Iontophoretic microneedle device
Inventors
RONNANDER, James Paul • Simon, Laurent
Assignees
LTS Lohmann Therapie Systeme AG • New Jersey Institute of Technology
Publication Number
US-11534589-B2
Publication Date
2022-12-27
Expiration Date
2038-09-12
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Abstract
A medical drug devices for transdermal drug delivery systems (TDDS) comprising a novel iontophoretic polymeric microneedle device and its use in administration of drugs.
Core Innovation
The invention provides a novel iontophoretic polymeric microneedle array device specifically designed for transdermal delivery of bio macromolecules or drug macromolecules through the skin. The microneedle array is composed of dissolving biodegradable, water-soluble polymeric solutions that encapsulate active pharmaceutical ingredients (API). Upon application, the microneedles penetrate the stratum corneum, allowing the encapsulated API to be delivered directly into the underlying dermis, which is rich in capillaries and facilitates systemic drug uptake.
This device integrates the benefits of microneedles and iontophoresis in a single system, addressing key limitations associated with current transdermal drug delivery technologies. Microneedle systems alone have an inherent lag time before a therapeutic effect is achieved, while iontophoresis alone requires higher electrical energy. By combining both, the invention reduces lag time and the total electrical energy required, enabling a controlled and sustained therapeutic dose with lower power demands.
The problem addressed is the limitation of oral, subcutaneous, and intramuscular drug administration, such as poor absorption, first pass metabolism, pain, need for trained personnel, cost, sterility, and fluctuations in drug plasma levels. Existing transdermal systems are limited by the skin's barrier and primarily work for small, lipophilic molecules. This invention enables the delivery of hydrophilic and macromolecular APIs, such as sumatriptan for migraine therapy, through minimally invasive, self-administered, and reliable means, expanding the potential for transdermal delivery of a broader range of pharmaceuticals.
Claims Coverage
The patent contains three main independent inventive features based on the claims.
Method for preparation of a dissolvable polymeric microneedle array encapsulating macromolecular compounds
This inventive feature is directed to a method of preparing a polymeric microneedle array for skin delivery of macromolecular compounds. The method includes: 1. Dissolving specified amounts of: - 15 to 40 wt.% of a water soluble polymer as a binder - 0.5 to 1.5 wt.% of a humectant/softener - less than 2 wt.% of a surfactant - 1 to 15 wt.% of a macromolecular compound (API) in water to prepare a liquid polymer composition. 2. Molding the polymer composition in flexible molds with a negative form of the microarray to be produced. 3. Drying the polymer composition within the mold. 4. Removing the dried polymeric microneedle array, consisting entirely of solid dissolvable microneedles, from the mold.
Active transdermal patch device comprising an iontophoretic dissolvable microneedle array with a power supply
The inventive feature covers an active transdermal patch device for delivering macromolecular compounds through skin, comprising: - A power supply with controllable current source; - A skin cathode electrically connected to the power supply; - A skin anode electrically connected to the power supply, the anode comprising a microneedle array having a plurality of micro-scaled, solid, dissolvable microneedles; - The microneedle array is obtained by the defined preparation method, ensuring the encapsulation of the macromolecular compounds within the dissolvable microneedles.
Polymeric microneedle array for delivery of macromolecular compounds through the skin
This feature claims a polymeric microneedle array for delivery of macromolecular compounds through the skin, where: - The array includes a plurality of micro-scaled, solid, dissolvable microneedles; - Each microneedle consists of a dried polymer composition comprising a water-soluble polymer binder, a humectant/softener, a surfactant, and encapsulated macromolecular compound; - The microneedle array is prepared by the previously described method ensuring the defined composition and properties.
In summary, the claims protect the specific method of formulating and manufacturing dissolvable polymeric microneedle arrays encapsulating macromolecular APIs, the incorporation of these arrays into an active iontophoretic patch device, and the microneedle array itself with a defined composition for transdermal macromolecule delivery.
Stated Advantages
Combining microneedle and iontophoretic technologies eliminates deficiencies inherent in either technology by reducing lag time and increasing drug diffusion for a more rapid therapeutic effect.
The electrical current required for iontophoretic delivery is reduced due to microneedle penetration of the stratum corneum, thereby lowering electrical energy needs and allowing for smaller battery requirements.
The device enables efficient, sustained, and controlled delivery of macromolecular and hydrophilic APIs through transdermal administration.
Self-administration is possible, avoiding the need for trained personnel and reducing pain and issues associated with hypodermic injections.
Documented Applications
Transdermal administration of macromolecular APIs for prophylaxis and therapy.
Transdermal administration of sumatriptan for prophylaxis and/or therapy of migraine in patients.
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