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Cefteram pivoxil

目录号 : GC25209

Cefteram Pivoxil is the pivalate ester prodrug of cefteram, a semi-synthetic, broad-spectrum, third-generation cephalosporin with antibacterial activity.

Cefteram pivoxil Chemical Structure

Cas No.:82547-81-7

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5mg
¥557.00
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25mg
¥1,663.00
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产品描述

Cefteram Pivoxil is the pivalate ester prodrug of cefteram, a semi-synthetic, broad-spectrum, third-generation cephalosporin with antibacterial activity.

Chemical Properties

Cas No. 82547-81-7 SDF Download SDF
分子式 C22H27N9O7S2 分子量 593.64
溶解度 DMSO: 0.01 mg/mL (0.02 mM);Water: Insoluble; 储存条件 Store at -20°C
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1 mg 5 mg 10 mg
1 mM 1.6845 mL 8.4226 mL 16.8452 mL
5 mM 0.3369 mL 1.6845 mL 3.369 mL
10 mM 0.1685 mL 0.8423 mL 1.6845 mL
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Research Update

Impurity profiling of Cefteram pivoxil based on Fourier transform ion cyclotron resonance MS

J Pharm Biomed Anal 2020 Nov 30;191:113591.PMID:32889346DOI:10.1016/j.jpba.2020.113591.

Profiling impurities for the active pharmaceutical ingredients (APIs) is an indispensable step in drug development process. Nowadays, high resolution mass spectrometry is the first choice for determining the chemical formula of organic impurities. However, merely base on the accurate mass to screen the formula is obviously not a flawless method. In this paper, a reliable strategy based on Fourier transform ion cyclotron resonance mass spectrometry (FT-ICR MS) was presented to profile the related impurities. Firstly, Cefteram pivoxil was subjected to forced degration under hydrolytic (acidic and basic), oxidative, photolytic and thermal conditions according to ICH guidelines. Then, a highly specific and efficient HPLC-FT-ICR MS compatible method was developed and it was used to separate and characterize the process related substances and the major degradation products in Cefteram pivoxil. Next, isotopic fine structures (IFSs) of all impurities were acquired to decisively determine their elemental composition. Finally, the possible chemical structures of impurities were predicted by combining the information of accurate mass, retention time, IFSs and characteristic fragmentation ions. As a result, a total of 20 related substances including 6 process related substances and 14 degradation products were identified and characterized. To the best of our knowledge, 13 of these related substances were not reported in the previous literature. It indicates that the developed strategy is accurate and standard independent to determine the chemical formulae of organic impurities in APIs. In conclusion, the impurity profiles obtained in this study are critical to the quality control and stability study of Cefteram pivoxil. Moreover, the developed method can be used as a versatile workflow to profile the impurities in APIs in the future, especially for the unknown impurities.

Pharmacokinetics and bioequivalence studies of Cefteram pivoxil in healthy Chinese volunteers

Eur J Drug Metab Pharmacokinet 2009 Jul-Sep;34(3-4):157-62.PMID:20166432DOI:10.1007/BF03191167.

A simple, sensitive and specific method has been developed for the determination of cefteram in human plasma. Sample preparation was accomplished through protein precipitation with 20% trichloroacetic acid (v/v) and chromatographic separation was performed on a C18 column at 25 degrees C. The mobile phase consisted of methanol-aqueous 20 mM ammonium acetate (18:82, v/v) at flow rate of 1.0 mL/min. Wavelength was set at 235 nm. The lower limit of quantification was 0.04 microg/mL and the assay exhibited a linear range of 0.04-3.2 microg/mL (r=0.9996). The relative recoveries of cefteram from human plasma at three different concentrations were more than 90%. The method was successfully applied to investigate the bioequivalence between two kinds of Cefteram pivoxil preparations (test vs reference) in 24 healthy Chinese volunteers. After a single 100 mg dose for the test and reference product, the resulting means of major pharmacokinetic parameters such as AUC(0-t), AUC(0-infinity), Cmax and Tmax of Cefteram pivoxil were 4.75 +/- 1.35 vs 4.76 +/- 1.29 microg h/mL, 4.89 +/- 1.36 vs 4.91 +/- 1.29 microg h/mL, 1.65 +/- 0.45 vs 1.73 +/- 0.45 microg/mL and 1.48 +/- 0.59 vs 1.73 +/- 0.45 h, respectively, indicating that these two kinds of preparations were bioequivalent.

Comparative clinical study of cefcapene pivoxil and Cefteram pivoxil in chronic respiratory tract infections by a double-blind method

J Int Med Res 2004 Nov-Dec;32(6):590-607.PMID:15587753DOI:10.1177/147323000403200604.

