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SODIUM STARCH GLYCOLATE

Sodium starch glycolate is manufactured in methanolic medium, and Explotab in ethanolic medium.
Sodium starch glycolate is a pharmaceutical excipient commonly used in the formulation of oral solid dosage forms such as tablets and capsules. 
Sodium starch glycolate is a white, odorless, and tasteless powder derived from starch, typically sourced from corn, potato, or wheat.

CAS Number: 9063-38-1
Molecular Formula: C2H4O3·xNa·x
EINECS Number: 618-597-7

SODIUM STARCH GLYCOLATE TYPE A, CARBOXYMETHYL STARCH SODIUM SALT, COVAGEL, SODIUM CARBOXYMETHYL STARCH, SODIUM STARCH GLYCOLATE, SODIUM STARCH GLYCOLATE (TYPE A) [EP MONOGRAPH], SODIUM STARCH GLYCOLATE TYPE A [USP-RS], SODIUM STARCH GLYCOLATE TYPE A, UNSPECIFIED SOURCE, SODIUM STARCH GLYCOLATE [II], SODIUM STARCH GLYCOLATE [JAN], SODIUM STARCH GLYCOLLATE, STARCH, CARBOXYMETHYL ETHER, SODIUM SALT, Sodium starch glycollate [WHO-DD], H8AV0SQX4D.

Sodium starch glycolate is preferred over other disintegrants in certain formulations due to its high efficiency, fast disintegration time, and compatibility with a wide range of drug substances and excipients.
Sodium starch glycolate is also chemically stable, inert, and generally well-tolerated, making it suitable for use in pharmaceutical products intended for oral administration.
Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations. 

Sodium starch glycolate is a white or almost white free-flowing very hygroscopic powder. 
The PhEur 6.0 states that when examined under a microscope Sodium starch glycolate is seen to consist of: granules, irregularly shaped, ovoid or pear-shaped, 30–100 mm in size, or rounded, 10–35 mm in size; compound granules consisting of 2–4 components occur occasionally; the granules have an eccentric hilum and clearly visible concentric striations. 
Between crossed nicol prisms, the granules show a distinct black cross intersecting at the hilum; small crystals are visible at the surface of the granules. 

The granules show considerable swelling in contact with water.
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 Sodium starch glycolate 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. 
Sodium starch glycolate belongs to the class of disintegrants, which are additives that promote the rapid breakup or disintegration of tablets or capsules in the gastrointestinal tract upon oral administration. 
This rapid disintegration allows for the release and dissolution of the active pharmaceutical ingredient(s) (APIs) for absorption in the body.

The mechanism of action of Sodium starch glycolate involves its ability to rapidly swell and absorb water upon exposure to aqueous environments, such as the gastric fluids in the stomach. 
This swelling action generates internal pressure within the dosage form, leading to mechanical disruption and fragmentation of the tablet or capsule into smaller particles. 
As a result, the surface area of the dosage form increases, facilitating the dispersion and dissolution of the APIs for absorption into the bloodstream.

Sodium starch glycolate 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. 
Sodium starch glycolate occurs by rapid uptake of water followed by rapid and enormous swelling.

Although the effectiveness of many disintegrants is affected by the presence of Sodium starch glycolate 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.

Sodium starch glycolate is a commonly used super-disintegrant employed to promote rapid disintegration and dissolution of IR solid dosage forms. 
Sodium starch glycolate is manufactured by chemical modification of starch, i.e., carboxymethylation to enhance hydrophilicity and cross-linking to reduce solubility.
Sodium starch glycolate is the sodium salt of carboxymethyl ether. 

Sodium starch glycolates are of rice, potato, wheat or corn origin. 
Sodium starch glycolate is a white to off-white, tasteless, odorless, relatively free flowing powder. 
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 

Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. 
Sodium starch glycolate is used as a disintegrant, a suspending agent and as a gelling agent. 
Without a disintegrant, tablets may not dissolve appropriately and may affect the amount of active ingredient absorbed, thereby decreasing effectiveness. 

