Bioequivalence study of two oral formulations of clarithromycin in human male subjects

To assess the bioequivalence of tablets formulations of Clarithromycin 500mg each of test and reference products. A single post oral dose of each formulation was given to 14 male healthy volunteers. The study was conducted phase 1, open-label, randomized, complete two- way crossover designed with 7 days wash out period. The plasma concentration of Clarithromycin was quantified by validated microbiological assay method. The precision of the method was evaluated using calibrated 14-hydroxyClarithromycin concentration was detected semi quantitatively as equivalent of Clarithromycin /ml. The peak plasma concentrations of [3.63 +/- 0.80 ug/ml] and [-3.31 +/- 0.35 ug/ml] was attained in about 1.42 hours and 1.49 hours for both test and reference Clarithromycin tablets respectively. The mean +/- SD values for total area under the curve [AUC] were 22.07 +/- 4.90 and 20.16 +/- 2.35 h.mg/L for both test and reference tablets respectively. This study indicated that the differences in all the bioequivalence parameters for test and reference Clarithromycin formulations are statistically non-significant; hence both formulations are considered bioequivalent

Critical care of gynecological and obstetric patients: a decade of surgical intensive care experience

Despite the emergence of therapeutic advances, the morbidity and mortality still occur in the obstetric patients, although intensive care utilization by obstetric and gynecological patient, are still rare compared to the general population. Majority of obstetric patients needed the intensive care therapy compared to gynecological patients. The aim of our study was to know the indications for the intensive care admission by obstetric and gynecological patients, length of stay and outcome of these patients. We retrospectively reviewed the medical records of all obstetric and gynecological patients admitted to our Surgical and Trauma Intensive Care Units [SICU and TICU] from February 1995 to March 2005. Indication for admission, nationality, age, and length of stay in ICU, severity of disease and outcome of these patients were recorded. Data analyzed with SPSS program. A total of 182 patients were admitted to the SICU of the Hamad Medical Corporation in Doha, Qatar, from the Women's Hospital. 159 [87%] patients were obstetric patients and 23 [13%] patients gynecological patients, 126 [69.6%] patients were admitted post Lower Segment Caesarean Section [LSCS]. The most common indication for admission was 73 [39.3%] patients obstetric hemorrhage and Disseminated Intravascular Coagulation [DIC], and then 44 [25.3%] patients of hypertensive disorder of pregnancy. The major anesthesia related indication was scoline apnea, 21[11.6%]. Total three obstetric patients died, two due to severe sepsis and multi-organ failure and one due to cerebral sinus thrombosis, giving mortality rate of 1.66%. Intensive care therapy required by gynecological and obstetric patient is less than the general population. The commonest indication for admission was obstetric hemorrhage, DIC, and hypertensive disorders of pregnancy. The mortality was due to septic shock with multi-organ failure, and cerebral venous sinus thrombosis

Varicocele management - a comparison of palomo versus inguinal approach

The purpose of this work was to find presentations of "varicocele and compare the results of Palomo versus Inguinal Approach". It is a prospective randomized study of 52 cases of varicocele over 2 years from Jan 2006 to Dec 2007 at Surgical Unit, Allama Iqbal Medical College / Jinnah Hospital Lahore. Presentation, indication for surgery, complications and results of palomo versus inguinal approach for surgery of varicocele are main variable compared. The mean age was 26.6 years. The swelling was left sided in 65.4% [n=34], right sided in 9.6% [n=5], and bilateral in 25% [n=13]. The clinical presentation was a dragging sensation in 2 cases [7.7%] infertility in 9 cases [17.3%] and for fitness reasons 15 cases [28.8%]. The collective postoperative infection rate was 1.95%. Haematoma formation in 2 cases [7.7%] in inguinal and 1 case [3.9%] of palomo operation. In 1 case [3.9%] of inguinal approach there was hydrocele formation at 1 year. No testicular atrophy noticed in immediate post operative period in both groups. In 2 [7.7%] patients of palomo group there was no symptomatic relief. In inguinal group in 1 patient [3.9%] there was no symptomatic relief. It was concluded that palomo operation is better than inguinal approach as there are less complications and decreased recurrence rate. However fertility is improved in both groups almost equally

Bioavailability of ciprofloxacin tablets in humans and its correlation with the dissolution rates

Bioavailabilities of seven tablets of ciprofloxacin were determined. The co-rrelation between in-vivo bioavailability parameters and in-vitro dissolution rates were studied. Ciprofloxacin concentration from the blood was determined by microbiological assay technique. The release pattern of ciprofloxacin from tablets, which were determined by dissolution USP paddle method and spectrophotometric method was used to determine the concentration. All the parameters of ciprofloxacin bioavailability i.e., Tmax, Cmax, AUC and absorption rate constant [Ka] showed no significant correlation with dissolution rates at T30%, T50%, T90% and dissolution at 30 mins with aims as in-vivo bioequvalence waiver. The value of dissolution test used as quality tool for predicting in-vivo performance of drug product is significantly enhanced, if the in-vivo - invitro relationship [correlation or association] is established

Gastric endosonography in non hodgkin lymphoma

Endoscopic ultrasound [EUS] examinations are necessary to determine the intramural and gastric lesions. The aim of the present study was to evaluate the role of EUS in detection of lesions in patients with Non Hodgkin Lymphoma [NHL], whether the patients have gastric or not. We evaluated gastric lesions in 2 groups of NHL, ten patients with gastric [group A] and 10 patients without gastric symptoms [Group B]. EUS was performed with 7.5 frequency oblique probe. EUS showed normal wail layers with multiple paragastric lymph nodes with malignant criteria in five patients in group A and 3 patients in group B, signs of chronic #ion with multiple malignant paragastric lymph nodes in four patients in group A and 2 patients group B and gastric involvement with lymphoma and malignant paragastric lymph nodes in one patient both groups. No abnormal findings were detected in 4 patients in group B. In conclusion: EUS is a reliable tool for detection of gastric involvement and staging of NHL even without gastric symptoms and endoscopic findings

Effects of treatment with zinc sulphate on the oxidative stress state during chronic exposure to lead in Humans

Oxidative stress has been recently implicated in the pathogenesis of lead poisoning. Consequently, the potential protective effects of antioxidant agents had been raised. This study was designed to explore the potential protective effects of zinc against the oxidative stress due to chronic exposure to lead. Lead-exposed workers were treated with lOOmg zinc sulphate / day for 2 months, and the extent of oxidative stress was evaluated by measuring of erythrocytes and plasma content of GSH and MDA, in addition the Cu, Zn and Pb blood level were measured also. The results of this study showed that treatment with zinc sulphate significantly lowered MDA production and increased glutathione levels in plasma and erythrocytes. Blood lead levels, which were elevated significantly due to chronic exposure, showed a reproducible reduction after treatment with zinc sulphate, associated with improvement in copper and zinc levels in the plasma of lead workers. In conclusion, daily supplementation with zinc as antioxidant to lead exposed workers seems to be beneficial in the prevention of oxidative stress associated with chronic exposure