Manufacturing | Timing | API consumption | Technology Comparison | Case Study

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Comparing Amorphous Solid Dispersions with our Eutectic Technology

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Choosing the optimal formulation for your drug is a critical decision. It demands careful consideration of your drug's unique properties, associated formulation development time, api consumption, and the complexities involved insubsequent GMP manufacturing. In this comparison, we explore the differences between Amorphous Solid Dispersions (ASD) and SeraNovo's innovative eutectic solvent technology. Our goal is to equip you with the knowledge necessary to make well-informed and strategic decisions for your drug development journey.
 
ASD or SeraNovo's Eutectic Solvent Technology?

 

Amorphous Solid Dispersion (ASD) is a widely used drug formulation technique designed to enhance the solubility and bioavailability of poorly soluble drugs. Through this process, the drug is dispersed in its amorphous form within a hydrophilic carrier matrix. Despite improving dissolution rates and the ability to form a supersaturated solution compared to the crystalline form, ASD has challenges. The amorphous form may be susceptible to recrystallization, particularly in high humidity conditions during manufacturing or storage, impacting its physical stability and overall system performance.

 

Moreover, ASDs are associated with higher manufacturing costs compared to SeraNovo's Eutectic Technology. This is due to the complexity of the manufacturing process, specialized equipment requirements, need for expert knowledge, and the larger amount of drug (1-2 kg) necessary for developing and manufacturing a formulation.

 

In contrast, SeraNovo's innovative Eutectic Technology tailors a liquid formulation for specifically for your drug. By incorporating strategic additives, like polymers, cosolvents, surfactants, and lipids, we can optimize the dissolution rate of the formulation. This results in a physically stable, high drug-load product with enhanced bioavailability.

 

One of the benefits of using SeraNovo's technology is that it significantly reduces the cost and time required for process transfer and manufacturing. No specialized equipment or manufacturing expertise is needed, and only a significantly lower quantity of the drug (100 g) is required for developing and producing clinical trial material.  This manufacturing approach is straightforward, cost-effective, easily scalable, and already used in approved drug products offering a more efficient solution for drug formulation production both from a technical perspective that has regulatory approval.

Simple, Cost-effective and Scalable Manufacturing 

 Amorphous Solid Dispersions 

 

 

Manufacturing ASDs involves complex techniques such as melting fusion, where components are heated, mixed and then cooled. Alternatively, spray drying and other solvent evaporation methods can be employed. These techniques often require complex machinery and specialized expertise, resulting in higher costs. Consequently, scaling up the manufacturing process becomes challenging and resource-intensive.

 SeraNovo's Eutectic Formulations 

 

 

SeraNovo has developed Eutectic Formulation Technology, which involves only two simple steps to manufacture its formulation. The required components are homogeneously mixed and heated before being filled into capsules as a  liquid formulation. This manufacturing approach is straightforward, cost-effective, and easily scalable, offering a more efficient solution for drug formulation production.

Amorphous Solid Dispersions Manufacturing Steps

SeraNovo's Eutectic Formulation Manufacturing Steps


Our Technology develops 2-3x faster than ASDs

ASD formulation development and process transfer typically take over 12 months to complete. While it is possible to expedite the process, this comes with increased risk, and most companies prefer to avoid it.

SeraNovo's Eutectic Solvent Technology expedites formulation development and process completion, typically wrapping up within a 3 months timeframe. 


Our Technology requires up to 10x less API

ASD overall production requires between 1 -2 kilograms of API and more than 100 L of organic solvents.

SeraNovo's formulation process requires only 100 grams of API for high-drug-load liquid formulations. This includes development, process transfer, and the final clinical batch—all without the use of harmful solvents, ensuring eco-friendly formulations.


Technology Comparison

Please see the summary comparing the two formulation techniques below:

 ASDSeraNovo's
Bioavailability enhancement++
Chemical stability++
Physical stability-+
Speed of Formulation development-+
Cost of manufacturing-+
API usage-+
Manufacturing capacity-+

Case Study

 


To explore the real-world impact of SeraNovo's Eutectic Formulation Technology, delve into our Atazanavir case study. The data reveals a remarkable 75% higher bioavailability compared to traditional Amorphous Solid Dispersions (ASD), showcasing the effectiveness of our innovative approach in optimizing drug formulations. Access the case study here




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