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Product
Q. What is Sonanos™?
A. Sonanos™ is a next-generation pharmaceutical excipient primarily for injection formulations, with the ability to achieve sustained release of APIs and solubility enhancement of poorly water-soluble APIs.
Q. What is the appearance and composition of Sonanos™?
A. Sonanos™ is a cotton-like, freeze-dried solid (white to pale yellow) containing a nanogel (~50 wt%), which is an assembly of cholesterol-modified hyaluronic acid (CHHA), and sucrose (~50 wt%).
Q. What is the role of the nanogel contained in Sonanos™?
A. The nanogel can encapsulate APIs and act as a drug carrier.
Q. What is the size of the nanogel contained in Sonanos™?
A. The particle size of the nanogel is 20-100 nm, according to DLS measurements.
Q. How are APIs encapsulated in the nanogel?
A. We speculate that APIs are encapsulated in the nanogel primarily due to the hydrophobic interaction between the cholesterol domain in the nanogel and the API.
Q. Why does Sonanos™ contain sucrose?
A. Sucrose is added to prevent aggregation of the nanogel and facilitate reconstitution.
Q. How can I estimate the required amount of Sonanos™?
A. We recommend estimating the required amount of CHHA based on the target
amount of API and the recommended API/CHHA ratio provided in the latest User guides.
From there, you can calculate the necessary amount of Sonanos™.
Please note that Sonanos™ is a mixture of CHHA (approximately 50 wt%) and sucrose (approximately
50 wt%).
Q. What are the recommended storage/transportation conditions for Sonanos™?
A. Please check the SDS and User guides for the latest information.
Q. What is the difference between Sustained Release Grade “Sonanos™ PG” and Solubility Enhancement Grade “Sonanos™ DS”?
A. Sustained Release Grade “Sonanos™ PG” forms an in situ depot in response to physiological salt after subcutaneous administration above a certain CHHA concentration and serves as a platform for sustained release of APIs. Solubility Enhancement Grade “Sonanos™ DS” is suitable for intravenous administration as well as subcutaneous administration because the nanogel remains dispersed even under a physiological salt environment, and in addition, the solubility enhancement ability is enhanced by increasing the degree of cholesterol modification.
Q. What is the mechanism by which Sustained Release Grade “Sonanos™ PG” forms a depot in situ after subcutaneous administration?
A. We speculate that a salting-out process occurs in response to physiological salts when the CHHA concentration exceeds a certain threshold.
Application
Q. What modalities of compounds can Sonanos™ encapsulate?
A. Sonanos™ is capable of encapsulating a wide range of molecular modalities, including
biopharmaceuticals,
peptides, and small molecules (excluding hydrophilic small molecules). This is due to its simple
encapsulation mechanism,
in which APIs interact hydrophobically with the cholesterol domains within the nanogel.
However, the encapsulation efficiency may vary depending on the specific API. Therefore,
we recommend obtaining a sample of Sonanos™ and testing its encapsulation performance with your
compound.
Q. Can Sonanos™ encapsulate nucleic acids?
A. In many cases, encapsulating nucleic acids with Sonanos™ can be challenging. This is presumed to be due to electrostatic repulsion, as both nucleic acids and the nanogel particles possess abundant negative charges.
Q. Can Sonanos™ encapsulate cationic compounds?
A. Even cationic compounds can be encapsulated in Sonanos™, although specific formulation techniques are required for successful encapsulation. For more information on precautions when using cationic compounds, please refer to the latest User guides.
Q. Can Sonanos™ encapsulate IgG antibodies?
A. Basically it is possible, although there may be exceptions depending on the API. The User Guide for protein APIs provides examples of IgG antibody encapsulation. Please refer to the latest User guides for more details.
Q. What level of API dosage can be achieved in formulations using Sonanos™?
A. It is typically 2.5-10 mg (for Sonanos™ PG) or 3.5-14 mg (for Sonanos™ DS) per 1 mL of dosing volume, although it may differ depending on the API used. For more information on examples of formulation compositions containing Sonanos ™, please refer to the latest Posters/presentations issued for conferences or the latest User guides.
Q. What is the duration over which the API can be released when using the Sustained Release Grade “Sonanos™ PG”?
A. The duration over which the API can be released depends on various factors, including the properties of the API, formulation conditions, and the target therapeutic window. For more detailed information, please refer to the latest Posters/presentations issued for conferences. Additionally, unpublished data may be available upon request—please feel free to contact us.
Q. What is the release mechanism of APIs when using the Sustained Release Grade “Sonanos™ PG”?
A. We have conducted internal studies using model APIs and possess data that support the release mechanism. For further details, please refer to the latest Posters/presentations issued for conferences. Unpublished information may also be available upon request—please feel free to contact us.
Q. What types of poorly water-soluble compounds can be solubilized using the Solubility Enhancement Grade “Sonanos™ DS”?
A. We have confirmed solubility enhancement effects with a wide range of poorly water-soluble small molecules and peptides, particularly cyclic peptides. For more details, please refer to the latest Posters/presentations issued for conferences.
