Sonanos^™
Hyaluronic acid nanogel

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.

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.

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.

• Sustained Release Grade:
  －Sonanos™ PG－

  Forms gel-like depot induced by physiological salt

  

• Solubility Enhancement Grade:
  －Sonanos™ DS－

  Higher degree of cholesterol modification enhances solubility

  

The Sustained Release Grade (Sonanos™ PG) forms an in situ depot induced by physiological salt, which serves as a platform for sustained API release. Using semaglutide as a model long-acting peptide, Sonanos™ PG demonstrated suppressed burst release and prolonged release duration.

• It does not use organic solvents during encapsulation of API—making it suitable even for proteins that easily lose activity in such solvents.
• It does not alter the chemical structure of API.
• It is easy to formulate with Sonanos™—requiring only a simple mixing process—and it can be sterilized by filtration.

Note: molecular weight of cyclic peptide A and B is 2,201 and 1,036, respectively.

• It can achieve solubilization with a smaller amount of excipient.
• It is applicable even to components that have traditionally been difficult to solubilize—such as large molecules with a molecular weight over 800 (e.g., poorly water-soluble peptides or TPDs).
• It demonstrates a high level of safety.

Formulation Process 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.

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 0.22 μm filter.

FAQ

• Q. What is the business model for Sonanos™?
  A. We aim to manufacture and sell Sonanos™ as a pharmaceutical excipient, primarily supplying pharmaceutical companies and receiving payment for the excipient.
• Q. Is it possible to obtain patents independently for formulations using Sonanos™?
  A. We intend to allow cusomers to acquire patents on formulations limited to customer’s proprietary APIs, except for a certain application (cancer vaccines). On the other hand, we do not intend to allow customers to acquire patents on formulation covering wide ranges of APIs that could hinder our business model, including cancer vaccines applications. We are open to adjusting the collaboration style to suit your needs within the scope of our business model. Please contact us for details.
• Q. Is technical support available for formulation development using Sonanos™?
  A. For any questions regarding the use of Sonanos™, please feel free to contact us. Our representatives will respond accordingly. We also provide User guides to support your use of Sonanos™, which are available for download from our website upon free registration.
• Q. Has Sonanos™ been used as a pharmaceutical excipient in drug products administered to humans?
  A. Sonanos™ is currently in the business development stage as a novel pharmaceutical excipient and is awaiting first-in-human studies.
• Q. Is Sonanos™ derived from animal or cell culture sources?
  A. Sonanos™ is not derived from animal or cell culture sources. For U.S. customers, we can provide a statement document based on USDA Guideline 1105. This Statement is also available for download from our website upon free registration.

Developmer & Authority

Sonanos™ is developed by a pharmaceutical excipient manufacturer with extensive experience, particularly in the manufacture and sale of microcrystalline cellulose (Ceolus™) for tablet applications, supplying both domestic and international pharmaceutical companies. For corporate information and contact details, please refer to our official website.

Research Stage & Scientific Evidence

Sonanos™ has been evaluated through extensive in vitro and in vivo formulation studies. The data shown on this page are based on internal formulation experiments conducted under controlled laboratory conditions. To interpret results appropriately, please consider differences in API properties, experimental design, and formulation conditions.

Certifications & Quality Assurance

Our quality management systems are operated in accordance with internationally recognized standards to ensure consistent product quality and reliability.

Quality Management System: ISO 9001 Certified

Pharmaceutical Quality Compliance: We intend to comply with the international GMP guideline for pharmaceutical excipients, IPEC-PQG. Additionally, to ensure safe use in injectable formulations, we plan to comply with the ICH-Q3 impurity guideline.

Documentation: Test Results (results of quality analysis), Safety Data Sheets (SDS), statement document based on USDA Guideline 1105, and technical documentation are available upon request.

Please note that all certifications and compliance statements are based on our current operational scope and applicable facilities.

Safety & Biocompatibility

We possess non-GLP safety data for Sonanos™. Please refer to the latest Posters/presentations issued for conferences, which are available for download from our website upon free registration. Unpublished data or detailed study reports may also be available upon request.

Disclaimers

All information on this website is provided in good faith and believed correct, but Asahi Kasei Corporation undertakes no obligation, liability, warranty, or other responsibility, express or implied, for its completeness or accuracy. It is the responsibility of the user to determine the suitability of the product for the intended use, and the information herein is provided only on this condition. Asahi Kasei Corporation is under no obligation whatsoever, whether express or implied, in relation to any loss or damage occurring in or arising out of the use of any product or information described herein. This website does not represent and is not to be construed as a recommendation for any application or use of products, processes, equipment, or formulations described herein which may be in conflict with any valid patent. In relation to any and all of the above, Asahi Kasei Corporation is under no obligation or liability of any nature for any loss or damage, and undertakes no warranty relating thereto.

Intended Use

Sonanos™ is primarily designed for parenteral drugs. For Sustained Release Grade “Sonanos™ PG”, subcutaneous administration is recommended. For Solubility Enhancement Grade “Sonanos™ DS”, intravenous or subcutaneous administration is recommended.

Company Information

• Founding1922

  Beginning in Shiga Prefecture (Zeze) and Miyazaki Prefecture (Nobeoka)

• Consolidated subsidiaries309 companies

  Located in approximately 40 countries worldwide

• Employees50,352

  More than 40% overseas

• Net sales¥3,037.3 billion

• Operating income¥211.9 billion

• R&D expenditure¥110.6 billion

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