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By TRUNNANO | 31 October 2023 | 0 Comments

The working principle of magnesium stearate in pharmaceutical production

Magnesium stearate plays a lubricating role in drug production, which can effectively reduce the mutual friction between particles or powdered particles and enhance their fluidity, lubricity, or viscosity resistance. During the tablet pressing process, the addition of lubricant can reduce the conflict between the particles or powder and the mold, which is conducive to the smooth progress of the tablet pressing process and ensures the surface of the tablet is smoother. At the same time, the lubricant reduces the wear of the mold to a certain extent.
How does the prescribed lubricant work: the long chain molecules with active end groups in the fat are readily adsorbed on the surface of the metal or particles so that the cambium/film is formed between the covers or at the interface, which can effectively prevent the contact between the powder particles or the powder particles and the surface. Of course, we do not want it to form a continuous lubricating film because if the use of the lubricant dose is too high or the total mixing time is too long, the lubricant will be more widely covered on the surface of the particles and will gradually form a continuous lubricating film, which will lead to the weakening of the bond cooperation force between the particles, resulting in poor performance of the tablet; In addition, if more hydrophobic lubricant covers the surface of the particles, it will also affect the disintegration and dissolution rate of the tablet.
Stearic acid, magnesium stearate, and calcium stearate are hydrophobic lubricants. Among them, magnesium stearate has a good lubrication effect, is easy to mix evenly with particles, and the pressed tablet is one-sided, smooth, and beautiful. However, due to its strong hydrophobicity and contact Angle of 121°, if misused, such as excessive dosage or too long mixing time, it will cause poor pressure and slow disintegration and dissolution of tablets during the tablet pressing process.
Different types of excipients have different sensitivity to magnesium stearate. According to the deformation of the auxiliary materials after compression, the additional materials have elastic supplemental materials, plastic extra materials, and brittle supplementary materials. The sensitivity of these three excipients to magnesium stearate is in the order from large to minor: elastic excipients > plastic excipients > brittle excipients. For example, literature has studied the sensitivity of the following types of excipients to magnesium stearate, and the results show that the longer the mixing time of two kinds of direct pressure microcrystalline cellulose (PH101/PH102), pre-gelatinized starch, Cellactose80, and magnesium stearate, the greater the lubrication sensitivity. The lubrication sensitivity of spray-dried lactose and LubriToseSD was lower. To explore the reason, mainly because of the brittle material, after compression deformation, particles break smaller. They will form some surfaces not covered by magnesium stearate so that the particles can be closely combined, which can weaken the softening effect of magnesium stearate. The rough surface of plastic materials such as microcrystalline cellulose provides more adhesion points for magnesium stearate, so the longer the mixing time, the more magnesium stearate adhesion, the isolation film formed by magnesium stearate will block the binding surface, the binding force between the particles will become worse, and the compressibility of the tablet will become worse.

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