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Proteins & Peptides Microneedle Delivery System Development

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Microneedle transdermal delivery technology is mainly based on the microneedles causing tiny damage on the skin surface, thereby promoting the penetration and absorption of proteins/peptides, improving drug efficacy and therapeutic effects. As experts in the field of protein/peptide delivery, CD Formulation's microneedle array patches are designed for precise and reliable intradermal delivery of macromolecules such as proteins, antibodies, vaccines, peptides, and biologics. Our unparalleled capabilities and expertise can provide you with customized protein/peptide microneedle delivery system development solutions.

Potential Advantages of Microneedle Delivery of Protein/Peptide

Microneedle (MN) arrays consist of multiple microprotrusions assembled on one side of a support base, with a height of <1 mm. MN arrays effectively bypass the stratum corneum barrier by creating temporary microscopic water channels within the epidermis, through which drug molecules can diffuse into the dense microcirculation in the dermis.

The inherent properties of proteins and peptides, such as large molecular weight, poor stability, and conformational flexibility, make them difficult to formulate and deliver. Injection is the main route of clinical protein and peptide drug administration, which often leads to poor patient compliance. As a portable and minimally invasive device, microneedles (MNs) can overcome the skin barrier and create reversible microchannels to achieve effective macromolecular penetration, and the microneedles will not come into contact with deep dermal blood vessels and nerves, resulting in higher patient compliance and greater safety. In addition, the microsphere preparation conditions are mild and will not affect the biological activity of proteins and peptides. Figure 1 shows the mechanism of microneedle delivery.

Fig. 1 A schematic diagram of microneedle (MN)-based drug delivery approaches. Fig. 1 A schematic diagram of microneedle (MN)-based drug delivery approaches with the cross-section of the upper layer of the skin. (Avcil M, et al., 2021)

Explore Our Proteins & Peptides Microneedle Delivery System Development Services

As an expert in protein/peptide science and formulation science, CD Formulation has the most advanced industry knowledge and technology in protein and peptide delivery and is committed to providing you with comprehensive, innovative, and efficient microneedle delivery system development solutions.

Our scientists are composed of a team of scientists with decades of rich experience in formulation design and microneedle development and manufacturing. They have a deep understanding of the unique challenges associated with protein/peptide microneedle delivery and are focused on helping the pharmaceutical industry use the potential of microneedle arrays to improve the therapeutic effects of peptides and proteins.

Our laboratories are equipped with state-of-the-art analytical and manufacturing equipment, providing a full range of microneedle array design and manufacturing services. Our expertise covers the development of various microneedle array types, including but not limited to:

  • Solid MNs
  • Coated MN
  • Hollow MNs
  • Dissolving MNs
  • Hydrogel-forming MNs

Fig. 2 Types of MNs for proteins/peptides delivery. Fig. 2 Representative types of MNs for proteins/peptides delivery. (Liu T, et al., 2021)

Our Solutions for Proteins & Peptides Microneedle Delivery System Development

Designing and developing an excellent microneedle-based delivery system requires a comprehensive consideration of a range of factors, including parameters affecting MN insertion, biocompatibility, biodegradability and stability, loading and dosage accuracy, skin irritation, sterility, and regulatory compliance.

Our team of scientists has identified important contributors to protein/peptide delivery through extensive laboratory and preclinical testing and is continually expanding our in-house dataset around these features. We can create the optimal design for your protein/peptide and perform a range of characterization and regulatory compliance tests, including:

MN Design
  • Space between arrays.
  • Microneedle length.
  • Droplet volume/solids per microneedle.
  • Droplet shape.
  • Coating formulation.
  • Number of microneedles.

Regulatory Compliance Assessment:

  • Sterility testing.
  • Content uniformity testing.
  • MN reusability testing.
  • Potential immune effect testing.
  • Stability testing.

Our Microneedle Manufacturing Method

Microneedle micromolding is the most common method we use to design and manufacture microneedles, including hot pressing, injection, and solvent casting.

