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The oral floating matrix tablets of Ciprofloxacin Hydrochloride were formulated by Experimental design by using HPMC K100M and Ethyl Cellulose as the retardant polymers each with three different levels with an approach to increase gastric residence and thereby improve drug bioavailability. From FTIR results it was confirmed that there is no chemical interaction between the drug with the excipients used in tablet formulations. Also, there was no shift in the endotherm of in the drug- excipients mixtures indicating compatibility of drug with all the excipients. All the tablets were prepared by effervescent approach in which Sodium bicarbonate was added as a gas generating agent. Floating Matrix tablets were prepared by direct compression method and prepared tablets were evaluated for weight variation, percentage friability, hardness and drug content studies. All the formulations showed compliance with pharmacopeia standards (I.P. 1996). Floating lag times of all the formulations were within 1 minute and Total floating time of all the formulations were more than 12 hours. In vitro release studies revealed that the release rate decreased with increase polymer proportion of retarding polymers. The formulation CHE9 sustained release of drug for 12 hours with 21% release of drug after 1 hour and more than 97% at the end of 12 hours. From the Kinetic model it was found that the optimized formulation CHE9 showed linearity in case of Zero order (R2: 0.938) and Higuchi model (R2: 0.954). By fitting data to Korsmeyer-Peppas model and ‘n’ value lying above 0.5 indicating non Fickian release.
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Introduction@#Ciprofloxacin is a broad-spectrum antibiotic that acts against a number of bacterial infections. The study was carried out to examine the in vitro quality control tests for five leading brands of ciprofloxacin hydrochloride 500 mg tablet formulation, registered in Mongolia. The quality control parameters of five different brands of ciprofloxacin hydrochloride 500 mg tablets were determined weight variation, friability, hardness, and disintegration, dissolution and assay tests. In addition, 0 and first order kinetic models were applied for each sample.@*Method@#All the tablets were evaluated for conformity with British Pharmacopoeia (BP) and Mongolian Pharmacopoeia-National Formulary (MP-NF) standards.@*Results@#Among five brands of tablets Brand C had lower mean weight variation of 0.8% and Brand A had highest mean weight variation of 3.42%. For friability test Brand B had the lowest mean friability (0.57) and Brand A had highest mean friability (1.51). The percentages of the drug content of five brands of ciprofloxacin tablet were obtained in the following sequence: Brand E (98.4 %) < Brand C (100.3%) < Brand D (115.1%) < Brand A (138.5%) < Brand B (183.8%). E and C brands met the BP and MP-NF specifications for assay@*Conclusion@#The present study revealed that Brand A, B and D the leading brands of this tablet not met the quality control parameters as per pharmacopoeia specifications expect dissolution test for some brands (Brand A, Brand B).
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OBJECTIVE: To investigate the effect of polymers, including hydrophilic polymers and swelling aids, on floatability and dissolution of ciprofloxacin hydrochloride gastro-retentive tablets. METHODS: Hydroxypropyl methyl cellulose (HPMC), hydroxyethylcellulose (HEC) and hydroxypropylcellulose (HPC) were used as hydrophilic swelling excipients, and disintegrants crospovidone (PVPP XL and PVPP XL-10) or croscarmellose sodium (CCS) were used as swelling agents to facilitate the swelling/floating and drug release. Initial floating time and floating duration were tested to evaluate buoyance, and drug dissolution was tested to evaluate the controlled release. RESULTS: Using HPMC K250 and PVPP XL as excipients for ciprofloxacin hydrochloride gastro-retentive tablets could obtain products with rapid onset of floating, long floating durion and desirable drug release. CONCLUSION: Variety and amount of polymers have dramatic effects on buoyance and drug release of gastro-retentive tablets. HPMC K250 and PVPP XL are suitable excipients for ciprofloxacin hydrochloride gastro-retentive tablets.
