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Nucleic Acid Mucosal Delivery Formulation Development

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With over 15 years' experience, CD Formulation offers comprehensive formulation solutions to support gene therapy and vaccine programs. One of our specialized areas is customizing formulations for mucosal administration, and we can assist innovators in navigating the complex path of nucleic acid drug sprays/inhalants development.

Why Choose Mucosal Delivery?

Key Steps in RNA Inhalant Development
(Chow M.Y.T.; et al. 2020)

It provides a non-invasive route, eliminating the need for injections and improving patient comfort and compliance.
Mucosal administration enhances drug bioavailability, allowing for rapid absorption into the bloodstream and faster therapeutic effects.
By bypassing first-pass metabolism in the liver, the drugs maintain their integrity and activity, leading to higher concentrations reaching the target tissues.

What Can We Do for the Mucosal Delivery of Nucleic Acids?

Nucleic Acid Nasal Spray Development	Advantages
CD Formulation offers comprehensive services for nucleic acid nasal spray formulation development. Utilizing technology platforms of polymer bioadhesive and nanocomplexes, our formulation scientists expertly load nucleic acid vaccines and therapeutics into nebulizer devices to precisely deliver drugs to target upper respiratory tract sites.	The nasal mucosa has a rich blood supply and a large surface area, allowing for efficient absorption of the drug into the systemic circulation. Nasal sprays are easy to administer and offer rapid drug absorption, making them suitable for respiratory conditions and diseases.
Nucleic Acid Inhalant Development	Advantages
For lower airway gene delivery research, we provide nucleic acid inhalant formulation development and characterization. Dry powder and liquid nebulizer preparations containing DNA or RNA payloads are tailored for maximum lung cell uptake and therapeutic gene expression. Aerosol performance is rigorously assessed in vitro and in vivo.	This route is effective for targeting respiratory diseases, including lung infections and pulmonary disorders. Inhalation aerosols provide localized drug delivery to the lungs, where the drug can directly act on the target cells or tissues.

Our Formulation Development Process for the Mucosal Delivery of Nucleic Acids

Targeted Mucosal Assessment
- We evaluate factors like permeability, metabolic activity, immune response at different mucosal sites.
- Reconstructed tissues are used to rank sites based on feasibility for transfection and uptake kinetics.
Formulation Design
- Biopharmaceutical properties of the nucleic acid drug are characterized.
- Depending on the target site, we design formulations such as sprays and aerosols to control the dosage.
Excipient Selection
- Excipients are screened to enhance stability against enzymatic degradation and mucosal absorption.
- We test buffers, cytoprotectants and penetration enhancers to achieve optimal compatibility.
Polymer Carriers Optimization
- Using techniques like DLS and zeta potential, we evaluate a range of natural and synthetic polymers to densely pack nucleic acids into nanosized complexes.
- In vitro studies identify lead polymers that protect drugs and promote mucosal cell transfection.
Preclinical Evaluation
- Formulated drug products are tested in reconstructed tissues for permeability, uptake and duration of therapeutic gene expression.
- Animal models further assess toxicity, bioavailability, and efficacy at the target site through tissue distribution, gene expression and protein activity studies.

Our Analysis Services for the Mucosal Delivery Formulation

Measure the size distribution and concentration of nucleic acid-loaded nanocomplexes in solution.
Provide accurate hydrodynamic size and surface charge characterization of polymeric carriers.
Evaluate nucleic acid binding efficacy, protection from enzymatic degradation.
Measure mucosal membrane transport using reconstituted tissues/cell monolayers.
Assess non-invasive transfection localization and kinetics in cultured epithelial/immune cells.
Provide high-resolution organ/tissue section analysis of fluorescent nanocarrier distribution.
Quantify gene/genome editing levels from expression, knockdown or base editing experiments.

Highlights of Our Nucleic Acid Mucosal Delivery Formulation Development Services

Experienced formulation scientists and engineers
Robust transfection models for mucosal tissues
Rich experience in nanocarrier design and optimization
Full physicochemical and biological characterization
Rapid screening of multiple formulation variables
In vitro and in vivo analyses of the leading candidates

From nasal to pulmonary applications of nucleic acid vaccines/drugs, CD Formulation optimizes formulations for efficient and targeted delivery. Contact us now to explore our tailored formulation solutions for nucleic acid mucosal delivery!

References

Chow M.Y.T.; et al. Inhaled RNA therapy: from promise to reality. Trends Pharmacol Sci. 2020, 41(10):715-729.
Ruzycki C.A.; et al. Inhalation delivery of nucleic acid gene therapies in preclinical drug development. Expert Opin Drug Deliv. 2023, 20(8):1097-1113.
Chavda V.P.; et al. Nasal sprays for treating COVID-19: a scientific note. Pharmacol Rep. 2023, 75(2):249-265.

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