  • The first step in our microneedle manufacturing process is designing the microneedle geometry using computer-aided design (CAD) software. Once the design is finalized, we use a micro molding technique to create a master mold for the microneedles.
  • In hot pressing, a silicon micromole is used to create the microneedles by applying heat and pressure to a polymer material. This process allows for precise control over the microneedle shape and size.
  • Injection molding involves injecting molten polymer into a micromole cavity under high pressure. This method is suitable for the mass production of microneedles and allows for high throughput.
  • Solvent casting is another method we use to manufacture microneedles, where a polymer solution is poured into a micromole and the solvent is allowed to evaporate, leaving behind the solid microneedle structure.
  • After the microneedles are fabricated, We undergo a rigorous quality control process testing to ensure they meet the desired specifications. This includes measuring the dimensions, mechanical strength, and sharpness of the microneedles.

Fig. 3 MNs manufacturing methods. Fig. 3 Microneedle (MN) manufacturing methods.(Jamaledin R, et al., 2020)

Why Choose Us for Proteins & Peptides Microneedle Delivery System Development?

  • Extensive expertise and experience in performing protein/peptide microneedle delivery system development.
  • We have advanced microneedle manufacturing technology that allows the design and control of microneedle size, shape, and arrangement to ensure effective delivery.
  • We have a flexible team of experts responsible for microneedle formulation feasibility, process development, and commercial manufacturing.
  • We provide comprehensive microneedle characterization testing services to meet regulatory compliance requirements.
  • We provide flexible and tailored solutions to meet our customers' specific needs and requirements.
  • Fast and efficient services ensure that our customers' projects are delivered on time.

Publication

Published Data

Technology: Microneedle-array patches loaded with dual mineralized protein/peptide particles.

Journal: Nat Commun.

IF: 17.646

Published: 2017

Results:

The authors successfully constructed a smart exendin-4 (Ex4) delivery device based on a microneedle (MN) array patch, which integrates dual mineralized particles containing Ex4 and glucose oxidase (GOx), respectively. Due to the differential response to the microenvironment caused by biological stimuli, the dual mineralized particle-based system can specifically release Ex4 while immobilizing GOx. In this way, the system can respond rapidly and specifically to the hyperglycemic state and exhibit good glucose regulation ability, thereby significantly improving the therapeutic performance of exendin-4 173. In addition, the integration of mineralized particles can enhance the mechanical strength of alginate-based MNs through cross-linking to promote skin penetration, thereby supporting painless and non-invasive transdermal drug delivery.

Fig. 4 Characterization of MN-array patches. Fig. 4 Characterization of dual mineralized particle-loaded MN-array patches. (Chen W, et al., 2017)

CD Formulation is constantly researching and developing new technologies to improve protein/peptide microneedle delivery systems. Our scientists stay up to date on the latest advances in the field and focus on providing innovative solutions for enhanced protein and peptide delivery. Please don't hesitate to contact us if you are interested in our services.

References

  1. Avcil M, Çelik A. Microneedles in Drug Delivery: Progress and Challenges. Micromachines (Basel). 2021, 12(11):1321.
  2. Kirkby M, Hutton ARJ, Donnelly RF. Microneedle Mediated Transdermal Delivery of Protein, Peptide and Antibody Based Therapeutics: Current Status and Future Considerations. Pharm Res. 2020, 37(6):117.
  3. Liu T, Chen M, Fu J, et al. Recent advances in microneedles-mediated transdermal delivery of protein and peptide drugs. Acta Pharm Sin B. 2021, 11(8):2326-2343.
  4. Jamaledin R, Di Natale C, Onesto V, et al. Progress in Microneedle-Mediated Protein Delivery. Journal of Clinical Medicine. 2020,9(2):542.
  5. Chen W, Tian R, Xu C, et al. Microneedle-array patches loaded with dual mineralized protein/peptide particles for type 2 diabetes therapy. Nat Commun. 2017, 8(1):1777.
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