COPOLYVIDONE

Copolyvidone provides good adhesion, elasticity, and hardness, and can be used as a moisture barrier.
Copolyvidone is also used in cosmetics as a thickener, dispersant, lubricant, film-forming agent and binder.
Copolyvidone is widely used in the food, cosmetic and pharmaceutical industry.

CAS Number: 25086-89-9 
EC Number (EINECS): 500-044-2
Chemical nature: A copolymer of N-vinyl-2-pyrrolidone (VP) and vinyl acetate (VA) in certain weight or mole proportions (commonly ~60:40 VP:VA by weight)
Molecular Formula: (C_6H_9NO)_n·(C_4H_6O)_m — being a copolymer, the formula depends on the ratio of vinylpyrrolidone (VP) and vinyl acetate (VA) units.
Average Molecular Weight: Typically ~50,000 g/mol, but it varies depending on polymerization degree and grade.

SYNONYMS:
Copovidone, Copolyvidone, Poly(1-vinylpyrrolidone-co-vinyl acetate), PVP/VA copolymer, Vinylpyrrolidone-vinyl acetate copolymer, PVP-VA 64 (trade name), Copovidone, Copolyvidone, PVP/VA copolymer, Vinylpyrrolidone-vinyl acetate copolymer

Copolyvidone is a versatile pharmaceutical excipient widely used for decades in tablet and solid dosage formulations due to its favorable binder and film‐forming characteristics, good solubility profile in hydrophilic solvents, and acceptable safety profile.
While Copolyvidone is not highly hazardous, good manufacturing practice (GMP) and standard industrial hygiene measures apply.

Copolyvidone is generally regarded as nontoxic.
Copolyvidone is a water-soluble copolymer derived from vinylpyrrolidone (VP) and vinyl acetate (VA). 

Copolyvidone combines the excellent film-forming and adhesive properties of PVP (polyvinylpyrrolidone) with the flexibility and hydrophobicity of vinyl acetate.
Copolyvidone appears as a white to off-white hygroscopic powder and is odorless and tasteless. Copolyvidone is nonionic, chemically stable, and physiologically inert.

Copolyvidone is produced by free-radical polymerization of vinylpyrrolidone and vinyl acetate in a specific monomer ratio, typically around 60:40 (VP:VA).
The resulting polymer, Copolyvidone, exhibits intermediate polarity, balancing hydrophilicity and hydrophobicity.
Copolyvidone is freely soluble in water and ethanol

USES and APPLICATIONS of COPOLYVIDONE:
Copolyvidone, an analog of povidone, is used as a tablet binder, a film-former, and as part of the matrix material used in controlled-release formulations.
In tableting, Copolyvidone can be used as a binder for direct compression and as a binder in wet granulation.

Copolyvidone is often added to coating solutions as a film-forming agent.
Copolyvidone provides good adhesion, elasticity, and hardness, and can be used as a moisture barrier.

Copolyvidone has better plasticity than povidone as a tablet binder, is less hygroscopic, more elastic, and better for film-forming applications than povidone.
Copolyvidone is also used in cosmetics as a thickener, dispersant, lubricant, film-forming agent and binder.

Copolyvidone is widely used in the food, cosmetic and pharmaceutical industry.
In the pharmaceutical industry, Copolyvidone is used widely as a tablet binder (for both wet granulation and direct compression), film-forming agent, matrix former in controlled-release or amorphous solid dispersions.

In many formulations, Copolyvidone acts as a polymeric excipient that helps with drug loading, dissolution rate enhancement, solid dispersion formation, stability of active pharmaceutical ingredients (APIs).
Copolyvidone is also used for coating films, moisture barrier layers, as a binder in granules/tablets, and other formulation functions.

When used in formulations, Copolyvidone facilitates improved dosage form performance (hardness, friability, disintegration, dissolution) and may help stability of active ingredients when appropriately selected.

CHARACTERISTICS & BENEFITS of COPOLYVIDONE:
Copolyvidone has good solubility in water and many organic solvents allows flexibility in formulation design (wet granulation, spray drying, film coating).

Its polymeric binder properties: when used in direct compression or wet granulation, Copolyvidone provides good tablet hardness, reduced friability, improved porosity/disintegration behaviour: for example, one study showed tablets with Copolyvidone binder had less brittleness.

Compared to some older binders, Copolyvidone offers improved plasticity and mechanical strength in tablets.
Lower hygroscopicity compared to some other polymers (e.g., homopolymer povidone), which helps in stability under humidity conditions.

BENEFITS OF USING COPOLYVIDONE IN PHARMACEUTICAL PRODUCTS:
There are many benefits to using copolyvidone in medicines.

