Microneedle patch for immunostimulatory drug delivery
Inventors
WALDMAN, Reid • DeWANE, Madeline • Lee, Ming Hua • Durso, Lauren Sweeney
Assignees
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Publication Number
US-12005220-B2
Publication Date
2024-06-11
Expiration Date
Abstract
The application provides a dissolvable microneedle device to deliver immune stimulants to the skin. The application also provides a method of treating a skin condition comprising applying a dissolvable microneedle device to the skin.
Core Innovation
The invention relates to a dissolvable microneedle patch for delivery of a therapeutically active ingredient to skin. The patch includes a plurality of microneedles attached to a removable substrate, where each microneedle comprises a tapered tip extending away from the removable substrate. The microneedles comprise a biodegradable polymer with a therapeutically active ingredient dispersed in the biodegradable polymer.
The therapeutically active ingredient is an immunogenic stimulator selected from the group consisting of Candida antigen, trichophyton antigen, and tuberculin. The immunogenic stimulator is substantially free of glycerin.
In treatment, sufficient force is exerted on the dissolvable microneedle patch to permit the plurality of microneedles to penetrate to a location selected from the group consisting of epidermis, dermis, and papillary dermis. The microneedles are allowed to remain in the skin until the biodegradable polymer degrades, and an adhesive substrate is removed from the dissolvable microneedle patch.
Claims Coverage
The document provides two independent claims, one to a patch for delivery and one to a method of treating a skin condition. The independent claims share the core combination of a dissolvable microneedle patch having tapered microneedles on a removable substrate, a biodegradable polymer with an immunogenic stimulator dispersed therein, and a glycerin-free immunogenic stimulator; the method claim adds skin-penetration locations, retention until polymer degradation, and removal of an adhesive substrate.
Dissolvable microneedle patch with tapered biodegradable microneedles
A dissolvable microneedle patch for delivery of a therapeutically active ingredient to skin comprising a plurality of microneedles attached to a removable substrate, where each microneedle comprises a tapered tip that extends away from the removable substrate.
Biodegradable polymer dispersion of immunogenic stimulator
The microneedles comprise a biodegradable polymer with a therapeutically active ingredient dispersed in the biodegradable polymer.
Glycerin-free immunogenic stimulator selection
The therapeutically active ingredient is an immunogenic stimulator selected from the group consisting of Candida antigen, trichophyton antigen, and tuberculin, and the immunogenic stimulator is substantially free of glycerin.
Targeted skin penetration and retention until degradation
A method of treating a skin condition comprising exerting sufficient force on the dissolvable microneedle patch to permit the plurality of microneedles to penetrate to a location selected from the group consisting of epidermis, dermis, and papillary dermis, and allowing the plurality of microneedles to remain in the skin until the biodegradable polymer degrades.
Removal of adhesive substrate
A method of treating a skin condition further comprising removing an adhesive substrate from the dissolvable microneedle patch.
Claim coverage centers on a dissolvable microneedle patch with tapered microneedles on a removable substrate, a biodegradable polymer carrying an immunogenic stimulator dispersed therein, and an immunogenic stimulator that is substantially free of glycerin. The method claim further specifies penetration to epidermis, dermis, or papillary dermis, retention until biodegradable polymer degradation, and removal of an adhesive substrate.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of a skin condition by applying the dissolvable microneedle patch to permit microneedle penetration into epidermis, dermis, or papillary dermis, allowing the biodegradable polymer to degrade, and then removing an adhesive substrate from the patch.
Immunological inflammation signs (e.g., rubor/tumor/calor) in connection with the disclosed delivery approach are described as being associated with Langerhans cells and dermal dendritic cells [procedural detail omitted for safety].
Use cases described include skin lesion vs adjacent locations, as well as skin conditions including viral and neoplastic conditions, wart; condyloma acuminatum; molluscum contagiosum; actinic keratosis; squamous/basal/verrucous carcinoma; epidermodysplasia verruciformis; and alopecia areata and vitiligo.
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