Microneedle assembly formulation for skin treatment
Inventors
Assignees
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Publication Number
US-9795774-B2
Publication Date
2017-10-24
Expiration Date
Abstract
A problem to be solved of the present invention is to provide a drug formulation and a method of administering an active ingredient which allow the active ingredient to be delivered evenly into the site of action in the skin with high efficiency while ensuring stability of the active ingredient over a long time, and which are easily handled and are less stressful for patients. Mean for solving the problem is a microneedle assembly formulation for skin treatment comprising a platform and a plurality of conical or pyramidal microneedles formed on the platform containing a base composed of a bio-soluble and thread-forming polymer substance and an objective substance retained in the base, wherein the objective substance is a substance effective for prevention or treatment of skin senescence, or treatment of skin scar.
Core Innovation
The invention provides a microneedle assembly formulation for use in prevention or treatment of one or more target symptoms selected from skin aging, UV-damaged skin, hypertrophic scar, atrophic scar, keloids, acne scar, hair loss, suture wound, burn wound, ulcer, bedsore, diabetic ulcer, or a disease requiring angiogenesis. The formulation comprises a platform and a plurality of conical or pyramidal microneedles formed on the platform, where each microneedle contains a base composed of a bio-soluble and thread-forming polymer substance and an objective substance retained in the base.
Each microneedle is structured to have a first layer forming a tip part containing the objective substance and a second layer forming a bottom part not containing the objective substance. The tip part is configured to deliver the objective substance to a dermal layer of skin but not to an epidermal layer of skin.
The objective substance loading is defined as being present in an amount from 0.11 to 56 μg/cm² of the microneedle assembly. The objective substance is basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), or a nucleic acid and a plasmid encoding the gene thereof, and the formulation is configured to prevent or treat the one or more target symptoms without causing pigmentation in the skin to occur.
Claims Coverage
The independent claim set comprises one independent claim that defines the microneedle assembly formulation, followed by dependent claims that refine base excipients, microneedle dimensional constraints, microneedle density, a delivery/insertion treatment approach, and packaging configuration. The main inventive features across the independent claim focus on the microneedle layer structure that confines an objective substance to a tip part for dermal-only delivery while avoiding epidermal delivery and preventing pigmentation, under defined objective-substance identity and loading constraints.
Conical or pyramidal microneedles on a platform for dermal-targeted delivery
The microneedle assembly formulation includes a platform and a plurality of conical or pyramidal microneedles formed on the platform, wherein each of the microneedles contains a base composed of a bio-soluble and thread-forming polymer substance and an objective substance retained in the base.
First layer tip part with objective substance and second layer bottom part without objective substance
Each of the microneedles has a first layer forming a tip part containing the objective substance and a second layer forming a bottom part not containing the objective substance.
Dermal layer delivery but not epidermal layer delivery
The first layer has a length such that the tip part containing the objective substance is configured to deliver the objective substance to a dermal layer of skin but not to an epidermal layer of skin.
Objective substance identity and loading range
The objective substance is present in an amount from 0.11 to 56 μg/cm² of the microneedle assembly, wherein the objective substance is basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), or a nucleic acid and a plasmid encoding the gene thereof.
No pigmentation while preventing or treating target symptoms
The microneedle assembly formulation is configured to prevent or treat the one or more target symptoms without causing pigmentation in the skin to occur.
Overall claim coverage centers on a platform-based microneedle assembly with a bio-soluble thread-forming polymer base that retains an objective substance, with layer-by-layer confinement to a tip part for dermal-only delivery while explicitly avoiding pigmentation, and with defined objective-substance identity and loading.
Stated Advantages
Prevents or treats the one or more target symptoms without causing pigmentation in the skin to occur.
Documented Applications
Use in prevention or treatment of skin aging and UV-damaged skin.
Use in prevention or treatment of hypertrophic scar, atrophic scar, keloids, and acne scar.
Use in prevention or treatment of suture wound, burn wound, ulcer, bedsore, and diabetic ulcer.
Use in prevention or treatment of hair loss.
Use in prevention or treatment of a disease requiring angiogenesis.
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