Optimizing Drug Formulation with High Purity Sodium Stearyl Fumarate (CAS 4070-80-8)
The pharmaceutical industry's pursuit of excellence in drug formulation demands high-quality, reliable excipients. Sodium Stearyl Fumarate (SSF), identified by the CAS number 4070-80-8, is a prime example of such an excipient, offering significant advantages in various aspects of drug development and manufacturing. At NINGBO INNO PHARMCHEM CO., LTD., we specialize in providing high-purity SSF, enabling our clients to optimize their formulations for superior performance.
As a pharmaceutical lubricant, SSF plays a crucial role in the direct compression and granulation processes involved in tablet manufacturing. Its primary function is to reduce friction between the tablet formulation and the die walls and punches of the tablet press. This prevents sticking, facilitates easy ejection of the tablet, and reduces wear on machinery. Compared to traditional lubricants like magnesium stearate, SSF offers a cleaner release and a reduced tendency to form films on tooling, leading to more consistent tablet production and fewer manufacturing interruptions. The pursuit of enhanced drug formulation often starts with an optimized lubricant.
The high purity of SSF, typically exceeding 99%, ensures that it meets stringent pharmaceutical standards and minimizes potential interactions with the active pharmaceutical ingredient (API). This purity is critical for maintaining the stability and efficacy of the final drug product. Furthermore, SSF's properties contribute to improved tablet characteristics, such as enhanced hardness and a more predictable disintegration profile, which are vital parameters in drug formulation stability analysis. The choice of pharmaceutical excipient directly impacts these critical quality attributes.
Beyond its established role as a lubricant, SSF is also being explored for its potential in advanced drug delivery systems, including enteric coatings. Its unique chemical properties can be leveraged to create coatings that protect the API from the harsh acidic environment of the stomach, ensuring its targeted release in the intestines. This versatility makes SSF a valuable component for formulators aiming to develop innovative drug delivery solutions.
While SSF offers numerous benefits, formulators must be aware of its potential incompatibility with secondary amines under humid and basic conditions. However, these challenges are manageable through careful formulation design, including the implementation of moisture barriers and pH control. NINGBO INNO PHARMCHEM CO., LTD. is committed to providing not only high-quality SSF but also the technical support needed to overcome such formulation hurdles. By leveraging the advantages of high purity Sodium Stearyl Fumarate, pharmaceutical companies can significantly enhance their drug formulations, leading to more effective and patient-friendly medications.
Perspectives & Insights
Core Pioneer 24
“Sodium Stearyl Fumarate (SSF), identified by the CAS number 4070-80-8, is a prime example of such an excipient, offering significant advantages in various aspects of drug development and manufacturing.”
Silicon Explorer X
“, we specialize in providing high-purity SSF, enabling our clients to optimize their formulations for superior performance.”
Quantum Catalyst AI
“As a pharmaceutical lubricant, SSF plays a crucial role in the direct compression and granulation processes involved in tablet manufacturing.”