cefpodoxine group and Cefaclor group were 5.0％ and 3.8％,respectively,with no significant difference (P ＞ 0.05).Conclusions The clinical effect of Cefpodoxime pro-xetil granules in treating children with acute bronchitis is more significant than that of Cefaclor.It has high safety and no serious side effect.

Simultaneous estimation of Cefpodoxime proxetil and Ofloxacin In tablet dosage form using RP-HPLC.

A simple, rapid and precise reverse phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for simultaneous estimation of Cefpodoxime proxetil and Ofloxacin in combined fixed dose oral formulation. The analysis was carried out using X-terra C8 (4.6 x 250mm, 5μm, Make: ACE), prepacked column. The separation was carried out using a mobile phase containing a 0.25%v/v triethyl amine buffer of pH 3.5 and acetonitrile (30:70 v/v), was pumped at a flow rate of 1.2 ml/min with UV-detector and PDA detection at 227 nm. Both the drugs were well resolved on the stationary phase and the retention times were around 2.747 minute for Cefpodoxime proxetil and 2.076 minute for Ofloxacin. The method was validated and shown to be linear for Cefpodoxime proxetil and Ofloxacin. The correlation coefficients for Cefpodoxime proxetil and Ofloxacin are 0.998 and 0.999 respectively. The relative standard deviations for five replicate measurements in two sets of each drug in the tablets is always less than 2% and mean % error of active recovery not more than ±1.5%. The method was validated for precision and accuracy. The developed method could be applied for routine analysis of Cefpodoxime proxetil and Ofloxacin in tablet dosage form without any interference of excipients.

Characterization of impurities in cefpodoxime proxetil using LC-MS (n)

Reversed-phase liquid chromatography coupled with electrospray ionization tandem mass spectrometry (ESI-MS/MS) was used to characterize impurities in cefpodoxime proxetil, an ester-modified prodrug. Based on the mechanisms by which cephalosporins are degraded, stress tests were designed and performed. The bulk material and capsule were eluted through a C18 column with formic acid-methanol-water as the mobile phase. In total, 15 impurities were characterized in commercial samples, including 7 known impurities and 8 new impurities. The structures of these unknown compounds were deduced via comparison with the fragmentation patterns of cefpodoxime proxetil. Data from this systematic study will help improve the safety and quality of cefpodoxime proxetil.

Efficacy and Safety of Fixed Dose Combination of Cefpodoxime Proxetil and Potassium Clavulanate (Cefchamp) in Comparison with Cefuroxime Axetil in Patients with Lower Respiratory Tract Infections.

Objectives: To evaluate the efficacy and safety of Fixed Dose Combination of Cefpodoxime Proxetil and Potassium Clavulanate (Cefchamp) in comparison with Cefuroxime Axetil in patients with Lower Respiratory Tract Infections.Methods:In this open, randomized, and controlled, parallel-group study of 7 days, 57 patients of both gender above 18 years of age with diagnosis of lower respiratory tract infection were randomized to receive Fixed Dose Combination (FDC) of Cefpodoxime Proxetil plus Potassium Clavulanate (Cefchamp), or Cefuroxime Axetil (CA) for a period of 7 days. Efficacy was assessed by symptoms of cough, dyspnoea, wheezing, Rhonchi, and chest pain based on 4-point scale as 0=none,1=mild, 2=moderate, 3=severe. Fever was recorded as the patient’s actual temperature. Safety assessment included adverse events and adverse drug reactions during the study period.Results: Three patients lost to follow up with CA.The improvement in all symptoms except cough was greater with CC as compared to CA group(p, >0.05). Fever improved from 37.18°C at baseline to 37.01 on day 3 with CC, whereas with CA the fever improved from 37.l5 at baseline to 37.05 on day 3 with CA. Fever subsided in all the patients in both treatments by day 5 of study therapy. Clinical cure was seen in 57.14% (16/28) patients on CC, whereas 42.3% patients (11/26) on CA had clinical cure.Conclusions:The fixed dose combination of Cefpodoxime Proxetil 200 mg and Potassium Clavulanate 125mg (Cefchamp) in comparison with Cefuroxime Axetil 500 mg showed improvement in the cure of respiratory tract infections in terms of decreasing the patient’s LRTI symptoms, improving the patient’s general health and with few adverse events and adverse drug reactions. However, further studies of greater sample size and blinded nature are needed to further substantiate this effect.

