Rubatosis Publications (E-Journals)
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Antibacterial Activity of AegleMarmelos against Fruit Extracts
Get PDFThe antibacterial activity of the ethanol, and aqueous extracts from the fruit of A. marmelos was studied using disc diffusion method against five pathogenic bacterial strains, three Gram-positive bacteria (B. cereus, S. epidermidis, S. aureus) and two Gram-negative bacteria (E. aerogens, K. pneumoniae).The maximum 14.3mm zone of inhibitionwas observed at the concentration of 40mg/ml foraqueous extract. This may be due to the presence of the compounds Cuminaldehyde and Eugenol. In the case of ethanol, the maximum antibacterial activity was seen against E. aerogensfollowed by S. epidermidisand K. pneumonia. At the highest concentration of 160 mg/ml, it showed 18.3mm zone of inhibition. The antibiotic susceptibility showed that among all the bacterial strains S. aureuswas found more susceptible to ampicillin followed by K. pneumonia. Results suggest that the ethanolic extract has significant antibacterial activity against tested bacteria. The present study justifies the claimed uses of A. marmelos in the traditional system of medicine to treat various infectious diseases
Regulatory approach for the approval of Artificial intelligence/ Machine language (AI/ML) Based Software as medical devices (SaMD)
No full textArtificial Intelligence and Machine Language (AI/ML)-Based medical technologies has the potential to change the medical care by determining new and significant experience from the huge measure of information produced during the conveyance of medical care each day.The capacity for AI/ML programming to gain from certifiable criticism (preparing) and improve its presentation (variation) makes these advancements particularly arranged among programming as a clinical gadget (SaMD) and a quickly extending territory of innovative work. Our vision is that with fittingly customized administrative oversight, AI/ML-based SaMD will convey protected and powerful programming usefulness that improves the nature of care that patients get. Different types of medical devices and various documentation procedures for the approval of the AI/ML based SaMD was discussed and the modifications or the updates regulatory approach to the SaMD were clearly mentioned for the easy approval considering the IMDRF, GMLP, TPLC and FD&C regulations. The future trend and the current approved SaMd were discussed
In Vitro Antiviral Activity of AegleMarmelos against Influenza A (H1N1) Pdm09
No full text<p>Due to the high prevalence of viral infections having no specific treatment and the constant appearance of resistant viral strains, the development of novel antiviral agents is essential. The aim of this study was to evaluate the antiviral activity of aqueous and ethanolic extracts of Aeglemarmelosagainst Influenza A (H1N1) pdm09. The extract was subjected to cytotoxicity as well as antiviral activity on MDCK cells. The concentration range from 10 to 100μg/ml in MDCK cell line was conducted. It showed that the treated cells with drug was nontoxic to the cells at the concentration of 50μg/ml for ethanolic and 60μg /ml for aqueous extract at 48 hrs to 72 hrs and was comparable to that of controls. Hence crude extract of both ethanolic and aqueous up to 50-60μg /ml (CC50) could be used to test the antiviral activity without affecting much of the cell viability. In simultaneous anti viral assay, 80% viral inhibition was observed at the concentration of 50μg/ml in aqueous extract whereas 100 % viral inhibition was observed in ethanolic extract at concentration of 60μg/ml. In the post treatment assay, the aqueous extract did not show viral inhibition, whereas the ethanolic extract showed 100% reduction at the concentrations of 60μg/ml. This data suggest that ethanolic extract inhibit the Influenza virus infection by blockage of viral attachment by inhibition of viral HA protein, this is consistent with previous studies.</p>
An overview on comparative study of registration requirements for generics in US, Canada and Europe
Get PDFGeneric Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market
Analytical method development and validation for simultaneous estimation of Moxifloxacin Hydrochloride and Ketorolac Tromethamine by using RP-HPLC
Get PDF<p>The main objectives of the present research were to develop the new method for the simultaneous estimation and validation of Moxifloxacin HCl and Ketorolac Tromethamine in pure form and in pharmaceutical dosage form by RP-HPLC. The chromatogram of Moxifloxacin HCl and Ketorolac Tromethamine was developed through column (Inertsil ODS C18), UV detection at 304 nm at a flow rate of 1.0 ml/min with Buffer (pH 4.0):Acetonitrile:Methanol (50:30:20) V/V as mobile phase. The method was validated by various validation parameters such as accuracy, precision, linearity, specificity as per the ICH guidelines. A linearity range of Moxifloxacin HCl and Ketorolac Tromethamine was found to be 60 to 140 µg/ml and 48 to 112 µg/ml respectively. The retention time of Moxifloxacin HCl and Ketorolac Tromethamine was found to be 2.07 min and 4.06 min respectively. % RSD of retention time and peak areas obtained in system precision for Moxifloxacin HCl was 0.21 and 0.80 respectively and for Ketorolac Tromethamine were 0.90 and 1.06 respectively. The % recovery of standard Moxifloxacin HCl and Ketorolac Tromethamine was found to be 100.18 to 100.08% and 99.97 to 99.93% respectively. The % recovery of Moxifloxacin HCl and Ketorolac Tromethamine in dosage form was found to be 98.73 to 100.92% and 98.10 to 100.77% respectively. This method was simple, accurate, precise, and sensitive. Hence, the developed method was employed for the routine analysis of Tenofovir in the pharmaceutical dosage form.</p>
To study the organization of LDL-C/HDL-C ratio and inflammatory marker CRP in acute myocardial infarction