Sodium starch glycolate is a pharmaceutical excipient and superdisintegrant composed of the sodium salt of cross-linked carboxymethyl starch. 
Sodium starch glycolate is widely recognised in the pharmaceutical industry for its adaptability and compatibility with many active pharmaceutical ingredients, and processing technologies. 
Sodium starch glycolate is supplied as a white or almost white, free-flowing very hygroscopic powder.

Sodium starch glycolate Market is expected to develop at a significant rate. 
Carboxymethylating starch from diverse sources, such as potato, corn, rice, and wheat, yields Sodium starch glycolate. 
Because of its capacity to absorb water quickly, it is commonly employed as a disintegrant in the formulation of tablets and capsules. 

Sodium starch glycolate is made mostly from potato and corn starch. 
Sodium starch glycolate is used in wallpaper adhesives and food goods such as snacks, meat products, and juices as a thickening and stabilizer. 
Due to the high number of car manufacturers, the comeback of the automobile industry is predicted to increase demand for adhesives. 

Because of its cost-effectiveness, the use of sodium carboxymethyl starch in Sodium starch glycolate has increased. 
Because of changing lifestyles and an aging population, the number of noncommunicable diseases such as cardiovascular, high blood pressure, and chronic respiratory diseases is expected to rise. 
Because of expanding health awareness and longer life expectancies among customers around the world, its use in the pharmaceutical sector is increasing. 

The pharmaceutical business is seeing an increase in demand for the product as chronic diseases become more prevalent as a result of changing lifestyles and stressful work schedules. 
Sodium starch glycolate is a white to off-white, tasteless, odorless, relatively free flowing powder. 
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 

Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. 
Sodium starch glycolate is used as a disintegrant, a suspending agent and as a gelling agent. 
Without a disintegrant, tablets may not dissolve appropriately and may affect the amount of active ingredient absorbed, thereby decreasing effectiveness.

Sodium starch glycolate is a white, odourless, and tasteless powder that is used in some personal care and oral care products.
Sodium starch glycolate's typically derived from processing vegetable starches, such as corn, wheat or potatoes.
When used in toothpaste tablets, sodium starch glycolate helps the tablet to rapidly disintegrate and release its active ingredients upon contact with saliva. 

This ensures that the toothpaste is delivered efficiently to the teeth and gums, allowing for maximum effectiveness.
Sodium starch glycolate is biodegradable and is also approved for use in food products. 
When combined with other ingredients, such as baking soda, silica, and essential oils, this ingredient helps to create a gentle and effective toothpaste that promotes oral health and sustainability.

Sodium starch glycolate is derived from potato. 
Sodium starch glycolate is also known as Carboxymethyl Ether Sodium Salt. 
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 

Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. 
Sodium starch glycolate is used as a disintegrant, a suspending agent and as a gelling agent.
Sodium starch glycolate is the sodium salt of carboxymethyl ether. 

Sodium starch glycolates are of rice, potato, wheat, or corn origin. 
Sodium starch glycolate is a white to off-white, tasteless, odorless, relatively free flowing powder. 
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 

A disintegrant, a suspending agent and as a gelling agent, Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 
Sodium starch glycolate takes up more than 20 times its own weight of water. 
Reference standards of Sodium Starch Glycolate API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.

Sodium starch glycolate is used as a pharmaceutical-grade dissolution agent and super disintegrant which is produced from corn or potato starch. 
Sodium Starch Glycolate is spherical granules that absorbs water rapidly and swell up.
Sodium Starch Glycolate can be added in capsules and tablets to let them dissolve better and making it easier to absorb. 

PCSPL is manufacturing Sodium Starch Glycolate which is well-suited for use in tablets and capsules, matching all the international standards.
Sodium starch glycolate can be used in the synthesis of capsules for delivery of drugs or medicaments. 
Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations.

Sodium starch glycolate is the sodium salt of a carboxymethyl ether of starch. 
Sodium starch glycolate is widely used as a pharmaceutical grade dissolution excipient for tablets and capsules.  
Sodium starch glycolate absorbs water rapidly. 

The reason is by absorbing water quickly so the pill swells and breaks apart into small pieces. 
Sodium starch glycolate can also be used to help form gels. 
By this way it will swell and accelerate the disintegration of tablets and granules. 

