Solid Dispersions of Cefixime Using β-Cyclodextrin: Characterization and in vitro Evaluation

Cefixime, a BCS class II drug, is insoluble in water but freely soluble in acetone and in alcohol. The aqueous solubility of cefixime in water is poor and exhibits exceptionally slow and intrinsic dissolution rate. In the present study, cefixime and β-Cyclodextrin (β-CD) solid dispersions were prepared with a view to study the effect and influence of β-CD on the solubility and dissolution rate of this poorly aqueous soluble drug. Phase solubility profile revealed that the solubility of cefixime was increased in the presence of β-CD and was classified as AL-type. Effect of variable, such as drug:carrier ratio, was studied. Physical characterization of the solid dispersion was characterized by Fourier transform infrared spectroscopy (FT-IR) and Differential scanning calorimetry (DSC). These studies revealed that a distinct loss of drug crystallinity in the solid molecular dispersions is ostensibly accounting for enhancement of dissolution rate in distilled water. The drug release from the prepared solid dispersion exhibited a first order kinetics. Solid dispersions of cefixime showed a 6.77 times fold increase in dissolution rate over the pure drug.

Pefloxacin as a Surrogate Marker for Ciprofloxacin Resistance in Salmonella: Study from North India

Fluoroquinolones form the mainstay of therapy for the treatment of infections due to Salmonella enterica subsp. enterica. There is a complex interplay between several resistance mechanisms for quinolones and various fluoroquinolones discs, giving varying results, making detection and interpretation of fluoroquinolone resistance difficult. For detection of fluoroquinolone resistance in Salmonella ssp., we compared the use of pefloxacin and nalidixic acid discs as surrogate marker. Using MIC for ciprofloxacin as the gold standard, 43.5% of strains showed MIC as ≥1 μg/ml and were thus resistant to fluoroquinoloes. Based on the performance of nalidixic acid and pefloxacin discs as surrogate marker for ciprofloxacin resistance, both the discs could correctly detect all the resistant phenotypes; however, use of nalidixic acid disc showed false resistance in the majority of the sensitive phenotypes. We have also tested newer antimicrobial agents like cefixime, imipenem, tigecycline and azithromycin against Salmonella spp. Moreover, there was a comeback of susceptibility to older antimicrobials like ampicillin, chloramphenicol, and cotrimoxazole. We can also use cefixime, imipenem, tigecycline and azithromycin in the treatment of multidrug resistant S. typhi due to their high susceptibility.

Method Development and Validation for the Determination of Cefixime in Pure and Commercial Dosage Forms by Specrophotometry

A simple, accurate and precise direct spectrophotometric method has been developed for the determination of cefixime in tablets and capsules. The method is based on the reaction of cefixime with a mixture of potassium iodide and potassium iodate to form yellow coloured product in ethanol-distilled water medium at room temperature which absorbed maximally at 352 nm. The factors affecting the reaction product were carefully studied and optimized. The validation parameters based on International Conference on Harmonisation (ICH, USA) guidelines were followed. The effect of common excipients used as additives has been tested and the tolerance limit was calculated for the determination of cefixime. Beer’s law is obeyed in the concentration range of 4 – 24 ug mL-1 with apparent molar absorptivity of 1.52 × 104 L mol-1cm-1 and Sandell’s sensitivity of 0.033 ug/cm2/ 0.001 absorbance unit. The limits of detection and quantitation for the proposed method are 0.32 and 1.06 ug mL-1, respectively. The proposed method has been successfully applied for the determination of cefixime in pharmaceutical formulations. The results obtained by the proposed method were statistically compared with the reference method using t- and F- values and found no significant difference between the two methods. The proposed method can be used as an alternate method for routine quality control analysis of cefixime in pharmaceutical formulations.