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Sodium Stearyl Fumarate CAS 4070-80-8

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  • Appearance: White powder
  • Purity: 99. 0%min
  • Stock: In stock
  • Sample: Available
  • Zhishang Chemical: Sodium Stearyl Fumarate Supplier & Manufacturer

Basic Info

What is Sodium Stearyl Fumarate?

Sodium stearyl fumarate is obtained by reacting stearyl alcohol with maleic anhydride, and then isomerizing the reaction product to form a salt. Sodium stearyl fumarate is a hydrophilic lubricant used as a lubricant in pharmaceutical excipients. It can overcome many problems related to magnesium stearate, such as the main drug being affected and excessive lubrication; in effervescent tablets Forming a protective film in the product can improve disintegration and promote dissolution, thereby improving bioavailability.

Sodium stearyl fumarate is produced by ring-opening esterification of maleic anhydride and stearyl alcohol, and then through isomerization reaction to form a salt. Sodium stearyl fumarate has strong compatibility and is often used not only in pharmaceutical preparations, but also as a lubricant for tableting to improve tablet strength, disintegration and dissolution caused by the traditional lubricant magnesium stearate. Disadvantages: It is widely used in food and chemical products.

Sodium Stearyl Fumarate Uses

Sodium stearyl fumarate (C22H39NaO4) is a widely used and important pharmaceutical and food excipient. During the metabolism of sodium stearyl fumarate in animals, most of it can be absorbed and hydrolyzed to produce stearyl alcohol and stearic acid. A small part can be directly and quickly metabolized, and it is non-toxic and non-irritating.

In the pharmaceutical field, sodium stearyl fumarate is added to pharmaceutical preparations. It can be used as a lubricant for tablets and capsules. It can also form a protective film in effervescent tablets, which can solve the problem of stearate lubricants. existing problems, and can improve drug disintegration and promote drug dissolution.

In the food field, the FDA allows sodium stearyl fumarate to be used as a regulator and stabilizer to be directly added to foods for human consumption, such as various baked goods, flour thickened foods, dried potatoes and processed grains, etc. Its addition amount can account for 0.2 to 1.0% of the food weight.

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Application Comparison of Sodium Stearyl Fumarate and Magnesium Stearate

Sodium stearyl fumarate and magnesium stearate have similar applications in preparations, and are mainly used as lubricants in tablets and capsules. But unlike magnesium stearate, it is compatible with most APIs and is an excellent substitute for magnesium stearate. Magnesium stearate is the most commonly used lubricant, but due to incompatibility with strong acids, strong bases and iron salts, it is used in carboxyl-containing drugs such as aspirin, nifedipine, some vitamins and most alkaloid pharmaceutical preparations. Out of service. Sodium stearyl fumarate can well solve the incompatibility problem of magnesium stearate.

Due to its hydrophobic properties, magnesium stearate will prevent the dissolution of the drug from the solid dosage form during the preparation process. Therefore, its concentration should be reduced as much as possible in the prescription, especially in direct powder tableting prescriptions. The dosage of magnesium stearate generally does not exceed 0.5%, otherwise a softening effect will occur on the tablets. During the tableting process, increased mixing time of magnesium stearate and tablet particles can cause tablet dissolution, friability, and hardness to decrease. Likewise, in capsule formulations, high amounts of magnesium stearate or mixing times that are too long can form a bed of hydrophobic powder, preventing the contents from dispersing after the capsule shell dissolves. Sodium stearyl fumarate has stronger hydrophilicity, which can not only improve drug dissolution and bioavailability, but also greatly improve the problem of reduced stability of preparations caused by prolonged mixing time. In addition, sodium stearyl fumarate has a much smaller effect on drug dissolution than magnesium stearate due to the increased amount of lubricant.

Magnesium stearate will form a large amount of insoluble foam during the effervescent process of effervescent tablets, which seriously affects the appearance and taste; during the disintegration process of orally disintegrating tablets, too much insoluble material or too long disintegration time will often affect the patient’s medication experience. . Sodium stearyl fumarate can not only improve the foam generated during the effervescence process of effervescent tablets, reduce insoluble substances, but also improve the disintegration efficiency.

Application of Sodium Stearyl Fumarate

References

  1. Sodium stearyl fumarate – PubChem
  2. Determination of heavy metal lead content in pharmaceutical excipients sodium stearyl fumarate using atomic absorption spectrophotometry

Sodium Stearyl Fumarate Supplier and Manufacturer

As a sodium stearyl fumarate supplier and manufacturer with a strict standard product quality system certificate, Zhishang Chemical has long been providing the best sodium stearyl fumarate raw materials to customers all over the world.

Over the years, relying on professional team experience and customer-centric team concept to meet customer needs in a timely manner, our company enjoys a high reputation in the world. At present, our company has served more than 6,000 customers and has established long-term cooperative relations with customers from many countries.

If you have a demand for sodium stearyl fumarate and related products, please contact our service staff Zhishang Chemical – White directly, and we will provide you with high-quality products at the best price.

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