Ofloxacin Tablets Research Articles

Total combined global risk assessment applied to pharmaceutical equivalence – A case study of ofloxacin medicines

Pharmaceutical equivalence studies are critical for determining the interchangeability between test and reference medicines by ensuring that their chemical, physical, microbiological, and biological properties are identical. Typically, this equivalence is evaluated by comparing a single batch of generic medicine to a single batch of the reference medicine. However, regulatory authorities may mandate continuous monitoring of the medicine's quality to maintain compliance with standards. The objective of this study was to assess the total combined global risk of making false decisions regarding the pharmaceutical equivalence of test and reference medicines. To achieve this, ofloxacin ophthalmic solutions and ofloxacin tablets were subjected to pharmacopeial tests and assays. Particular and total global risks were estimated using the Monte Carlo method (MCM) implemented in a MS-Excel spreadsheet. Consumers' risk values were calculated based on the historical mean and standard deviation for quantitative tests or the probability of a compliant batch for qualitative tests. The risk values differed depending on whether the tests had interval specification limits or only minimum or maximum specification limits. Lower risk values were observed when historical means were far from the specification limits, the probability of a compliant batch was high, or when the standard deviation values were low. Similarly, for qualitative analysis, higher probabilities of a compliant batch led to lower consumers' risk values. Reduced risk values were also associated with historical means being distant from the specification limits and with a high probability of a compliant batch, or when standard deviation values were low. The total combined global risk of a false pharmaceutical equivalence decision was found to be significantly high (above 5%) under certain simulated conditions. These conditions include historical mean values close to the specification limits and/or an increased standard deviation of the manufacturing process. As a result, there is an increased risk of failing to establish pharmaceutical equivalence between test and reference medicines manufactured under such conditions.

Discrimination of Pharmaceutical Tablets Based on the Analysis of Solid-State Structures of Ingredients Using Terahertz Transmission Spectroscopy with the Injection-Seeded Parametric Generation Technique.

A frequency-domain terahertz (THz) spectrometer that uses a tunable source, called an injection-seeded THz parametric generator, was applied to the analysis of solid-state structures of ingredients in pharmaceutical tablets, and its performance on discriminating pharmaceutical products was evaluated. The spectrometer has a dynamic range of 70 dB at 2 THz and is suitable for analyzing materials such as pharmaceutical ingredients that often have characteristic absorption peaks between 0.5 and 2.5 THz. Nine ofloxacin (racemate) and four levofloxacin (levorotatory enantiomer) tablet products commercially available in Japan were used as samples. They contain 8–12 additives in addition to the API. The sample tablets were filed down to a thickness of 1.2 mm (ofloxacin tablets) and 1.6 mm (levofloxacin tablets) to obtain transmission spectra over the wide spectral range of 0.8–2.1 THz. The absorption spectra obtained from the spectrometer were preprocessed by the second derivative; then, principal component analysis (PCA) was conducted on the results. Next, quadratic discriminant analysis (DA) was conducted on the scores of the three PCA components. The accuracy of the DA for all 13 products was 96.1%. In addition to the difference in crystal forms of the active ingredient, the small differences in the formulation were clearly discriminated using the THz absorption spectra. The spectrometer combined with data analysis shows potential for applications such as identifying pharmaceutical tablets, monitoring the stability of production processes, evaluating the stability of formulations during storage, and detecting counterfeit drugs on the market.

Port site infection by Mycobacterium fortuitum after laparoscopic hysterectomy and its management– A case report

In the department of gynaecology vaginal hysterectomy and laparoscopic hysterectomy are popular methods of surgery. They involve less amount of blood loss, with short hospital stay. In recent times, laparoscopic hysterectomy is done commonly. Forty-two-year female was admitted in surgery ward, Tagore Medical College and Hospital, with pain in abdomen at the laparoscopic site and lower abdomen. Pus discharge through the port site, left loin for the last 3 months. The microbiological examination of the pus showed the presence of Mycobacterium fortuitum. After identification of atypical mycobacterium, the patient was administrated with amikacin injection for 3 months and clarithromycin and ofloxacin tablet for one year. Patient was discharged and was advised to come for periodical review.

