CD Formulation has professional production equipment and management experience, and has professionals with rich professional knowledge. We can customize lubricant excipients of different specifications and quality requirements, and produce corresponding products according to customer requirements.
A certain amount of lubricating material must be added to the drug particles (or powder) before tableting to increase the fluidity of the particles (or powder) and reduce the friction between the particles (or powder) and the die. It is helpful to push the tablet out of the die hole, so that the dosage of the tablet is accurate, and the surface is smooth and beautiful, such materials are generally called lubricants.
Lubricity refers to the ability to reduce the friction between the particles (or powder) or tablets and the die hole wall, so that the tableting force distribution and tablet density distribution can be uniform, so that the compressed tablet can be pushed out of the die hole At the same time, the required force is reduced, and at the same time, the wear of the die is reduced.
Anti-adhesion property refers to the ability to prevent the tableting raw materials from sticking to the surface of the punch or the wall of the die hole, so that the surface of the tablet is smooth and beautiful.
Glidability refers to the ability to reduce the friction between particles (or powder) and increase the fluidity of particles (or powder). It can smoothly flow into the die hole, and the difference in film weight is qualified.
The classification diagram of lubricants commonly used in production is as follows:
Fig.1 Classification of Lubricants
Since the hydrophobic lubricant has a certain influence on the disintegration of the tablet and the dissolution of the drug, in order to meet the requirements of preparing water-soluble tablets such as buccal tablets, effervescent tablets, etc., water-soluble or hydrophilic lubricants should be selected Agent. Commonly used water-soluble lubricants and their dosages are shown in the following table:
|Boric acid||1||Sodium chloride||5|
|Sodium benzoate||5||Sodium acetate||5|
|Sodium oleate||5||Sodium lauryl sulfate||0.5~2.5|
|Polyethylene glycol 4000||1~4||Magnesium lauryl sulfate||1~3|
|Polyethylene glycol 6000||1~4||Polyoxyethylene monostearate||1~3|
Experiments have proved that boric acid and sodium chloride are not effective in reducing friction; boric acid is not suitable for oral administration; some lubricants are expensive and not suitable for promotion. Studies in recent years have proved that magnesium lauryl sulfate has a better lubricating effect. Although it is not as good as magnesium stearate, it is better than talc, polyethylene glycol and sodium lauryl sulfate. The adverse effect of this product on tablet hardness is less than that of magnesium stearate.
This product is a white, delicate and relaxing powder with a large specific volume (1g of magnesium stearate has a volume of 10-15ml). It has good adhesion. It is evenly distributed after mixing with particles and is not easy to separate. It is the most commonly used lubricant. This product has strong lubricity, good anti-adhesion properties, and poor flow aid. If it is mixed with other lubricants, it will have better lubricity. －The general dosage is 0.25%～1%. Magnesium stearate is a hydrophobic substance. Excessive dosage can affect the disintegration time of the tablet or produce splits. When using this hydrophobic lubricant, an appropriate amount of surfactant such as sodium lauryl sulfate can be added to overcome it. Since this product contains a trace amount of alkaline impurities, drugs that are prone to change in contact with alkali (such as belladonna alkaloids, aspirin, etc.) should not be used.
This product is white to off-white crystalline powder, preferably white. High density, good anti-adhesion and flow aid, but poor adhesion and lubricity. The general dosage is 3%～6%. Sometimes it is used in combination with magnesium stearate in production, but some experiments have proved that talc has interference on the lubricating effect of magnesium stearate, so it is best not to use the same. Talc is a hydrophilic substance and does not hinder the disintegration of the tablet. This product also has a trace amount of alkaline impurities, which should be overcome by acid treatment before use.
1. Stearic acid
The usual concentration of this product is 1%～5%, with good lubricity, poor anti-adhesion, and no glidity.
2. High melting point wax
The usual concentration of this product is 3% to 5%, with good lubricity, poor anti-adhesion, and no flow aid.
3. Corn starch
The usual concentration of this product is 3%-10%, which has good flow-aiding and anti-adhesion properties, and poor lubricity.
If you have any requirements for excipients, please contact us by phone or email, and our colleagues will reply to you within 2-4 working days.