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Polyvinyl alcohol | CAS No: 9002-89-5 | GMP-certified suppliers
A medication that provides lubrication to the eyes for the temporary relief of dryness and irritation, supporting ocular surface hydration and protection in ophthalmic applications.
Therapeutic categories
Primary indications
- For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s)
Product Snapshot
- Polyvinyl alcohol is formulated primarily as ophthalmic solutions and suspensions for topical ocular application
- It is intended for use as a lubricant to prevent irritation and relieve dryness of the eyes
- The product is approved for use in regulatory markets including the US and Canada
Clinical Overview
The clinical indication for polyvinyl alcohol-containing products is the temporary relief of burning and irritation caused by dryness of the eyes or exposure to environmental factors such as wind and sun. These formulations act as artificial tears, providing hydration and protection to the ocular surface.
Pharmacodynamically, polyvinyl alcohol functions by lubricating the eyes and creating a protective barrier that helps shield against further dryness or irritation. Its mechanism of action relates to its synthetic resin structure with hydrophilic properties, allowing it to increase the persistence and stability of the tear film on the eye surface. This enhanced tear film retention supports the mitigation of discomfort associated with dry eyes.
Regarding absorption, distribution, metabolism, and excretion (ADME), polyvinyl alcohol is characterized by minimal systemic absorption when applied topically to the eye. It primarily remains localized on the ocular surface, minimizing systemic exposure and associated risks. Due to its polymeric nature, it is not metabolized or significantly absorbed through ocular tissues.
Safety considerations for polyvinyl alcohol are generally favorable given its inert and non-toxic profile when used as directed in ophthalmic preparations. However, potential adverse reactions may include transient blurred vision or mild ocular irritation. It is critical to ensure that formulations maintain sterility to prevent microbial contamination.
Notable commercial ophthalmic products incorporate polyvinyl alcohol as the active lubricating agent in artificial tear solutions. Regulatory approval supports its safe and efficacious use in this indication.
For API sourcing and quality assurance, it is essential to procure polyvinyl alcohol that meets pharmacopeial standards for ophthalmic use, emphasizing high purity, consistent molecular weight distribution, and absence of endotoxins or contaminants. Suppliers should provide detailed certificates of analysis and comply with relevant regulatory guidelines to ensure product safety and performance in pharmaceutical formulations.
Identification & chemistry
| Generic name | Polyvinyl alcohol |
|---|---|
| Molecule type | Small molecule |
| CAS | 9002-89-5 |
| UNII | 532B59J990 |
| DrugBank ID | DB11060 |
Pharmacology
| Summary | This synthetic resin exhibits hydrophilic properties that enhance tear film stability, providing ocular lubrication. It targets the ocular surface to temporarily alleviate dryness-related irritation and burning. The pharmacodynamic effect centers on maintaining moisture and protecting the eyes from environmental stressors. |
|---|---|
| Mechanism of action | As a synthetic resin with hydrophilic properties, it increases the persistence of tear film and therefore lubricates and soothes dry/irritated eyes . |
| Pharmacodynamics | Temporarily relieves burning and irritation due to dryness of the eye or from exposure to wind or sun. Lubricates the eyes and helps protect against further eye irritation/dryness . |
ADME / PK
| Absorption | Polyvinyl alcohol is poorly absorbed from gastrointestinal tract, and readily eliminated from the body . |
|---|---|
| Half-life | When injected intravenously, polyvinyl alcohol has a half-life of 90 min . Intraocularly, in eye drop form, the half-life is 7.2 minutes . |
| Volume of distribution | This drug does not accumulate in the body when administered orally . |
Formulation & handling
- Polyvinyl alcohol is a small molecule API primarily formulated as ophthalmic solutions or suspensions for topical, conjunctival, and intraocular administration.
- Formulations typically contain the API in aqueous solutions at concentrations ranging from 0.014% to 3%, requiring sterile preparation and packaging to maintain ocular safety.
- The solid form should be handled with care to prevent contamination; solutions must be stored under conditions that preserve viscosity and prevent microbial growth.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently off-patent in both the US and Canada, allowing for generic competition and widespread market availability. As a result, the API is considered to be at a mature stage in its commercial lifecycle within these regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Polyvinyl alcohol is supplied by multiple originator companies offering branded products primarily in the US and Canadian markets. The presence of several branded artificial tear products suggests established market demand. Patent expiries in this category indicate existing or potential generic competition, supporting a diversified supply landscape. |
|---|
Safety
| Toxicity | The oral acute toxicity of PVOH (LD50) in rats and mice are 20 g/kg and 14.7 g/kg, respectively . Adverse effects include eye pain and changes of vision, and redness or irritation of the eye . Mild stinging or irritation of the eye, crusting of eyelid, eye pain, ocular hyperaemia, eye pruritus, foreign body sensation, eye discharge, and increased lacrimation may also occur . |
|---|
- PVOH exhibits low acute oral toxicity with LD50 values of 20 g/kg in rats and 14
- 7 g/kg in mice
- Exposure may cause ocular irritation symptoms including eye pain, redness, hyperaemia, pruritus, and increased lacrimation
Polyvinyl alcohol is a type of Dental and Oral Agents
Dental and oral agents belong to the pharmaceutical API category, playing a crucial role in oral health care. These agents are specifically designed to address various dental and oral conditions, ranging from tooth decay and gum diseases to oral infections and inflammation.
One of the primary types of dental and oral agents is antimicrobial APIs. These active pharmaceutical ingredients are known for their ability to inhibit the growth of bacteria and fungi in the oral cavity, helping to prevent and treat infections. Common antimicrobial APIs used in dental and oral care include chlorhexidine, cetylpyridinium chloride, and triclosan.
Another important category is analgesic APIs, which provide pain relief in dental and oral procedures. These agents work by blocking pain signals and reducing inflammation. Popular analgesic APIs in dental care include lidocaine, benzocaine, and ibuprofen.
Fluoride APIs are widely used in dental products to strengthen tooth enamel and prevent tooth decay. These APIs aid in remineralization, making teeth more resistant to acid attacks from bacteria and sugary foods.
Furthermore, there are APIs specifically formulated for treating specific oral conditions such as dry mouth or halitosis. These agents help restore moisture in the mouth and neutralize odor-causing compounds.
Dental and oral agents are typically formulated into various dosage forms, including mouthwashes, toothpaste, gels, and oral sprays. These formulations ensure convenient and effective delivery of the APIs to the affected areas in the oral cavity.
In summary, dental and oral agents are a vital component of oral health care, offering antimicrobial, analgesic, remineralizing, and specific therapeutic benefits. Incorporating these pharmaceutical APIs into dental products helps individuals maintain optimal oral health and prevent dental problems.
Polyvinyl alcohol API manufacturers & distributors
Compare qualified Polyvinyl alcohol API suppliers worldwide. We currently have 1 companies offering Polyvinyl alcohol API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Shanxi Yanghe Pharmaceuti... | Producer | China | China | CoA, GMP, ISO9001, WC | 4 products |
When sending a request, specify which Polyvinyl alcohol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Polyvinyl alcohol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
