SonoPrep® for Drug Delivery

The skin is the natural barrier between the outside world and the vital tissues of the human organism. Historically, transdermal drug delivery has been limited to drugs of small molecular weights.  Echo's FDA-cleared SonoPrep system includes ultrasound-based skin permeation technology and involves a non-invasive and painless method of enhancing the flow of molecules across the skin’s membrane for up to 24 hours. Echo's application of ultrasonic energy creates reversible channels in the skin through which large molecules can be delivered. This novel use of ultrasound technology makes it possible for painless and transdermal drug delivery. These benefits may be realized through new routes for continuous transdermal drug delivery and improved patient compliance to treatment.

Clinical and pre-clinical studies have been conducted to demonstrate the safety and effectiveness of the SonoPrep system in transdermal drug delivery applications. SonoPrep skin permeation can accelerate the delivery of topical drugs and facilitate the delivery of large molecular weight protein and carbohydrate drugs such as insulin and heparin, respectively. SonoPrep has also been shown to shorten the effective onset of topical anesthetics from as long as 60 minutes to 5 minutes or less, while improving the therapeutic effect over the traditional application.

Ultrasound-based skin permeation has the potential to change the paradigm of transdermal drug delivery that limits applications to small molecules, chronic applications and potent drugs.  Echo's SonoPrep enables the delivery of large MW drugs (MW > 500 Da) and accelerates the delivery of current transdermal drugs up to ten fold. Effective use of ultrasound-based skin permeation to facilitate transdermal drug delivery depends also on the application of transdermal drug formulation technologies and may be improved by combining with active transport means such as Echo's AzoneTS technology. 

Echo's SonoPrep technology was invented by Dr. Robert Langer and Dr. Joseph Kost at the Massachusetts Institute of Technology (MIT). Echo licensed the technology from MIT.

SonoPrep and Transdermal Insulin

A feasibility study was performed to evaluate the use of SonoPrep ultrasound pretreatment to enable passive transdermal delivery of human recombinant insulin in an in vivo swine model. The study demonstrated that it is feasible to treat skin in a non-invasive manner using SonoPrep-based ultrasound to enable passive delivery of large protein (hexamer insulin, MW= 36 kDa at pH 7) into systemic circulation and allow the protein to express biological activities.

SonoPrep and Transdermal Heparin

The feasibility of Low Molecular Weight Heparin (LMWH) delivery through SonoPrep-pretreated skin was demonstrated in in vitro studies with porcine skin and in vivo studies in a rat model. In vivo studies in which LMWH was delivered trasndermally through ultrasonically pretreated skin demonstrated significant antifactor-X activity (aXa) well beyond 5 hours after a 2 hour lag time. In comparison, subcutaneous injection controls showed immediate activity that declined rapidly over 5 hours. Transdermal LMWH delivery exhibited prolonged activity similar to intravenous delivery. 

SonoPrep for Pain Free Vein Catheterization and Phlebotomy Procedures

Intravenous (IV) catheterization and vein punctures for blood sampling are common procedures in the emergency room, operating room, nursing floors and home care settings. These procedures are performed by trained nurses and technologists who rate their performance in these procedures by their ability to minimize patient pain and anxiety.

Echo's SonoPrep and procedure tray enables healthcare workers and homecare givers to perform standard IV catheterization and phlebotomy procedures with minimal or no pain.

SonoPrep also can be used as a needle-free adjunct to IV therapy, anesthesia and pain management. SonoPrep has been shown to shorten the effective onset of topical anesthetics from as long as 60 minutes to 5 minutes or less, while improving the therapeutic effect over the traditional application.

SonoPrep System

Echo's SonoPrep system permits controlled increased skin permeability and is intended for preparing the patient with normal intact skin for therapeutic instrumentation procedures where improved permeability at a specified skin site is desirable.  

The SonoPrep system operates by transferring a low level of ultrasound energy for a short time from the hand piece, causing the outer most layer of skin (stratum corneum) to become permeable.  The size of the sonocation site is 0.8 cm2. Echo has conducted studies to demonstrate that skin conductivity is significantly enhanced and that the enhancement lasts for several hours.  A key feature of the SonoPrep system is real-time skin conductance feedback. SonoPrep measures the increase in skin conductance (or decrease in skin impedance) during the application of ultrasound and stops the sonocation procedure when the desired level of conductance has been achieved. The SonoPrep system is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream for local dermal anesthesia prior to a needle insertion or IV procedure.

SonoPrep is not designed to be used on injured or otherwise compromised skin.  This product is classified as CLASS 2 TYPE BF IPX0 electromedical equipment according to EN IEC 60601-1:1990.  MAXIMUM RATINGS: 115 V~ 60Hz 8W. 

  • SPECIFICATIONS
    IEC Device Class:       Class 2
    IEC Device Type:        Type BF
    IEC Environment         Ordinary, IPX0
    Device Operation       Continuous
    Charger Input:             115 VAC, 60 Hz, 8 VA
    Charger Output:         11.6 VDC @100 mA
    Generator Output:     12 VA, 55,000 Hz
    Sensor Signal:  100 mVAC, 100 Hz
  • OTHER LABELS/ INDICATORS
    Sonocate:  Indicates SonoPrep is treating the skin
    Fault:  Indicates the skin was not sonocated properly or completely
    Low Battery:   Indicates the battery needs re-charging
    Charging:  Indicates the battery is charging

SonoPrep Procedure Tray

The SonoPrep Procedure Tray provides the components needed to achieve effective skin permeation in less than one minute. The SonoPrep Procedure Tray consists of a SonoPrep ultrasonic coupling medium cartridge, a cleaning cartridge, a locator ring, injection site marker and two skin preparation pads.