Microneedles

Microneedles allow the transdermal delivery of a variety of substances (including small-molecule drugs, proteins, and cytokines), with the rapid release of active ingredients. Micromolding is the most widely used method for microneedle manufacturing, but design complexity and customization are limited. Furthermore, molding techniques are not feasible for the efficient production of microneedles.

3D printing is an additive manufacturing technology suitable for microneedle production. Microneedles of customized sizes and shapes can be manufactured quickly and with high precision using 3D printing.

Our Services

Protheragen Release focuses on fast release formulations. We efficiently manufacture soluble microneedles and hydrogel-formed microneedles with our home-made unique 3D printer to meet personalized needs. Higher bioavailability of medicines than the microneedle patches produced by mold-casting due to the ability of 3D printing to increase/enlarge the fractional volume of the microneedle tips which penetrate inside the dermis tissue.

Fabrication Process for Microneedles

• Prototype design

Microneedle prototypes are created in computer-aided design (CAD) software according to customer requirements or project characteristics.

• 3D printing

Send the prototype file of the CAD design to our homemade 3D printer. The software of the 3D printer divides the 3D model data into successive 2D slices, and subsequently the material is stacked in a layer-by-layer manner to fabricate microneedles.

Our home-made 3D printing system is suitable for rapid iterative design and fabrication of microneedles, supporting shape modification at any time during development according to demand.

There are two ways to load API into our microneedles: encapsulation by mixing the medicine into the aqueous solution of microneedle-forming materials prior to fabricating microneedles, and impregnation by inserting already made microneedles into an aqueous solution of API. The API should be hydrophilic or water-soluble. For pharmaceutical dosage forms, drug load and release kinetics may have to meet certain requirements according to demands.

Specifications of Microneedles

Specification of microneedles not only affects the user experience, but also affects its efficacy. Therefore, the size and geometry of microneedles should be considered when designing microneedles to ensure optimal performance.

• The ratio of the height of the microneedles to the diameter of the substrate affects the insertion difficulty and mechanical strength of the microneedles.
• Optimize the height of microneedles and control their penetration depth to minimize pain, bleeding and infection.
• The density of microneedles should be reasonably controlled to ensure the drug loading of a single piece and the insertion efficiency of microneedles.
• The geometry of microneedles is closely related to skin penetration, mechanical strength and delivery effect.

In general, for the size of a circular microneedle patch, the center of the patch must not be away from the edge of the patch more than 7.5 mm in order to have the needles at the center be pressed by the adhesive back against the skin. For the size of a microneedle patch oval or rectangle in shape, the distance between the central line and the edge should be within 7.5 mm. The heights of microneedles are in general 0.25~0.3 mm for cosmetic application, and 0.9~1.0 mm for drug administration. The interval between microneedles is 0.6~1.2 mm, and the sharpness of microneedles is 30°~60° in general. The diameter of the base of microneedles is between 0.2~0.6 mm.

The characteristic parameters of our microneedles fall into the range of the above. We may select these parameters precisely and flexibly according to specific applications due to our unique 3D printing fabrication method. The shape of our microneedles is determined by parameters, such as corn-shaped microneedles and slim-waist microneedles. The slim-waist needle shape increases dermal tissue contact and enhances transdermal absorption and bioavailability.

Materials for Microneedles

We use the following materials to fabricate microneedles using our home-made 3D printer.

• Polyvinyl alcohol
• Hyaluronate
• Gelatin
• Carboxyl methylcellulose
• Collagen

Our Advantages

• Efficient production by printing multiple needles simultaneously, 199 needles per 100 seconds.
• Dramatic improvement in the bioavailability of protein medicines.
• Our hydrogel-forming microneedles may offer safer administration of insulin by its convenience to be easily removed from the skin in case of overdose.
• Our microneedle patches loaded with biologic medicines can be carried and used at room temperature without the need for refrigeration.
• Our printing system supports the fabrication of almost any microneedle design. You can quickly modify the height, base radius, tip characteristics, and density of the microneedle array.
• Manufacture on demand, reduce inventory and reduce costs.
• Integral molding, no assembly, high manufacturing efficiency.

Applications

Protheragen Release has a deep expertise in 3D printing and microneedles. With Protheragen Release, you can obtain innovative, flexible, and low-cost products for your development, making you stand out from the competition.

Medicine

Our microneedles are suitable for medicine, avoiding the effects of gastrointestinal inactivation and the blood drug concentration can reach the effective therapeutic range quickly. Microneedles significantly reduce patient discomfort and pain, and increase medication compliance. Microneedles have broad application prospects in local or systemic skin drug delivery.

Our microneedle technology provides a new therapeutic approach to diabetes. It can effectively lower blood glucose and reduce the side effects caused by subcutaneous injections. In addition, we can optimize needle shape to significantly improve insulin bioavailability.

PK/PD of Insulin Microneedle Patches in Model Pigs

Cosmetics

Microneedles can puncture the stratum corneum of the skin and form a micro-scale pore between the epidermis and dermis to promote the penetration of macromolecular components, thereby overcoming the problem of low transdermal penetration of traditional cosmetics. Protheragen Release's homemade 3D printer can efficiently manufacture high-precision microneedles to meet individual needs and provide a new solution for improving the utilization of active ingredients in the cosmetics industry.

We have no plans to provide microneedle patches for scientific research currently because the purposes and requirements are diversified and the quantity is small. However, we may provide samples if the requirement does not exceed our capability and the order meets our MOQ (approximately 60~100 patches).

At Protheragen Release, your ideas are no longer limited by the mold, and you can easily get any shape of microneedles!

If you are interested in our services, please contact us for customization services.