Magnesium Stearate is widely used as a lubricant at concentrations between 0.25% and 5.0% in the manufacturing of tablets, capsules and other oral dosage forms. The safety profile of Magnesium Stearate is well documented for use as excipient in pharmaceuticals, cosmetics and food.
Parmlub is produced by the reaction of stearic acid with magnesium hydroxide followed by purification, micronisation, drying and sifting. In accordance with the US and European Pharmacopoeia, it contains between 4% and 5% magnesium and a fatty acid mixture of palmitic and stearic acid. Parmlub is economically priced and derived entirely from vegetable source.
Parmlub is usually added extra granularly in tablet formulations in a concentration between 0.25% and 1.0%. In some cases, concentration of up to 5% might be necessary to achieve sufficient lubrication.
The lubricating effect of Parmlub is mainly related to its plate-like structure. If these plates are exposed to shearing forces, the layers are easily shifted and glide on each other. When added to a tablet formulation Parmlub forms a layer on the particles or granules thereby reducing the friction between tablet and die wall. Therefore, problems such as high ejection forces, sticking and picking to the punches, tablet cracking and chipping are reduced. Additionally, the wear and tear of dies and punches can be also minimised. Due to its hydrophobicity, Parmlub reduces the angle of repose of powder formulations and optimises powder flow in hopper during encapsulating and tableting processes. Parmlub can also be applied in dry granulation processes to reduce powder sticking on the rollers.
Extended mixing time with concentrations of above 1% Magnesium Stearate should be avoided, because this might lead to prolonged disintegration times and reduced tablet strength. In these cases, a disintegrant such as Ultramyl can be added to the formulation to improve disintegration time.
For tablet formulations containing poorly soluble drugs or those, where a very fast release is desired, we recommend the use of our high performance lubricant Parmlub SSF.
Packing and storage
Packing: | 10 kg fibre drum |
Shelf life: | 3 years |
Storage: | At ambient temperature, protected from moisture. |
Material Safety Data Sheet for Parmlub
Parmlub - Specifications | |
Parmlub - MSDS |