*Improved stability and shelf life:
Copolyvidone, as a film-forming agent, can be used to prepare film coatings that protect drugs from external environmental influences such as humidity, oxygen and light, thereby improving drug stability and extending shelf life.

*Optimizing the preparation process of pharmaceutical products:
Copolyvidone, as a binder and disintegrant, can simplify the drug preparation process and reduce the preparation cost.

*Improve the release properties of drugs:
Controlled release rate; Improve drug absorption.

*Enhance the flexibility and water absorption resistance of drugs:
Copolyvidone has good flexibility and resistance to water absorption, which can reduce the adhesion and deformation problems of drugs during storage and use, and improve the quality and appearance of drugs.

*Improving the safety of medicines:
As a pharmaceutical excipient, copolyvidone meets the pharmacopoeia standards and is non-toxic, non-irritating, and has no allergic reactions, thus ensuring the safety of the drug.
Copolyvidone has a high safety profile in the pharmaceutical industry and is strictly regulated.

Pharmaceutical companies and regulatory agencies need to work together to ensure that the quality and safety of Copolyvidone in pharmaceutical preparations meet regulatory requirements to ensure the safety of patients’ medication.

STABILITY AND REACTIVITY of COPOLYVIDONE:
*Long-term stability
Copolyvidone is used in direct tableting and dry material preparation processes.
Copolyvidone is an a spray-dried powder with good fluidity and can be mixed very evenly with other components of the tablet formula.

The glass transition temperature of Copolyvidone is relatively low, which allows it to deform and bond with its adjacent particles when compressed, making it an excellent dry binder.
Copolyvidone also undergoes good plastic deformation when compressed, and the resulting tablets and particles have no recovery stress, so they have long-term stability.

*Excellent functional additives
About the Copolyvidone structure, Copolyvidone has a lower glass transition temperature than K30 and is less hygroscopic, so the amount of Copolyvidone used is about 5%-50% of the total solids to improve the performance and reliability of the selected system, such as improving the plasticity of cellulose film and reducing cracks or fragments even without using plasticizers.

HISTORY of COPOLYVIDONE:
Copolyvidone, a copolymer of vinylpyrrolidone and vinyl acetate, has played a significant role in the advancement of medicinal and nutritional products.
Copolyvidone's origins date back to the mid-20th century, when it was first synthesized to improve the solubility and stability of various pharmaceutical compounds.

Historically, Copolyvidone emerged as a valuable excipient due to its exceptional binding properties, making it a cornerstone in tablet formulation for both conventional and herbal remedies.

In medicinal applications, Copolyvidone has facilitated the development of more effective remedies by enhancing the bioavailability of poorly soluble active ingredients.
This has been especially important for herbal extracts, which often possess limited water solubility.

By serving as a binder and solubilizer, Copolyvidone helps ensure consistent dosing and improved therapeutic outcomes.
Its use extends to granulation processes, where Copolyvidone imparts mechanical strength and uniform dispersion of herbal actives.

Copolyvidone’s adaptability has also made it a preferred ingredient in the formulation of herbal combinations.
Copolyvidone enables the creation of complex multi-herb tablets and capsules that maintain potency, stability, and patient acceptability.

Copolyvidone's low toxicity and excellent safety profile have further solidified its reputation as a reliable component in natural health products.
Overall, Copolyvidone’s contributions have greatly enhanced the efficacy, stability, and versatility of both traditional and modern medicinal remedies, helping to bridge the gap between herbal wisdom and contemporary pharmaceutical technology.

TRADITIONAL AND SCIENTIFIC VALIDATION of COPOLYVIDONE:
Copolyvidone, also known as copovidone or by its chemical name polyvinylpyrrolidone-vinyl acetate copolymer, is a versatile excipient widely utilized in the pharmaceutical and nutritional industries.

First introduced in the latter half of the 20th century, Copolyvidone's primary role has been as a binder and solubilizer in tablet formulations and dietary supplements.

Its unique copolymer structure enables Copolyvidone to improve the dissolution and bioavailability of active ingredients, particularly those with poor water solubility.
Scientific research supports Copolyvidone's utility in enhancing the performance of various nutraceutical and pharmaceutical products.

Multiple studies have demonstrated that Copolyvidone-based solid dispersions can significantly increase the absorption rates of certain vitamins, minerals, and bioactive compounds, potentially leading to improved efficacy.

For example, research published in peer-reviewed journals has shown that formulations containing Copolyvidone can enhance the solubility of fat-soluble vitamins such as vitamin D and E, supporting their use in advanced nutritional products.

While Copolyvidone is generally recognized as safe and is well tolerated in oral formulations, comprehensive long-term clinical studies specifically on its effects in nutritional products remain limited.

