ABSTRACT
Candesartan [CAN], an ARB-blocker, antihypertensive, was analyzed in human plasma by a simple, accurate and precise RP-HPLC [reverse phase-High performance liquid chromatography assay method which was then validated for its accuracy, specificity and precision. The mobile phase has a constitution of acetone, diethylamine and distilled water, while Phosphoric acid was used to adjust the pH to 2.5 +/- 0.1. This mobile phase was run at 1.1ml/min and the fluorescence wavelength was set to 392 nm. A C-18 HPLC, column particle size [5 [micro]m] Mediterranean Sea ® L x 1.D. 25cm x 4.6 mm [Supelcosil] , with auto sampler injection volume of 30[micro]l ,an internal standard Valsartan was utilized for chromatographic detection. Candesartan took a retention time of 6 +/- 0.5 minutes. This method was validated by the parameters of selectivity, accuracy, precision, repeatability, reproducibility, recovery, linearity and stability. Candesartan's calibration curves were found to be linear in the range of 200ng/ml to 3.125ng/ml and the coefficient of determination [r2] was found to be 0.99. Analytical recovery obtained was above 88%. Hence, this method has been found to be useful for determining Candesartan in plasma
ABSTRACT
The initiation of newer techniques and development of mouth dissolving [MD] products has created new avenues of higher patients' compliance. MD formulations are actually lessen the difficulties associated with solid swallowing with better bioavailability of especially poorly soluble drugs. In the current study mouth dissolving tablet [MDT] formulations of cinitapride [1 mg] were prepared by direct compression method using various proportion and combination of superdisintegrants. Nine formulations in three batches were compressed by incorporating low [2%], intermediate [6%] and higher [10%] levels of crospovidone, croscarmellose sodium, sodium starch glycolate. Micromeritic assessment of the powder blends were carried out and were found within the acceptable official limits. All newly developed trial formulations were exposed to different pharmacopoeial and non-pharmacopoeial testing. It was found that FC2 trial tablets containing polyplasdone XL [crospovidone] at level of 6% [4.5 mg] presented the best physico-chemical attributes deemed to be desirable for the ODT products. Disintegration and wetting time of optimized FC2 was computed between 15-17 and 12-15 seconds respectively. The assay and content uniformity of FC2 were estimated to be 100.02+/-0.36 and 99.66+/-1.70 percent correspondingly. On the basis of the findings it was concluded that MDT could be successfully developed by incorporating appropriate concentration of superdisintegrant and their combinations
ABSTRACT
Drug-drug interactions [DDIs] are extremely significant concern, particularly in sensitive population including pediatric and geriatric. Propensity for the development of DDIs is high in patients admitted at intensive care units [ICU]. This study was conducted to evaluate the DDIs incidence, facts and measures in ICU. From a total of 150 cases studied for ICU patients, with the mean age of 56.37+/-12.45 years, 55.33% were male and the rest were female 44.66%. The demographic information like age, gender and main diagnosis details of study participants that were extracted from the patients' clinical record. A statistically significant association between the drug interaction and the number of drugs prescribed per prescription was observed [p <0.0001]. Concerning the onset of outcome, 52% of DDIs distinguished as delayed onset of effect [past 24 hours] and 35% were categorized as rapid onset [within 24 hours]. Despite the facts regarding patient safety and minimizing DIs error, polypharmacy is still frequent in critically ill patients admitted in ICU attributed high risk of adverse reactions due to use of multiple interventions to treat severity of disease condition. Such studies may be used to develop an effective tool for the diagnosis and management of DDIs
ABSTRACT
Irrational, over and misuse of antibiotics arise as global concern in both hospital and community settings and lead to adverse events including antimicrobial resistance, associated health problems, amplified hospitalization stay and cost. Hence, Drug Utilization Evaluation [DUE] studies are designed to evaluate and improve the prescribing, administration and the rational use of medications. The present study was designed to assess the pattern of antimicrobial drug utilization in in-patients cohort of tertiary care setup in Karachi, Pakistan. This cross sectional observational study was conducted in retrospective manner. World health organization [WHO] guidelines and criteria are considered to evaluate the appropriateness of drug use in various disease conditions. ATC/DDD system was applied to determine the study outcome. High frequency of antibiotics utilization found in respiratory tract infections of both lower [LRTI] 16.8% [n=42] and upper [UTI] 13.2% [n=33]. The estimated total number of drug units administered per month was greater with cefixime [46] and ciprofloxacin [45] both. DDD/100 bed days drug utilization of antibiotics was higher with ciprofloxacin, cefexime and meropenem [47, 46 and 29.25] correspondingly. In conclusion, the current investigation signifies extensive scope for progress in prescribing trend. Drug adherence to customary guidelines of disease management and constraint policies to endorse judicious drug use may be considered vital in healthcare setup
ABSTRACT
A simple stability indicating UV-spectrophotometric method has been developed and validated for the determination of cinitapride hydrogen tartrate [CHT] in bulk and solid pharmaceutical dosage form. Drug absorption was measured in different analytical mediums however; maximum absorption was seen in 0.1 N HCl at wavelength [lamda [max]] of 266 nm. The calibration curve was found to be linear over the concentration range from 6 to14 micro g/mL with the correlation coefficient value [r] of 0.999. The LOD and LOQ were estimated to be 0.1019 micro g/ml and 0.309 micro g/ml respectively. The accuracy was evaluated by determining the percent drug recovery, performed at three different levels of 50%, 100% and 150%. The% recovery was found to be in the range of 99.96-100.64%. The precision of the method was determined by inter-day and intra-day variations. The % RSD value <0.5 indicates the underlying method is precise and accurate as well. The developed method was applied to characterize in vitro assay content of few brands of cinitapride [1 mg] available in local market. No interference of the formulation excipients with the drug absorption was observed during assay. Drug substance and drug product were exposed to various stressed conditions [acid, base, oxidative, thermal and photolysis]. Forced degradation testing of drug product showed that the oxidation [20%] was found to be the major degradation pathway of the cinitapride. However; drug estimation was not influenced in presence of degradation moieties formed during acid, base, oxidation, thermal and photolytic breakdown. Overall, the investigated technique is robust and specific that would be successfully used to quantify the cinitapride hydrogen tartarate in pharmaceutical dosage and bulk form in future