Sodium starch glycolate is an emulsifying chemical compound treated with sodium compounds. It serves to improve and accelerate the release of the drug into the intestine.
Sodium Starch Glycolate is a polymer derived from the glycolation of starch, typically sourced from plants like corn or potatoes. It is commonly used as a disintegrant in pharmaceutical tablets and as a thickening and stabilizing agent in cosmetics. This ingredient is valued for its ability to absorb water and swell rapidly, aiding in the disintegration of tablets and improving the consistency of cosmetic products.
Chemical Composition and Structure
Sodium Starch Glycolate consists of chemically modified starch with glycolate groups, which enhance the polymer’s water-absorbing and swelling properties. Its chemical structure is highly hydrophilic, allowing it to absorb large amounts of water and expand, making it particularly effective in pharmaceutical applications where rapid disintegration is required.
Physical Properties
It appears as a white or off-white powder, soluble in cold water. Sodium Starch Glycolate has excellent water-absorbing and swelling capacity, which makes it useful in both pharmaceutical and cosmetic products. It offers excellent stability and disperses easily in formulations.
Production Process
Sodium Starch Glycolate is produced by glycolation of natural starch, a chemical process that modifies the starch to improve its water absorption and swelling properties. The product is then neutralized with sodium to create the final form.
The name describes the structure of the molecule:
- Sodium (Na). Sodium is an alkaline metal, a group of highly reactive elements found in group 1 of the periodic table. Sodium is soft and silvery-white in color. It is highly reactive, especially with water, and is commonly found in salts and minerals. In baking soda it makes up 27.37% of the mass.
- Starch refers to a type of polysaccharide that is produced by most green plants as an energy deposit. It is a large molecule composed of many smaller glucose units linked together.
- Glycolate refers to the salt or ester of glycolic acid, a type of alpha-hydroxy acid that is often used in skin care products.
The synthesis process takes place in several stages:
Etherification. In the first phase, starch is etherified with a reagent such as monochloroacetic acid or its sodium salt in the presence of a strong alkali such as sodium hydroxide. This results in the introduction of carboxymethyl groups (-CH2-COOH) into the starch molecule.
Neutralization and washing. After etherification, the reaction mixture is neutralized, usually with hydrochloric acid. The product is then washed with alcohol to remove reagents and unreacted by-products.
Drying and grinding. The wet mass is dried, usually in an oven or using a spray dryer. After drying, the product is ground into a fine powder to produce the final product, sodium starch glycolate.
Quality control: The final product is tested to ensure it meets the required specifications. This may involve the search for parameters such as degree of replacement, pH, moisture content and particle size distribution.
What it is for and where
Sodium glycolate starch (SSG) is a pharmaceutical excipient used in oral medications for its ability to quickly disintegrate tablets and capsules that allows faster release of the medicinal active ingredient.
Medical
Together with crospovidone, croscarmellose sodium and others it is considered a super disintegrant (1).
In particular, sodium glycolate starch guarantees a rapid release of the drug thanks to its ability to fragment the layer in a few seconds (2).
Commercial applications
Pharmaceutical. It's used as a disintegrant in tablets and capsules. It helps to break the drug quickly once ingested, allowing for rapid release of the active ingredient.
Cosmetics. It can be used in cosmetic products as a thickening agent or to enhance texture.
Food. In some applications, it might be used as a thickener or stabilizer in food products.
Personal Care Products. Found in some products like shampoos and body washes to improve consistency and feel on the body.
Paper Industry. It can be used as a coating agent or as an additive to enhance paper properties.
Health and Safety Considerations
Safety in Use
Sodium Starch Glycolate is considered safe for use in pharmaceutical and cosmetic products. It is generally well-tolerated and is not known to cause significant irritation or allergic reactions, making it suitable for a wide range of applications.
Allergic Reactions
Allergic reactions to Sodium Starch Glycolate are rare. However, individuals with specific starch allergies (such as corn starch) should exercise caution.
Toxicity and Carcinogenicity
There is no evidence that Sodium Starch Glycolate is toxic or carcinogenic. It is considered safe for long-term use at recommended concentrations in both pharmaceutical and cosmetic products.
Environmental and Safety Considerations
Derived from natural sources such as corn or potato starch, Sodium Starch Glycolate is biodegradable and poses no significant environmental risks. It is a sustainable choice for use in cosmetics and pharmaceuticals.
Regulatory Status
Sodium Starch Glycolate is approved for use in pharmaceutical and cosmetic products in many regions, including the European Union and the United States, where it is regulated to ensure safe use.
To better understand the functionalities of sodium glycolate starch:
Zarmpi P, Flanagan T, Meehan E, Mann J, Fotaki N. Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants. AAPS J. 2020;22(2):46. Published 2020 Feb 11. doi:10.1208/s12248-019-0406-y
Mahesparan VA, Bin Abd Razak FS, Ming LC, Uddin AH, Sarker MZI, Bin LK. Comparison of Disintegrant-addition Methods on the Compounding of Orodispersible Tablets. Int J Pharm Compd. 2020;24(2):148–155.
Luo Q, Wu M, Sun Y, et al. Optimizing the Extraction and Encapsulation of Mucilage from Brasenia Schreberi. Polymers (Basel). 2019;11(5):822. Published 2019 May 7. doi:10.3390/polym11050822
Srivastava P, Singh M, Bhargava S. A Comprehensive Study on Fast Dispersible and Slow-Releasing Characteristic of Orange Peel Pectin in Relation to Established Synthetic Polymer. Pharmacogn Mag. 2017;13(Suppl 3):S401–S404. doi:10.4103/pm.pm_193_17
Wren SAC, Alhusban F, Barry AR, Hughes LP. Mechanistic understanding of the link between Sodium Starch Glycolate properties and the performance of tablets made by wet granulation. Int J Pharm. 2017;529(1-2):319–328. doi:10.1016/j.ijpharm.2017.07.004
References________________________________________________________________________
(1) Yousaf AM, Naheed F, Shahzad Y, Hussain T, Mahmood T. Influence of sodium starch glycolate, croscarmellose sodium and crospovidone on disintegration and dissolution of stevia-loaded tablets. Polim Med. 2019;49(1):19–26. doi:10.17219/pim/111516
Abstract. Background: Sugar substitutes are used by diabetic, obese and calorie-conscious people. As artificial sweeteners are harmful to the body, natural sweeteners are more suitable. Sugar substitutes are available on the market in tablet forms, which are added to hot or cold drinks. Rapid disintegration and dissolution of sugar substitute-loaded tablet is desired. However, the tablets should be hard enough to maintain their integrity during mechanical shocks. Objectives: The objective of this research was to develop rapidly disintegrating and dissolving stevia-loaded tablets with appropriate wetting, hardness and friability....Conclusions: The tablet consisting of stevia, crospovidone, lactose, and magnesium stearate at the weight ratio of 15/2.5/32/0.5 showed excellent results with regards to dissolution and disintegration; accordingly, this formulation could be a potential sugar substitute for diabetic, obese and/or calorie-conscious individuals.
(2) Anam Nasir, Umar Farooq Gohar, Bashir Ahmad A Review Article on Superdisintegrants ISSN: 0976-5700
Sodium starch glycolate 