Sodium starch glycolate consists of oval or spherical granules, 30-100 μm in diameter with some less-spherical granules ranging from 10-35 μm in diameter. 
Sodium starch glycolate can be made from several different starchy foods, for example corn, wheat, rice and potatoes.
Sodium starch glycolate is an off-white, odourless, tasteless, free-flowing sodium salt of carboxymethyl ether powder. 

Sodium starch glycolate is made from corn or potato starch and is used as a pharmaceutical-grade dissolving agent and super disintegrant.
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules.
Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. 

Sodium starch glycolate is used as a disintegrant, a suspending agent and as a gelling agent. 
Pharmaceutical companies add sodium starch glycolate to capsules and tablets to help make them disintegrate and dissolve better, making it easier for your body to absorb the medication. 
Sodium starch glycolate does this by absorbing water quickly so the pill swells and breaks apart into small pieces. 

Sodium starch glycolate can also be used to help form gels.
Sodium starch glycolate, commonly referred to as Sodium stannate trihydrate, is an inorganic metal oxide containing Sodium, an alkali metal. 
Sodium starch glycolate is supplied by Actylis in the form of a white water soluble powder. 

This versatile Sodium starch glycolate finds extensive applications across multiple industries.
Sodium starch glycolate has exhibited anti-cancer and anti-oxidant activity, along with demonstrating anti-inflammatory properties.
Sodium starch glycolate is frequently utilized as a catalyst in the synthesis of various other compounds. 

Moreover, Sodium starch glycolate plays a crucial role in the modification of glassy carbon electrodes used in analytical chemistry. 
Additionally, Sodium starch glycolate serves as both a raw material and a reagent in the synthesis of metallic compounds, nanomaterials, and pharmaceuticals.
Sodium starch glycolate is a very fine free flowing powder that is white or off white in color and has almost no odor. 

Its property of insolubility is remarkable, with complete insolubility in most organic solvents, and even in water. 
Sodium starch glycolate is a sodium salt of carboxyl ether of starch, and is appreciated for its stability and binding properties. 
Sodium starch glycolate finds much usage in pharmaceutical industry, to disintegrate tablet formulations & capsules and in tablets that employ wet-granulation or direct compression processes.

Sodium starch glycolate is chemically derived from starch, a polysaccharide carbohydrate found in plants. 
Sodium starch glycolate undergoes a modification process called carboxymethylation, in which carboxymethyl groups are introduced into the starch molecule. 
This modification increases the water solubility and swelling capacity of the starch, enhancing its disintegrating properties.

Sodium starch glycolate is available in various grades and types, including Type A and Type B. 
Type A is derived from potato starch and is typically used in acidic pH formulations, while Type B is derived from corn starch and is suitable for use in both acidic and alkaline pH environments.
The production of sodium starch glycolate involves several steps, including starch purification, carboxymethylation, and drying. 

Sodium starch glycolate is first purified to remove impurities and then chemically modified through the carboxymethylation reaction, which introduces carboxymethyl groups into the starch molecule. 
The resulting product is then dried and milled to produce a fine powder suitable for pharmaceutical applications.
Sodium starch glycolate is compatible with a wide range of pharmaceutical dosage forms, including immediate-release tablets, delayed-release tablets, and orally disintegrating tablets (ODTs). 

Sodium starch glycolate can also be used in granules, powders, and capsules to improve disintegration and dissolution characteristics.
As a disintegrant, sodium starch glycolate facilitates the rapid breakup of tablets or capsules into smaller particles upon exposure to aqueous fluids, such as saliva or gastric fluids. 
This disintegration process enhances drug release and absorption, leading to faster onset of action and improved bioavailability of the active ingredient(s).

Sodium starch glycolate is listed as an approved pharmaceutical excipient by regulatory authorities such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). 
Sodium starch glycolate complies with stringent quality standards and specifications for purity, potency, and safety.
Sodium starch glycolate should be stored in a dry, cool, and well-ventilated environment, away from moisture and direct sunlight, to prevent degradation and maintain its physical and chemical stability.