Escherichia coli adhesive coating as a chiral stationary phase for open tubular capillary electrochromatography enantioseparation

Bacteria, the microorganism with intrinsic chirality, have numerous fascinating chiral phenomena such as various chirality-triggered biological processes and behaviors. Herein, bacteria were firstly explored as novel chiral stationary phases in open-tubular capillary electrochromatography (OT-CEC) for enantioseparation of fluoroquinolone enantiomers and simultaneous separation of six fluoroquinolone antibiotics. The model strain, i.e. non-pathogenic Escherichia coli (E. coli) DH5α, was adhered onto the inner surface of positively charged polyethyleneimine (PEI) modified capillaries based on the bacterial adhesion characteristics and strong electrostatic interaction. The morphology and thickness of the bacteria adhesive coatings in the capillary were characterized by field emission scanning electron microscopy (FESEM) and atomic force microscopy (AFM). Baseline separation of ofloxacin and partial separation of lomefloxacin enantiomers could be achieved by the E. coli coated columns. The preparation parameters including the coating time and concentration of bacteria that affecting the chiral resolution were intensively investigated. The electrophoretic parameters, including pH, buffer concentration and applied voltage, were also optimized. The developed method was validated (linearity, LOD, LOQ, intra-day, inter-day and column-to-column repeatability and recovery) and successfully utilized for the quantitative analysis of ofloxacin enantiomers in the ofloxacin tablets. Moreover, only a slight decrease in the separation efficiency was observed after 90 consecutive runs on the E. coli@capillary. These results demonstrated that bacteria are promising stationary phases for chiral separation in CEC.

Cefixime and Ofloxacin fixed dose combination induced petechial rash: a case report

Petechial rash is a type of rash which is associated with many infectious and non-infectious conditions. We present a case of Petechial rash induced by administration of cefixime with ofloxacin tablet. A eighteen year old male patient reported to us with a presentation of rash with itching for three days on administration of the fixed dose combination of cefixime + ofloxacin along with paracetamol for the previous symptoms of fever with chills, headache and bodyache. Patient describes itching in the rash which is increasing. The duty doctor attended the patient and immediately stopped the further administration of the offending medication. The patient was prescribed tablet cetirizine orally along with calamine lotion for local application. The patient reported back in for follow-up and was without any residual rashes or other such complaints. He was advised to remember and cautious from the use of drugs in the offending category.

Electrochemical Sensor Based on a Novel Pt−Au Bimetallic Nanoclusters Decorated on Reduced Graphene Oxide for Sensitive Detection of Ofloxacin

AbstractPt−Au nanoclusters decorated on the surface of reduced graphene oxide (rGO/Pt−Au) was facilely prepared by one‐pot electrochemical reduction. The morphology and composition of rGO/Pt−Au composites had been characterized by scanning electron microscopy (SEM) coupled with energy‐dispersive X‐ray spectrometry (EDX), fourier transform‐infrared spectroscopy (FT‐IR) and electrochemical methods. Ofloxacin is a member of synthetic quinolones which has been widely used for the treatment of common diseases in humans and animals. The performance of the rGO/Pt−Au nanocomposite toward the oxidation of ofloxacin was compared with the other similar nanostructures like rGO/Pt and rGO/Au. In the optimized conditions, two linear calibration curves were obtained, from 0.08 to 10 μM and 10 to 100 μM ofloxacin. A detection limit of 0.05 μM ofloxacin was observed at pH 5.7 for the GCE/rGO/Pt−Au. The proposed sensor was successfully applied to determine ofloxacin in tablets and human urine samples and the results were satisfactory.

Antibiotic prophylaxis in the prevention of rebleeding in acute variceal hemorrhage: A randomized trial.

