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Abstract Ramipril being ACE inhibitor belongs to BCS class II drug with low solubility and undergoes first-pass metabolism that leads to reduced bioavailability of 28%. The current research is aimed at formulating and evaluating ramipril fast dissolving oral films (FDOF). Solubility enhancement of ramipril was done by formation of inclusion complex with β-cyclodextrin in 3 ratios (1:0.5, 1:1, 1:2). Based on higher drug content and dissolution values the physical mixture of ramipril with β-cyclodextrin in 1:1 ratio (IC2) was chosen for further studies. Total 12 formulations of ramipril FDOF containing IC2 prepared with various polymers and evaluated for physicochemical properties. The optimized formulation F9 shown better tensile strength (11.6 g/cm2), significant % elongation (9.8) and maximum % drug content of 99.98 %. The formulation F9 exhibited minimum disintegration time of 9 sec that is desirable for immediate onset of action and maximum drug release. The FTIR data of F9 assured the compatibility of drug and formulation excipients, found to be stable for 180 days at accelerated conditions. The study confirmed that ramipril FDOF lead to quicker onset of action and enhanced therapeutic efficiency in comparison to marketed product.
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Back ground: Impetigo is the most common bacterial infection in children. This acute, highly contagious infection of the superficial layers of the epidermis is primarily caused by Staphylococcus aureus or Streptococcus Pyogenes. The Objective of this study is to find out the role of probiotic among children suffering from impetigo. Materials and methods: This was a prospective, randomized, single-blinded interventional study, conducted in Paediatric OPD, Dermatology OPD and Paediatric Ward in Rajah Muthiah Medical College and Hospital for a period of 6 months. A total of 50 patients were enrolled in the study as per the inclusion criteria. They were treated with probiotic (50 million spores of Lactobacillus sporegenes, Streptococcus faecalis 30 million spores, Clostridium butyricum 2 million spores, Bacillus mesentericus 1 million spores) twice daily for 5 days. As a conventional treatment, Azithromycin 10 mg/kg/day once a day for 5 days given along with probiotic. Microbiological examination of pus from the first swab was used to prepare smears and was stained by Gram’s method. The pus from the second swab was inoculated on blood agar and Mc Conkey’s agar. Results: Bacteriological response and the clinical response were highly significant from baseline to the fifth day of treatment with probiotic along with azithromycin. Conclusion: The result of our study explores a new possibility in the horizon of treatment of impetigo. Since the adverse effects caused by probiotic are minimal and tolerable, it could be further exploited for the treatment of other inflammatory or immune conditions that are refractory to treatment with current chemotherapeutic agents.
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Background: Epilepsy is a common neurological disorder in children and its treatment still remains a challenge for the physicians. Though there are a number of anti-epileptic drugs with varying mechanisms of action, their adverse effects, and drug interactions are to be analyzed before starting a therapy. Aim: To study the pattern of prescription in the treatment of pediatric seizures. Objectives: To observe the pharmaco-epidemiology, utilization pattern and effectiveness of monotherapy and polytherapy in the treatment of seizures in children aged above 2 years. Materials and methods: This prospective, longitudinal study was conducted for a period of 8months in Paediatric Neurology Department of a tertiary care teaching hospital. The data collected from 41 children at the end of the study, were compiled in a specially designed data form and were analyzed. Henry Daniel Raj T, Sylvia A, Chidambaranathan S, nirmala P. Monotherapy and polytherapy in Paediatric seizures: A prospective, observational study in a tertiary care teaching hospital. IAIM, 2017; 4(10): 97-104. Page 98 Results: The distribution of Paediatric seizures was found to be high in male children (62%) and in the age group of 2 to 5 years (46%). GTCS (85%) was the dominant type of seizure seen in children and 83% of the children were treated with monotherapy. Polytherapy was found to be efficacious compared to monotherapy, with a good seizure control (100%: 94%), good compliance and minimal adverse effects (14.2%: 14.7%). Conclusion: Monotherapy still remains the mainstay of treatment in pediatric seizures. Though polytherapy appears to be a better option in this study, epilepsy in children requires a long term treatment and hence adverse effects in long term and the effects of drug interactions are the main criteria to be taken care of. A study of longer duration in the treatment of pediatric seizures will provide a better knowledge in the adverse effects of polytherapy.