Nevertheless, Copolyvidone's successful track record in pharmaceutical applications, coupled with favorable safety profiles and regulatory acceptance, underscores its positive contributions to product quality and consumer experience.

Continued research is warranted to further elucidate Copolyvidone's full spectrum of benefits and potential impacts in the context of nutritional supplementation.

COMPARISON AND ANALYSIS: COPOLYVIDONE VS POVIDONE
Stability and Reactivity of Copolyvidone
Povidone is a thermally initiated polymerization of NVP at 140°C or higher.

When NVP and peroxide are heated to 110°C, polymerization occurs quickly, and the reaction temperature rises to 110-190°C on its own, generating a molten polymer.

After cooling, it is crushed to form a hygroscopic polymer powder.
Copolyvidone is an analog of povidone.
Copolyvidone uses as a tablet binder, a film-former, and as part of the matrix material used in controlled-release formulations.

In tableting, Copolyvidone can be used as a binder for direct compression and as a binder in wet granulation.
Copolyvidone is often added to coating solutions as a film-forming agent.

Copolyvidone provides good adhesion, elasticity, and hardness, and can be used as a moisture barrier.
Copolyvidone has better plasticity than povidone as a tablet binder, is less hygroscopic, more elastic, and better for film-forming applications than povidone.

Copolyvidone is also used in cosmetics as a thickener, dispersant, lubricant, film-forming agent and binder.
Copolyvidone is widely used in the food, cosmetic and pharmaceutical industry.

Copolyvidone can be a wetting agent, stabilizer, is a water-soluble polymer resin, odorless and tasteless, easy to absorb moisture, soluble in water, ethanol and anhydrous alcohols, with good adhesion, hygroscopicity, film-forming and surface activity, white or milky white powder, its aqueous solution is colorless or light yellow transparent liquid.

COPOLYVIDONE’S ROLE IN DRUG FORMULATION:
In the process of drug manufacturing, copolyvidone plays a very important role.
It is not only the “super glue” in the adhesive, but also the “invisible cloak” on the coating, and also the “accelerator” of drug dissolution.

Copolyvidone: The “super glue” of the pharmaceutical world
Imagine that you have a bunch of small tablet raw materials in your hand.
They are like a pile of scattered building blocks.

COPOLYVIDONE: THE “SUPER GLUE” OF THE PHARMACEUTICAL WORLD
How can you stick them together tightly to form a complete tablet?
At this time, copolyvidone is like a skilled “super glue master”.
Copolyvidone is composed of two magical chemicals – N-vinyl pyrrolidone and vinyl acetate.

These two substances are like two tacit partners, which together give copolyvidone excellent bonding ability.
When copolyvidone encounters drug raw materials, it is like glue, which tightly bonds the drug particles together to form a solid tablet.
In this way, the tablet can remain intact when taken, ensuring that the active ingredients of the drug can be released evenly.

COPOLYVIDONE: THE “INVISIBLE CLOAK” OF DRUG COATING
In addition to being a “super glue”, copolyvidone has another important identity – the “invisible cloak” of drug coating.
We all know that during the storage and transportation of drugs, they are easily affected by the external environment, such as moisture, oxygen and light.

These external factors are like a group of “troublemakers” that will destroy the stability of the drug and reduce its efficacy.
Copolyvidone is like a brave “invisible cloak warrior”, which can tightly wrap around the surface of the drug to form a protective film.

This protective film is like an invisible shield that can resist the invasion of external factors and protect the drug from damage.
At the same time, copolyvidone can also control the release rate of the drug, like a careful “time manager”, ensuring that the drug is slowly released at the right time to achieve the best therapeutic effect.

COPOLYVIDONE: THE “ACCELERATOR” OF DRUG DISSOLUTION
In addition, copolyvidone has a hidden skill – improving the solubility of drugs.
Copolyvidone can shorten the distance between drugs and water, making drugs more easily dissolved in water.
In this way, drugs can be absorbed by the body faster and exert their efficacy.

PHYSICAL and CHEMICAL PROPERTIES of COPOLYVIDONE:
CAS Number: 25086-89-9. 
EC / EINECS (European) Identifier: According to the European Chemicals Agency (ECHA) database the substance is listed under Substance Information (though I did not find a specific “EC number” printed in the publicly accessible summary). 
Typical pharmaceutical designation/trade names: e.g., “Kollidon® VA 64” (by BASF) is a commercial grade of copovidone. 
Chemical nature: A copolymer of N-vinyl-2-pyrrolidone (VP) and vinyl acetate (VA) in certain weight or mole proportions (commonly ~60:40 VP:VA by weight)
Molecular Formula: (C_6H_9NO)_n·(C_4H_6O)_m — being a copolymer, the formula depends on the ratio of vinylpyrrolidone (VP) and vinyl acetate (VA) units.
Average Molecular Weight: Typically ~50,000 g/mol, but it varies depending on polymerization degree and grade.

