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Changing Patterns in Drug Delivery

For decades, the predominant delivery method [[wysiwyg_imageupload:157:]]
for pharmaceutical products has been oral tablets, capsules or liquids, with the fewer, less complicated doses a day the better. 

If a new medication was introduced requiring four doses a day, competitors would strive to develop a drug requiring three or two or even only one dose a day.  If it could be taken any time of day with or without food or other drugs it was even better.  Fewer daily doses were invariably said to improve compliance because there were fewer doses to miss.  It should be noted, though, that these were “small molecule” drugs – ones developed using chemistry that either because of their own properties or through formulation manipulation could be absorbed through the digestive tract into the body.  Not surprisingly, according to a recent article in Drug Development and Delivery, of the medications currently available in the United States, 7,468 are oral and less than 3,000 are injectable.  (Topical, ophthalmic and other routes are far less prevalent.) 

This pattern, however, is shifting, with injectable drugs in companies’ pipelines outnumbering oral dosage forms 3,327 to 2,686. 

Why the change?  In large part, this is being driven by an increase in “druggable” targets resulting from greater insight into diseases such as cancer, inflammatory bowel disease, rheumatoid arthritis, hepatitis C and other infectious diseases and neurological diseases such as multiple sclerosis.  As the targets become better defined, the drugs designed to interact with them are increasingly proteins, which are generally large molecules that cannot pass through the digestive tract intact and are therefore more likely injectables.  Optimizing these drugs centers on developing formulations that require the fewest dosages and tailoring the injection/adminstration device to be as targeted and patient-friendly as possible.

For medical communicators, the evolving pharmaceutical pipeline presents challenges as well.  More information has to be conveyed about these new drugs than in the past.  Not too long ago, package inserts for drugs could dismiss how the drug worked as “The mechanism of [action]…. has not been established.”  Increasingly, the mechanism of action is known in exquisite detail, leaving the writing challenge of how much to convey without being simplistic or getting bogged down in an esoteric discussion of genomics.