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Background: Diacerein and S-adenosyl methionine (SAMe) are symptomatic slow-acting drugs in osteoarthritis (SYSADOA). Diacerein is a semisynthetic, anthraquinone derivative, an interleukin 1beta inhibitor with anti-inflammatory, anti-catabolic and pro-anabolic properties on cartilage and synovial membrane. SAMe is a dietary supplement used in the management of OA. The objective of this study is to find out compliance and tolerability evaluation of Diacerein versus S-adenosyl methionine inpatients suffering from Osteoarthritis. Materials and methods: This was a prospective, randomized, interventional study conducted in Orthopedic OPD and ward in Rajah Muthiah Medical College and Hospital for a period of one year. A total of 80 patients were enrolled in this study as per the inclusion criteria. 40 patients in each group were randomly assigned to receive either diacerein 50mg BD or SAMe 200 mg TDS for12 weeks. The NSAID diclofenac 50 mg BD was administered orally for a short course of one week to both the groups to relieve acute symptoms. Efficacy of both the drugs was assessed using Lysholm knee scoring scale. The tolerability profile was evaluated during each clinical visit on weeks 1, 4 and 12. Gayathri C.R., Vanitha Samuel, Senthilnathan A, Nirmala P. Compliance and tolerability evaluation of diacerein versus sadenosyl methionine in osteoarthritis patients. IAIM, 2017; 4(11): 6-13. Page 7 Results: Diacerein and SAMe which were symptomatic slow-acting drugs show a profound reduction in pain starting from 4th to 12th week of treatment. Lower GI side effects like diarrheawere observed in the diacerein group and insomnia was reported in the SAMe group. Though the overall adverse effects were more in the diacerein group, compliance was better with regard to drug intake Conclusion: Both diacerein and SAMe were found to be effective in reducing the pain in Osteoarthritis patients. Diacerein with a good compliance factor was less tolerable because of the incidence of diarrhea. SAMe though better tolerated has a compliance score of fair to good.
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Introduction: The sacrum is a large triangular bone, formed by the fusion of five sacral vertebrae. The opening at the caudal end of sacral canal is known as sacral hiatus. It is formed due to the failure of fusion of laminae of the fifth (occasionally fourth) sacral vertebra. Sacrum is one of the bones which exhibit variations and the variation of sacral hiatus is of great clinical significance because it may also leads tomechanical low back pain. Previousworks on themorphometrical study on the sacral hiatus is limited, especially in Nepal, Parsa population. The present study was undertaken to help in filling this gap at least to a certain extent and also made an attempt to find out the variations of sacrum. Materials: One hundred dry human sacra were collected from the Department of Anatomy of National medical college & Teaching Hospital, Nepal. Methods& Observations: Themorphometrical studieswere done, and the parameters (Shape, length, Transverse width & Antero-posterior width of sacral hiatus and level of apex & base of sacral hiatus) were measured with the help of divider, the observations were recorded, tabulated & analyzed. Result: The study showed a significant co-relation between anatomical variations of sacral hiatus with the previous studies.
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Background: Diabetes mellitus is a group of metabolic disorders characterized by hyperglycemia. Hyperglycemia is the etiological factor for oxidative stress-induced microvascular and macrovascular complications. Many animal experimental models and clinical trials have proved the antioxidant defense mechanism of flavonoids in ameliorating the progression of chronic diabetic complications. Hence, the objective of this study was to evaluate the nephroprotective effects of silymarin in alloxan induced Type I diabetes. Methods: Male Wistar rats were divided into five groups of six each. Group I served as control. Group II, III, IV and V were diabetic rats. Group II diabetic rats received the vehicle. Groups III and IV were treated with 200 mg/kg and 400 mg/kg of silymarin, respectively. Group V was treated with glibenclamide (0.5 mg/kg). After 3 weeks, blood samples were collected from all the groups of animals to measure serum glucose, urea and creatinine. Lipid peroxidation study and histopathological study were conducted in the renal tissue to confirm the oxidative damage. Results: The serum glucose, urea and creatinine significantly increased in untreated diabetic rats. In addition, there was a significant rise in lipid peroxidation with a glomerular atrophy and necrotic tubular epithelium in the renal tissue. The rise in serum glucose, urea and creatinine was ameliorated by silymarin. The renal tissue showed increased antioxidant levels, decreased lipid peroxides and only mild changes in glomeruli and tubules. Conclusion: The results of this study indicate silymarin is an effective nutritional supplement to prevent complications of diabetes.
