FDA has posted a premarket notification for Huperzine A as a new dietary supplement product in 1999. Huperzine A is a natural alkaloid compound isolated from the Chinese club moss, Huperzia Serrata, which has been used in traditional Chinese medicine for years to enhance focus, memory and concentration. It is orally administered two to three times per day. The objective of this proposal is to develop a Once-a-week Huperzine A transdermal delivery system for Alzheimer's disease. Based on the physicochemical and pharmacokinetic profiles of Huperzine A, it may be feasible to develop a transdermal matrix system. The scope of this proposal ranges from concept development to determination of technical feasibility and optimal transdermal formulation. A matrix system will be evaluated and the formulations will be selected based on in vitro skin permeation studies through human cadaver skin. The preliminary physical and chemical stability studies will also be evaluated. We expect this transdermal patch with a natural cholinesterase inhibitor will improve patient compliance as well as the efficacy.
Alzheimer's disease, which affects an estimated 4 million Americans is a progressive condition affecting memory, judgement and the ability to reason. The need for a 7-day patch will be immense since this product will improve the quality of life for both patients and caregivers. There is a large market potential for the proposed transdermal patch.
