Lakshmi K

With India and the United States having the highest rates of the disease, diabetes mellitus is becoming a global public health concern. In India, which is expected to have the world's biggest diabetic population (more than 101 million by 2023), accessibility and price are major concerns. A significant component of the antidiabetic medication market, which is projected to reach a valuation of USD 1.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% to reach USD 2.01 billion by 2029[1]. The primary treatment for Type 2 Diabetes (T2DM) is still metformin, which is augmented by sulfonylureas, DPP-4 inhibitors, and more recently, SGLT2 inhibitors. With new limitations on illogical fixed-dose combinations, regulatory bodies such as the CDSCO are actively trying to guarantee the safety and effectiveness of pharmaceuticals [2]. Diabetes is a chronic, metabolic disease characterized by elevated blood glucose levels or hyperglycaemia, which results from abnormalities in either insulin secretion or insulin action, or both. According to the report from CDC’s National Diabetes Statistics Report, there are about 37.3 million cases of diabetes in the US which is 11.3% of the US population. The kind of drug most frequently used to treat type 1 diabetes Insulin. Insulin, alpha-glucosidase inhibitors, biguanides, dopamine-2 agonists, DPP-4 inhibitors, GLP-1 receptor agonists, meglitinides and SGLT2 inhibitors, sulfonylureas, thiazolidinediones, and other drugs are commonly used orally to treat type 2 diabetes [3]. Keywords: Antidiabetics, Diabetes Mellitus, Regulatory Bodies, CDSCO, FDA, United States

The objective of present work was to develop and validate a rapid reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantitative analysis of lenvatinib in bulk and pharmaceutical dosage forms. Chromatographic analyses were performed on an ODC column of 250mm 4.6mm: i.d and 5µ particle size with a mobile phase comprising of 0.5M ammonium acetate and acetonitrile in the ratio 90:10 v/v. The   flow rate maintained at 1 ml/min, detected lenvatinib at RT 1.15 minutes. The lenvatinib was detected and quantitated using a photodiode array detector at a wavelength of 367 nm. The method was shown to be specific and linear in the range of 20-120?g/ml (r2= 0.999). The precision (intra- and inter-day) was demonstrated. The method is robust relative to changes in flow rate, column and temperature. The limits of detection and quantitation were 0.4 and 0.12µg/ml respectively. Validation parameters such as specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The method fulfilled the requirements for reliability and feasibility for application to the quantitative analysis of lenvatinib in bulk and pharmaceutical dosage forms.

Prenatal diagnosis employs a variety of techniques to determine the health of fetus. Without knowledge gained by prenatal diagnosis, there could be an untoward outcome for the fetus or the mother or both. There are a variety of non-invasive and invasive techniques available for prenatal diagnosis. Each of them can be applied only during specific time periods during the pregnancy for greatest utility. All current methods of fetal karyotyping are invasive and carry a definite, albeit small, procedure-related risk. Because of this and testing costs, only women older than 35 years who have a greater risk for fetal aneuploidy are currently offered prenatal testing. The isolation and analysis of fetal cells from maternal blood would allow non-invasive prenatal genetic screening and diagnosis. One method that is currently being explored involves culturing fetal cells. Developing conditions which allow the number of fetal-derived cells to expand in culture and the number of maternally derived cells to be suppressed in culture may lead to a new selection process for obtaining fetal cells. In this paper the isolation of fetal cells using magnetic cell sorter methods was discussed. It was found that 5000 cells were present in 28 million maternal cells.

  The purpose of the present study was to develop an optimized gastric floating extended release matrix tablet of Metformin hydrochloride (FERMTs) using a hydrophilic polymer, HPMC K4M, a hydrophobic polymer ethyl cellulose and sodium bicarbonate as buoyancy contributor. The formulation of FERMTs were designed by D-optimal mixture design taking % of HPMC K4M, ethyl cellulose and sodium bicarbonate as formulation variables and prepared by wet granulation method. The FERMTs were then evaluated for hardness, friability, weight variation, content uniformity, in vitro drug release and floating capacity. Finally, the floating lag time (FLT) and cumulative % drug release at 1h, 2h, 6h and 10h were taken as response variables and the FERMT formulation was numerically optimized by D-optimal mixture design using Design-Expert software (version 8.1). The optimized formula showed excellent floating efficiency over 10 h period with FLT of 9.61 mins. The release profile of optimized formula showed much closed similarity with that of USP reference dissolution profile (f2 value= 87.95). Analysis of dissolution data showed that the kinetic of drug release followed Korsemeyer-Peppas and Higuchi model.