Easily overlooked ingredients in the prescription
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- Time of issue:2021-04-26 15:49
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Easily overlooked ingredients in the prescription
(Summary description)Easily overlooked ingredients in the prescription Lubricant-magnesium stearate Magnesium stearate (MagnesiumStearate) is a mixture of magnesium stearate (C36H70MgO4) and magnesium palmitate (C32H62MgO4) as the main components. It is white, easy and sand-free The fine powder has a slight special smell, and it feels slippery in contact with the skin. Magnesium stearate is one of the most commonly used lubricants in the production of pharmaceuticals. It has or has three properties: flow aid, anti-sticking, and lubrication. The key attribute of magnesium stearate as a lubricating function is its comparative area. The larger the specific surface area, the better the lubricity. In the mixture and tablet press one
- Categories:Application Case
- Author:
- Origin:
- Time of issue:2021-04-26 15:49
- Views:
Easily overlooked ingredients in the prescription
Lubricant-Magnesium Stearate
Magnesium Stearate is a mixture of magnesium stearate (C36H70MgO4) and magnesium palmitate (C32H62MgO4) as the main components. It is a white, easy and sand-free fine powder, with a slight special smell, and it is slippery in contact with the skin. feel. Magnesium stearate is one of the most commonly used lubricants in the production of pharmaceuticals. It has or has three properties: flow aid, anti-sticking, and lubrication.
The key attribute of magnesium stearate as a lubricating function is its comparative area. The larger the specific surface area, the better the lubricity. Under certain conditions of the mixture and tablet press, the larger the specific surface area of magnesium stearate, the smaller the tensile strength of the tablets, the higher the friability, and the slower dissolution and disintegration. The specific surface area of magnesium stearate on the market is between 3~54m2/g, usually between 5~20m2/g, but this is also a considerable range. When using magnesium stearate as a lubricant, attention should be paid to the manufacturer's material quality, and the lubrication process parameters should be controlled. Pay attention to its key quality attributes, such as chemical composition, form, moisture, particle size, bulk density, specific surface area, etc.
The commonly used detection methods for specific surface area currently include "continuous flow method", "volume method", "direct comparison method", "BET multi-point adsorption method", and the BET multi-point adsorption method is a common method for testing the specific surface area of magnesium stearate. Its advantage is the BET theory. It is closer to the actual adsorption process of the substance, the range of measurable samples is wide, the test result is accurate and reliable, and it is suitable for scientific research and production units.
BP and EP magnesium stearate standards stipulated in the specific surface area measurement method and measurement conditions are as follows:
Specific surface area (2.9.26, Method I). Determine the specific surface area in the P/P0 range of 0.05 to 0.15. Sample outgassing: 2h at 40℃.
The specific surface area measurement method and measurement conditions specified in the USP Magnesium Stearate Standard are as follows:
"LABELING: Where the labeling states the specific surface area, it also indicates which method specified in Specific Surface Area (846) is used. Label to indicate that the fatty acid are derived from edible sources."
The specific surface area measurement methods specified in the above standards are all based on the BET adsorption theory to determine the specific surface area. The BP and EP methods are 2.9.26 Method I, and the USP method is General Rule 846, but which method is not specified. At present, there are no regulations and determination methods for specific surface area in the standard of magnesium stearate in the 2015 edition of the Chinese Pharmacopoeia.
If magnesium stearate is used as a lubricant, attention should be paid to the supplier’s material quality and the lubrication process parameters should be controlled. In the release quality standard of magnesium stearate. Determine its key quality attributes such as specific surface area, etc. The preparation process of magnesium stearate should also be determined and controlled. It is important to understand the lubrication process of each product, including the amount of magnesium stearate used, the method of addition, and the mixing time. And study the limits of these parameters. Evaluate the range of lubricant dosage and lubrication time, and determine their influence on product quality, such as dissolution, disintegration, weight change, content uniformity, hardness and friability. Once the lubrication process is determined, it must be accurately recorded in the batch record. Avoid using vague language, such as "Add magnesium stearate to the blender and blend for 3 minutes", as this will make the method of addition variable. Magnesium stearate is an uncertain excipient. However, if the raw materials are consistent with the production process, important attributes are monitored, and the lubrication process is determined and controlled, it can become a high-quality lubricant.
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