VALIDATED STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ASENAPINE MALEATE

Objective: A stability indicating high performance liquid chromatography method using the photodiode array detector is developed and validated for the analysis of asenapine in bulk and in its tablet formulation. Methods: The method utilized a BDS Y Persil C18 (250 x 4.6 mm, 5 µm) column with 0.1% orthophosphoric acid and methanol (65:35 v/v) as mobile phase. The analysis was performed at 30 oC column temperature with a flow rate of 1 ml/min and detection at 227 nm. The method was validated for specificity, sensitivity, precision, linearity, accuracy and robustness. Asenapine was subjected to stress degradation studies under acidic, basic, oxidative, thermal and photolytic conditions. Results: Under optimized experimental conditions, asenapine was eluted from the column at a retention time of 6.781 min. The method was linear in the range of 100-300 µg/ml. The linear regression data showed good relationship (correlation coefficient (R2) = 0.9999). The relative standard deviation and mean recovery values were within limits. The analytical performance of the method was not affected when small variations in the experimental parameters were made. Degradation products resulting from stress degradation studies did not interfere with the detection of asenapine. Conclusion: The proposed stability indicting high performance liquid chromatography method is sensitive, precise, accurate, robust and specific. This method can be used for quantification of asenapine in bulk drug and in tablet dosage form in the presence of its stress degradation products

Prescription pattern in indoor patients of cardiovascular diseases: a descriptive study in a tertiary care hospital attached to a government medical college

Background: In India, one of the leading causes of death is cardiovascular diseases (CVDs). The study of prescription pattern ensures rational pharmacotherapy and assures quality medical care to the patients. Hence the present study was conducted to observe the prescription pattern of drugs among the indoor patients of cardiovascular diseases in a tertiary care hospital attached to a Government Medical college.Methods: A retrospective observational study of 9 month duration was undertaken from January- September 2015. A total number of 113 indoor cardiovascular disease patients’ case sheets were utilized for our study from medicine and ICCU department of a tertiary care hospital. The data was analysed and the results were expressed as counts and percentage.Results: Of 113 patients, most of the patients were of the age group of 56-65 years (40.71%). The prevalence of CVDs was higher in females (56.64%) than males (43.36%). Hypertension (58.41%) and Ischemic heart disease (41.59%) were found to be predominant CVDs. Nifedipine (53.10%), Atenolol (31.86%), Isosorbide dinitrate (40.71%), Atorvastatin (53.10%) were the most commonly prescribed cardiovascular drugs. Aspirin and Clopidogrel combination was prescribed in 46.90% of CVD patients. The average number of drugs per prescription was 6.53.Conclusions: The present study shows that most of drugs were prescribed rationally according to the current treatment guidelines except the under use of ACEIs and ARBs in hypertensive diabetes mellitus patients. Standard treatment guidelines should be circulated among practicing physicians to encourage rational prescription

Current trends in highly active anti-retroviral therapy in an anti-retroviral therapy centre attached to a remote government medical college of Maharashtra, India: a retrospective study

Background: Highly active anti-retroviral therapy (HAART) became the keystone of national AIDS program. There is lack of awareness and inadequate training about drug safety monitoring among health care professionals in India. Hence, the present study was carried out to study current trends in HAART and pattern of associated adverse drug reactions.Methods: A retrospective observational study was conducted at an anti-retroviral therapy (ART) Centre. A total of 151 HIV/AIDS Patients (old and new cases) receiving HAART during July 2015 to December 2015 were randomly included in the study. Causality and severity assessment of adverse drug reactions (ADRs) was done by using Naranjo’s ADR causality scale and modified Hartwig and Siegel scale respectively. The data was computed using MS Excel and descriptive results were expressed as counts and percentages. The study was approved by institutional ethics committee.Results: The prevalence of HIV/AIDS infection was higher in adult males (51.66%). Zidovudine+lamivudine+nevirapine (ZLN) was the most commonly prescribed HAART combination. Out of 132 ADRs reported, 76.52% of the ADRs were related to haematological system and ZLN was the commonest combination causing ADRs. 90.91% ADRs belong to possible category on causality assessment and 68.94% of the ADRs were of moderate severity. Tuberculosis (28.47%) was the commonest diagnosed opportunistic infection among the HIV/AIDS patients.Conclusions: The prescribing pattern of HAART regimens was in accordance with national guidelines for antiretroviral therapy. We recommend a pharmacovigilance system for sustainable management of ADRs in HIV/AIDS patients as we found under reporting of ADRs

Study of current prescribing pattern of antimicrobial drugs in indoor cases of enteric fever in a tertiary care hospital