Objective:To assess the role of antibiotic prophylaxis in the prevention of rebleeding in acute variceal hemorrhage.Materials and Methods:A total of 60 patients who underwent endoscopic therapy for bleeding esophageal varices were randomized into the prophylaxis group and the on-demand group. Patients in the prophylaxis group received antibiotic prophylaxis using intravenous ofloxacin till the patient resumed oral fluids, followed by oral ofloxacin tablet for a total of 7 days. In the on-demand group, antibiotics were used only when infection was evident. Patients were monitored for rebleeding and infection during the hospital stay.Results:A total of 30 patients in the prophylaxis group and 26 patients in the on-demand group were analyzed. The clinical characteristics in both the groups were similar. The Child–Pugh score was around 7 in both the groups. The incidence of infection was 5/30 (16.7%) in the prophylaxis group and 7/26 (26.9%) in the on-demand group (P = 0.52). The incidence of early rebleeding in the prophylaxis vs. the on-demand group was 3 vs. 5 (P = 0.69), and the incidence of late rebleeding was 6 vs. 8 (P = 0.48). The differences were not significant.Conclusion:The present study shows a trend toward lower rate of early and late rebleeding, infection rate and mortality in the prophylaxis group; hence, routine use of antibiotics in all such patients may not be necessary. Further studies with a larger sample size and a longer follow-up period are required to validate the usefulness of antibiotics in these patients.

A Case of Cefixime, Ofloxacin Combination Tablet Induced Erythematous Macules

Erythematous macule is a type of rash which is associated with many dermatological conditions. We present a case of erythematous macules induced by administration of cefixime + ofloxacin tablet, its treatment and management. A seventeen year old female patient reported to us with a presentation of rash with scaling and itching for three days. On administration of the drug, the patient described a sensation of itching and discomfort on her entire body. The duty doctor attended the patient and immediately stopped the further administration of the offending medication. The patient was infused intravenous (iv) Dexamethasone 4 mg/ml and iv Pheniramine Maleate 1 ampoule (25 mg in 2 ml) immediately. The patient reported back in for follow-up and was without any residual rashes or other such complaints. She was advised to remember and refrain from the use of drugs in the offending class.

Formulation and In Vitro Evaluation of Ofloxacin Tablets using Natural Gums as Binders.

Natural gums are economical, easily available, and useful as tablet binders. In the present investigation, an attempt was made to formulate Ofloxacin tablets using three natural binders, namely Acacia arabica, Hibiscus esculentus, and xanthan gum. Such six batches of Ofloxacin tablets were prepared by using different types and amounts of the natural binders by the wet granulation method. The tablets were analyzed for their hardness, friability, and weight variation, and in vitro release was performed in a phosphate buffer at pH 6.8. The prepared tablets were also evaluated for their various release kinetics and similarity factors f2. The physical properties of the tablets containing the natural binders showed sufficient hardness, desirable disintegration time, and low friability. Their better percentage of drug release was observed as compared to the marketed formulation showing more than 85% drug release within 45 minutes. The in vitro release data was well-fitted into zero-order and the values of release exponent ‘n’ were between 0.303 and 0.514. The high similarity factor f2 of 64.50 was achieved with the best batch in comparison to the marketed tablets. The results obtained indicated that the gum Acacia arabica performed as well as gelatin compared to the other binders for the Ofloxacin tablet formulation.

Simple and Selective Spectrophotometric Determination of Ofloxacin in Pharmaceutical Formulations Using Two Sulphonphthalein Acid Dyes

Two new simple and sensitive extraction-free spectrophotometric methods have been established for the determination of ofloxacin (OFX). The methods are based on ion-pair complex formation reaction between OFX and acidic sulphonphthalein dyes, bromocresol purple (method A), and bromocresol green (method B) in dichloromethane. The experimental variables such as reaction medium, reaction time, and reagent concentration have been carefully optimized to achieve the highest sensitivity. Both dyes react spontaneously with OFX to give yellow-colored complexes. Beer’s law is obeyed over the concentration ranges of 1.0–16 µg ml−1 OFX with correlation coefficient of 0.999 in both methods. The molar absorptivity values are calculated to be and l mol−1 cm−1, for method A and method B, respectively, with corresponding Sandell's sensitivity values of 0.015 and 0.019 µg cm−2. The limits of detection (LOD) and quantification (LOQ) are also reported. A Job’s plot of the absorbance versus the molar ratio of OFX to each of dyes under consideration indicated (1 : 1) ratio and the conditional stability constant () of the complexes have been calculated. The proposed methods were applied successfully to the determination of OFX in tablets with good accuracy and precision and without interference from common additives. The results obtained by the proposed methods were compared favorably with those of the reference method.

