Characterization and evaluation of novel film forming polymer for drug delivery.

Abstract

DB is a whitish to yellowish resin, characterized initially in terms of solubility, acid value, molecular weight (Mw), polydispersity index (Mw/Mn) and glass transition temperature (Tg). Neat plasticized films of DB (Damar Batu) are investigated for mechanical, water vapor transmission and moisture absorption properties. To improve the mechanical properties of the free films dibutyl sebacate, a hydrophobic plasticizer was added to film composition. The biomaterial was further investigated for sustaining the drug release from spherical units (multiparticulates). The core of pellet was prepared using Diclofenac sodium (10% w/w) as a model drug by extrusion and speronization. The drug containing pellets were coated using DB plasticized film-coating solutions. With 2% coat build-up, sustained drug release up to 10 h was achieved with coating solution containing 20% and 30% w/w (based on DB weight) plasticizers. Less than 3% drug was released in the first 2 h which may be explained in terms of the insolubility of DB and the drug in acidic milieu. The release from pellets coated using DB film coating solution containing 20% and 30% plasticizers followed first order release pattern. DB seems to be a promising film former for pharmaceutical coating due to its reasonably good mechanical properties, low water vapor transmission and sustained release capability.