9063-38-1

Basic information

• Product Name: Sodium carboxyl methylstarch
• Synonyms: sodium carboxyl methylstarch;SODIUM STARCH GLYCOLATE;SODIUM STARCH GLYCOLLATE;PRIMOJEL(R);CARBOXYMETHYL STARCH SODIUM;CARBOXYMETHYL STARCH SODIUM SALT;CMS-Na;explotab
• CAS NO: 9063-38-1
• Molecular Formula: [C6H7O2(OH)2OCH2COONa]n
• Molecular Weight: 0
• EINECS: 1308068-626-2
• Mol File: 9063-38-1.mol
• Article Data: 0

Chemical Properties

• Appearance: White fine powder
• Storage Temp.: Inert atmosphere,Room Temperature
• Solubility: Practically insoluble in methylene chloride. It gives a translucent suspension in water.
• CAS DataBase Reference: Sodium carboxyl methylstarch(CAS DataBase Reference)
• NIST Chemistry Reference: Sodium carboxyl methylstarch(9063-38-1)
• EPA Substance Registry System: Sodium carboxyl methylstarch(9063-38-1)

Safety Data

• WGK Germany: 1
• Hazardous Substances Data: 9063-38-1(Hazardous Substances Data)

Usage

Description

Sodium carboxyl methylstarch, also known as sodium starch glycolate, is a starch derivative of potato origin with α1-4 short linear linkages and branched α1-6 linkages between glucose units. It is a white or almost white, fine, free-flowing, and very hygroscopic powder. Under a microscope, it is seen to consist of granules with an eccentric hilum and clearly visible concentric striations, and it shows considerable swelling in contact with water.

Uses

Used in Pharmaceutical Industry:
Sodium carboxyl methylstarch is used as a disintegrant in oral pharmaceuticals for capsule and tablet formulations, particularly in tablets prepared by either direct compression or wet granulation processes. It aids in the efficient delivery of drugs or medicaments by enhancing the disintegration and dissolution of the formulations in the gastrointestinal tract.
Used in Capsule Synthesis:
Sodium carboxyl methylstarch is also used in the synthesis of capsules for the delivery of drugs or medicaments, providing a suitable matrix for encapsulation and controlled release of the active ingredients.

Production Methods

Sodium starch glycolate is a substituted derivative of potato starch. Typically, commercial products are also crosslinked using either sodium trimetaphosphate (Types A and B) or dehydration (Type C). Starch is carboxymethylated by reacting it with sodium chloroacetate in an alkaline, nonaqueous medium, typically denatured ethanol or methanol, followed by neutralization with citric acid, acetic acid, or some other acid. Vivastar P is manufactured in methanolic medium, and Explotab in ethanolic medium.

Pharmaceutical Applications

Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations. It is commonly used in tablets prepared by either direct-compression or wet-granulation processes. The usual concentration employed in a formulation is between 2% and 8%, with the optimum concentration about 4%, although in many cases 2% is sufficient. Disintegration occurs by rapid uptake of water followed by rapid and enormous swelling. Although the effectiveness of many disintegrants is affected by the presence of hydrophobic excipients such as lubricants, the disintegrant efficiency of sodium starch glycolate is unimpaired. Increasing the tablet compression pressure also appears to have no effect on disintegration time. Sodium starch glycolate has also been investigated for use as a suspending vehicle.

Safety

Sodium starch glycolate is widely used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. However, oral ingestion of large quantities may be harmful.

storage

Tablets prepared with sodium starch glycolate have good storage properties. Sodium starch glycolate is stable although very hygroscopic, and should be stored in a well-closed container in order to protect it from wide variations of humidity and temperature, which may cause caking. The physical properties of sodium starch glycolate remain unchanged for up to 3 years if it is stored at moderate temperatures and humidity.

Incompatibilities

Sodium starch glycolate is incompatible with ascorbic acid.