UV Spectrophotometric Method for Estimation of Ofloxacin in Tablet Dosage Form and Comparative Study of its Two Brands

Ofloxacin is used to treat a bacterial infection. It is indicated for the treatment of adults with mild to moderate infections triggered by susceptible strains of the nominated microorganisms in the infections likes acute bacterial exacerbations of chronic bronchitis, community acquired pneumonia, uncomplicated skin and skin structure infections, acute, uncomplicated urethral and cervical gonorrhea, nongonococcal urethiritis and cervicitis, mixed infections of the urethra and cervix, acute pelvic inflammatory disease (including severe infection), uncomplicated cystitis, complicated urinary tract infections and prostatitis. The most common side-effects are feeling sick, diarrhea, feeling dizzy and headache. Spectrophotometry is regarded as by its speed and simplicity, accuracy and inexpensive instrument needed, and hence it is a significant substitute to further analytical methods, through clear advantages in terms of cost of analysis. Assay of Ofloxacin tablets is carried out by a rapid, simple, accurate, and economical least time consuming spectrophotometric method and then compares it with the assay of two different brands available in Karachi, Pakistan. Results of assay reveal that both trademarks of Ofloxacin are bioequivalent and are within the endorsed range. Brand A shows a percent assay of 100% while Brand B shows low value for percentage assay that is 96.31%.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CEFIXIME AND OFLOXACIN IN TABLETS BY RP-HPLC METHOD

A chromatographic method has been developed as per ICH norms for the simultaneous estimation of cefixime and ofloxacin from pharmaceutical formulations. The method was carried out on a column -Gemini (250 x. 4.6, 5 mc) with a mobile phase consisting of 0.2 M potassium dihydrogen phosphate buffer (adjusted to pH 7 with 1 % w/w triethylamine), acetonitrile and methanol in 70:20:10 ratio and filtered through 0.45 mc cellulose nitrate filters. The flow rate 1.0 mL/min. Detection was carried out at 288 nm. The retention time of CEF and OFL was 2.16 and 7.86 min respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.

STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF OFLOXACIN IN BULK DRUG AND TABLETS USING TRIFLUOROACETATE AS COUNTER ANIONS

A stability-indicating reversed-phase HPLC method for the quantitative determination of ofloxacin in bulk samples and tablet formulation has been developed and validated. The separation was performed on a C18 column (4.6 × 250 mm, 5 µm) using an isocratic mobile phase comprising of acetonitrile and buffer pH 3.3 (16: 84, v/v) with a diode array UV/Vis detection at 294 nm. The buffer was composed of ammonium acetate (50 mM) and ion-pairing reagent, trifluoroacetic acid (20 mM). Forced degradation studies were performed on bulk sample as per ICH prescribed stress conditions using acid hydrolysis, alkaline hydrolysis, neutral hydrolysis, oxidative, thermal stress, and photolytic degradation to show the stability indicating power of the method. The proposed method provided linear responses (r2=0.9999) over the concentration range of 10–30 μg mL−1. LOD and LOQ values for the active substance were 0.13 and 0.45 μg mL−1, respectively. The method validation showed good results for specificity, linearity, precision, accuracy, limit of detection, limit of quantitation, and robustness. The proposed method was successfully employed for quantification of ofloxacin in tablets.

