Excipient Basics - Part I

What have Magnesium Stearate, Shellac and Chitosan have in common? They are part of over 300 excipients used in the pharmaceutical industry. At an earlier stage I shared an introduction on Microcrystalline Cellulose and worked on some further excipients in the meantime. In this week′s edition we cover some basic information on further excipients. Hope you like the read and please get in touch for any improvements and things to be added so everybody get′s most out of it.

Chitosan as a pharmaceutical excipient

Chitosan is a biopolymer derived from chitin, a natural polymer found in the shells of crustaceans such as shrimp, crabs, and lobsters. It is a linear polysaccharide composed of randomly distributed β-(1→4)-linked D-glucosamine (deacetylated unit) and N-acetyl-D-glucosamine (acetylated unit). Chitosan has a range of applications due to its unique physical and chemical properties, including its ability to form films, gels, and beads, and its biocompatibility.

Chitin can also be extracted from insects or mushrooms. But these types of raw material are not used in pharmaceuticals sector yet, due to a lack of information (safety, impurities profile).

The properties of chitosans can be modified by varying the degree of deacetylation, molecular weight, and other factors during the production process. It is important to know / to specify parameter like degree of deacetylation, viscosity and/or molecular weight to achieve consistent properties as excipient. Continue reading here

Shellac a pharmaceutical Excipient

Shellac is a natural resin that is widely used in the pharmaceutical industry as a?coating?material for tablets and capsules. It is derived from the secretions of the female lac insect, which feeds on certain trees in Southeast Asia and India. Shellac has been used for centuries in a variety of applications, including as a varnish, food glaze, and adhesive. In the pharmaceutical industry, shellac is highly valued for its ability to provide a protective coating for drugs that are sensitive to moisture, light, or air.

Description of Shellac by drugs.com –?Excipient (pharmacologically inactive substance)

“Shellac is composed of hydroxyaliphatic acids and alicyclic acids. Shellac has been used in the pharmaceutical industry as a tablet coating, often for enteric coating on tablets. In the cosmetics industry, shellac has been used in mascara, hair spray, nail polish and eyeliner. Traditionally, shellac has been used in the furniture industry as a wood or paint sealant.

The median lethal dose for shellac has been found to be more than 5 grams per kilogram, many more times than what the average consumer might be exposed. Toxicity studies in animals have shown no adverse effects from oral, dermal, ocular or respiratory tract exposure to formulations containing up to 6 percent shellac. Mutagenicity, irritation, sensitization and photosensitization were not seen in clinical analysis of cosmetic formulations containing up to 6 percent shellac. However, reports from 2011 note cases of allergic contact dermatitis in the eye area of those who used certain cosmetics, such as mascara.” Continue reading here

Magnesium Stearate a pharmaceutical exicpient

Magnesium stearate, also known as magnesium octadecanoate, is a common additive used in the pharmaceutical industry. It is a white, odorless, and tasteless powder that is highly insoluble in water, but soluble in organic solvents. The chemical formula for magnesium stearate is Mg(C18H35O2)2.

Manufacturing of Magnesium Stearate

Magnesium stearate can be derived from various sources such as animal, vegetable, and synthetic materials. Animal-derived magnesium stearate is usually sourced from beef or pork tallow, while vegetable-derived magnesium stearate is obtained from hydrogenated cottonseed or palm oil. Synthetic magnesium stearate is produced by combining magnesium oxide or magnesium hydroxide with stearic acid. Continue reading here