Proper handling practices should be followed to avoid contamination and ensure product integrity.
Sodium starch glycolate is generally regarded as safe for use in pharmaceutical formulations when used at recommended levels. 

Sodium starch glycolate has a low potential for toxicity and is not known to cause adverse effects when administered orally. 
However, individuals with known allergies to starch or related compounds should exercise caution when using products containing sodium starch glycolate.

Melting point: >210°C (dec.)
storage temp.: Inert atmosphere,Room Temperature
solubility: Practically insoluble in methylene chloride. It gives a translucent suspension in water.
color: White to Off-White

Pharmaceutical companies add Sodium starch glycolate to capsules and tablets to help make them disintegrate and dissolve better, making it easier for your body to absorb the medication. 
Sodium starch glycolate does this by absorbing water quickly so the pill swells and breaks apart into small pieces. 
Sodium starch glycolate can also be used to help form gels.

Sodium starch glycolate is most widely used excipient in the field of pharmaceutical sciences. 
Sodium starch glycolate is extensively used as a superdisintegrant in different drug formulations. 
This review article aims to discuss chemistry, synthesis, level used as superdisintegrant, different types of Sodium starch glycolate’s and various physicochemical properties. 

Sodium starch glycolate available as different brands i.e Primojel, Explotab and Vivastar with different properties. 
Excipient, generally considered as an inert component, are of great importance in drug product development. 
Interchange between different suppliers can lead to final products with different quality attributes.

Sodium starch glycolate is a pharmaceutical ingredient used primarily as a dissolution excipient for tablets and capsules. 
Sodium starch glycolate also works as a disintegrant and a gelling agent. 
The use of Sodium Starch Glycolate in drugs and dietary supplement products has been shown to increase the effectiveness of active ingredients as the compound helps improve overall bioavailability.

Sodium starch glycolate is the sodium salt of a carboxymethyl ether of starch or of a cross-linked carboxymethyl ether of starch. 
Sodium starch glycolate may contain not more than 7.0 percent of Sodium Chloride. 
The pH and assay requirements for Type A and Type B are set forth in the accompanying table.

Sodium starch glycolate is a superdisintegrant for pharmaceutical applicationbs such as swallowable tablets, orally dispersible tablets and hard capsules. 
Sodium starch glycolate absorbs water quickly so the pills swell and can also be used to help form gels.
The increased tablet compression pressure also appears to have no effect on the disintegration time.

In spite of the presence of hydrophobic in excipients such as lubricants, the disintegrates the efficiency of sodium starch glycolate is unimpaired.
Sodium starch glycolate has good flowability and remarkable mixing properties.
Sodium starch glycolate is a superdisintegrant for pharmaceutical and nutraceutical swallowable tablets, orally dispersible tablets and hard capsules. 

Features Different grades designed to meet specific needs: Withstanding high shear granulation Acidic conditions Low organic solvent content
Sodium starch glycolate comprises spherical granules that absorb water quickly and swell.
Sodium starch glycolate improves good flowability and mixing properties.

Sodium starch glycolate works as a dissolution enhancer.
Sodium starch glycolate works as a food stabiliser and as an anti-ageing agent for bread and in the manufacturing of ice-creams.
Sodium starch glycolate works as a disintegrant, a suspending agent, and as a gelling agent.

Sodium starch glycolate is recommended that it should be used at a concentration of 6%.
Sodium starch glycolate is nearly insoluble in water and most organic solvents.
Sodium starch glycolate is the sodium salt of carboxymethyl ether. 

Starch glycolates are of rice, potato, wheat or corn origin. 
Sodium starch glycolate is a white to off white, tasteless, odorless, relatively free flowing powder.
Sodium starch glycolate is a white, odourless, and tasteless powder that is used in some personal care and oral care products. 

Sodium starch glycolate's typically derived from processing vegetable starches, such as corn, wheat or potatoes.
When used in toothpaste tablets, sodium starch glycolate helps the tablet to rapidly disintegrate and release its active ingredients upon contact with saliva. 
This ensures that the toothpaste is delivered efficiently to the teeth and gums, allowing for maximum effectiveness.

