By Eric S. Gruff

[This Expert Opinion is a response to Frank Chrzanowski’s March 22 column, How Long Before We Run Out of Ideas? Click here to read that Expert Opinion.]

I certainly agree with much that Frank had to say. If you look at novel drug delivery mechanisms in the context of only time-release, there is not a tremendous amount that still can be done. However, if you consider that modified release delivery systems can play a larger role, then we have not even scratched the surface. For instance, delivery systems that could detect the presence of certain other drugs (e.g., opiates), and release/fail to release a therapeutic in the undesirable situation to prevent dangerous interactions. You can imagine how useful it would be to have systems that would only release a drug in the event that a particular metabolic enzyme isoform were present (e.g., in the liver) to prevent overdosage in non-metabolizers. A version of this would be a system that would release a portion of a dose in all cases, and a higher dose when a metabolizing enzyme is present. In this fashion, you could tailor doses to individual genetic populations. You can take this further to imagine systems where drug is released/withheld in the presence or absence of certain genes, proteins, etc. For antibiotics, a system that responded to the quantity of bacteria present might alleviate the current fear of creating additional drug-resistant strains.

There are many more situations that cry out for specialty delivery systems. Some are technically feasible today, and many are not. Companies that look to future needs will thrive as other “me-too” providers will abandon the field due to saturation and generic competition.

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Eric S. Gruff, Ph.D., MBA, is the founder of Poway, CA-based E4 Pharmaceutical Consulting. He can be reached at eric@E4consult.com and tel: 858-735-0320. E4 can be found online at www.e4consult.com.