Titrimetric assay of ofloxacin in pharmaceuticals using cerium(IV) sulphate as an oxidimetric reagent

Two titrimetric methods which are simple, rapid, cost-effective and eco-riendly are described for the determination of ofloxacin (OFX) in bulk drug and in tablet formulations based on the oxidation of OFX by Ce(IV) sulphate. In direct titrimetry (method A), the acidified solution of OFX is titrated directly with Ce(IV) sulphate using ferroin as indicator, and indirect titrimetry (method B) involves the addition of known excess of Ce(IV) sulphate to an acidified solution of OFX followed by the determination of unreacted oxidant by back titration with ferrous ammonium sulphate (FAS) using the same ferroin indicator. In both the methods, the amount of Ce(IV) sulphate reacted corresponds to OFX concentration. Method A and method B permit the determination of OFX over the concentration range of 1.5–15 mg in both the methods and the quantitation is based on a 1: 5 reaction stoichiometry (OFX: Ce (IV) sulphate). The methods were statistically evaluated by calculating percent relative error (% RE) for accuracy and percent relative standard deviation (% RSD) for precision, and were applied successfully to the determination of OFX in tablets with mean recoveries in the range of 96.50–98.42%. No interference was observed from common additives found in pharmaceutical preparations. The accuracy and reliability of the methods were further ascertained by performing recovery tests s standard-addition technique.

Spectrophotometric determination of ofloxacin in pharmaceuticals by redox reaction

Two simple spectrophotometric methods have been developed to analyze ofloxacin (OFX) in pharmaceuticals. The methods are based on the oxidation of OFX by a measured excess of cerium(IV) sulfate in H(2)SO(4) medium. This was followed by the determination of the unreacted oxidant by reacting it with either p-toluidine (p-TD) and measuring the absorbance at 525 nm (method A) or o-dianisidine (o-DA) and measuring the absorbance at 470 nm (method B). In both methods, the amount of cerium(IV) sulfate reacted corresponds to the amount of OFX. Calibration graphs were linear over the ranges of 0-120 and 0-4 g/ml OFX for methods A and B, respectively. The calculated molar absorptivity (2.34.10(3) and 5.99.10(4)), Sandell sensitivity, and limit of quantification for the methods are reported. The intra-day precision (%RSD) and accuracy (%RE) were < 8.0 and <= 4.0%, respectively, and the inter-day RSD and RE values were within 5 and 4.0%, respectively. The applicability of the methods was demonstrated by determining OFX in tablets with an accuracy (%RE) of < 3% and precision (%RSD) of <= 2.65%. The accuracy of the methods was further ascertained by recovery experiments via a standard-addition procedure.

Rapid titrimetric and spectrophotometric determination of ofloxacin in pharmaceuticals using N-bromosuccinimide

One titrimetric and two spectrophotometric methods have been described for the determination of ofloxacin (OFX) in bulk drug and in tablets, employing N-Bromosuccinimide as an analytical reagent. The proposed methods involve the addition of a known excess of NBS to OFX in acid medium, followed by determination of unreacted NBS. In titrimetry, the unreacted NBS is determined iodometrically, and in spectrophotometry, unreacted NBS is determined by reacting with a fixed amount of either indigo carmine (Method A) or metanil yellow (Method B). In all the methods, the amount of NBS reacted corresponds to the amount of OFX. Titrimetry allows the determination of 1-8 mg of OFX and the calculations are based on a 1:5 (OFX:NBS) reaction stoichiometry. In spectrophotometry, Beer's law is obeyed in the concentration ranges 0.5-5.0 µg/mL for method A and 0.3-3.0 µg/mL for method B. The molar absorptivities are calculated to be 5.53x10(4) and 9.24x10(4) L/mol/cm for method A and method B, respectively. The methods developed were applied to the assay of OFX in tablets, and results compared statistically with those of a reference method. The accuracy and reliability of the methods were further ascertained by performing recovery tests via the standard-addition method.

