INVESTIGATION ON INFLUENCE OF VARIOUS CURING CONDITIONS FOR DEVELOPMENT OF SUSTAINED RELEASED PELLETS FOR GASTRO PRO-KINETIC AGENT

Abstract

The aim of this study is to better understand the effect of the curing conditions on the resulting drug release pattern from pellets coated with aqueous polymer dispersions. Nowadays, Industrialists are facing various difficulties while performing curing step on Multi Particulate Drug Delivery System such as Pellets, Mini-Tablets, etc. Accelerated curing conditions also effect on the release behaviour of the drug coated with polymer and plasticizer. Harsh curing conditions improved the storage stability of polymer coated pellets. Such changes in release profile of dosage form with curing are shown due to loss of plasticizer molecules, leading to the formation of molecular scale voids and channels. During curing, it is found that time and temperature are effecting significantly on dissolution profile. Furthermore, it is shown that the type of plasticizer has a major effect on drug release in not completely coalesced and equilibrated film coating. In not flatteringly coalesced films, polymer particle fusion can continue during storage, resulting in less permeable film coatings and decreasing drug release rates. It is often difficult to assure complete film formation during coating. This is why generally a thermal posttreatment (curing) is required to enhance the degree of polymer particle coalescence. Critical parameters in this processing step include the temperature, elative humidity, and time, which need to be optimized. With increasing temperature, the mobility of the macromolecules increases, facilitating polymer particle coalescence which leads to film formation on outer surface of pellets.