No full textThere is an increasing incidence of coronary artery disease in India. We therefore need a tool to evaluate the severity and prognosis of this acute myocardial infarction. In acute myocardial infarction, the function of plaque rupture and inflammation has already been identified. Aim: To study the organization of LDL-C/HDL-C ratio and inflammatory marker CRP in acute myocardial infarction. Methods and Material: Patients who have been diagnosed as acute myocardial infarction (ST Elevation Acute myocardial Infarction or Unstable angina/Non ST Elevation Myocardial Infarction) and admitted to ICCU of Rajiv Gandhi institute of Medical Sciences, Kadapa, AP. are the subjects. Sample consists of 100 cases of acute myocardial infarction. Case history was taken from the patients, and studied according to proforma. Conclusion: Elevated levels of CRP are independent indicators of adverse effects. When contrast with the LDL / HDL ratio, CRP is used for risk stratification and as a prognostic predictor. These findings suggest that in patients with acute myocardial infarction, raised CRP Levels is significant as compared to LDL/HDL ratio
Analytical method development and validation for the estimation of Mirabegron in pure and its solid dosage form by UV spectrophotometric method
No full textA simple, economical, rapid, accurate, precise spectrophotometric method has been developed and validated according to ICH Guidlines for the Mirabegron as active pharmaceutical ingredient (API) by UV spectrophotometric method. The absorption maxima of Mirabegron was found to be at 249 nm wavelength using 1N Hcl as a solvent. Linearity range was found to be 3-15μg/ml, with the correlation coefficient being more than 0.999. The relative standard deviation was found to be < 2%. The percentage recovery was within the range of 98% -105%, indicating that there is no significant interference from the other ingredients present in the formulation. The method can be applied for the routine analysis of Mirabegron as API in pharmaceutical preparation
Formulation, design, optimization and evaluation of cimetidine floating tablets by using 32 factorial design
No full textThe present study was aimed to formulate and evaluate floating tablets of Cimetidine which is a histamine H2 receptor antagonist in increasing usage in the medical management of peptic ulcer. In this study, excipients like HPMC K4M ,HPMC K100M were used as polymers and sodium bi- carbonate were incorporated in 9 different concentrations (F1-F9) along with other excipients.to formulate floating tablets. Then all the nine formulations were evaluated for uniformity of weight, hardness, thickness, friability test, floating lag time, drug content, dissolution studies and stability studies.The 32 Factorial design experiments helps the investigator in resource management and economy. The dissolution profile of F2 was observed to be better than other formulations. Trial-F2 formulation showed a good dissolution profile for a controlled period of time which was noticed to be as 98 % at the end of 12th hour. Thus, it can be concluded that the floating drug delivery system of cimetidne using the appropriate polymers in right amount may enhance the activity of the drug by prolonging the gastric residence time or reducing the floating lag time
Descriptive Outcome Based Study for Treatment Strategies of Lower Respiratory Tract Infections using Medication Therapy Management
No full textLower respiratory tract infections (LRTI`s) are the fifth leading cause of death due to infections being responsible for 2.74 million deaths worldwide. Antibiotics are used primarily to treat these infections. The aim of this research is to study the medication therapy management of patients with lower respiratory tract infections admitted in ESI hospital, Bangalore, and to improve the quality of life of patients. It is a descriptive, observational, and interventional study. The data is collected through suitably designed forms and by direct interaction with the patients as well as their caretakers. The study cohort consists of 40 patients, of that males were 24 (60%) and females were 16 (40%). Most of the infected cases were in the age group of 51 to 60 years and the minimum infected were of 11 to 20 years and 81 to 90 years. The symptoms like Hyperthermia (30%), Tachycardia, and tachypnea (32.5%) were observed. A high count of RBS, PPBS, FBS were seen among 25%. Observations including leukocytopenia (7.5%), neutropenia (15%), lymphocytopenia (22.5%), leukocytosis (22.5%), neutrophilia (27.5%), lymphocytosis (35%), eosinophilia (7.5%), monocytosis (2.5%), and all cases have increased ESR (100%). LRTI was among 13 (32.5%) patients and remaining were with complications associated with LRTI. 40 (100%) patients received IV fluids along with Duolin, Budecort, Augmentin, Cough syrup, and Deriphylline. Maximum drug interactions are seen in Pantoprazole + Deriphylline combination among 14 (35%). Process measures (type and frequency of drug therapy problems detected), economic measures (number of medications dispensed), and humanistic measures, (patient satisfaction with services) were the main outcomes in this process after providing MTM services
Assessment of In-Vitro Cytotoxicity and In-Vivo Antitumor Activity of Syzygium aqueum
No full textThe present study aims to evaluate the cytotoxicity and antitumor activity of the ethanolic extract ofleaves of Syzygium aqueum (EESA) on K562 tumor cell line (chronic myeloid leukemia) andtransplantable tumor Dalton’s ascites lymphoma (DAL). In-vitro cytotoxicity on K562 tumor cell linewas evaluated using micro-culture tetrazolium (MTT) assay. In-vivo antitumor activity was studied onDAL tumor bearing mice. Activity was assessed by monitoring the mean survival time, tumor cellcount, percentage increase in body weight and effect on haematological parameters like red blood cell(RBC) count, haemoglobin content (Hb), white blood cell (WBC) count, Differential cell (DC) count.Histopathological studies were also evaluated during this study. EESA exhibit potent in-vitro cytotoxicity activity against K562 tumor cell line. The result also showed an increased life spanand decreased tumor cell count in S.aqueum treated animals. The hematological studies revealed thatthe Hb count decreased in DAL bearing mice, whereas S.aqueum treated mice showed an increase inthe Hb or near to normal levels and other hematological parameters such as RBC, WBC was alsosignificantly reduced. Histopathalogical studies evaluated the destruction of tumor cells by showingcell wall destruction, membrane blebbing, degradation, vacuolated cytoplasm. The results suggestedthat the EESA exhibited cytotoxicity in dose dependent and it showed significant antitumor activityon DAL bearing mice