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Ophthalmic Nucleic Acid Formulation Development

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As a top collaborator in ophthalmic treatment innovation, CD Formulation excels in pioneering nucleic acid therapies for ophthalmic use. Leveraging cutting-edge technology and specialized knowledge, we offer tailored formulation development that spans from initial design to process refinement, guaranteeing products meet high standards of quality and safety.

About Ophthalmic Nucleic Acid Formulation Development

The drive to innovate in ophthalmic nucleic acid formulations stems from the need to refine current delivery systems. Innovations in polymeric micelles, nanoparticles, and advanced delivery systems such as in-situ gels and implants address these needs by improving drug retention and utilization in eye tissues, while also reducing dosage frequency and enhancing drug stability. These benefits propel ongoing research and development in the field.

Fig.1 Development of nucleic acid formulations for ophthalmic applications.Fig.1 Ophthalmic nucleic acid formulation development. (CD Formulation)

Explore Our Ophthalmic Nucleic Acid Formulation Development Services

Ophthalmic Nucleic Acid Formulation Development Services

CD Formulation has a professional quality control system and well-equipped R&D and formulation laboratories. Our scientific experts boast extensive experience in handling complex ophthalmic nucleic acid drug products and solutions as well as suspensions.

Our Expertise Includes:

  • Efficient formulation and development of ophthalmic nucleic acid preparations
  • Micro and nanoparticle formulations
  • Finished dosage form manufacturing and packaging
  • Method development, validation, and stability testing

Development of Ophthalmic Dosage Forms

Items Descriptions
Development of Solution Ophthalmic Formulations Solutions represent a fundamental ophthalmic formulation, typically comprising a drug dissolved in a suitable solvent. The primary focus is on selecting solvents that maintain drug stability and solubility, alongside careful pH and osmotic pressure adjustments.
Development of Suspension Ophthalmic Formulations Ideal for poorly soluble or controlled-release drugs, suspension development emphasizes managing particle size, ensuring stability, and minimizing sedimentation. It also involves refining the rheological properties of the suspension medium to achieve desired outcomes.
Development of Ointment Ophthalmic Formulations As a semi-solid formulation, ointment development focuses on the selection and lubrication of the base to ensure good distribution and retention of the drug in the eye. Ointment bases are usually composed of fats, waxes, and the development needs to verify their physicochemical stability.

Safety Analysis of Ophthalmic Nucleic Acid Formulation

We offer safety analysis services for ophthalmic nucleic acid formulations, including biocompatibility assessment of ingredients, monitoring of local reactions, and long-term toxicity studies. Through systematic experimental design and data analysis, we ensure that formulations meet industry safety standards and provide clients with detailed reports and recommendations.

Bioanalytical Services for Ophthalmic Nucleic Acid Formulations

CD Formulation supports bioanalysis for ophthalmic nucleic acid drug formulations, encompassing nucleic acid drug quantification, biomarker, and immunogenicity analysis. Our advanced instruments and analysis platforms provide ultra-low sensitivity required for TK/PK samples in ophthalmic drug development. Additionally, our ophthalmic scientists excel in handling rare and limited matrices, such as tears.

Scale-up Services for Ophthalmic Nucleic Acid Formulations

We formulate and develop various ophthalmic dosage forms and offer flexible filling options to accommodate formulations at different scales. Fillable containers include multi-dose bottles, vials, droppers, pre-filled syringes, cartridges, and tubes.

Our Workflow for Ophthalmic Nucleic Acid Formulation Development

Fig.2 A visual guide to developing ophthalmic nucleic acid formulations.Fig.2 Flow chart of ophthalmic nucleic acid formulation development. (CD Formulation)

  • Formulation Screening

Initial screening of formulations under laboratory conditions to select suitable excipients and ratios, optimizing physical and chemical properties of the formulation such as solubility, stability, and retention time through a series of trials.

  • Process Development

Verification of process parameters on small-scale test equipment, determination of key process steps and conditions, ensuring that formulation produced in small trials meets expected standards and provides a reliable basis for scale-up production.

  • Quality Testing

Comprehensive quality testing of small trial-produced formulations to evaluate their biocompatibility and safety, with corrections and improvements as needed to ensure compliance with relevant regulations and standards.

  • Pilot Scale-Up and Validation

Conducting scale-up production on medium-scale production equipment to validate the feasibility and stability of the process, ensuring the characteristics of the formulation remain consistent under scale-up production conditions.

Our Technology Platforms

Nucleic Acid Formulation Preparation Technology

Our platform utilizes industry-leading technology to enhance the stability and biocompatibility of formulations, ensuring that nucleic acid components maintain their structure-function relationship and stability in complex ocular environments.

Analytical Technology Platforms

Equipped with modern analytical instruments, our platform accurately measures the concentration, purity, and degradation products of nucleic acid formulations. It also supports complex bioanalysis needs, including immunogenicity and biomarker detection, to ensure nucleic acid formulations meet stringent industry standards.

Our Advantages of Ophthalmic Nucleic Acid Formulation Development Services

  • Our state-of-the-art R&D labs and seasoned scientists excel in complex ophthalmic nucleic acid formulation, streamlining development.
  • We craft diverse ophthalmic dosage forms-solutions, suspensions, nano-suspensions, and gels—to meet various drug and formulation requirements.
  • Utilizing cutting-edge instruments and comprehensive testing platforms, we conduct method development, validation, and stability testing, ensuring product quality and stability meet international standards.
  • We offer flexible production and packaging services, supporting scale-up of formulations and providing various packaging solutions to meet clients' specific needs and market strategies.

Publication Data

Technology: Complex ophthalmic formulation technologies

Journal: Journal of Drug Delivery Science and Technology

IF: 4.5

Published: 2023

Results:

The eye's intricate anatomy and its physiological barriers serve as a shield against external agents. Yet, disruptions in these defenses could harm the eye, causing discomfort or vision loss. Sophisticated ophthalmic products hold promise for addressing these issues by enhancing permeability, solubility, bioavailability, targeted administration, and minimizing dosing frequency. This review provides a comprehensive overview of ocular barriers, advanced ophthalmic solutions, their biopharmaceutical aspects, and considerations for their formulation.

Fig.3 Progress in sophisticated technologies for ophthalmic formulations.Fig.3 Advancements in complex ophthalmic formulation technologies. (Srivastava V, et al., 2023)

At CD Formulation, we excel in developing ophthalmic nucleic acid formulations with unmatched skill and accuracy. Our committed team works in partnership with clients to create unique solutions that align with top industry standards. Contact us today to see how our cutting-edge technologies and all-encompassing services can drive the success of your project and meet your specific requirements.

References

  1. Srivastava V, Chary P S, Rajana N, et al. Complex ophthalmic formulation technologies: advancement and future perspectives. J Drug Deliv Sci Technol. 2023, 82: 104317.
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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