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.
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 with the cross-section of the upper layer of the skin. (Avcil M, et al., 2021)
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:
Fig. 2 Representative types of MNs for proteins/peptides delivery. (Liu T, et al., 2021)
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:
Regulatory Compliance Assessment:
Microneedle micromolding is the most common method we use to design and manufacture microneedles, including hot pressing, injection, and solvent casting.
Fig. 3 Microneedle (MN) manufacturing methods.(Jamaledin R, et al., 2020)
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 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.
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