Sodium starch glycolate is biodegradable and is also approved for use in food products. 
When combined with other ingredients, such as baking soda, silica, and essential oils, this ingredient helps to create a gentle and effective toothpaste that promotes oral health and sustainability.
Sodium starch glycolates, are superdistintegrants made from potato starch by carboxymethylation and crosslinking for tablets and other oral solid dosage forms. 

Their unique combination of performance and cost-effectiveness has established them as globally recognized and widely used products in the pharmaceutical industry.
Sodium starch glycolate demonstrate strong swelling properties upon contact with water and other media. 
These highly pure excipients retain their spheroid structure to promote good flow, contain little sodium chloride or ethanol, and have high brightness.

Sodium starch glycolate functions primarily as a disintegrant in pharmaceutical formulations. 
Upon contact with aqueous fluids, such as saliva or gastric fluids, sodium starch glycolate undergoes rapid hydration and swelling. 
This leads to an increase in volume and internal pressure within the tablet or capsule, resulting in mechanical disruption and fragmentation of the dosage form into smaller particles. 

The increased surface area facilitates the dissolution and release of the active pharmaceutical ingredient(s) for absorption in the gastrointestinal tract.
The disintegration time of tablets or capsules containing sodium starch glycolate can vary depending on factors such as formulation composition, tablet hardness, and environmental conditions. 
Generally, sodium starch glycolate exhibits rapid disintegration properties, with disintegration times ranging from a few seconds to a few minutes. 

This rapid disintegration is desirable for ensuring timely drug release and absorption in the body.
Sodium starch glycolate is compatible with a wide range of pharmaceutical excipients commonly used in tablet and capsule formulations. 
Sodium starch glycolate can be used in combination with binders, lubricants, fillers, and coatings without compromising its disintegrating properties or overall formulation integrity. 

This versatility allows formulators to tailor dosage forms to specific drug delivery needs and manufacturing requirements.
The disintegrating efficacy of sodium starch glycolate is dose-dependent, meaning that higher concentrations of the excipient in the formulation can lead to faster disintegration times. 
However, excessive use of sodium starch glycolate may result in over-rapid disintegration, leading to tablet friability or loss of tablet integrity. 

Therefore, careful optimization of the Sodium starch glycolate concentration is necessary to achieve the desired disintegration profile while maintaining tablet quality.
Sodium starch glycolate is included in the monographs of major pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). 
These pharmacopeial standards provide specifications for the quality, purity, and performance of sodium starch glycolate, ensuring consistency and reliability in pharmaceutical formulations worldwide.

Manufacturers of Sodium starch glycolate adhere to strict quality control measures and conduct comprehensive testing to ensure compliance with regulatory standards and customer requirements. 
Quality control tests may include assessment of particle size distribution, moisture content, bulk density, solubility, and disintegration performance. 
Batch-to-batch consistency is crucial to maintaining product efficacy and reliability.

While sodium starch glycolate is widely used as a disintegrant in pharmaceutical formulations, alternative disintegrants such as croscarmellose sodium (CCS) and crospovidone (CP) may be employed based on formulation considerations and performance requirements. 
Each disintegrant offers unique characteristics and advantages, allowing formulators to optimize disintegration profiles for specific drug products and patient populations.

Uses Of Sodium starch glycolate:
Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in capsule and tablet formulations. 
Sodium starch glycolate is recommended to use in tablets prepared by either directcompression or wet-granulation processes.
Sodium starch glycolate is a starch of potato origin with α1-4 short linear linkages and branched α1-6 linkages between glucose units. 

Sodium starch glycolate is used in the synthesis of capsules for delivery of drugs or medicaments.
Sodium starch glycolate is often used in the formulation of pediatric and geriatric dosage forms, where ease of swallowing and rapid drug release are essential. 
Its ability to promote fast disintegration makes it suitable for use in formulations targeted towards these populations, who may have difficulty swallowing large tablets or capsules.

