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Medicinal Nanocrystals Technology for Nucleic Acid Formulations

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Nanocrystals technology dramatically increases the surface area of a drug by reducing its particle size to the nanometer scale, resulting in significant improvements in dissolution rates and bioabsorption. CD Formulation combines a dedicated research and development team with state-of-the-art equipment to offer customized solutions to meet the requirements of various drug properties.

Advantages of Medicinal Nanocrystal Technology

Nanocrystal technology involves transforming drugs into nanoscale particles to enhance drug solubility and bioavailability. This technology is crucial for developing drugs that are challenging to dissolve, as it boosts the drug's solubility in bodily fluids by increasing its specific surface area. Recently, nanocrystal technology has also been increasingly utilized in formulating nucleic acid drugs, such as DNA, RNA, and siRNA.

Fig.1 Advantages of nanocrystal technology for nucleic acid formulations Fig.1 Advantages of medicinal nanocrystals technology. (CD Formulation)

High Safety

Nanocrystals don't require carrier delivery, minimizing surfactants and carrier materials, and reducing metabolites, resulting in high safety.

High Bioavailability

Micronization reduces drug particles to the nanometer scale, increasing surface area and solubility, enhancing adhesion, and prolonging drug action in the gastrointestinal tract.

Improvement of Drug Formulation

Applicable to Class II and IV drugs in the Biopharmaceutics Classification System (BCS), it significantly boosts solubility and bioavailability of poorly soluble drugs.

High Drug Loading Capacity

The product requires only necessary stabilizers, using the drug itself as a delivery system, achieving a high drug loading capacity.

Classification of Medicinal Nanocrystals Preparation Technology

Top-Down Technology

Top-Down technology refers to the direct micronization of the drug itself into a product. This method aims to reduce large drug particles to nanoscale particles through mechanical force. It mainly includes the media milling method, high-pressure homogenization method, and others.

Bottom-up Technology

The basic principle of Bottom-up technology is to precipitate drug nanocrystals from the supersaturated solution of the drug. This process can be achieved through methods such as solvent-anti-solvent precipitation, supercritical fluid method, solvent evaporation, and spray drying.

Combined Method Technology

The combined method is a fusion of dispersion and precipitation techniques. Typically, the precipitation method is used to create large crystals, followed by the dispersion method to regulate the product's particle size and structure, resulting in the formation of small, uniform nanocrystals.

Medicinal Nanocrystals Technology for Controlling Particle Size in Nucleic Acid Formulations

For nucleic acid formulations, CD Formulation utilizes nanocrystal technology to optimize and control the particle size of the drug, enhancing stability, bioavailability, and efficacy. The following are approaches to control particle size.

Items	Descriptions
Wet Nanosizing	Through wet processes like solvent-nonsolvent precipitation, the drug is dissolved in a suitable solvent. Non-solvents are then rapidly added through mixing to regulate particle generation and size.
High-pressure Homogenization	A high-pressure homogenizer is utilized to process the drug suspension, refining the particles and controlling their final size through intense shear force and pressure.
Ultrasonic Processing	Treatment of mixtures using ultrasonic technology can effectively break up larger particles and ensure a uniform particle size distribution.
Use of Surfactants	Adding the appropriate amount of surfactants or stabilizers during the formulation process prevents particle aggregation and maintains a stable nanocrystal suspension.
Online Particle Size Monitoring	Implementation of real-time monitoring techniques involves using particle size analyzers to monitor particle size online. Timely adjustments of process parameters are made to ensure that the particle size is controlled within the target range.

Characterization of Nucleic Acid Formulations Using Medicinal Nanocrystals Technology

Particle size and size distribution analysis

Dynamic light scattering (DLS) and transmission electron microscopy (TEM) are used to accurately measure the particle size and distribution of nanocrystals.

Crystallinity and Crystal Shape Analysis

Using X-ray diffraction (XRD), differential scanning calorimetry (DSC), and other techniques to analyze the crystallinity and crystalline changes of nanocrystals.