Gastro-Retentive Floating Matrix Tablets of Cefpodoxime Proxetil.

The present work aims at the development and evaluation of Floating matrix tablets of Cefpodoxime Proxetil were undertaken to prolong gastric residence time. A visible Spectrophotometric method has been employed for the estimation of Cefpodoxime Proxetil at 263 nm and Beer’s law is obeyed in the concentration range of 5-40 μg/ml. Total 7 formulations (B1-B7) were prepared using guargum with carbopol 934P was used in different concentrations. Fourier transform Infrared spectroscopy confirmed the absence of any drug/polymers/excipients interactions. The tablets were prepared by direct compression technique, using polymer such as hydroxy propyl methyl cellulose (HPMC K4M), guargum and carbopol 934P in different combinations with other standard excipients like sodium bicarbonate and lactose. Tablets were evaluated for physical characterization viz. hardness, friability, swelling index, floating capacity, thickness and weight variation. Further tablets were evaluated in-vitro drug release for 12 hr. The effect of polymer concentrations on buoyancy and drug release pattern was also studied. In-vitro drug release mechanism was evaluated by PCP V-3 software. Carbopol 934P had a negative effect on the floating properties also decreased the drug release. A lesser FLT and a prolonged floating duration could be achieved by varying the amount of effervescent and using different polymer concentrations. The entire matrix tablets showed significantly greater swelling index, exhibited controlled and prolonged drug release profiles and some floated over the dissolution medium for more than12 hr. The paddle speed affected the floating lag time and floating duration it had a negative effect on the floating properties. The optimized formulation followed the higuchi release model and showed non-fickian diffusion mechanism. It also showed no significant change in physical appearance, drug content, floatability or in-vitro dissolution pattern after storage at 45 oC at 75 % RH for three months.

Simultaneous spectrophotometric determination of cefpodoxime proxetil and ofloxacin in tablets.

The present manuscript describe simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of cefpodoxime proxetil and ofloxacin in combined tablet dosage form. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Cefpodoxime proxetil and ofloxacin show an isoabsorptive point at 273.2 nm in methanol. The second wavelength used is 297 nm, which is the λ-max of ofloxacin in methanol. The linearity was obtained in the concentration range of 2-14 μg/ml for both cefpodoxime proxetil and ofloxacin. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of ofloxacin. The method was successfully applied to pharmaceutical dosage form because no interference from the tablet excipients was found. The results of analysis have been validated statistically and by recovery studies.

Improvement in Assay of Cefpodoxime Proxetil by Modified HPLC / 中国药房

OBJECTIVE:To modify the HPLC method for determining the contents of cefpodoxime proxetil and cefpodoxime proxetil capsules or suspension,and to compare it with the method of UV determination.METHODS:Column:ODS-C18,mobile phase:methanol-water(50∶50),flow rate :1.5mL?min-1,column temperature:40℃,detection wavelength:235nm.RESULTS:The standard curve was rectilinear when cefpodoxime proxetil was within the range of 25～150?g?mL-1(r=0.999 9).The average recovery rate was 98.56%(RSD=1.79%)and the average content of the samples was 101.54%.CONCLUSIONS:The method is simple,rapid,accurate and sensitive for determination of cefpodoxime proxetil and cefpodoxime proxetil capsules or suspension.

Treatment of Lower Respiratory Infections:A Cost-effectiveness Analysis of Two Cephalosporins / 中华医院感染学杂志

0.05). The total cost of two drugs were 163.85 yuan and 104.04 yuan respectively,showing significant difference (P