Background: Rational antibiotic prescription is very important to prevent antimicrobial resistance. Hence the present study was conducted to evaluate the prescribing pattern of antimicrobial drugs in indoor enteric fever patients of medicine and paediatric department of a tertiary care hospital.Methods: A retrospective study of 2 months duration was undertaken during July and August of 2015. A total number of 97 enteric fever patients’ case sheets were utilized for our study from medicine and paediatric in-patients department of a tertiary care hospital. The data was analysed and results were expressed as percentage.Results: Out of 97 enteric fever patients, 54.64% were females. 13.4% of paediatric population were suffered because of enteric fever. The incidence of enteric fever was 74.23% in 13-40 years. Most commonly prescribed antimicrobials were 3rd generation cephalosporins and fluoroquinolones. 43.30% patients received more than one antibiotic. Antimalarials chloroquine, artemisinin derivatives and metronidazole were other drugs prescribed to enteric fever patients concurrently for associated clinical conditions.Conclusions: Interventional programme should focus on the use of rational antibiotic prescription aimed at minimizing unnecessary cost, adverse drug reactions and emergence of bacterial resistance

Changing trends with respect to standard of methodological reporting and type of research published in a pharmacology journal over a decade: a descriptive study

Background: Criticisms against Indian research include features like redundant research topic, low quality methodological reporting leading to less credible results and poor statistical rigor to mention a few. A ‘publication audit’ of previously published studies in terms of research trend and standards of methodological reporting will help us to identify problem areas so that rectifications if required may be undertaken.Methods: This was a descriptive study conducted on the research articles published in a journal of Pharmacology during years 2005 and 2015. Comparison was done to see any differences in type of studies published and also to assess their standards of methodological reporting on the basis of a predesigned checklist. Descriptive statistics were used to analyse data.Results: The proportion of full length research articles published increased from 30.97% in the year 2005 to 46.58% in the year 2015, the number of studies involving human beings increased to 26.86% (as compared to 8% in 2005), studies using drugs as active principle doubled in 2015 as compared to 2005. Focus on area of research shifted from inflammation and wound healing in 2005 to central nervous system in 2015. With respect to standard of reporting, albeit some improvement in the studies published in 2015, some missing links still exist.Conclusions: There is scope for improvement in terms of report of study designs, justification of sample size and adherence to CONSORT (Consolidated statement for reporting randomized controlled trails) statement while reporting results of randomised controlled trials

Serum lipid profile in non-polycystic ovary syndrome and polycystic ovary syndrome women: a comparative and correlational study

Background: Polycystic ovary syndrome (PCOS), in addition to impaired ovulation, also affects metabolic pathways. Dyslipidemia, occurring in PCOS women leads to cardiovascular diseases in them. The purpose of the present study was to compare lipid profile and its correlation with biochemical and hormonal parameters in PCOS and non PCOS women, to analyse the correlation of lipid profile with hirsutism and body mass index (BMI) in PCOS women.Methods: The present study includes 68 women divided into non PCOS groups (n=30) and PCOS (n=38) as defined by Rotterdam criteria. PCOS group further divided into overweight / obese (n=23) and normal weight subgroups (n=15). Lipid profile, fasting blood glucose and hormonal profile were done in all the groups.Results: TG and TC/HDL ratio were significantly high in PCOS group. Hirsute patients had raised LDL levels as compared to non-hirsute. LDL showed positive significant correlation with insulin, HOMA, testosterone in PCOS group. TC was significantly positively correlated with insulin and HOMA in PCOS group. In both normal weight and overweight / obese PCOS subgroups, LDL had positive and significant correlation with testosterone. TC showed positive and significant correlation with HOMA in overweight/obese subgroup. HDL showed positive and highly significant correlation with FSH in normal weight PCOS.Conclusions: Hyperandrogenism in PCOS may be additionally marked by raised LDL. Overweight/obese PCOS subgroup may be prone to dyslipidemia as well as deranged glucose homeostasis, thereby making it an important therapeutic target

Follicular dendritic cell sarcoma of the neck with an aggressive and fatal course

Dendritic cell neoplasms are rare malignancies described with an increased frequency. They often involve the lymph nodes, but extranodal presentations are also described. The disease often has an indolent course. Surgery is the main modality though chemotherapy and radiation have also been tried. We present here a case of a 69-year-old male diagnosed to have follicular dendritic cell sarcoma of the neck which had a rapid and fatal course inspite of chemotherapy and radiotherapy. More studies are required to assess the biology of this rare tumor

Geriatric prescription analysis with respect to “STOPP” and “START” criteria: a descriptive study in the Indian scenario

