Sodium Starch Glycolate
Sodium Starch Glycolate is known as a disintegrant for tablets and capsules and is also referred to as Carboxymethyl Starch or Carboxymethyl Starch Ether. This product is part of the diverse portfolio offered by Arvin Kala.
Description
Sodium starch glycolate is a white or nearly white, free-flowing, and highly hygroscopic powder. According to PhEur 6.0, microscopic examination reveals that it consists of granules that are irregularly shaped, either ovoid or pear-shaped, measuring 30–۱۰۰ µm, or rounded, measuring 10–۳۵ µm. Occasionally, compound granules made up of 2–۴ components are observed. These granules feature an eccentric hilum and clearly visible concentric striations. When viewed under crossed Nicol prisms, the granules display a distinct black cross intersecting at the hilum, with small crystals visible on their surface. The granules exhibit significant swelling upon contact with water. The structural formula of Sodium Starch Glycolate is as follows:
Applications in Pharmaceutical Formulation
 It is used as a disintegrant in both capsule and tablet formulations. Commonly, it is incorporated into tablets produced through either direct compression or wet granulation methods. Typically, the concentration used in formulations ranges from 2% to 8%, with an optimal concentration around 4%, although 2% is often adequate. Disintegration happens through the rapid absorption of water, followed by significant and rapid swelling.
While the effectiveness of many disintegrants can be compromised by the presence of hydrophobic excipients like lubricants, the efficiency of sodium starch glycolate remains unaffected. Additionally, increasing the tablet compression pressure does not seem to impact the disintegration time.
Sodium starch glycolate has also been explored for its potential use as a suspending agent.
Stability and Storage Conditions
Tablets containing sodium starch glycolate exhibit excellent storage properties. Despite its high hygroscopicity, sodium starch glycolate remains stable. To prevent caking, it should be stored in a well-sealed container, protecting it from significant fluctuations in humidity and temperature.
The physical properties of sodium starch glycolate remain stable for up to three years when stored at moderate temperatures and humidity levels.
Method of Manufacture
Sodium starch glycolate is a modified derivative of potato starch. Commercially, it is often crosslinked using either sodium trimetaphosphate (Types A and B) or through dehydration (Type C).
Starch undergoes carboxymethylation by reacting with sodium chloroacetate in an alkaline, nonaqueous medium, typically using denatured ethanol or methanol. This process is followed by neutralization with citric acid, acetic acid, or another acid. Vivastar P is produced in a methanolic medium, while Explotab is manufactured in an ethanolic medium.
Safety
Sodium starch glycolate is commonly used in oral pharmaceutical formulations and is generally considered nontoxic and nonirritating. However, consuming large amounts can be harmful.
Handling Precautions
Take standard precautions based on the specific circumstances and the amount of material being handled. Sodium starch glycolate can irritate the eyes, so it is advisable to wear eye protection and gloves. For processes that produce a significant amount of dust, using a dust mask or respirator is recommended.
Typical Properties
Specifications Table of Sodium Starch Glycolate
Below, you will find more detailed information about Sodium Starch Glycolate.
Chemical-physical values
| TEST ITEM | Unit | Specification |
|---|---|---|
|
DESCRIPTION |
|
White or almost white, fine, free-flowing powder,very hygroscopic |
|
SOLUBILITY |
|
Practically insoluble in me tlJylene chloride. It gives a translucent suspension in water |
|
SODIUM GLYCOLLATE |
% w/w |
Not more than 2.0 |
|
SODIUM CHLORIDE |
% w/w |
Not more than 7.0 |
|
IRON |
ppm |
Not more than 20 |
|
LOSS ON DRYING |
% w/w |
NMT 10.0 |
|
ASSAY |
% w/w |
NLT 2.8 &
NMT 4.2
|
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