Delivery of biopharmaceuticals

An important issue that must be addressed during the preclinical phase of the drug development process relates to the route by which the drug will be delivered/administered. To date, the vast majority of biopharmaceuticals approved for general medical use are administered by direct injection (i.e. parenterally) usually by intravenous (i.v.), subcutaneous (s.c., i.e. directly under the skin) or intramuscular (i.m., i.e. into muscle tissue) routes. Administration via the s.c. or i.m. route is generally followed by slow release of the drug from its depot site into the bloodstream. Amongst the few exceptions to this parenteral route are the enzyme DNase, used to treat cystic fibrosis (Chapter 12), and platelet-derived growth factor (PDGF), used to treat certain skin ulcers (Chapter 10). However, neither of these products is required to reach the bloodstream in order to achieve its therapeutic effect. In fact, in each case the delivery system delivers the biopharmaceutical directly to its site of action (DNase is delivered directly to the lungs via aerosol inhalation, and PDGF is applied topically, i.e. directly on the ulcer surface, as a gel).

Parenteral administration is not perceived as a problem in the context of drugs which are administered infrequently, or as a once-off dose to a patient. However, in the case of products administered frequently/daily (e.g. insulin to diabetics), non-parenteral delivery routes would be preferred. Such routes would be more convenient, less invasive, less painful and generally would achieve better patient compliance. Alternative potential delivery routes include oral, nasal, transmucosal, transdermal or pulmonary routes. Although such routes have proven possible in the context of many drugs, routine administration of biopharmaceuticals by such means has proven to be technically challenging. Obstacles encountered include their high molecular mass, their susceptibility to enzymatic inactivation and their potential to aggregate.

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