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INTRODUCCCIÓN: las quinolonas son un grupo de agentes antimicrobianos de gran importancia en la clínica. El clorhidrato de ciprofloxacina monohidrato es una fluoroquinolona antibacterial de segunda generación que se indica en el tratamiento de diversas infecciones y se comercializa en forma de colirio, inyectable, cápsulas y tabletas. OBJETIVO: desarrollar y validar un método analítico por espectrofotometría ultravioleta, con vistas a su aplicación al control de calidad del clorhidrato de ciprofloxacina en tabletas Ciprecu recién elaboradas. MÉTODOS: se desarrolló el método en el laboratorio y se realizó una validación exhaustiva atendiendo a los parámetros de la categoría I. El método se seleccionó teniendo en cuenta la presencia de grupos cromóforos en la estructura del compuesto analizado. Se determinó la longitud de onda de máxima absorción a 273 nm de 5 µg/mL en ácido clorhídrico 0,1 mol/L. RESULTADOS: a partir del proceso de validación realizado, se demostró la adecuada especificidad frente a los componentes de la matriz en estudio, así como su linealidad, exactitud y precisión en el rango de 2,5 a 7,5 µg/mL. Los resultados de la aplicación de este método fueron similares a los obtenidos por el método oficial propuesto con iguales propósitos en USP 33, 2010. CONCLUSIONES: el método fue válido con el objetivo propuesto, lo cual constituye una nueva alternativa simple, rápida y económica para el control de calidad de clorhidrato de ciprofloxacina en tabletas Ciprecu(AU)
INTRODUCTION: quinolones are a group of antimicrobials of high clinical significance. Ciprofloxacin hydrochloride monohydrate is a second-generation antibacterial fluoroquinolone for treatment of several infections and is marketed as eye drops, injections, capsule and tablets. OBJECTIVE: to develop and to validate an ultraviolet spectrophotometric analytical method to be used in the quality control of ciprofloxacin hydrochloride monohydrate in newly manufactured Ciprecu tablets. METHODS: this method was devised at the laboratory and thoroughly validated pursuant to the category I parameters. The method was selected on account of the existence of chromophore groups in the structure of the analyzed compound. The maximum absorption wavelength was set at 273 nm of 5 µg/mL in 0.1 mol/L hydrochloric acid. RESULTS: based on the validation process, it was demonstrated that this method has adequate specificity against the study matrix components, as well as its linearity, accuracy and precision in the range of 2.5 to 7.5 µg/mL. The results of the application of this method were similar to those of the official procedure suggested for the same purposes in USP 33, 2010. CONCLUSIONS: The analytical method was valid for the suggested purposes, so it is a new simple, rapid and economic alternative for the quality control of Ciprofloxacin hydrochloride in Ciprecu tablets(AU)
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Humans , Quality Control , Spectrophotometry, Ultraviolet/methods , Ciprofloxacin/therapeutic use , Tablets , Validation Studies as TopicABSTRACT
This work assesses the bioequivalence of four selected brands of ciprofloxacin hydrochloride in the Nigerian market to Ciproflox® as a selected innovator brand. The brands selected were reperesented by samples A, B, C and D all are of Asian origin. The following parameters were employed in the assay- Weight uniformity, tablet hardness, friability, disintegration time and dissolution profile in 0.1N HCl , and minimum inhibitory concentration (MIC) determined by zones of inhibition on clinical isolates of Staphylococcus aureus. The mean hardness results were in the order Ciproflox(R) (14.55 ± 3.97) > C (12.51 ± 3.01) > D (9.87 ± 2.38) > B (9.67 ± 1.37) > A (8.98 ± 3.46) and they all fell within the acceptable values of 3 kgs ≤.hardness. The mean friability results were in the order A (0.07) < D (0.12) < Ciproflox (0.17) < B (0.30) < D (0.31). The drug content values were in the order -Ciproflox (500.02) > D (483.54) > Cipromax B > C (458.86) > A (420.29). By the USP standard, only A failed the test; while, by the BP standard only Ciproflox and D passed the test. The disintegration times were in the order- A (1.73±0.27) > C (3.22±0.20)> B (4.15±1.07)> Ciproflox (4.88±0.54)> D (7.60±0.44). The tablet dissolution rates (P12min values) were in the order – A (59.528 ± 8.427) > C (42.468 ± 1.863) > B (35.124 ± 4.408)> Ciproflox (15.403 ± 0.799) > D (8.808 ± 0.856). Ciproflox(R) with the highest drug content had the lowest MIC on Staphylococcus aureus (0.064 μg/ml ). This shows that Ciproflox is the most effective of the five brands, followed by D, C, B and A. The highest MIC value on Staphylococcus aureus was obtained with A 0.255 μg/ml which also had the lowest drug content. Ciproflox (R) with this reseach stands to be the oustanding product among the five brands.
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OBJECTIVE:To study the process and mechanism of thermal decomposition of ciprofloxacin hydrochloride(CPLX).METHODS:With Al2O3 as reference substance,the samples in nitrogen gas were analyzed by differential scanning calorimetry(DSC),thermogravimetry(TG),digital thermogravimetry(DTG).The thermal kinetic parameters including the energy of activation(E),pre-exponential factor(A),reaction order(n) and pk value were computed based on the data of the thermal analysis curves.RESULTS:The thermal kinetic parameters were as follows:E=101.18 kJ?mol-1,lnA=26.96 s-,n=1,and pk=7.01,and the storage life of ciprofloxacin hydrochloride under normal temperature was 2 years.CONCLUSION:The thermal analysis method is simple and the result is reliable in the study of thermal decomposition of ciprofloxa-cin hydrochloride.
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OBJECTIVE:To optimize base material compositions and preparation technology for compound ciprofloxacin gel.METHODS:4factors,ciprofloxacin,carbomer-940,glycerine,triethanolamine(in formula dosages)were selected as variable factors,the stability of the preparation was taken as the index for investigation and table L 9 (3 4 )was used to conduct the orthogonal experiment.RESULTS:The optimum base material composition and technology were the following,ciprofloxacin0.3%,carbomer-9401%,glycerine7.5%,triethanolamine2%.CONCLUSION:The compound ciprofloxacin gel prepared based on the optimized technology is in conformity with the specification stated in Chinese Pharmacopoeia(2000).