International Journal of Pharmaceutical Sciences and Drug Research

71-77

Authors: David S. Cohen1, Henry Broeska2*

Multiple sclerosis (MS) is a chronic and oftentimes disabling disease of the central nervous system. It affects almost 1 million people living in the United States and about 2.5 million people globally. Though the cause is not fully understood, MS occurs through an inflammatory process in the brain. This inflammation results in the destruction of the myelin sheath surrounding the nerves that enable conduction of nerve impulses within the brain and spinal cord. To overcome symptoms, MS patients are usually prescribed disease modifying drug therapies or immunosuppressive drugs for prolonged periods resulting in only temporary clinical improvement. In a large subset of patients, disease progression is measured by the continuing deterioration of physical ability. One of the most reliable measures of disease progression in MS is gait performance. Previous studies have demonstrated that clinically significant gait deviations occur at all stages of MS that involve walking. This report describes a Phase I clinical trial of a novel targeted delivery technique, selectively placing autologous bone marrow mononuclear stem cells into the central vein of multiple sclerosis patients, with post-operative functional changes measured by gait performance. To determine the functional benefit of selective stem cell placement, the timed 25-foot walk was administered to 31 MS patients before and after therapy. The time and number of steps taken to complete the test significantly decreased post-intervention. Currently, disease-modifying and immunosuppressive drugs are the only approved treatments for MS. Comparative trials between disease-modifying and immunosuppressive drugs measure benefit as a slowing of multiple sclerosis manifestations, not an improvement. This trial demonstrated an immediate global improvement in the level of disability as measured by the timed 25-foot walk. This suggests that recovery of function in MS patients is possible. Where pharmaceutical agents only mitigate symptoms and potentially slow disease progression, selective stem cell placement of autologous bone marrow mononuclear stem cells should be considered as a possible treatment for MS due to measured improvement in post-therapy functional ability. Further research is required to validate our findings.

85-90

Authors: B. Anjaneyulu Reddy1*, P. Radhakrishnanand2, Md. Irshad Alam3, P. Ravi Kiran4

A reproducible stability-indicating Reverse Phase-HPLC technique for the quantification of Enzalutamide in in pharmaceuticals was developed and validated. Chromatography was done on Inertsil ODS-C18 5µm (250 mm × 4.6 mm) analytical column with acetonitrile: methanol: water in 40:30:30% v/v proportion as a mobile phase and 1 ml/min as a flow rate. Enzalutamide was detected at 237 nm UV-wavelength maximum. In the present work mobile phase used as diluents, developed technique was validated over 20-150µg/ml linear concentration range for Enzalutamide. This method established with linearity coefficient value of 0.99 and the percentage recovery was found to be 99.3%. This method was proven with LOD and LOQ findings of 0.53µg/ml and 1.61µg/ml respectively. The drug was degraded in acid and alkaline conditions and the percentage degradation values were 3.10 % and 4.54 % respectively. There was no degradation of drug when exposed to neutral, UV, thermal, sun-light and oxidative conditions. Drug was undergoing degradation when exposed to acid and alkaline conditions. The developed technique was useful in the routine quantitation of Enzalutamide.

98-104

Authors: Alok Shukla1, Mridula Sachan2, Papiya Bigoniya3*

Standardization of polyherbal formulations with respect to bioactive phytocompounds is the need of the time for registration and marketing authorization in developed countries. This has prompted to prepare and evaluate a standardized bioactive phyotcompounds containing formulation. The study aims at development and screening of a standardized antidiabetic suspension containing active isolated phytoconstituents targeting better therapeutic effect with reduced bioburden. Suspension of isolated gymnemic acid and curcumin (GCS) was prepared, evaluated and authenticated by TLC and HPTLC. Antidiabetic efficacy of GCS was screened against alloxan induced diabetes on rats following 28 days of treatment comparative to Hyponidd tablet and Madhumehari granules. Body weight, relative organ weight, blood glucose, cholesterol (TC), triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL) and very low density lipoprotein (VLDL) level was measured. The formulation having pH 6.0, refractive index 1.41 and 45.58 mg/ml total solid content showed high alcohol and water soluble extractive value. The GCS treatment normalized liver and kidney weight, decreased body weight gain, TC, TG, LDL and VLDL level along with an increase in HDL level. Study outcome signifies similar antidiabetic potential of standardized formulation GCS compared to marketed Polyherbal formulation with antihyperlipidemic activity signifying as a promising natural and safe remedy for the prevention of diabetic complications.