Surface Potential Measurement

Zeta potential analysis is used to study the surface charge of nanocrystals and assess their stability.

Morphological analysis

Scanning Electron Microscopy (SEM) and Atomic Force Microscopy (AFM) are used to observe the morphology and surface features of nanocrystals.

Chemical Composition Analysis

Infrared spectroscopy (FTIR) and nuclear magnetic resonance (NMR) are used to analyze the chemical bonding and molecular structure of the nanocrystal surface.

Highlights of Medicinal Nanocrystals Technology for Nucleic Acid Formulation Preparation

CD Formulation utilizes advanced characterization techniques to thoroughly analyze nanocrystalline formulations to ensure product stability and efficiency. Common characterization methods include DLS, TEM, DSC and XRD.
Our nanocrystalline technology enables precise control of the particle size of nucleic acid formulations, typically achieved through wet milling, high-pressure homogenization, and ultrasonic treatment.
Nanosized particles significantly enhance the dissolution rate of drugs because of their large specific surface area. This property is particularly beneficial for nucleic acid drugs with low solubility in water, like siRNA and mRNA.

Custom Nucleic Acid Formulation Development Services

CD Formulation's nanocrystalline technology offers an innovative solution for customizing nucleic acid formulations. This technology effectively addresses drug stability in vivo and optimizes drug absorption and targeting by controlling particle size and surface properties.

Oral Nucleic Acid Formulation Development

Nanocrystalline technology can reduce the particle size of nucleic acid drugs, enhancing their solubility and absorption in the gastrointestinal tract, thereby improving bioavailability.

Injectable Nucleic Acid Formulation Development

With nanocrystalline technology, nucleic acid drugs can be formed into stable nanoparticles, enhancing their stability and targeting in the bloodstream.

Ophthalmic Nucleic Acid Formulation Development

Nanocrystal technology can effectively enhance the penetration of ophthalmic nucleic acid formulations and prolong the retention time of the drug in the eye, thereby improving efficacy.

Nasal Nucleic Acid Formulation Development

The utilization of nanocrystalline technology allows for the development of nucleic acid formulations designed for nasal administration to enhance the local absorption of the drug.

Transdermal Nucleic Acid Formulation Development

Transdermal formulations developed using nanocrystalline technology can enhance the permeability of nucleic acid drugs through the skin, enabling transdermal drug delivery.

Publication Data

Technology: Preparation of drug utilizing engineered nanocrystal technology

Journal: Journal of Controlled Release

IF: 10.5

Published: 2014

Results:

Formulating nanocrystals is a powerful way to improve the delivery of poorly water-soluble drugs, a long-standing challenge for the pharmaceutical industry. Large scale production of nanocrystals is achieved by techniques such as precipitation, media milling and high pressure homogenization. Application of appropriate stabilizers and drying can make nanocrystals stable and commercially viable in the long term. Nanocrystals are highly therapeutically applicable as they can be administered by oral, parenteral, pulmonary, dermal and ocular routes. They target drug molecules to specific regions through size tuning and surface modification. In addition to the aspects of pharmaceutical nanocrystals mentioned above, this review will also detail their in vivo fate and various applications.

Fig.2 Preparation of drug utilizing engineered nanocrystal technology Fig.2 Engineered nanocrystal technology to produce drugs. (Pawar V K, et al., 2014)

CD Formulation offers a comprehensive range of modern and scientific solutions for developing nucleic acid formulations using cutting-edge pharmaceutical nanocrystal technology. Please don't hesitate to contact us for further information on how our nanocrystal technology can be utilized in your project to achieve advancements in your nucleic acid formulations.

References

Pawar V K, Singh Y, Meher J G, et al. Engineered nanocrystal technology: in-vivo fate, targeting and applications in drug delivery. J Control Release. 2014, 183: 51-66.

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