Excipient Basics - Part II
In part I we talked about magnesium stearate together with the information on Shellac and Chitosan. This time we have a deeper into the excipients Talc and Sodium Stearyl Fumarate which both also act as lubricants in tablets, capsules.
Sodium Stearyl Fumarate a pharmaceutical excipient
Sodium Stearyl Fumarate (SSF) is an?excipient?widely used in the pharmaceutical industry as a lubricant and anti-adherent in various formulations. It is a white or almost white, odorless, and tasteless powder that is soluble in water and alcohol.
Manufacturing Process of Sodium Stearyl Fumarate
Sodium Stearyl Fumarate is derived from stearic acid and fumaric acid. The process involves the esterification of stearic acid with fumaric acid in the presence of sodium hydroxide. The reaction yields sodium stearyl fumarate along with water as a by-product. The product is then purified and dried to obtain the final powder form.
Talc a pharmaceutical Excipient
Talc is a naturally occurring mineral that is commonly used in a wide range of industries, including the pharmaceutical industry. In pharmaceuticals, talc is used as a lubricant and diluent in tablet formulations, as well as a glidant in capsule formulations. It is also used as an excipient in topical and oral suspensions, and as a bulking agent in some powders.
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Sources and Manufacturing Process
Pharmaceutical grade talc is derived from high-quality talc ores that are mined from deposits around the world. The majority of talc used in pharmaceuticals is sourced from mines in the United States, China, and India. The talc ore is then processed to remove impurities and produce a fine, white powder that meets the requirements of the pharmaceutical industry.
The manufacturing process for pharmaceutical grade talc involves several steps, including crushing, grinding, and milling the ore to a fine powder. The talc is then purified through a process of flotation, where the impurities are removed using water and chemicals. The resulting talc powder is then sterilized to ensure it meets the standards required for use in pharmaceuticals.
Use in Pharmaceuticals
Talc is widely used in the pharmaceutical industry due to its unique properties, including its ability to absorb moisture, lubricate, and flow easily. It is commonly used in tablet formulations as a lubricant and diluent, which helps to improve the flow properties of the powder mixture and ensure that the tablets are easily swallowed. Talc is also used as a glidant in capsule formulations to improve the flow of the powder into the capsule.
Lubricants
Lubricant excipients are substances that are added to tablet formulations to aid in the tableting process and to improve the flow of powders during the manufacturing of tablets. These?excipients?reduce friction and prevent the sticking of the tablet material to the surface of the die and punches, allowing for smoother tablet production and reducing the wear and tear on the tableting equipment.