SBIR-STTR Award

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. PROPOSED COMMERCIAL APPLICATION: 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

Gels are difficult to accurately dispense. Dosing of liquid pharmaceuticals can be measured using a calibrated dropper, cup, or teaspoon. Gels are viscous liquids and cannot be accurately dispensed using these devices. Adjustable dose valves on a barrier type container accurately deliver gels in a volume of 0.5ml to 2.0ml and covers the dosages required by young children. Adult doses can be administered at the 2.0ml setting, where one or two doses are given. Medication can be dispensed directly from the container, or onto a teaspoon. The objective of the project is to finalize an albuterol gel which can be accurately dispensed from the barrier aerosol system. This will be accomplished by production of adjustable dose valves, determining physical, chemical and stability characteristics of albuterol gel; and determination of the in-vitro rate of release of albuterol from the gel matrix. Blood levels of albuterol gel in humans will be determined. As a means of administering medicinal gels, the adjustable dose aerosol system is the only system of its kind. A high potential for commercialization especially for pediatrics, children, and elderly, and for those not able to take tablets and capsules exists. PROPOSED COMMERCIAL APPLICATIONS: The Adjustable Metered Dose System has commercial potential as a means of administering both prescription and O-T-C medications in gel form. The dispenser offers an alternative to tablets, capsules and liquids. Medicinal gels, such as albuterol has the potential of increased and sustained bioavailibility. Potential markets include health care providers, the elderly, physically disab1ed children and adults who cannot swallow tablets and capsules.

Thesaurus Terms:
drug administration rate /duration, drug delivery system, gel, inhalation drug administration, self care, technology /technique development albuterol, dosage, pharmacokinetics, swallowing clinical research, human subject