Developping of biopolymer-hydrogel systems for controlled release of protein-based drugs

Protein drugs are increasingly becoming a very important part of therapeutic agents with the rapid advances in the field of biotechnology. The most challenging task in the development of protein pharmaceuticals is to deal with physical and chemical instabilities of proteins. Protein instability is one of the major reasons by which protein pharmaceuticals are administered traditionally through injection rather than taken orally like most small chemical drugs. Oral delivery is the most popular and convenient method for drug delivery. However, the gastrointestinal condition is not suitable for peptide and protein drugs because of acid catalyzed degradation in the stomach. Several approaches have been proposed to overcome these problems. One approach is to deliver the proteins to the colon. Colonic fluid is not acidic and contains relatively low levels of proteolytic enzymes capable of destroying the peptide and protein drugs. Hydrogels are three-dimensional, crosslinked networks of water-soluble polymers. Hydrogels can be formulated in a variety of physical forms, including slabs, films, coatings microparticlesand nanoparticles. As a result, hydrogels are commonly used in clinical practice and experimental medicine for a wide range of applications, including tissue engineering and regenerative medicine, cellular immobilization, diagnostics, separation of biomolecules or cells, and barrier materials to regulate biological adhesions. In this study, the release of protein based drugs which are taken via oral route were investigated. We aimed to develop a suitable carrier system for controlled delivery of protein drugs. For this purpose bovine serum albumin (BSA) was used as a model drug. BSA was encapculated into alginate composite beads and the studies were carried on with these beads. Swelling studies and the in vitro release of BSA in simulated body fluids were investigated. The morphology of beads were characterized by FTIR, SEM and TGA analysis.