Abstract

Recent advances in biotechnology allow the selection and the preparation of novel macromolecular compounds such as peptides, proteins and DNA analogs (produced by Hybridoma cell technology and Recombinant DNA technology) to be used as drugs (e.g., hormones, monoclonal antibodies, vaccines) for therapeutic purposes. Such compounds show powerful and selective therapeutic activity, but unfortunately they must often be dropped at some development stage, because of their high enzymatic susceptibility, short shelf life or unsuitable efficacy after the administration to the patient, owing to immunogenic reactions or poor bioavailability. A number of approaches have been used to overcome these limitations. As these therapeutic proteins and peptides are made available, it will be essential to formulate these drugs into safe and effective delivery systems. Due to its wider applications in pharmaceutical industries, they will replace many existing organic based pharmaceuticals. Now days, many drugs are in the world market, while several hundred are in clinical trials. This article reviews the various problems associated and novel approaches for formulation and development of oral protein and peptide drug delivery systems.

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