Development and validation of RP-HPLC method for pitavastatin calcium in bulk and formulation using experimental design

The optimization of HPLC method involves several variables whose influence has been widely studied. However, inmost of the cases, only process variables are taken into account. In this work, the influence of mixture compositionon peak quality parameters of Pitavastatin calcium in bulk and tablet dosage form has been studied using a mixturesimplex design. A simplex centroid design with axial points in a pseudo-component representation was generated fromthe pure mixture components. Twelve ternary mixture mobile phases corresponding to augmented design points weretested to separate the drug in sample. The statistical analysis was performed to generate the polynomial equation foreach response. The desirability approach was used to determine the optimal mobile phase composition. Furthermore,the method was validated as per the ICH guidelines using specificity, linearity, accuracy, precision, sensitivity, systemsuitability, and robustness. The results of experimental design were statistically tested for full and in portion to getbest fitted model which accurately describe changes in the proportion of these solvents in the mobile phase close to theregion of optimal peak quality. The method demonstrated optimum chromatographic separation with isocratic elutionof the mobile phase containing a mixture of acetonitrile-water (pH 3.0)-tetrahydrofuran (43:55:02, v/v/v) with a flowrate at 1.0 ml/minute. Design of experiment optimization strategy is a powerful tool to acquire the maximum qualitydata while performing minimum number of experiments. The mobile phase composition was successfully optimizedusing simplex centroid mixture design with desirability approach. Additionally, developed method can be appliedfor routine quantitative analysis of Pitavastatin calcium in bulk and tablet dosage form as it was found to be simple,sensitive, and robust.

Sociodemographic profile of patients and prescribing trend of drugs in organophosphate poisoning at tertiary care teaching hospital in Central India: a descriptive study

Background: India is an agrarian country, where pesticides are most widely used in farming. Monsoon dependent agricultural practices are common in India. In present study socioeconomic class and prescribing pattern of commonly used drugs in organophosphate poisoning in indoor setting at tertiary care hospital is evaluated. The aim of the study was to evaluate prescribing trend of drugs and socioeconomic class of patients in organophosphate poisoning in monsoon season.Methods: Prospective observational study was conducted at Medical Intensive Care Unit (MICU) and Medicine Wards for 4 months at 540 bedded tertiary care teaching hospital.Results: Total 64 diagnosed cases were enrolled and analyzed in present study (n=64). Maximum number of cases (57.81%) were male followed by female (42.18%). Most of the cases (37.50%) were from the age group of 21-30 years. 49 (76.56%) patients were of primary intentional poisoning followed by 15 (23.43%) patients of accidental poisoning. Most common drugs prescribed were atropine, pralidoxime, cefotaxime and ranitidine. The average amount of atropine and pralidoxime used per patient/day were 37.89±63.63 mg and 10.07±26.87 gm respectively.Conclusions: Present study revealed that young male adults with low socioeconomic class from rural background were prone for intentional organophosphate poisoning in central India.

Endodontic Management of Variants of C-Shaped Canal: Case Series

A thorough knowledge of the root canal morphology is required for successful endodontic therapy. One of the most important anatomic variations is the C-shaped configuration of the root canal system. The presence of high incidence of transverse anastomoses, lateral canals, and apical deltas makes it difficult to clean and seal the root canal system in these teeth and may complicate endodontic interventions. Meticulous mechanical and chemical debridement of the canal space with additional efforts is essential for complete elimination of pulpal pathology in the anatomical irregularities. Obturation of the canal space also requires special attention as obtaining a three dimensional fill of a C-shaped canal may prove to be a problem due to the various intricacies present within the root canal system. Hence, this case series presents various types of C-shaped canal morphologies of mandibular second molars and their management.

Microbial xylanases and their biomedical applications: a review .

Xylanases have a great potential, mainly known for industrial applications. They can hydrolyze the xylose (Hemicellulose of plant cell wall) and can be used for bio-bleaching the kraft pulp. As it reduces the requirement of harsh chemicals in the process, it can be used further to a number of bio-products with a great aggregate value. Microbial-origin xylanases can also be used in improving the nutritional quality of animal feed (e.g. food additives to poultry, piggery or fishery) and indirectly affect the humans. Additionally they can be used directly in human food in bakery, clarification of juices and in xenobiotics like tobacco processing. The great value of xylanase as a bio-bleaching agent has now a new dimension of fiber digesting agent having relevance to food, drugs and cosmetics act. This review presents some important applications of Xylanases extended up to biomedical sciences.

