Temperature influencing permeation pattern of alfuzosin: an investigation using DoE.

BACKGROUND AND OBJECTIVE: There has been relatively little investigation of the effect of temperature on skin permeation compared to other methods of penetration enhancement. A principal physicochemical factor which controls the passive diffusion of a solute from a vehicle into the skin arises from the skin temperature. The aim of this ex vivo study was to probe into the effect of heat on transdermal absorption of alfuzosin hydrochloride from ethyl cellulose-polyvinyl pyrrolidone (EC-PVP) based transdermal systems. MATERIALS AND METHODS: Principles of design of experiment (DoE) were used to systematically study the influence of temperature on transdermal permeation of alfuzosin. Ex vivo transdermal permeation studies were carried out at varied donor compartment temperatures. Permeation data analysis was carried out and activation energy for transdermal permeation was estimated. RESULTS: Temperature found to enhance ex vivo permeation parameters of alfuzosin hydrochloride from its transdermal systems. It was also noted that chemical permeation enhancers potentiate permeation enhancing effect of temperature. The permeation flux values approximately doubled after exposure to 45°C. The activation energy for transdermal permeation was found lower for the runs with chemical permeation enhancers indicating existence of a lower energy barrier in the presence of chemical permeation enhancers. CONCLUSION: The method reported here is a simple and useful tool for studying the effect of heat on percutaneous absorption. Such temperature dependent enhancement of flux can be more pronounced at skin surface temperatures >45°C.

Adverse events following pediatric immunization in an Indian city

Purpose@#Adverse effects are noticeable immediately after vaccination, especially when vaccinated to healthy people at the time of vaccination. The vaccine may cause adverse events which are very rare but adverse event following immunization surveillance becomes correspondingly more important in a less studied population like India. Hence, there is a need for carrying out a study pertaining to vaccine safety in the pediatric population of age 0–12 years and assessing the events occurring post-vaccination. @*Materials and Methods@#A prospective observational study was conducted in three primary healthcare centers and two tertiary care hospitals for 6 months from April 2016 to September 2016 with a total of 826 children enrolled. Detected adverse events for suspected vaccines were analyzed for causality by the World Health Organization causality assessment instrument. Sex-specific differences in incidences of adverse events were assessed. @*Results@#The cumulative adverse events were found highest in pentavalent vaccines (510 incidences, 62.04%) followed by the bacillus Calmette-Guérin vaccine (189 incidences, 22.99%). The study didn’t reveal any significant association in incidences of adverse events following immunization and sex of the children. @*Conclusion@#Vaccine safety surveillance studies are need of the hour in developing countries to maintain public trust in vaccines, the ultimate objective being to have vaccines with the most favorable benefit-risk profile. The present study discussed the various adverse events following immunization and suggested the absence of any sex-specific difference in incidences of adverse events in children.