Magnesium Stearate |
Product model | Application and characteristics of preparation |
ZW-N | Smooth lubrication, strong adhesion resistance and demoulding. Less dosage can achieve better lubrication effect |
ZW-D1 | The lubrication effect is excellent, the reproduction rate of flow aid effect is high, and the usage is generally 0.1% - 1% |
ZW-S | Improve the fluidity of particles. It has little effect on the hardness, brittleness and disintegration time of the tablets. It is more suitable for aerosol and skin care cream |
*The prospect is based on the specific physical characteristics of magnesium stearate to improve the applicability advantages and improve the impact on the preparation.
Focus on improving solid preparation, with good lubricity and excellent flow aid effect
Advantage
◎ more than 90% of the tablets / capsules passed in the consistency evaluation use magnesium stearate as lubricant.
◎ the use concentration is low (0.25 ~ 5.0%) w / W, and the improvement effect is remarkable.
Main points
◎ due to its hydrophobicity, it can delay the dissolution rate of solid preparation drugs, so it is required to use the concentration as low as possible.
◎ avoid using with drugs that are incompatible with alkalinity, and pay attention to the particle size difference between API and magnesium stearate.
*Magnesium stearate is a white, precipitated or ground, hard to touch and perceptible fine powder, a mixture of magnesium stearate and magnesium palmitate in different proportions.
*Tablets and capsules are recommended as lubricants. The recommended dosage is 0.25-5.0% (w / W).
Application in pharmaceutical preparation or preparation technology
◎ magnesium stearate is hydrophobic and can block the dissolution of drugs from solid preparations; Use in the prescription and reduce the dosage as much as possible.
◎ effect on capsule: large dosage and prolonged mixing time are easy to form hydrophobic layer, which makes it difficult to disperse the contents after the capsule shell is dissolved.
◎ effect on tablets: the dissolution rate of tablets will decrease with the increase of mixing coefficient of variation. With the increase of mixing time, the dissolution rate and crushing strength of the tablets decreased and the brittleness increased.
◎ the blocking effect of magnesium stearate causes the reduction of dissolution rate, which can be eliminated by adding high expansive disintegrating agent to the prescription.
Product special purpose
◎ there are many crystal forms of magnesium stearate, and it is uncertain which crystal form of pure magnesium stearate has the best lubrication performance.
◎ the physical properties of magnesium stearate vary with the manufacturer and different batch numbers. Various physical properties of different batches of magnesium stearate, such as specific surface area, particle size, crystal structure, water content and fatty acid composition, are related to the lubrication effect.
◎ literature tips: it is forbidden to be compatible with strong acids, bases and iron salts. Avoid mixing with strong oxides. Magnesium stearate shall not be used in products containing aspirin, some vitamins and most alkaloid salts.
Zhejiang, China
