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Sodium Stearyl Fumarate Role in Formulation Development


Sodium stearyl fumarate is increasingly preferred over magnesium stearate as a lubricant in the formulation of certain drugs


I’m thrilled to share some insights into why sodium stearyl fumarate is becoming the go-to lubricant in tablet formulations, surpassing traditional options like magnesium stearate for Certain drugs. Here are the reasons for this preference:


1. Enhanced Compatibility: Sodium stearyl fumarate is pH-independent, making it ideal for active ingredients sensitive to pH levels. This compatibility ensures that formulations maintain their integrity and effectiveness.


2. Improved Dissolution Rates: This lubricant is more hydrophilic than magnesium stearate, which means it enhances the wettability of tablets. As a result, we see faster disintegration and dissolution, leading to better bioavailability of the active ingredients.


3. Fewer Drug-Excipient Interactions: Sodium stearyl fumarate minimizes adverse interactions with drugs, which is crucial for maintaining the quality of sensitive formulations. Unlike magnesium stearate, it helps prevent issues like lamination and adhesion during tablet production.


4. Superior Mechanical Properties: Tablets formulated with sodium stearyl fumarate exhibit greater hardness at similar compression forces. This results in stronger tablets that are less prone to breakage during handling and transport.


5. Lower Residue: Its semi-soluble nature leads to lower residue in solutions, making it a fantastic choice for formulations where clarity and purity are paramount as for effervescent tablets.


These advantages make sodium stearyl fumarate a preferred choice for specific drugs, particularly those that require enhanced compatibility, improved dissolution profiles, and better mechanical properties.


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Resource Person:  Jamal Jameel

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