Radhika S

Neurodegenerative disorders are conditions in which cells of the brain and/or spinal cord degenerate.  The brain and spinal cord are composed of neurons with different functions such as controlling skilled movements, processing sensory information, storage of information and making decisions. Cells of the brain and spinal cord do not usually regenerate, so damage to the nervous system can be devastating. Normally, the neurodegenerative process begins long before any symptoms appear. Neurodegenerative diseases result from deterioration of neurons or their myelin sheaths which over time will lead to dysfunction and disabilities. Neuro-degenerative diseases markedly affect the lives of millions and lead to a growing public health challenge with increased costs for individuals and society. The prevention and treatment of these neurodegenerative disorders represent a critical goal of medical research today. Most of these disorders increase with age. Today, there are 25 million suffering from dementia and it is generally believed that the prevalence will be 130 million demented persons by 2050. As the human outer skin proved it to be the largest organ of sense of body, that can be potentially used for the delivery of multiple therapy for the successful management of neurobehavioral disorders. Various novel approaches can be introduced for which further study is essential .The focus on this route has not been in limelight till yet. Transdermal drug delivery is helpful for topical and local action of the drug. . For the patients who have difficulties swallowing solids or liquids, a transdermal drug delivery may offer great advantages over conventional delivery methods. Drug delivery directly to the brain interstitium has recently been markedly enhanced through the rational design of polymer-based drug delivery system. After the oral administration of drugs, the huge variations were associated in plasma levels with regular gastintestinal symptoms including nausea, vomiting, diarrhea, constipation, anorexia, abdominal pain and abdominal distention. This drug administration route could therefore allow optimal therapeutic dose, potentially further improving the effectiveness of treatment. The transdermal delivery bypasses the first past metabolism and lesser side effects. This route may be explored for the delivery of nano-sized pharmaceuticals to the CNS as an alternate route.

Simple, accurate and precise and economical UV–spectroscopy method have been developed and validated for the estimation of Tadalafil and Fluoxetine HCl in a synthetic mixture. Tadalafil is used in treatment of Erectile Dysfunction and Fluoxetine HCl is used in depression. The Tadalafil and Fluoxetine HCl stock solutions are prepared in methanol solution. At zero crossing point (ZCP) of Tadalafil (230nm) Fluoxetine HCl showed a measurable derivative absorbance, whereas at zero crossing point (ZCP) of Fluoxetine HCl (235nm) Tadalafil showed a appreciable derivative absorbance value. The Tadalafil and Fluoxetine HCl are linear in concentration range of 5-25 μg/ml. Developed method was validated according to the ICH Q2 (R1) guidelines. The precision were found within limits (RSD< 2%). Accuracy were determined by recovery studies and showed % recovery between 97 to 100 % for both the drugs Tadalafil and Fluoxetine HCl. The LOD and LOQ values of Tadalafil at ZCP 230 nm were found to be 0.24 and 0.74 correspondingly and for Fluoxetine HCl at ZCP235nm were found to be 0.29 and 0.89 correspondingly.

To compare the bioavailability of two tablet formulations of Balofloxacin 100 mg in adult, male, healthy human subjects under fasting conditions.The study was conducted as an open label, balanced, randomized, two-period, two-sequence, two treatment, single dose cross over study to determine the bioequivalence of two tablet formulations of Balofloxacin 100 mg in 24 healthy, adult, male, human subjects under fasting conditions. Serial blood samples were collected at 0, 0.5, 1.0, 1.50, 2.0, 2.50, 2.75, 3.0, 3.25, 3.50, 3.75, 4.0, 4.50, 4.75, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0h during each study period. A washout period of 7 days was given between two study periods. 90% confidence interval(CI) for the ratio of logarithmic transformed pharmacokinetic parameters Cmax, Tmax, AUC0-t and AUC 0- ∞ were used to determine bioequivalence. The data of 23 subjects was analyzed in the study. Tmax (hrs),  Cmax (µg/ml),  AUC 0-t  and AUC0-∞ (µg.h/ml) for test formulation were 1.174±0.535 , 852.431±361.274, 4682.785±1616.552 and 5375.882±1727.286 and that of reference formulation were 1.033±0.428, 850.238±312.422, 4447.628±1240.125 and 5125.723±1304.619 respectively. The 90% CI for the T/R ratios of  log transformed  Cmax, AUC0-t and  AUC 0-∞ were 89.58%-108.19%, 98.86%-109.88% and 97.70%-110.01% respectively. The two tablet formulations of Balofloxacin 100mg (both test and reference) met the  requisite bioequivalence criteria (80-125%) .