Method of manufacturing microneedle and microneedle manufactured thereby
Inventors
Baek, Seung Ki • AHN, Myun Hwan • BAEK, Sun Young
Assignees
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Publication Number
US-10786662-B2
Publication Date
2020-09-29
Expiration Date
Abstract
A method of manufacturing a microneedle according to the present disclosure includes a step of preparing a microneedle; a step of cooling the microneedle; and a step of inducing an endothermic reaction of the cooled microneedle, and coating the cooled microneedle with an active ingredient at least once. In accordance with such a configuration, coatability of the active ingredient can be improved due to an endothermic reaction without a separate drying process, thereby providing superior medication.
Core Innovation
The invention relates to a method of manufacturing a microneedle for drug delivery, where a water-soluble microneedle is prepared and then cooled. The cooled microneedle is sequentially coated with a water-soluble active ingredient at least once, and waterproof-coated with a waterproofing agent including a mineral-based substance or a lipid-based material.
The cooling and the coating are sequentially performed under a vacuum or dry air condition without a separate drying process of the cooled water-soluble microneedle. During cooling, a relative humidity is maintained at 1% to 30%, and during coating the relative humidity is maintained at 1% to 20%.
The cooling includes placing the microneedle in a sealed cooling chamber and cooling while the microneedle remains in the sealed chamber. The cooled water-soluble microneedle is coated with the active ingredient by an electro-spinning coating method, an ultrasonic coating method, an atomization coating method, or a non-contact spray coating method, including multilayer coating with two or more active ingredients having same solubility.
The waterproof-coating coats the end portion or entire surface of the microneedle by at least one of a dip-coating method, an atomization coating method, an electro-spinning coating method, and an ultrasonic coating method, and the manufacturing sequence avoids a separate drying process of the cooled water-soluble microneedle prior to coating. The waterproof-coated microneedle is dried at room temperature.
Claims Coverage
The document provides one independent claim describing a full manufacturing method sequence with 8 inventive features.
Sequential cooling and coating without separate drying before coating
Cool the water-soluble microneedle and sequentially coat the cooled water-soluble microneedle with a water-soluble active ingredient at least once under a vacuum or dry air condition without a separate drying process of the cooled water-soluble microneedle.
Humidity-controlled vacuum/dry-air sequential processing
Maintain a relative humidity in the cooling of 1% to 30% and a relative humidity in the coating of 1% to 20% while performing the cooling and the coating sequentially under a vacuum or dry air condition.
Sealed cooling chamber cooling
Cool the water-soluble microneedle by placing it in a sealed cooling chamber and cooling the water-soluble microneedle while it is placed in the sealed cooling chamber.
Rapid cooling methods and cooling substances
Cool the microneedle by at least one rapid cooling method of a screw method, a piston method, a mono-pump method, a time-pressure method, a valve method, a spray method, a piezo method, an air-solenoid method, and immersing the microneedle in a cooling substance, where the cooling substance is at least one of liquid nitrogen, tetrafluoroethane, a Peltier element cooling fan, or dry ice.
Water-soluble active ingredient coating by non-contact coating techniques
Coat the cooled water-soluble microneedle with the active ingredient by one of an electro-spinning coating method, an ultrasonic coating method, an atomization coating method, and a non-contact spray coating method.
Multilayer coating with same-solubility active ingredients
Coat the water-soluble microneedle, in a multilayer structure, with two or more active ingredients having same solubility.
Waterproof coating with mineral-based or lipid-based waterproofing agent
After coating with the water-soluble active ingredient, waterproof-coat the microneedle with a waterproofing agent including a mineral-based substance or a lipid-based material, where an end portion or entire surface is coated by at least one of a dip-coating method, an atomization coating method, an electro-spinning coating method, and an ultrasonic coating method.
Room-temperature drying after waterproof coating
Dry the waterproof coated microneedle at room temperature after performing the waterproof coating with the waterproofing agent including the mineral-based substance or the lipid-based material.
Overall, the claim coverage centers on a manufacturing workflow in which a water-soluble microneedle is cooled in a sealed cooling chamber under vacuum or dry air with specified low relative humidity, then sequentially coated with a water-soluble active ingredient using specified non-contact coating techniques, including multilayer same-solubility active ingredients, without a separate drying step of the cooled microneedle, followed by waterproof coating with a mineral-based or lipid-based agent and drying at room temperature.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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