| Identification | Back Directory | [Name]
Sodium carboxyl methylstarch | [CAS]
9063-38-1 | [Synonyms]
CMS-Na
explotab
Primojel
PRIMOJEL(R)
Sodium Starch g
Sodium Starch GL
Carboxy methyl starc
SODIUM STARCH GLYCOLATE
SODIUM STARCH GLYCOLLATE
Sodiumcarboxymethylstarch
SodiuM starch glycolate NF
Sodium carboxymethyl starc
CARBOXYMETHYL STARCH SODIUM
sodium carboxyl methylstarch
sodium carboxymethoxy starch
sodium starch glycolate (SSG)
Carboxyl methylstarch (sodium)
Sodium starch glycolate type B
SODIUM STARCH GLYCOLATE USP 24
SODIUM STARCH GLYCOLATE USP/NF
SodiumStarchGlycolateExtraPure
Carboxymethylstrke, Natriumsalz
CARBOXYMETHYL STARCH SODIUM SALT
SODIUMSTARCHGLYCOLATE,PH5.5-7.5,NF
Carboxy Methyl starch sodiuM (CMS)
Sodiumcarboxymethylstarchmedicinal
Starch,carboxymethylether,sodiumsalt
Carboxy methyl starch sodium (CMS), AR
Sodium carboxyl methylstarch USP/EP/BP
Sodium Starch Glycolate Type A (400 mg)
Sodium Starch Glycolate Type B (400 mg)
SODIUM STARCH GLYCOLATE (MAIZE & POTATO)
CarboTab MCR (Carboxymethylstarch sodium)
Starch, carboxymethyl ether, monosodium salt
SodiuM Starch Glycolate, pH 5.5-7.5, Type A, NF
Sodium Starch Glycolate ex. Maize (SSG) ExiPlus, Multi-Compendial | [EINECS(EC#)]
1308068-626-2 | [Molecular Formula]
C2H4O3·xNa·x | [MDL Number]
MFCD00217761 |
| Hazard Information | Back Directory | [Chemical Properties]
White or almost white, fine, free-flowing powder, very hygroscopic. | [Uses]
Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations. It is recommended to use in tablets prepared by either directcompression or wet-granulation processes. | [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. | [Regulatory Status]
Included in the FDA Inactive Ingredients Database (oral capsules
and tablets). Included in nonparenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients. |
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