Pharmaceutical Technology is pleased to recognize the winners of its Innovations in Pharma Science Awards. These awards honor achievements in drug delivery, formulation, dosage-form manufacturing, pharmaceutical analysis, and the synthesis and manufacturing of active ingredients. We received 20 nominations, based on original research or already published work, from companies around the world. Fourteen members of our Editorial Advisory Board reviewed the nominations to determine the winners, showcased here.
Orally therapeutic proteins
Created by Lila Drittanti, Fernanda Sanchez, Thierry Guyon, Sophie Guillier, Mathilde Breton, and Manuel VegaNautilus Biotech SA (Evry, France)
The proteins can be administered orally in the form of a lyophilized powder, which can be filled into gastro-resistant capsules or used to make tablets. Nautilus developed a product pipeline around this innovation since 2002 that includes two orally available versions of Belerofon, a novel form of interferon alpha, and Vitatropin, a single point mutation of native human growth hormone. Both are designed for higher resistance to proteolysis in blood and other tissues. Nautilus is exploring additional routes of delivery (sublingual, buccal, and nasal).
Nautilus' protease–resistant proteins are intrinsically bioavailable when delivered orally, thereby providing for better patient compliance. The US Food and Drug Administration approved the company's investigational new drug application (IND) for the oral administration of Belerofon in a Phase I clinical trial; an IND for Vitatropin is underway.
Intravail macromolecular absorption enhancers
Created by Dennis J. Pillion and Eli Meezan
Pharmacology & Toxicology, University of Alabama (Birmingham, AL) & Aegis Therapeutics (San Diego, CA)
Intravail excipients also provide controlled transient permeation of the mucosal barrier by both the paracellular and transcellular routes. In intranasal administration, they speed onset of action. Nasal delivery also circumvents "first-pass" metabolism in the liver. The technology has been demonstrated to work in human and animal studies with more than 20 drugs. Intravail formulations can be administered using off-the-shelf metered nasal spray pumps.