In a double-blind study, the efficacy and safety of the novel cephem antibiotic cefcapene pivoxil (CFPN-PI; 450 mg/day) was compared with Cefteram pivoxil (CFTM-PI; 600 mg/day) in 171 patients with chronic respiratory tract infections. There was no significant difference between the clinical efficacy of the two drugs (80.2% for CFPN-PI versus 78.9% for CFTM-PI). There was no significant difference in the rate of elimination of the causative bacteria (60.5% for CFPN-PI versus 65.9% for CFTM-PI). Side-effects were observed in 6.0% of patients treated with CFPN-PI compared with 6.4% of patients treated with CFTM-PI. There were no significant differences in incidence of abnormal laboratory findings following treatment with the two drugs (13.9% for each), and none of the side-effects was severe. We conclude that CFPN-PI (450 mg/day) was as effective and as well tolerated as CFTM-PI (600 mg/day) in the treatment of chronic respiratory tract infections.

[Laboratory and clinical studies on Cefteram pivoxil in the field of pediatrics]

Jpn J Antibiot 1989 Aug;42(8):1849-59.PMID:2810748doi

Laboratory and clinical studies on Cefteram pivoxil(cefteram) a new cephem antibiotic, were carried out in the field of pediatrics. The results obtained are summarized as follows: 1. Serum concentrations, urinary concentrations and urinary recovery rates of cefteram (CFTM) were determined upon oral administration after meal of Cefteram pivoxil (CFTM-PI) at doses of 3 mg/kg granules in 2 cases and 6 mg/kg granules in 2. Peak serum levels of CFTM were obtained at 3 hours in 2 cases and 4 hours in 2 cases after administration of the drug with a range of 0.74-2.2 micrograms/ml with half-lives of 0.77-3.62 hours. Urinary recovery rates in 8 hours after administration ranged from 9.6-23.0%. 2. MICs of CFTM against 22 clinical isolates (Streptococcus pyogenes 4 strains, Streptococcus pneumoniae 4, Staphylococcus aureus 2, Branhamella catarrhalis 1, Haemophilus influenzae 8, Haemophilus parainfluenzae 1, and Escherichia coli 2) were compared with those of cefaclor (CCL), cephalexin (CEX), and ampicillin (ABPC). The antibacterial activity of CFTM was superior to those of CCL and CEX, and was superior against Gram-negative rods and equal against Gram-positive cocci to those of ABPC. 3. Twenty-six pediatric patients with acute infectious diseases (scarlet fever 3 cases, tonsillitis 7, epiglottitis 1, bronchitis 5, pneumonia 5, urinary tract infection 3, cervical lymphadenitis 2) were treated with CFTM-PI at daily doses of 9.3-15.3 mg/kg t.i.d. as a rule. The efficacy rates were 100% clinically and 70% bacteriologically. 4. Side effects or abnormal laboratory test values were not observed except for an increased platelet count in 1 case.

Pharmacokinetic and bioequivalence comparison of a single 100-mg dose of Cefteram pivoxil powder suspension and tablet formulations: a randomized-sequence, open-label, two-period crossover study in healthy Chinese adult male volunteers

Clin Ther 2008 Apr;30(4):654-60.PMID:18498914DOI:10.1016/j.clinthera.2008.04.003.

Background: Cefteram pivoxil (CFTM-PI) is an oral antibiotic available in powder suspension and tablet formulations indicated in China for the treatment of bacterial infections. Although these 2 formulations are marketed in China, published information regarding their pharmacokinetics and bioequivalence in the Chinese population is not available. Objective: The aim of this study was to compare the pharmacokinetics and bioequivalence of the powder suspension (test) and tablet (reference) formulations of CFTM-PI 100 mg available in China. Methods: This single-dose, randomized-sequence, open-label, 2-period crossover study was performed at the Nanjing First Hospital of Nanjing Medical University. Eligible subjects were healthy male volunteers who were randomly assigned at a 1:1 ratio to receive a single 100-mg dose of the test or reference formulation, followed by a 1-week washout period and administration of the alternate formulation. The study drugs were administered after a 12-hour overnight fast. Plasma was assayed using a high-performance liquid chromatography method. For analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to 6 hours (AUC(0-6)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were obtained at intervals over the 6-hour period after study drug administration. The formulations were considered bioequivalent if the log-transformed ratios of C(max) and AUC were within the predetermined equivalence range (80%-125%) as established by the US Food and Drug Administration (FDA). Tolerability was assessed by monitoring vital signs and laboratory tests (hematology, blood biochemistry, hepatic function, and urinalysis), and by questioning subjects about adverse events (AEs). Results: Twenty-four Chinese male subjects (mean [range] age,24.2 [23-32] years;weight,64.3 [58-67] kg; height, 172 [167-185] cm) enrolled; all completed the study. No period or sequence effect was observed. The 90% CIs for the log-transformed ratios of C(max), AUC(0-6;), and AUC(0-infinity) were 96.5 to 120.1, 95.7 to 110.2, and 96.2 to 110.4, respectively (all, P>0.05). Similar results were found for the data without log-transformation. No AEs occurred or were reported during the study. Conclusions: In this small study in healthy Chinese adult male volunteers, a single 100-mg dose of the powder-suspension formulation was bioequivalent to a single 100-mg dose of the tablet formulation based on the US FDA's regulatory definition (rate and extent of absorption). Both formulations were well tolerated.