Sodium starch glycolate can be incorporated into combination drug products containing multiple active ingredients. 
Sodium starch glycolate helps ensure uniform dispersion and dissolution of all components within the dosage form, allowing for consistent drug release and therapeutic efficacy.
While sodium starch glycolate is primarily used in immediate-release formulations, it can also be employed in modified-release formulations with appropriate formulation design. 

In such cases, sodium starch glycolate may contribute to the initial disintegration of the dosage form, followed by controlled drug release over an extended period.
Sodium starch glycolate is widely used in the formulation of generic drug products as a cost-effective and well-established disintegrant. 
Its availability from multiple suppliers and compatibility with various manufacturing processes make it a preferred choice for generic pharmaceutical manufacturers seeking to develop bioequivalent alternatives to brand-name drugs.

In addition to its disintegrating properties, Sodium starch glycolate may also contribute to the stability of pharmaceutical formulations by preventing tablet capping, sticking, or other formulation-related issues during storage and handling. 
Its use can help maintain the physical integrity and appearance of tablets or capsules throughout their shelf life.
Sodium starch glycolate is commonly used in the formulation of over-the-counter (OTC) pharmaceutical products, including analgesics, antacids, cold and flu remedies, and dietary supplements.

Its fast-disintegrating properties enhance the convenience and consumer acceptability of these products, particularly for individuals seeking quick symptom relief.
Sodium starch glycolate may be used in clinical and hospital formulations, such as orally administered medications administered in healthcare settings. 
Its rapid disintegration helps ensure timely drug delivery and absorption, which is important for patients in acute care settings or those with urgent medical needs.

Sodium starch glycolate is also utilized in veterinary medicine for the formulation of oral dosage forms for animals. 
Its disintegrating properties are beneficial for ensuring efficient drug delivery and absorption in veterinary patients, including companion animals and livestock.
Sodium starch glycolate may be included in specialty formulations for specific patient populations or therapeutic purposes, such as formulations for patients with dysphagia (swallowing difficulties) or those requiring customized dosage forms. 

Its versatility and compatibility with various formulation techniques make it suitable for a wide range of specialty applications in pharmaceutical compounding.
Sodium starch glycolate is used as rapid disintegrant that releases the medicine immediately when in contact with water.
Sodium starch glycolate can be used in a direct-compression or wet-granulation process.

Sodium starch glycolate can also be used as a suspending vehicle.
Sodium starch glycolate acts as a dissolution enhancing agent.
Sodium starch glycolate is used as a food stabilizer and as an anti-ageing agent for bread and in manufacturing of ice-creams.

This is used as a component for manufacturing processes in pharmaceuticals, food, textiles, paper and adhesives.
Sodium starch glycolate is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 
Sodium starch glycolate absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules. 

Sodium starch glycolate is used as a disintegrant, a suspending agent and as a gelling agent. 
Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness.
Sodium starch glycolate is commonly used in tablet formulations to promote tablet disintegration. 

Sodium starch glycolate helps ensure that the tablet breaks apart quickly and completely into smaller particles when exposed to aqueous fluids in the gastrointestinal tract. 
This rapid disintegration facilitates drug dissolution and absorption, leading to faster onset of action and improved bioavailability of the API.
In capsule formulations, sodium starch glycolate can be used as a disintegrant to enhance the dissolution and release of the encapsulated drug. 

Sodium starch glycolate helps ensure that the capsule contents are rapidly dispersed upon ingestion, allowing for efficient drug absorption in the body.
Sodium starch glycolate is an essential ingredient in the formulation of orally disintegrating tablets, also known as fast-dissolving or quick-dissolve tablets. 
These tablets are designed to disintegrate rapidly in the mouth without the need for water, making them convenient for patients who have difficulty swallowing or prefer a more palatable dosage form. 

Sodium starch glycolate plays a critical role in achieving the rapid disintegration and subsequent dissolution of ODTs.
Effervescent tablets contain effervescent agents such as citric acid and sodium bicarbonate, which react with water to produce carbon dioxide gas. 
Sodium starch glycolate may be included in effervescent tablet formulations to facilitate disintegration and drug release. 

