Proteins & Peptides Intranasal Delivery System Development

The nose-brain route provides an alternative non-invasive route for delivering protein/peptide macromolecule drugs. With decades of experience in protein/peptide nasal formulations and expertise in delivery, CD Formulation can help you overcome the development challenges of any protein/peptide nasal solution, protein/peptide suspension, and protein/peptide dry powder formulations, providing the key performance and quality testing required for successful product development. Our scientists optimize the performance and quality of nasal drugs through formulation, stability, testing, and in vitro bioequivalence study services. We develop safe and reliable drugs through strategic formulation and comprehensive analytical testing.

Potential Advantages of Protein/peptide Intranasal Delivery

The nasal route of administration has emerged as a promising strategy for protein/peptide delivery. Compared with other delivery routes, nasal administration has the following advantages:

• Avoid first-pass metabolism in the liver, thereby directly delivering proteins/peptides to the systemic circulation.
• Direct absorption, rapid drug absorption.
• Enhanced pharmacokinetic properties.
• Avoid first-pass metabolism.
• Directly targeting the brain, avoiding crossing the blood-brain barrier and possible systemic side effects of the drug.
• Non-invasive, painless method.
• Patient compliance.

Explore Our Proteins & Peptides Intranasal Delivery System Development Services

With decades of experience supporting protein/peptide inhalation therapy development for clients around the world, our experts provide one-stop formulation development, product characterization studies, method development and validation, inhalation product analysis and testing, and preclinical manufacturing services.

Our comprehensive protein/peptide nasal inhalation product development services and unique project management approach enable you to achieve rapid success and help you accelerate product launches.

Protein/peptide nasal inhalation formulations The low permeability of the nasal mucosa and the clearance of nasal cilia hinder the absorption of protein/peptide drugs through the nasal cavity. Our formulation scientists deploy a series of formulation strategies to increase the residence time of proteins/peptides in the nasal cavity, thereby promoting the absorption of protein/peptide drugs, including:

Fig. 1 Formulation strategies for proteins/peptides intranasal delivery. (CD Formulation)

• Penetration Enhancer Strategy: Use penetration enhancers or surfactants (such as polysorbate and lecithin) to enhance the transport of proteins/peptides across the nasal mucosa.
• Mucolytic Strategy: Use N-acetyl-L-cysteine (NAC) to enhance nasal absorption.
• Bioadhesive Strategy: Able to prolong the duration of action at the nasal mucosa site and provide a controlled drug release rate.
• In situ gelation Strategy: Free flow during mixed spraying, forming a viscous gel after actuation, prolonging the duration of action and promoting absorption.
• Liposome Strategy: Enhance absorption by encapsulating proteins/peptides in liposomes.
• Nanoemulsion Strategy: Enhance absorption by encapsulating proteins/peptides in emulsions.
• Nano/microparticle Strategy: Enhance absorption by encapsulating proteins/peptides or surface modification.
• Spray-freeze Drying Strategy: Enhance stability and promote absorption by micro-differentiating protein/peptide solutions.

Our formulation team will customize the above formulation development strategies to meet your product delivery needs - for example, designing and developing spray freeze-dried polymer liposomes to enhance nasal mucosal absorption.

Our Intranasal Formulation Expertise

All of our protein/peptide nasal delivery system development services are performed in Good Manufacturing Practice (GMP) compliant laboratories and include comprehensive formulation development and scale-up, device screening, accelerated stability studies, clinical supply manufacturing, and comprehensive CMC support to help you optimize the performance of your protein/peptide nasal drug in aqueous, powder or propellant-driven form.

Our expertise covers:

• Protein/peptide Aqueous Solutions
• Protein/peptide Suspensions
• Protein/peptide Dry Powders
• Protein/peptide Pressurized Solutions or Suspensions
• In vitro bioequivalence studies (IVBE) of generic protein/peptide nasal drugs.

Our Analytical Testing Capabilities

Nasal delivery is typically supplied as a nasal aerosol product that produces droplets in the 20-200 micron range when administered. Regulatory requirements necessitate the characterization of nasal biologics in accordance with ICH Q6B and EMA drug quality guidance for inhaled and nasal products.

We continually invest in cutting-edge nasal drug product equipment and use current industry-standard nasal drug product analytical testing techniques to support the characterization of protein/peptide nasal delivery systems with support in the following aspects:

• Particle/droplet size distribution testing and spray pattern/plume geometry using laser diffraction and high-speed laser imaging.
• Measurement of protein/peptide active pharmaceutical ingredient (API) particle size in nasal suspensions using Morphological Directed Raman Spectroscopy (MDRS).
• Identification of excipients using MDRS.
• Content uniformity testing using UPLC/HPLC.
• Powder/Particle characterization using Powder rheology testing.
• Particle size analyzers, and morphology/shape analyzers.

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 Intranasal Delivery System Development?

• We have hundreds of successful projects executing protein/peptide nasal delivery system development.
• Our labs provide comprehensive quality assurance expertise in GMP-compliant laboratories equipped with the latest testing instrumentation.
• We have decades of analytical and formulation support experience applied to the development of nasal solutions, suspensions, and dry powders.
• We support critical performance and quality testing required for the development of protein/peptide nasal formulations and delivery systems. 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 intranasal 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.