RP-HPLC method for simultaneous estimation of nitazoxanide and ofloxacin in tablets

A reverse phase high performance liquid chromatography method was developed for simultaneous estimation of nitazoxanide and ofloxacin in tablet formulation. The separation and quantification was achieved by Hiq Sil C18V Size 4.6 mm Ø *250 mm column in isocratic mode, with mobile phase consisting of acetonitrile-methanol-0.4 M citric acid, (60:30:10, v/v/v). Citric acid used to stabilize nitazoxanide and ofloxacin in mobile phase. The mobile phase was pumped at a rate of 0.6 ml/min and the detection was carried out at 304 nm. The retention time of ofloxacin and nitazoxanide was found to be 3.122 and 5.902 min, respectively. The method was validated for linearity, accuracy, and precision. Linearity for ofloxacin and nitazoxanide were in the range 2-36 μg/ml and 5-90 μg/ml, respectively. The developed method was found to be accurate, precise and selective for simultaneous estimation of ofloxacin and nitazoxanide in tablets.

Simultaneous spectrophotometric estimation of nitazoxanide and ofloxacin in tablets.

Two simple, accurate and precise spectrophotometric methods have been developed for simultaneous determination of nitazoxanide and ofloxacin in tablets. Method I is Q-absorbance ratio method which involves Q-absorbance at isobestic point (306.25 nm) and max (347.5 nm) of nitazoxanide, while method II is two wavelength method, where 244.6 nm and 273.0 nm were selected as 1 and 2 for determination of nitazoxanide and 294.3 nm and 388.1 nm were selected as 3 and 4 for determination of ofloxacin. Both drugs obeyed the Beer's law in the concentration range 2-30 μg/ml,correlation coefficient (r2<1). Both methods were validated statistically and recovery studies were carried out to confirm the accuracy. Commercial tablet formulation was successfully analyzed using the developed methods.

Formulation and evaluation of sustained release bioadhesive tablets of ofloxacin using 32factorial design

Background:Oral sustained release gastroretentive dosage forms offer many advantages for drugs having absorption from upper gastrointestinal tract and improve the bioavailability of medications that are characterized by narrow absorption window. The aim of current study was to design sustained release bioadhesive gastroretentive dosage form of ofloxacin.Materials and Methods:A 32 full factorial design was employed to systematically study the drug release profile and bioadhesive strength. Carbopol 934P and HPMC K100M were selected as the independent variables. Compatibility between drug and polymer was tested by fourier transform infrared (FTIR) and X-ray diffraction (XRD) techniques. Tablets were prepared by direct compression and were evaluated for tablet characteristics, swelling study, adhesion strength, percent drug released, radiographic imaging study and stability study. The optimized formulation was then compared with marketed formulation (Oflin OD®).Results:Tablets prepared showed good tablet characteristics, optimum swelling property, and good adhesion strength with high detachment force. Most of the formulations including the optimized formulation followed Higuchi kinetics and the drug release mechanism was found to be anomalous. Radiographic image proved that tablet remains intact in its structural integrity and shape in stomach up to 24 h. The short-term accelerated stability testing was carried out for the optimized formulation, and results revealed that drug content, in-vitro dissolution and all other parameters were within acceptable limits.Conclusion:Thus, the prepared bioadhesive gastroretentive ofloxacin tablet may prove to be a potential candidate which increases the bioavailability of ofloxacin for any intragastric condition.

Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations

A gradient reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for separation and quantitation of impurities in pharmaceutical dosage form of ofloxacin tablets. The developed method was a stability indicating test method for estimation of related impurities generated during synthesis, formulation, and storage of ofloxacin tablets. Forced degradation studies were performed on ofloxacin tablets including acid hydrolysis (5.0 M hydrochloric acid), base hydrolysis (5.0 M sodium hydroxide), oxidation (30% hydrogen peroxide), heat (105°C) humidity degradation 25°C/92% RH/119 b & 40 min, and photolytic degradation (2600 Lux/119 h & 40 min). From the degradation study, the degradation was found between 0–15%. Limit of detection and limit of quantification were established in terms of percentage for all potential impurities. The recovery studies were conducted on finished dosage samples (tablets) for all potential impurities and the average percentage recovery was ranged from 90.8 to 104.2. Placebo interference was verified by taking the placebo (composition of excipients) equivalent to weight in portion of test preparation and no interference was observed. The method was validated and found to be linear, accurate, precise, specific, robust, and reliable. The developed method was established in accordance to ICH guidelines.