What Is Hyaluronic Acid Nanogel?

Hyaluronic acid nanogels are nanoscale, hyaluronic acid–based hydrogels that are typically spherical in shape and range from 1 to 1,000 nanometers in diameter. Owing to their three-dimensional network structure, these nanogels can encapsulate a wide variety of active pharmaceutical ingredients (APIs) within the gel matrix, serving as promising therapeutic carriers in biomedical applications.

Although most hyaluronic acid nanogels remain at the academic research stage, Asahi Kasei Corporation is actively pursuing their commercialization as a novel pharmaceutical excipient to provide pharmaceutical companies with an innovative approach to overcoming formulation challenges.

Reference:

S. S. Myint et al. Pharmaceutics 2023, 15, 2671.
https://doi.org/10.3390/pharmaceutics15122671

Formulation Challenges We Address: Limited Options to Modulate Release Profile & Poor Solubility of High MW Compounds

Drug discovery is increasingly shifting toward higher‑molecular‑weight modalities such as proteins, including CD‑targeted bispecific antibodies, and targeted protein degraders (TPDs), leading to formulation challenges like limited options to modulate release profiles and poor solubility.

Sonanos™: Cutting-Edge API Carrier to Prolong Drug Release and Enhance API Solubility

These challenges and demands in formulation research have motivated us to investigate a novel pharmaceutical excipient, Sonanos™ (hyaluronic acid nanogel). The main component of Sonanos™ is a nano-sized hydrogel particle (nanogel) capable of encapsulating a wide range of APIs—including proteins (such as CD-targeted bispecific antibodies), peptides, and low‑molecular‑weight compounds— through simple mixing in aqueous solution, without causing denaturation. Sonanos™ enables subcutaneous sustained release of APIs via in-situ depot formation and significantly enhances the solubility of poorly water-soluble APIs.

Why Can Sonanos™ Encapsulate APIs?

The main component of Sonanos™ is a nano‑sized hydrogel particle (nanogel) composed of Cholesterol‑Modified Hyaluronic Acid (CHHA). APIs are encapsulated primarily through hydrophobic interactions, whereby the API becomes entrapped within the cholesterol domains inside the nanogel.

Grade Lineup

We offer two grades. Sustained Release Grade (Sonanos™ PG) forms a depot upon exposure to physiological salt, enabling in situ subcutaneous sustained release. Solubility Enhancement Grade (Sonanos™ DS), with a higher degree of cholesterol modification, improves the solubility of poorly water‑soluble APIs and is suitable for both subcutaneous and intravenous administration.

Formulation Process of Sonanos™

Appearance & Composition of Sonanos™

We deliver Sonanos™ as a cotton-like, freeze-dried solid composed of nanogel (assembly of cholesterol-modified hyaluronic acid, CHHA) and sucrose, which can be reconstituted into a nanogel dispersion by adding water.

Typical Formulation Process for Sonanos™: Very Simple

Formulating with Sonanos™ is straightforward: the nanogel encapsulates APIs through simple mixing. First, solubilize Sonanos™ in water. Once the aqueous Sonanos™ solution is prepared, add the API and stir to encapsulate it into the particles. You may also use an isotonic agent, such as sucrose. After the formulation is obtained, sterilization can be achieved using a 0.22µm filter.

Requirements for Formulation Production Facility

No need for special facilities

Encapsulation of API into Sonanos™ can be achieved by a simple mixing process and aseptic filtration.
*Optimization of formulation process parameters may be required to improve the loading efficiency.

Recommendations for CMO (if used)

Sonanos™ does not restrict the choice of CMO, unless the Sonanos™ concentration is too high to conduct sterile filtration.

Typical Formulation Composition

Below is the typical formulation composition with a dosing volume of 1 mL when using Sonanos™. The envisioned API dose would be approximately 2.5-14mg for a 1mL dosing volume, which is the typical maximum dosing volume for subcutaneous (SC) injection.

Benefits to customers (pharmaceutical companies)

Benefits to end-users (patients)

Reduced patient
burden

Fewer injections are needed, reducing the burden on patients.

Reduced side effects

Sonanos™ is made of materials with low toxicity, which reduces concerns about side effects derived from excipients.

Improvement in
anticipated effects

Solving formulation issues, such as poor water solubility, can increase expectations for the anticipated effects of new pharmaceuticals development.

Improvement in
quality of life

Reducing the burden, anxiety and side effects on patients, and raising expectations for the development of new pharmaceuticals, will contribute to the overall improvement of patients’ quality of life.