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Background: Elevated plasma lipoprotein (a) (Lp(a)) levels, which act synergistically with low-density lipoprotein cholesterol (LDL-C), are an independent risk factor for cardiovascular diseases (CVD). The effect of statin drugs on Lp(a) levels has not been well-demonstrated in clinical studies. This prospective, randomized, comparative clinical study with parallel treatment groups was conducted to assess the effect of simvastatin, atorvastatin and rosuvastatin, on serum Lp(a) levels and serum lipid profile, in treatment-naive dyslipidemic patients without CVD. Methods: A 12 weeks study, with 85 patients, aged 40-70 years, diagnosed with borderline high LDL-C, were assigned to three groups with their informed consents. Group A (n=28) was treated on simvastatin 20 mg/day; Group B (n=29) on atorvastatin 10 mg/day; and Group C (n=28) on rosuvastatin 5 mg/day. Patients’ lipid profile and Lp(a) levels were assessed at 0, 4th and 12th week of treatment period. Statistical analysis was done using Duncan’s test (p<0.05) and one-way ANOVA (p<0.001). Results: At the end of 12 weeks, serum Lp(a) reduction was substantial at 18.73% in atorvastatin group; at insignificant levels (3.15%) in simvastatin group, whereas an elevated level of 8.58% in Lp(a) was recorded in rosuvastatin group. All three treatment groups showed a significant positive impact on the lipid profile. No adverse drug reactions were reported. Conclusion: The impact of statin monotherapy on lipid profile doesn’t correlate with its effect on Lp(a). Atorvastatin has shown a significant reduction in Lp(a) unlike the other statins, and should be preferred in patients with increased risk of CVD.
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The new diagnostic criteria recommended by the American Diabetes Association (ADA) will only detect diabetic patients with fasting hyperglycemia, and leave patients with isolated post-challenge hyperglycemia (IPCH) and imparied glucose tolerance (IGT) unidentified. The WHO recommends that all those with abnormal fasting glucose should undergo the oral glucose tolerance test (OGTT) to exclude the diagnosis of diabetes (two-step strategy). This two-step strategy will leave out subjects with normal fasting glucose (<109 mg/dl). The aim of this study is to compare the WHO two-step strategy and the gold standard OGTT for all subjects. We re-analyzed the results of 907 high-risk patients who have been screened for diabetes mellitus and impaired glucose tolerance. All subjects were screened with an OGTT containing a 75-gram glucose load after fasting for 12 hours. The results were classified into three categories: the ADA criteria, the two-step strategy, and the OGTT. Using the ADA criteria, these 907 subjects can be classified has having normal fasting glucose (fasting plasma glucose - FPG < 109 mg/dl) in 715 subjects (78.9%), abnormal fasting glucose (FPG 110 - 125 mg/dl) in 107 subjects (11.8%), and diabetes mellitus (FPG > 126 mg/dl) in 85 subjects (9.4%). The WHO two-step strategy performed in 107 IFG subjects identified another 30 diabetic patients (FPG < 109 mg/dl and 2 hour post load > 200 mg/dl = IPCH) or 3.3%, and 49 patients with IGT, or 5.4% from all subjects. If the OGTT was performed on the 715 normal fasting glucose, it could identify another 40 diabetic patients or 4.4%, and another 178 IGT patients, or 19.6% of all subjects. This means that without OGTT to all subjects, 40 diabetic patients or 25.8% of all diabetic patients and 178 patients or 78.4% from all IGT subjects would have remained unidentified. From this study we can conclude that applying the WHO two-step strategy in subjects with IFG would fail to detect 25.8% of diabetic patients and 78.4% of IGT subjects. It is recommended that the old strategy of screening--the gold standard OGTT--should be used instead of the two-step strategy, at least in high-risk groups.