CAS Number: 25086-89-9
EC Number (EINECS): 500-044-2
Appearance: White to off-white or slightly yellowish amorphous powder (spray‐dried). 
Odour / taste: Slight, faint taste; basically minimal odour. 
Density: ~ 1.27 g/mL at 25 °C for typical product. 
Glass transition temperature (T₉): For e.g. Kollidon® VA 64, ~64 °C (some sources report ~106 °C or higher depending on polymer grade) . 
Solubility: Soluble in water and in many hydrophilic solvents; examples: water, ethanol, isopropanol, methanol, acetone, dichloromethane, glycerol, propylene glycol; much less soluble in non-polar solvents (e.g., cyclohexane, diethyl ether). 

Miscibility / behaviour: It has good compatibility with many pharmaceutical excipients; hygroscopicity is lower than some similar polymers (e.g., povidone) but still present. 
Stability/Reactivity: Generally stable under normal storage; combustible in fine powdered form; incompatible with strong oxidising agents/reducing agents as per some chemical databases. 
Molecular weight / polymer grade: The polymer is not a single defined molecular mass; one manufacturer notes weight-average molecular weight (M_w) in the range ~45,000–70,000 g/mol for their product. 
Composition: For one grade, nitrogen content ~7.0-8.0%, vinyl acetate content ~35.3-42.0% by weight.

CAS No: 25086-89-9
Synonyms: Copovidone, Copolyvidone, PVP/VA copolymer, Vinylpyrrolidone-vinyl acetate copolymer
Appearance: White to off-white amorphous powder
Density: ~1.27 g/mL at 25 °C
Glass transition (Tg): ~64 °C (some grades ~100+ °C)
Solubility: Readily soluble in water, ethanol, isopropanol, acetone, etc; poorly soluble in non-polar solvents
Molecular Weight: ~45,000–70,000 g/mol (for some commercial grade)
Hygroscopicity: Moderate (lower than some comparable polymers)
Uses: Pharmaceutical binder, film former, matrix former, excipient in coatings
Safety Hazard: Harmful if swallowed (H302); combustible powder; avoid ingestion/inhalation
Typical Benefits: Good binder strength, flexibility in formulation, improved tablet mechanical properties, relatively lower hygroscopic uptake

FIRST AID MEASURES of COPOLYVIDONE:
-Description of first-aid measures
*General advice:
Show this material safety data sheet to the doctor in attendance.
*If inhaled:
After inhalation: 
Fresh air.
*In case of skin contact: 
Take off immediately all contaminated clothing. 
Rinse skin with
water/ shower.
*In case of eye contact:
After eye contact: 
Rinse out with plenty of water. 
Call in ophthalmologist. 
Remove contact lenses.
*If swallowed:
After swallowing: 
Immediately make victim drink water (two glasses at most). 
Consult a physician.
-Indication of any immediate medical attention and special treatment needed.
No data available

ACCIDENTAL RELEASE MEASURES of COPOLYVIDONE:
-Environmental precautions:
Do not let product enter drains.
-Methods and materials for containment and cleaning up:
Cover drains. 
Collect, bind, and pump off spills. 
Observe possible material restrictions. 
Take up dry. 
Dispose of properly. 
Clean up affected area.

FIRE FIGHTING MEASURES of COPOLYVIDONE:
-Extinguishing media:
*Suitable extinguishing media:
Carbon dioxide (CO2) 
Foam 
Dry powder
*Unsuitable extinguishing media:
For this substance/mixture no limitations of extinguishing agents are given.
-Further information:
Prevent fire extinguishing water from contaminating surface water or the ground water system.

EXPOSURE CONTROLS/PERSONAL PROTECTION of COPOLYVIDONE:
-Control parameters:
--Ingredients with workplace control parameters:
-Exposure controls:
--Personal protective equipment:
*Eye/face protection:
Use equipment for eye protection. 
Safety glasses
*Body Protection:
protective clothing
*Respiratory protection:
Recommended Filter type: Filter A 
-Control of environmental exposure:
Do not let product enter drains.

HANDLING and STORAGE of COPOLYVIDONE:
-Conditions for safe storage, including any incompatibilities:
*Storage conditions:
Tightly closed. 
Dry.

STABILITY and REACTIVITY of COPOLYVIDONE:
-Chemical stability:
The product is chemically stable under standard ambient conditions (room temperature).
-Possibility of hazardous reactions:
No data available