The invention provides a means for a novel drug delivery method utilizing dendrimers as a quantitative and controlled mechanism of delivery. More specifically, the invention uses biocompatible linkers with biodegradable bonding such that drug molecules can be incorporated into a dendritic structure to form a dendritic drug that consists of a known amount of drug molecules. Conceivably, each layer of the cascade structure of the dendrimer is designed to contain a known amount of drug, with the largest amount at the periphery and the least amount at the core of the dendrimer. The dendrimer delivery platform appears to be very flexible as there are many classes of drugs that could possibly be delivered through this way. These include anti-fungals, anti-inflammatory agents, anticancer drugs, anti bacterials and a number of others. Moreover, the delivery method may be delivery mode agnostic as the platform could possibly be designed to be administered orally, rectally, or parenterally, by intravenous, intramuscular, intraperitoneal, intraspinal, intracranial, topical, ocular, and subcutaneous routes. While the platform is currently being validated for the delivery of small molecules, there may be particular interest in the potential for this delivery mechanism to deliver peptide based pharmaceutical agents. The chemical synthesis of the dendrimer delivery platform involves a series of protection and deprotection steps and the most suitable drug candidates for this delivery platform are drugs that contain functional groups that are unreactive in the synthetic scheme. For example, drugs having one or two functional groups capable of providing a starting point for the preparation of the dendritic molecule would be ideally suited for this platform. In addition, multifunctional drugs that have bi-functionality or tri-functionality are preferred, but the technology is not limited to those functionalities. Ultimately, drugs that provide a starting point for the preparation of a dendritic molecule are those groups in the therapeutically active material that are susceptible to reaction and that are part of the generic make up of the drug. In these cases, the reactive functional groups are protected before the preparation of the dendritic drug has begun, to avoid undesired reactions. The protection step also provides a means for retaining the necessary groups of the drug that make it effective. While the technology is in its early phases of development, the focus has been on validating the concept through incorporating known drugs into the platform such as aspirin and L-Dopa. In addition to the novel delivery potential with pharmaceutical agents in various stages of development currently, this technology could potentially offer a novel way to reinvigorate existing drug markets by offering a way to reformulate and reintroduce drugs that are headed toward patent expiry.

File Number: 2006-01