U-Strip Insulin Delivery System: The U-Strip Drug Delivery System generates ultrasonic transmissions of variable intensity and frequency, which are pulsed through a modified transdermal patch, acting to kinetically motivate the drug contained within the patch. A unique design for a transducer system intended to be utilized in an active transdermal drug delivery system, powered by ultrasound was developed at Encapsulation Systems. The system postulated that a small, lightweight battery powered ultrasonic transducer could be attached to a transdermal patch and be used to enlarge the sweat and hair follicle pores of the skin. This pore enlargement process could enable large molecule drugs to be delivered transdermally.
The U-Strip Drug Delivery System generates ultrasonic transmissions of variable intensity and frequency, which are pulsed through a modified transdermal patch, acting to kinetically motivate the drug contained within the patch.
The transducer patch array generates an ultrasonic signal which serves to dilate the skin pores and increase the likelihood of absorption of the drug through the skin.
The U-Strip device can be programmed to deliver a prescribed amount of active pharmaceutical agents on a programmed drug delivery regimen, customized for each patient.
The portability of this drug delivery system is designed to improve the quality of life for many patients afflicted with chronic diseases requiring the constant delivery of therapeutic medicines.
“High Performance Liquid Chromatographic (HPLC) Analysis Of Ultrasound Treated Insulin Samples”
Ram B. Roy, PhD and Bruce K. Redding, Jr.
Encapsulation Systems, Inc., PO Box 759, Broomall, PA. 19008 USA
November 29, 2003 *
A unique design for a transducer system intended to be utilized in an active transdermal drug delivery system, powered by ultrasound was developed at Encapsulation Systems. The system postulated that a small, lightweight battery powered ultrasonic transducer could be attached to a transdermal patch and be used to enlarge the sweat and hair follicle pores of the skin. This pore enlargement process could enable large molecule drugs to be delivered transdermally where, normally, drugs above 1,000 Daltons were difficult to deliver transdermally. Critical to the functionality of the ultrasonic transdermal drug delivery system were the effects of ultrasound upon the insulin molecule. A number of experiments were conducted to examine the effect of low frequency ultrasound upon Humulin Reg. Insulin supplied by Eli Lilly Co. The objective of these experiments was to determine the stability of insulin when exposed to ultrasound.
Dermisonics Begins Next-Phase Clinical Trial of Proprietary Insulin Patch Drug-Delivery System for $5.4 Billion Insulin Market; New Human Pilot Trial to Test for Skin Sensitivity of Painless, Noninvasive U-Strip Insulin Patch
WEST CONSHOHOCKEN, Pa., Nov 16, 2005 (BUSINESS WIRE) — Dermisonics, Inc. (DMSI) (FWB: FQC), a developer of painless, injection-free, ultrasonic transdermal drug-delivery patches and technologies with broad pharmaceutical and consumer applications, today announced the launch of clinical trials to test for skin sensitivity to its U-Strip(TM) Insulin Patch on patients with Type-2 diabetes. The trials, an essential part of the clinical phase of Dermisonics’ transformative transdermal drug delivery method called the U-Strip(TM), is a precursor to the completion of Phase-1 Clinical Evaluations in the Company’s mission to commercialize the proprietary technology platform for the $5.4 billion insulin delivery marketplace.
This irritation study is an exciting step in the U-Strip(TM) clinical and regulatory development program, and we look forward to its successful completion," said Dermisonics CEO Bruce Haglund. "The patch design employed in the study is a versatile, truly unique and transformative system that can enable the pain-free, needle-free, ultrasonically improved delivery of insulin and more than 175 other large molecule drugs."
The trials received IRB approval from the Allendale Investigative Review Board in Allendale, NJ. These tests are intended to demonstrate that Dermisonics’ technology presents no adverse reactions or skin irritation when worn over a 5-hour period and will test the sensitivity of the patch on the skin of 25 Type-2 diabetic volunteers over a three-day test period.
Dermisonics’ innovative pain-free drug delivery technology positions the Company to help redefine the future of the $19 billion dollar drug delivery market with the possibility of improving the lives of about 55 million insulin-dependent diabetics worldwide who must endure needle injections or catheter-based insulin pumps for their required insulin regimens.
— About the Human Pilot Trial 3 (HPT-3) – The trials involve a small group of volunteers, Type-2 diabetes patients, who will undergo a medical test and evaluation on their first visit. That will be followed by a second visit in which the Company’s insulin patch, loaded with 150 units of Humalog (R) Insulin (Eli Lilly Co.), will be placed on the upper left arm of the subject and worn for five hours. On the third visit, the patch will be placed over the abdomen and also worn for a five-hour period. The patches will then be removed and examined for any degradation, and the skin will be studied for any sign of irritation over the testing period. The study will also focus on possible unique skin attributes of diabetics, who may have conditions unique to this disease. The Company’s goal is to demonstrate that the patch will pose no major irritation or discomfort to patients.
— About Diabetes Sufferers – When final regulatory approval has been obtained, the U-Strip(TM) Insulin Patch technology has the potential to improve the lives of both Type-1 and Type-2 diabetics. Approximately 55 million of the 185 million diabetics worldwide are insulin-dependent, and must endure painful needle injections to survive this debilitating disease.
About Dermisonics, Inc.
Dermisonics is an intellectual property company and advanced technology incubator that is primarily focused on the ongoing development, testing and eventual commercialization of drug-delivery patch systems designed to facilitate the efficient, painless and needle-free delivery of drugs with large molecular structures through the skin and into the bloodstream. Its breakthrough system, called the U-Strip, is based on a radical integration of microelectronics and ultrasonic science with a product-carrying patch, and represents a quantum leap in non-invasive, transdermal delivery technology. Tests have shown that this system facilitates the transdermal delivery of insulin as well as potentially at least 175 other existing drugs that at present cannot be effectively delivered through the pores of the skin using conventionally available transdermal technology due to their large molecular size. The Company has also developed other portable ultrasonic systems for applications in the medical (Antiseptic Wand) and skin care (U-Wand) fields. For more information visit http://www.Dermisonics.com