The most common route of administration of proteins has been parenterals using invasive ways of administration but this route has many side effects like lack of patient compliance, cost, high drug levels etc. The development of an oral dosage form that improves the absorption of protein drugs is the most desirable formulation but one of the greatest challenges in the pharmaceutical field. The major barriers in developing oral formulations for peptides and proteins include poor intrinsic permeability, luminal and cellular enzymatic degradation and chemical and conformational stability. A number of innovative oral drug delivery approaches have been recently developed, including the drug entrapment within polymer nanoparticles. The various advantages of oral delivery of proteins are like ease of administration, can be used as cure in primary stages of disease eg. Thrombosis, no internal bleeding, patient compliance and economical Our formulation development approach is to develop the formulations targeted to bypass the stomach with an aim to release the drug in the intestine; with extended residence time in the GIT and for this polymer like Chitosan is used. To improve the lipophillic property of chitosan, to modify biodegradation pattern of polymer and for oral delivery of proteins (Insulin and serratiopeptidase), modification is done using lactic-acid and polyethyleneglycol by copolymerization.
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