Background: Patients; sixty-five years of age and above, are a special risk group as far as drug prescribing is concerned. Prescription irregularities in such patients may be hazardous. STOPP/START criteria are considered as the most up to-date set of explicit criteria for evaluating geriatric prescriptions. To analyse geriatric prescriptions in a tertiary care centre with respect to STOPP/START criteria and WHO core drug prescribing indicators so as to get an idea of pattern of drug prescription in geriatric patients as well as frequency of potentially inappropriate prescriptions. Descriptive cross-sectional study in a tertiary care hospital.Methods: All inpatients aged 65 years and above who were prescribed at least one allopathic medication and consented to participate in the study were included and patients admitted for medical emergencies were excluded. Demographic data and details of drugs prescribed were collected from prescription chits and indoor case papers.Results: There was a high frequency of polypharmacy, prescription of antimicrobials and injections. Proportion of patients receiving at least one potentially inappropriate medication (PIM) as per STOPP criteria was 21.01%. Proportion of patients subjected to at least one potential prescribing omission (PPO) as per START criteria was 33.33%. Proportion of patients exposed to potentially inappropriate drug prescriptions as a whole (PIPs=PIMs+PPOs) was 46.37%. Statistical analysis used as descriptive statistics like numbers and percentages were used for data analysis.Conclusions: With regards to geriatric prescribing, adherence to WHO core prescribing indicators, prescription of drugs as per STOPP and START guidelines are indicative of scope for improvement

Current pattern of adverse drug reactions to anti-retroviral therapy in an antiretroviral therapy centre attached to a government medical college of Maharashtra, India: a retrospective study

Background: Antiretroviral drug therapy (ART) has brought a ray of hope to people living with HIV/AIDS. Adverse drug reactions (ADRs) can often cause significant morbidity among individuals on ART, occasionally leading to mortality. The present study was conducted to assess the nature, causality, severity of ADRs to ART, and to identify risk factors for ADRs in HIV-positive patients receiving ART in India.Methods: A total of 109 patients reported with ADRs to ART during July 2015-December 2015 were randomly included in a retrospective observational study conducted at an ART center attached to a government medical college of Maharashtra. Causality and severity assessment of ADRs was done by using Naranjo’s ADR Causality scale and Modified Hartwig and Siegel scale respectively. The data was computed using MS Excel and descriptive results were expressed as counts and percentages. The study was approved by Institutional Ethics Committee.Results: Among 109 patients, females (60.55%) had higher prevalence of ADRs than males (39.45%). A total of 132 ADRs were reported. Anemia (76.52%) was the commonest ADR reported followed by skin rash (11.36%) and raised renal function tests (6.06%). Zidovudine + Lamivudine + Nevirapine (ZLN) were the commonest ART regimen causing anemia as ADR.Conclusions: Reporting of ADRs is a very inefficient system in detecting drug-related conditions, leading to underestimation of the burden due to ADRs in India. A well-structured, efficient pharmacovigilance systems, which assesses and monitor safety profile and impact of antiretroviral medicines is very much needed at present in India

Comparison of cardiovascular safety of escitalopram and sertraline based on electrocardiographic alterations: a pharmacovigilance study

Background: Escitalopram and sertraline are the most commonly prescribed antidepressant drugs, belongs to SSRI class. Both the drugs are long been considered as free from cardiovascular adverse effects. Recently number of studies reported potential association between these drugs and pronounced cardiovascular adverse effects. ECG changes like prolongation of QT interval are frequently used as markers for the increased risk of a fatal cardiac arrhythmia. The potential cardiovascular adverse reaction profile of both these drugs is little studied in Indian rural population.Methods: This was a 6 weeks prospective open label observational study carried out in a drug naive 209 patients receiving either escitalopram (n=106) or sertraline (n=103). ECG parameters like heart rate, RR interval, PQ/PR interval, QRS duration and QTc interval, were obtained directly from the digital machine recordings, additionally the QT interval was measured manually with the help of caliper. Statistical analysis was done by using Statistical software SPSS 17.0.Results: Out of 209 drugs naive patients, 12 from escitalopram group and 10 patients from Sertraline were lost to follow-up. Hence ECG recordings of the remaining 94 patients under escitalopram group, 93 patients under sertraline group were used for study analysis. The ECG alterations caused by the escitalopram were compared with that caused by sertraline. It was observed that the differences between the ECG alterations caused by either of escitalopram or sertraline were statistically non-significant.Conclusions: It was concluded, at therapeutic doses neither of the drugs have the potential risk of drug induced arrhythmias, throughout the study.