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Injectable Nucleic Acid Formulation Development

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CD Formulation is dedicated to delivering efficient and reliable development services for innovative injectable nucleic acid formulations. Our experienced team of experts leverages advanced technology platforms to meticulously optimize formulations, catering to diverse and evolving research needs across various fields.

About Injectable Nucleic Acid Formulation

Injectables are sterile pharmaceutical products administered into the body via injection. These include solutions, suspensions, emulsions, powders for injection or infusion, gels for injection, and implants. They are intended for administration through direct injection (intravenous, intramuscular, or subcutaneous), controlled infusion, or direct IM or SC implantation for humans or animals.

Types of Nucleic Acid Injectable Formulations

Items Descriptions
Solutions Most injectables are solutions, typically aqueous, or mixtures with non-aqueous solvents like glycol and alcohol.
Suspensions A challenging parenteral formulation requiring a delicate balance of variables to ensure easy resuspension and injection within shelf life through 18-21 gauge needles.
Emulsions Intrinsically unstable, emulsions are dispersions of two immiscible liquids and their formulation is limited by available stabilizers and emulsifiers. Adverse physiological effects limit their use in intravenous administration.
Dry Powders Drugs too unstable in aqueous media are formulated as dry powders, reconstituted with water before administration.

Explore Our Injectable Nucleic Acid Formulation Development Services

Formulation Development of Injectable Products

Items Descriptions
Subcutaneous Injection The formulation creates a deposit for the gradual release of the drug into circulation. This release is influenced by the formulation itself, it occurs rapidly in aqueous solutions but is slower and more sustained in depot forms.
Intramuscular Injection The delivery system administers drugs through the dermis and subcutaneous layers into the muscle, facilitating rapid absorption by targeting deep muscle layers that have a rich blood supply.
Intravenous Injection The most common parenteral route for rapid and accurate dosing is the direct delivery of drugs into systemic circulation, bypassing any absorption delays.

pH Development for Nucleic Acid Injectables

Aim for pH close to physiological levels, acceptable range varies: IV and IM injections prefer pH 2-11, while SC prefers pH 4-9 to avoid irritation. Buffers like acetate, phosphate, citrate, histidine, and TRIS facilitate ideal pH 5-8 and minimal buffer capacity hastens adaptation by bodily fluids.

Our Workflow for Injectable Nucleic Acid Formulation Development

Fig.1 Injectable nucleic acid formulation development flow diagram.Fig.1 Flow chart of injectable nucleic acid formulation development. (CD Formulation)

  • Material Selection

Screening of appropriate nucleic acid materials, such as DNA, RNA, or their modifications, to ensure stability and functionality in vivo.

  • Carrier Design

Development of carrier systems like liposomes and nanoparticles to effectively deliver and release nucleic acids, enhancing bioavailability.

  • Formulation Optimization

Adjusting parameters like pH, concentration, and proportions for optimal physical and chemical properties.

  • Physicochemical Evaluation

Comprehensive analysis of physical and chemical properties to ensure formulation stability, consistency, and injectability.

  • Manufacturing Process Development

Refining process steps including blending, sterilization, and filling to scale from laboratory to industrial production.

Our Technology Platforms

Nucleic Acid Formulation Preparation Technology

Focuses on optimizing formulations of small interfering RNA, antisense oligonucleotides, and messenger RNA for enhanced stability and biocompatibility. Employ advanced manufacturing techniques like solid dispersion and hot melt extrusion to ensure peak performance under specific conditions.

Analytical Technology Platforms

Offer a range of high-efficiency testing techniques, including HPLC and mass spectrometry, to ensure the quality and purity of nucleic acid formulations. Utilize methods like dynamic light scattering for extensive characterization of physicochemical properties and integrity.

Our Advantages of Injectable Nucleic Acid Formulation Development

  • Custom formulation development services tailored to meet specific project needs and specifications.
  • Advanced technology platforms that increase development efficiency and success rate.
  • Multidisciplinary team support encompassing chemistry, biology, and engineering for comprehensive technical support.
  • Equipped with state-of-the-art laboratory equipment and instruments to support complex and precise formulation and measurement processes.

Publication Data

Technology: Long-acting injectable and implantable platforms

Journal: Molecular Pharmaceutics

IF: 4.55

Published: 2024

Results:

In recent years, the pharmaceutical industry has embraced strategies, adapting to the dynamic healthcare environment shaped by increased access to information and social media. Long-acting injectables (LAIs) are pivotal in this shift, reducing administration frequency and enhancing patient adherence, especially for those with HIV or schizophrenia. This study explores available LAIs across therapeutic fields, noting a rise in offerings, primarily as aqueous suspensions and solutions, alongside technologies like polymer microspheres and in situ gels. It provides insights into the characteristics and excipients typical of each formulation method.

Fig.2 Patient-focused extended-release injectable and implantable systems.Fig.2 Patient-centric long-acting injectable and implantable platforms. (Alidori S, et al., 2024)

CD Formulation boasts a strong track record in developing injectable drug formulations. Our team, adhering to the BEST philosophy (Brilliant Technology, Excellent Service, Superior Quality, and Trust), employs nanocarrier technologies, formulation expertise, and seasoned scientists to tackle your most challenging injectable formulation needs. Contact us and we will provide you with professional solutions.

References

  1. Alidori S, Subramanian R, Holm R. Patient-centric long-acting injectable and implantable platforms - an industrial perspective. Mol Pharm. 2024, 21(9): 4238-4258.
How It Works
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At CD Formulation, we understand the unique challenges and opportunities associated with nucleic acid formulation development. Our team of experts is dedicated to providing tailored solutions...

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