Efficacy and Tolerability of Trandolapril in Mildto- moderate Hypertension: A Double-blind Comparison with Enalapril.

Objective: To compare the efficacy and tolerability between trandolapril and enalapril in mild-to-moderate hypertension. Material and Methods: This was a prospective, double-blind, parallel, comparative clinical trial involving 120 patients with mild-to-moderate hypertension. Patients were randomized to receive trandolapril 2-4 mg once-daily and enalapril 5-10 mg once-daily. The participants were followed for eight weeks. Results: Both the drugs achieved effective control of blood pressure (BP) at the end of eight weeks. The mean reduction in systolic BP (SBP) was 22.17 mmHg with trandolapril and 21.47 mmHg with enalapril group; the mean reduction of diastolic BP (DBP) was 9.57 mmHg with trandolapril and 11.13 mmHg with enalapril. Adverse events developed in 11 (18.3%) and 12 (20%) patients in trandolapril and enalapril group, respectively. Conclusion: The efficacy and tolerability of trandolapril was comparable to enalapril in mild-to-moderate hypertension with minor adverse events.

Anti-venom potential of aqueous extract of stem bark of Mangifera indica L. against Daboia russellii (Russell’s viper) venom.

Several plant extracts rich in pharmacologically active compounds have shown to antagonize venom of several species. Mangifera indica has been used against snakebite by the traditional healers, However, there is paucity of scientific data in support. In this study, we evaluated the antivenom potential of aqueous extract of stem bark of M. indica against D. russellii venom-induced pharmacological effects such as life myotoxicity, edema, LD50 etc. The extract inhibited the phospholipase, protease, hyaluronidase, 5`nucleotidase, ATPase and alkaline phosphomonoesterase activities with varying IC50 values. It significantly inhibited both metalloproteases and serine proteases activities. Further, the extract significantly reduced the myotoxicity of the venom, as evident by the reduction of serum creatin kinase and lactate dehydrogenase activities. Though the extract completely inhibited in vitro PLA2 activity, it was unable to completely inhibit in situ hemolytic and in vivo edema-inducing activities, usually brought about by PLA2s. In lethality studies, co-injection of the venom preincubated with the extract showed higher protection than the independent injection of venom, followed by the extract in the mice. However, in both the cases the extract -a cocktail of inhibitors significantly increased the survival time, when compared to that of mice injected (i.p) with the venom alone. These results encourage further studies on the potential use of cocktail of inhibitors in improving the treatment of snake envenomation. Further, this study substantiates the use of M. indica as an antidote against snakebite by the traditional healers.

Traumatic aorto-mesenteric-portal fistula: percutaneous management: case report

Two months after a stab injury to the abdomen, a 35-year-old male presented at the All India Institute of Medical Sciences with haematemesis, shock and portal hypertension. Computed tomography of the abdomen and abdominal angiography revealed a large fistulous communication between an abdominal aortic pseudoaneurysm and a branch of the superior mesenteric vein. The fistula was occluded percutaneously, which allowed the patient to stabilise haemodynamically and, finally, to undergo a definitive surgical excision of the pseudoaneurysm and repair of the aortic defect

Sequence and recombination analyses of the geminivirus replication initiator protein.

The sequence motifs present in the replication initiator protein (Rep) of geminiviruses have been compared with those present in all known rolling circle replication initiators. The predicted secondary structures of Rep representing each group of organisms have been compared and found to be conserved. Regions of recombination in the Rep gene and the adjoining 5' intergenic region (IR)of representative species of Geminiviridae have been identified using Recombination Detection Programs. The possible implications of such recombinations on the increasing host range of geminivirus infections are discussed.

Prophylactic surgery in non-cirrhotic portal fibrosis:is it worthwhile?

