Statistical assurance of process validation by analytical method development and validation for efavirenz tablets and blend.

A new simple, rapid and reliable UV Spectrophotometry method was developed and validated for the estimation of Efavirenz in blend & Tablets formulations. The method was based on simple UV estimation in cost effective manner for regular laboratory analysis. The instrument used was Perkin Elmer, UV Spectrophotometer (Lambda 25) and using 0.1 N NaoH as solvent system. Sample were analysed using UV Win Lab 5.2.0 Software and matched quartz cells 1 cm and was monitored at 302 nm. Linearity was obtained in the concentration range of 2 - 10 mg mL–1 for Efavirenz. The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. Spectrophotometric interferences from the Tablets excipients were not found. The results of blend uniformity and content uniformity, done on process validation batches samples.

Design and evaluation of levofloxacin hemihydrate floating tablets.

In the present study, the tablets were prepared by melt granulation method, using the polymer, hydroxy propyl methyl cellulose (HPMC K100M) with different amounts and other excipients and sodium bicarbonate as gas generating agent. The present study is to develop a floatable drug delivery system of Levofloxacin hemihydrate for sustained drug delivery and gastric retentive property with special emphasis on optimization of formulations for floating matrix tablets. Thus the study aims to improve the oral bioavailability of the drug and to achieve extended retention in the stomach which may result in prolonged absorption. Tablets were evaluated by different parameters such as weight uniformity, content uniformity, thickness, hardness, IR spectral analysis, in vitro release studies, Buoyancy determination and kinetic analysis of dissolution data, stability studies Levofloxacin floating tablet drug delivery system showed improved in-vitro bioavailability and extended drug release which may favour the reduced dose frequency and patient compliance.

Preparation and evaluation of ofloxacin microspheres using natural gelatin polymer.

In the present study, gelatin microspheres containing ofloxacin were prepared by coacervation phase separation method and characterized by optical microscopy and scanning electron microscopy. The microspheres were analyzed for drug entrapment, bulk density, angle of repose, particle size and In-vitro release pattern. The effect of process variables on microsphere size was studied and based on these preliminary studies, different batches of microspheres were prepared by altering the drug: polymer ratio and cross-linking with glutaraldehyde. The size of microspheres was in range of 42- 45μm. They were spherical in shape as evidenced by photomicrographs and scanning electron microscopy. The percent drug entrapment was in the range of 78-90 % and they could sustain drug release over a period of 8 hrs.

Studies on rapid assessment methods in leprosy.

A study was undertaken in Pudukottai district, Tamilnadu, India to test rapid assessment methods: viz (i) sample surveys with lower coverages for clinical examination in estimating the disease problem in the community, (ii) utility of registered case prevalence for estimating the actual prevalence in a given area, (iii) leprosy in school-going children and its utility in estimating leprosy prevalence in the community, and (iv) information on disability and smear positivity in estimating leprosy prevalence; and develop correction factors for estimating leprosy situation. A sample of 23 clusters from 582 clusters of contiguous villages and hamlets was further divided into two random sub-samples for two surveys with differing coverages. One team covered nine clusters comprising 34 villages with a population of 17,562 and examined 15,596 with a population of 26,927 and examined 16,622 (62%) persons for leprosy. The results showed that: (i) leprosy sample surveys with lowered coverages would tend to miss valuable information, in terms of quality and quantity; (ii) from 'known case' registers, to estimate the true burden of leprosy disease and to monitor its trend over time is inadequate; (iii) school surveys are of limited value for estimating the disease burden in the community or to monitor its trend over time; (iv) the number of smear-positive cases is to small to serve as an indicator for the total case load in the community; and (v) the prevalence of active disease and that of grade 2 disability in the community are poorly correlated. Reliable methods other than those used here need to be developed for evaluation and monitoring of the disease burden particularly in the post-MDT era.