1.1 PROTEIN PHARMACEUTICALS – AN OVERVIEW
The biotechnology revolution has produced novel peptides and proteins as they hold greatpromise as therapeutic agents.
More than 200 FDA approved protein drugs are in the market and 500 more areundergoing clinical trials. About one-third of drug candidates in clinical trials arepolypeptides.
1.2 PROTEIN PHARMACEUTICALS – PROBLEMS
Isolation and purification of Protein Pharmaceuticals is very difficult. But these issues aresolved with the advances in genetic engineering
Storage and hence the issue of stability is again a major problem of proteinpharmaceuticals. It could be achieved by appropriate formulation and applying properstorage conditions viz. refrigeration, etc.
Delivery to the target site is one of the major problems which the proteins are facing tilltoday, and many different approaches were tried but no technology has sufficed to fullextent.
1.3 PROTEIN DELIVERY TO THE TARGET SITE – SHORTCOMINGS
Protein drugs are:
Susceptible to destruction by proteolytic enzymes
Short circulating half-life
Short shelf life
Rapid kidney clearance
Propensity to generate antibodies
1.4 ATTEMPTS TO IMPROVE CLINICAL PROPERTIES ….
Scientists have searched for years to overcome the problems associated with protein delivery.Initial approaches tried were:
of amino-acid sequences to reduce degradation by enzymes and antigenic side-effects
them to immuno-globulins or albumin to improve half-life
in insoluble matrices
Incorporating them into the drug delivery vehicles such as
to prolong action