Sodium starch glycolate helps ensure that the effervescent tablets break apart quickly upon contact with water, allowing for rapid drug dissolution and absorption.
Sodium starch glycolate is particularly well-suited for use in immediate-release formulations where fast drug release is desired. 
By promoting rapid disintegration of the dosage form, sodium starch glycolate helps achieve prompt drug release and therapeutic effects.

Sodium starch glycolate is compatible with a wide range of drug substances, including both hydrophilic and hydrophobic compounds. 
Sodium starch glycolate can be used in formulations containing small molecule drugs, biologics, and other active ingredients to improve their dissolution and bioavailability characteristics.
Sodium starch glycolate is a key ingredient in the formulation of orally disintegrating tablets (ODTs), also known as fast-dissolving tablets or mouth-dissolving tablets. 

These dosage forms are designed to disintegrate rapidly in the mouth without the need for water, offering convenience and ease of administration, especially for patients who have difficulty swallowing conventional tablets. 
Sodium starch glycolate contributes to the rapid disintegration of ODTs, ensuring quick release and absorption of the active pharmaceutical ingredient(s) (APIs).
In low-dose formulations where the amount of API is relatively small, sodium starch glycolate can serve as an effective superdisintegrant. 

Even at low concentrations, it provides sufficient disintegrating action to promote tablet disintegration and drug release. 
This makes it suitable for use in formulations with potent or highly active drugs requiring precise dosing.
Sodium starch glycolate exhibits excellent compatibility with other commonly used excipients in pharmaceutical formulations, including binders, lubricants, and fillers. 

Its compatibility allows for flexibility in formulation design and optimization of tablet properties such as hardness, friability, and dissolution profile.
Sodium starch glycolate can be incorporated into complex dosage forms such as multi-layer tablets, matrix tablets, and combination products. 
Its disintegrating properties ensure uniform disintegration and release of multiple drug substances or sustained-release formulations, maintaining therapeutic efficacy and patient compliance.

Researchers are exploring novel drug delivery systems and technologies that incorporate sodium starch glycolate to enhance drug solubility, bioavailability, and patient acceptability. 
Examples include orally disintegrating films, buccal tablets, and mucoadhesive formulations, where sodium starch glycolate contributes to rapid drug release and absorption across mucosal membranes.
Sodium starch glycolate can be used in formulations to mask the unpleasant taste or odor of certain drugs, improving patient acceptance and compliance, particularly in pediatric and geriatric populations. 

Its neutral taste and odor characteristics make it suitable for enhancing the palatability of orally administered medications.
Formulators utilize sodium starch glycolate as part of a Quality-by-Design (QbD) approach to pharmaceutical product development. 
By understanding the critical quality attributes (CQAs) and performance requirements of the final dosage form, sodium starch glycolate can be optimized for specific formulation needs, ensuring consistent product quality and performance throughout the product lifecycle.

Sodium starch glycolate is recognized and approved by regulatory authorities worldwide, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). 
Its inclusion in pharmacopeial monographs ensures compliance with established quality standards and specifications for pharmaceutical excipients.

Storage Of Sodium starch glycolate:
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.

Preserve well in closed containers, Sodium starch glycolate is preferred to keep away from wide variations in temperature and humidity. 
This will prevent the caking of the product.
Having a Shelf-life of up to five years from the date of manufacturing, Sodium Starch Glycolate is FDA approved and ISO certified product.

Safety Profile Of Sodium starch glycolate:
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.
Direct contact with sodium starch glycolate powder or solutions may cause irritation to the skin, especially in individuals with sensitive skin or prolonged exposure. 

Symptoms of skin irritation may include redness, itching, or dermatitis. 
Proper handling practices, including the use of protective gloves and clothing, can minimize the risk of skin irritation.
Contact with sodium starch glycolate powder or solutions may cause irritation to the eyes. 

Symptoms of eye irritation may include redness, tearing, or discomfort. 
Eye protection, such as safety goggles or face shields, should be worn when handling sodium starch glycolate to prevent accidental eye exposure. 
In case of eye contact, thorough irrigation with water should be performed, and medical attention sought if irritation persists.


 

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