The elements of quality by design are examined and a consistent nomenclature for quality by design, critcal quality atribute, critcal proces parameter, critcal material atribute, and control strategy is proposed. A proces is wel understod when al critcal sources of variabilty are identified and explained, variabilty is managed by the proces, and product quality atributes can be acurately and reliably predicted over the design space. Quality by Design (QbD) is a systematic aproach to development of products and proceses that begins with predefined objectives and emphasizes product and proces understanding and proces control based on sound science, statistical methods and quality risk management. In an atempt to curb rising development costs and regulatory bariers to inovation and creativity, the FDA and ICH have recently started promoting QbD in the pharmaceutical industry [1, 3, 7,]. QbD is partialy based on the aplication of multivariate statistical methods [2, 4, 6] and a statistical Design of Experiments strategy [4, 5, 6] to the development of both analytical methods and pharmaceutical formulations. The talk will review the basics of QbD with case studies from the pharmaceutical industry

Drug delivery systems have become important tols for the specific delivery of a large Number of drug molecules. Liposomes are microparticulate lipoidal vesicles which are under extensive investigation as drug cariers for improving the delivery of herapeutic agents. Initaly they were used to study biomembrane behavior but later on developed into a drug delivery system for targeting specific sites of action like the tumor targeting, gene and antisense therapy, genetic vacination, immunomodulation, topical, cytosolic, and respiratory various infections etc.

The conventional drug delivery system for colonic disease may leads to absorption of drug acros biological membrane of gastrointestinal tract (GIT). The absorption of drug throughout GIT may leads to increase in dose and asociated side effects. Colon targeted drug delivery (CTDD) is a method of delivering medication to a patient in a maner that increases concentration of the medication in colon relative to other part of GIT. The aim of CTDD is to prolong, localize, target and have protected drug interaction to diseased tisue. The present review deals with primary as wel as recent aproaches of delivery of drug to colon.

The present research work was carried out to develop novel drug delivery system i.e. temperature-sensitve gel containing propolis for mastitis. Mastitis is an inflammatory disease of mammary gland caused by bacteria, especially Staphylococcus aureus and its toxins. For this study, propolis was used as a drug or active agent o defeat he side effects asociated with an antibiotic treatment and pluronic F127 (poloxamer 407) was used a geling agent. Polymer solution was prepared by cold method and on the basis of gelation temperature and viscosity of polymer gel thre batches having polymer concentration 18%, 19% and 20% were optimized and selected. Drug extract solution was then added in three optimized batches of polymer solution and final formulation was developed. After aditon of solution containing drug extract in polymer solution, final formulation was studied for various parameters and it was found that gel forming abilty of polymer solution was unaltered. Even after sterilzation, the gel forming abilty of formulation was unchanged which helped to select suitable method of sterilzation for developed formulation. On the basis of data colected from various evaluation parameters, it was found that developed formulation ofered a suitable and novel vehicle for drug delivery.