Q. When solubilizing APIs with Sonanos™ DS for intravenous administration, does Sonanos™ DS affect the pharmacokinetic (PK) profile of the API?
A. Based on our internal studies using several model APIs, the use of Sonanos™ DS appears to have minimal impact on the pharmacokinetic (PK) profile of intravenously administered APIs. For further details, please refer to the latest Posters/presentations issued for conferences. Unpublished data may also be available upon request.
Q. What are the recommended routes of administration for formulations using Sonanos™?
A. For Sustained Release Grade “Sonanos™ PG”, subcutaneous administration is recommended. For Solubility Enhancement Grade “Sonanos™ DS”, intravenous or subcutaneous administration is recommended.
Q. Can Sonanos™ be used in oral formulations?
A. While Sonanos™ may be applicable for certain oral formulations depending on the intended use, please note that its primary target application is parenteral drugs. As such, our available data on oral formulations applications are very limited. Additionally, oral formulations often have stricter cost constraints for pharmaceutical excipients. Therefore, we recommend consulting with us before initiating any development for oral use.
Q. What is the recommended sterilization method for formulations using Sonanos™?
A. We recommend sterilization by filtration. However, if the concentration of Sonanos™ (CHHA concentration) is too high, filtration may be difficult. Please refer to the recommended CHHA concentration in the latest User guides.
Core competencies & Accomplishments
Q. What are the advantages of Sonanos™ compared to other sustained release or solubility enhancement technologies?
A. Sustained release technology: Sonanos™ offers advantages such as no need for
API conjugation (vs. PEGylation), compatibility with proteins due to solvent-free processing
(vs. PLGA microspheres), and a simple formulation process.
Solubility enhancement technology: Compared to existing solubilizers, Sonanos™
provides high solubilization capacity per excipient unit, applicability to large molecules, and
excellent safety.
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. Does Asahi Kasei have experience in the pharmaceutical excipient business?
A. Asahi Kasei has extensive experience in the pharmaceutical excipient business, particularly in the manufacture and sale of microcrystalline cellulose (Ceolus™) for tablet applications, supplying both domestic and international pharmaceutical companies.
Collaboration
Q. Is it possible to obtain a sample of Sonanos™?
A. As a first step, we can provide non-GMP samples for feasibility studies under a materials transfer agreement (MTA).
Q. Is GMP-grade Sonanos™ available?
A. GMP manufacturing is planned. Please contact us for details. We intend to comply with the international GMP guideline for pharmaceutical excipients, IPEC-PQG.
Q. What is the price of Sonanos™?
A. Please contact us for pricing information.
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. Can Sonanos™ be obtained through distributors?
A. Currently, Sonanos™ is only available directly from us.
Q. Is it possible to obtain and evaluate a sample of Sonanos™ for non-pharmaceutical purposes?
A. Please contact us to discuss potential evaluation for non-pharmaceutical purposes.
Quality & Regulatory
Q. Is the Safety Data Sheet (SDS) for Sonanos™ available?
A. The SDS is available for download from our website upon free registration. For customers outside Japan, please note that this SDS is for reference only, and importers are responsible for preparing their own SDS.
Q. Is the Certificate of Analysis (COA) for Sonanos™ available?
A. Please contact us.
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.
Q. What guidelines does the GMP manufacturing of Sonanos™ follow?
A. 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. If you have requirements beyond these standards, please consult with us.
Q. Is Sonanos™ registered in a Drug Master File (DMF)?
A. Sonanos™ is not currently registered in a Drug Master File (DMF), but we are considering registration based on customer demand.
Technical Documents
Q. Are there documents available that describe general preparation protocols, evaluation protocols, or in vitro release testing methods suitable for formulations using Sonanos™?
A. We provide User guides to support your use of Sonanos™, which include general preparation and evaluation protocols. These guides are available for download from our website upon free registration.
Q. Are safety data available for Sonanos™?
A. We possess non-GLP safety data. 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.
Q. Are storage stability data available for Sonanos™?
A. We are continuously collecting storage stability data. Please refer to the latest Posters/presentations issued for conferences, available for download from our website upon free registration. Unpublished data may also be available upon request.
Formulation Protocol
Q. What precautions should be taken when handling Sonanos™?
A. Sonanos™ is hygroscopic. Please pay attention to humidity and handling conditions. For details, refer to the latest User guides.
Q. Can you provide general preparation protocols, evaluation protocols, or in vitro release testing methods suitable for formulations using Sonanos™?
A. Please refer to the latest User guides.
Q. What are the recommended CHHA concentration, API/CHHA ratio, pH, incubation temperature, incubation time, and ionic strength for formulation using Sonanos™?
A. Please refer to the latest User guides.
Q. What pH adjusters and isotonic agents are recommended for formulation using Sonanos™?
A. Please refer to the latest User guides.
Q. What sterilization filter membranes are recommended for formulations using Sonanos™?
A. Please refer to the latest User guides.