ABSTRACT

Evaluation of Freezing Effect on Stability of Large Volume Parenteral Products Parenteral formulations, applied to the one or multilamellar layers of skin and blood vessels, are sterile pharmaceutical dosage forms. In the field of pharmaceutical technology, production of parenteral preparations needs special area, application and care. However in all steps beginning from production to the consumption including processing and current conditions the stability of parenteral products are very important. Drugs in their shelf life period and until used by patients must be effective and safe. Stability studies are the sum of planned and systematic efforts made for determination of shelf life, appropriate packaging material and required storage conditions until - it reaches the patient care. The stability studies related with parenteral preparations are very rare and limited with a few active ingredients. It is very important that the safe usage of parenteral products which expose to different climatic conditions, possible stability changes and their reversibility especially after freezing.

The main purpose of this study is to inspect and investigate the stability of parenteral preparations exposed to especAccording to our study, it has been found that large volume parenteral products can be use safely in the treatement after agitation until a homogene mixture occurs following freezing, storage in controlled room temprature (25 C) and 40 C in an incubator. Thus, it should been carried out the similar stability studies for all parenteral solutions and the effects of freeze-thaw conditions on the products should be considered during the treatment.ially lower freezing temperatures in a wide variety of geographic and climate conditions.