.) Oral pharmaceuticals currently are not delivered in gel form because doses cannot be accurately measured by pouring a gel into a calibrated cup or a spoon. However, an aerosol dispenser recently invented by the principal investigator for this project, Dr. James Martin, appears to offer potential as a means for orally administering incremental, metered doses of gel medication. J. H. Martin, Inc., the applicant organization, owns the patent rights to this dispenser. The objective of the proposed Phase I study is to evaluate the feasibility of the Martin adjustable dose dispenser for dispensing medicinal gel. The work plan calls for formulating a prototype medicinal gel and then testing and assessing the mechanical action, physical and chemical compatibility, and stability of the Martin dispenser in conjunction with the gel. Dr. Martin will administer the project and evaluate the research findings to determine the dispenser's feasibility. Laboratory research will be performed, on a contractual basis, by John J. Sciarra, PhD, of Sciarra Laboratories, Inc. As a means of easily and accurately administering medicinal gels, the Martin dispenser has high commercial potential among groups that have difficulty accepting or using liquids or tablets, such as the elderly, children, and the disabled.
There are two areas of considerable commercial potential, namely 1) the Martin valve alone, and 2) a pharmaceutical gel dispenser using the Martin valve system. Successful completion of Phase I investigations would strengthen both potentials. There is already interest in the valve technology by pharmaceutical companies; the principal investigator has already completed one project and is involved in other negotiations. Strong argument was made for the gel dispenser's potential for over-the-counter drugs, veterinary applications, and, coupled with a device to indicate usage, a suitable means to ensure medication compliance. While several hurdles will have to be overcome beyond Phase I investigations before this product can mature (such as parallel development in medical gel technology, cost containment, FDA approval), the commercial potential of this device seems considerable.