BACKGROUND: In cirrhotic patients with portal hypertension prophylactic portasystemic shunts have been found to be ineffective as deaths from post-shunt liver failure exceed those from bleeding. However, in patients with non-cirrhotic portal hypertension, variceal bleeding rather than liver failure is the common cause of death. In developing countries shortage of tertiary health-care facilities and blood banks further increases mortality due to variceal bleed. AIM: To study the results of prophylactic operations to prevent variceal bleeding in patients with portal hypertension due to non-cirrhotic portal fibrosis (NCPF). METHODS: Between 1976 and 2001, we performed 45 prophylactic operations in patients with NCPF, if the patients had high-risk esophagogastric varices or symptomatic splenomegaly and hypersplenism. Proximal lienorenal shunt was done in 41 patients and the remaining underwent splenectomy with (2 patients) or without (2 patients) devascularization. RESULTS: There was no operative mortality. Thirty-eight patients were followed up for a mean 49 (range, 12-236) months. Three patients bled - one was variceal and two due to duodenal ulcers; none died of bleeding. There were 2 late deaths (6 weeks and 10 years after surgery), one from an unknown cause and one due to chronic renal failure. The delayed morbidity was 47%. This included 7 patients who developed portasystemic encephalopathy, 4 glomerulonephritis, 2 pulmonary arteriovenous fistulae and 5 ascites requiring treatment with diuretics. Thus only 20 (53%) patients were symptom-free on follow up. CONCLUSIONS: Prophylactic surgery is safe and effective in preventing variceal bleeding in NCPF but at the cost of high delayed morbidity.

Efficacy of diode laser for treating acne keloidalis nuchae.

Acne keloidalis nuchae is usually treated with oral antibiotics, local antiseptics or intralesional steroids but with limited success. I assessed the efficacy of diode laser for treating the inflammatory and keloidal papules of acne keloidalis nuchae in two cases. The lesions in both the cases showed about 90 to 95% clearance after 4 treatment sessions at one to one and half month intervals. No new lesions were observed during the follow up period of six months after the last laser treatment. Thus, after clearing bacterial infection, laser hair epilation can be used as the first line of therapy for treating papules of acne keloidalis nuchae. This is the first attempt at treating acne keloidalis nuchae with a diode laser.

Therapeutic radiological interventional procedures in hepatocellular carcinoma.

BACKGROUND: To improve the survival rate of patients with hepatocellular carcinoma (HCC) in whom surgery is not possible, various methods have been developed employing angiographic and percutaneous techniques. We analyzed our experience with various percutaneous therapeutic interventional techniques done for HCC in our center. METHODS: Sixty-one patients with inoperable HCC (mean age 48.9 [SD 13.8] y; 47 men) were treated between January 1997 and December 2000 by transcatheter arterial chemoembolization (TACE) alone (22), TACE with percutaneous alcohol injection (PEI) (20), transcatheter arterial embolization (TAE) with steel coils and gel foam for gastrointestinal bleed (7), percutaneous radiofrequency ablation (1), percutaneous preoperative right portal vein embolization (3) and percutaneous preoperative tumor embolization to reduce blood loss at surgery (8). RESULTS: In 42 patients treated by TACE and PEI and TACE alone, tumor necrosis was scored; over 50% necrosis was seen only after six and nine months in both treatment groups. The survival rates after six and nine months and the median survival were similar in the two groups. Of 7 cases treated with TAE with steel coils and gel foam, the gastrointestinal bleeding stopped in four; in the other three, bleeding did not stop completely although less transfusion was required. In the patient treated by radiofrequency ablation, follow-up contrast-enhanced CT did not show enhancing tumor mass. We noted left lobe enlargement after percutaneous preoperative right portal vein embolization, prior to right hepatectomy. CONCLUSION: In patients with HCC not amenable to surgical intervention, a variety of percutaneous therapeutic interventional techniques may be used.

Cloning and sequencing of beta toxin gene of Clostridium perfringens type C.

A gene encoding beta toxin was amplified by polymerase chain reaction from C. perfringens type C isolate and cloned in pUC 19 vector. The nucleotide sequence was identical with C. perfringens type B beta toxin gene sequence. The Southern hybridization using labelled beta toxin gene probe revealed the presence of positive signals only in beta producing C. perfingens.

Polyneuritic leprosy presenting with bone changes prior to the onset of florid skin manifestation.

A case of polyneuritic leprosy is reported. There were minimal changes on skin, but changes in the bones were predominant. It is emphasized that polyneuritic leprosy is an entity. It is also stressed that neuritic leprosy can produce changes in deeper structures like bones, with minimal changes on skin.