Avraham Domb, PhD, Department of Pharmaceutical Chemistry, School of Pharmacy, The Hebrew University of Jerusalem; Joseph Frucht-Perry, MD, Department of Ophthalmology, and Marvin Shapiro, MD, Department of Clinical Microbiology, Hadassah University Hospital.
Background
Iontophoresis is a non-invasive method which allows penetration of high concentrations of ionized molecules into tissue with the help of electric current. Iontophoresis using solutions or hydro gel-loaded membranes have been used in humans for transdermal and dermal drug delivery. In ophthalmology high doses of various antibiotics were introduced into the ocular tissues of animals with the help of iontophoresis.
The major limitations of the iontophoresis system include the inability to control the delivery of the drugs in a solution form into the desired tissue, spilloff of the iontophoresis drug solution, and the intolerance of the patients to a current of more than 1 mAmp for more than 2 min (skin iontophoresis requires a current of >1 mAmp for 30 min).
An efficacious and reproducible iontophoresis delivery system is of importance for treating and preventing ocular infections and other chronic and acute diseases of the eye.
Market
The device is intended to replace the use of postoperative traumatic injections of antibiotics and may replace the intolerable hourly applications of the antibiotics needed to achieve reasonable concentrations of the drugs in the corneal tissue in cases of microbial/fungal keratitis. It may also be important for intraocular delivery of high concentrations of other medications such as anti-inflammatory and antiglaucoma drugs when required.
The primary disease to be treated is Microbial Keratitis (MK) which may cause visual acuity loss and in some cases even leads to blindness. The intensive use of contact lenses in the last decade (25 million only in the USA) increased the incidence of Pseudomonas Aeriginosa-related MK.
The Innovation
The proposed product is a portable, easy to use, short duration iontophoretic device that ejects a high content of anionic or cationic molecules (i.e. a drug) from a soft gel upon application of a low current of <1mAmp for less than 120 seconds.
The iontophoretic device is a portable device that can be operated by battery or connected to an electric source. The preferred device is a pen size, battery operated probe with a variable current (micro Amp) for pre-set periods less than 120 seconds. The edge of the device has a conical or cylindrical hole for the insertion of the drug-loaded hydro gel disc and the estimated size is 15x4 cm. The cylindrical site can be replaced by different size and shape discs for the different applications (to be supplied as a package of 10-20 disposable cylindrical disks).
The main advantages of the device are:
- Efficient and elegant delivery system
- Delivers large amounts of the drug into the tissues
- Short time to use (seconds)
- Safe and easy to handle
- Low production cost
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R&D Program
During the last three years of research several rabbit studies were performed using the prototype. Typical data in rabbit study show very reproducible results with a 30 fold increase in drug cornea concentration. Further development includes the production of an advanced prototype, testing the prototype in clinical trails and expanding its use to other applications such as steroid insertion.
Contact
Stuart Bernstein
Business Development-Devices, Diagnostics & Imaging
Tel: +972-2-6777906
Email: stuart@hadasit.co.il
