Proteins & Peptides Inhaled Delivery System Development

Pulmonary delivery of proteins/peptides has been considered a viable alternative to parenteral administration for systemic drug delivery. With a deep understanding of the protective mechanisms of the lungs and pharmaceutical issues related to protein/peptide delivery, CD Formulation has been committed to the development of inhaled protein/peptide products for decades and can overcome a series of biological challenges, providing you with unparalleled protein/peptide inhalation delivery system development solutions.

Potential Advantages of Protein/peptide Inhalation Delivery

Protein and peptide drugs have become a research hotspot in recent years due to their obvious advantages such as strong efficacy, high specificity, and high safety. However, most of the current clinical products are administered by non-intestinal routes, which are less convenient to administer. The lung is an attractive non-invasive alternative route for biologics to treat respiratory and systemic diseases. Compared with parenteral delivery, pulmonary delivery of proteins/peptides has the following potential advantages, including:

• Large absorption surface area.
• High bioavailability.
• Large absorption surface area.
• Avoid first-pass metabolism.
• Fast onset of action.
• Wide formulation design space, including solutions, suspensions, and dry powders.
• Non-invasive.

However, there are still many difficulties in the development of protein/peptide inhalation delivery products. Rational formulation design strategies and selection of delivery devices are key steps to address these challenges.

Fig. 1 Specific challenges in the administration of protein/peptide by inhalation. (Fröhlich E, et al., 2021)

Explore Our Proteins & Peptides Inhaled Delivery System Development Services

With decades of experience supporting protein/peptide inhalation therapy development for clients worldwide, our expert provides one-stop formulation development, product characterization studies, method development and validation, inhalation product analysis and testing, and preclinical manufacturing services.

Unlike small molecules, the particle surface properties of large molecules such as proteins and peptides are key criteria for the distribution and retention of these active pharmaceutical molecules in the lungs. Our researchers typically formulate dry powder formulations using a single spray-drying or freeze-drying process and a combination of the two processes. We also provide protein/peptide nebulized solution/suspension product development services, if you need them.

Our comprehensive protein/peptide pulmonary product development services and unique project management approach enable you to achieve success quickly and help you accelerate your product launch.

Our expertise covers the formulation and delivery system development of the following protein/peptide products.

• Protein/peptide Nebulized Solution
• Protein/peptide Suspension
• Protein/peptide Dry Powder Formulation

Fig. 2 Types of protein/peptide inhalation products we can develop. (CD Formulation)

The type of inhaler is critical for the delivery of proteins/peptides. Taking into account the clinical application requirements, at CD Formulation, three types of inhalers are used to support the development of your protein/peptide inhalation delivery system, including:

• Pressurized metered dose inhaler (pMDI): Our scientists suspend the protein/peptide in a single propellant or a propellant mixture together with excipients such as cosolvents and surfactants. This is because proteins/peptides are poorly soluble in non-polar hydrofluoroalkane (HFA) propellants.
• Dry powder inhaler (DPI): It is used to deliver protein/peptide spray-dried particles, protein/peptide spray-freeze dried particles, and spray-freeze dried particles.
• Nebulizer: Includes ultrasonic nebulizer, jet nebulizer, and vibrating mesh nebulizer. Direct aerosol delivery of protein/peptide solution.

Our Analytical Testing Capabilities

Professional analysis and testing under controlled conditions and following established robust methods are essential for characterizing inhaled protein/peptide products. Our scientists have expertise in the development and testing of inhaled proteins/peptides to fully characterize inhaled proteins/peptides according to ICH Q6B guidelines and determine if the inhalation device delivery mechanism affects key parameters such as protein/peptide structure, purity, stability, and activity.

Our Powderization Technology Platforms

Spray-drying Technology

 A solution containing protein/peptide active drug molecules can be spray-dried in one step to obtain dry fine powder. This technology is suitable for organic and water-soluble drugs, but not for heat-sensitive proteins/peptides.

Spray-freeze Drying Technology (SFD)

A solution containing protein/peptide active drug molecules is first atomized into a refrigerant (usually liquid nitrogen) and then freeze-dried. This technology is suitable for thermosensitive formulations that are not suitable for spray drying. SFD particles usually have a porous structure and good aerosol properties, making them particularly suitable for inhalation.

Supercritical Fluid technology

A solution containing protein/peptide active drug molecules is dissolved in a supercritical fluid (SF). The rapid expansion of the SF solution causes rapid nucleation of the solute, producing very fine micronized particles. SF powder is spherical, uniform in shape, and smooth in surface.

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

• We have extensive expertise and experience in executing protein/peptide inhalation system development.
• We have hundreds of successful projects under our belt, aiming to develop user-friendly inhalation devices and easy-to-use formulations.
• Our expertise spans a wide range of peptides and proteins, allowing us to develop inhalation dosage forms for a variety of therapeutic applications.
• Various powdering technologies, including spray-drying technology, spray-freeze drying technology, and supercritical fluid technology, ensure the smooth implementation of protein/peptide inhaled delivery system projects.
• 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

CD Formulation is always at the forefront of protein/peptide inhaled delivery system development, mastering the most cutting-edge technologies and methods. Please don't hesitate to contact us if you are interested in our services.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.