PVP K30
Also known as: PVP K30, povidone K30, polyvidone K30, CAS No. 9003-39-8, Polyvinylpyrrolidone K30
Overview
Polyvinylpyrrolidone K30 (PVP K30) is a synthetic, water-soluble polymer derived from N-vinyl-2-pyrrolidone, widely utilized in the pharmaceutical and food industries. It functions primarily as an excipient, not an active ingredient, serving as a binder in tablet formulations, a solubility and dissolution enhancer for poorly soluble drugs, a film-former, and a stabilizer in various drug delivery systems. Characterized by its molecular weight of approximately 40,000 Da, high solubility in water and organic solvents, and ability to form hydrogen bonds, PVP K30 effectively inhibits drug crystallization. Its role is well-established, with extensive research focusing on optimizing its application in drug formulation and delivery, rather than its direct clinical efficacy.
Benefits
PVP K30 offers significant benefits in pharmaceutical formulation. Its primary effect is as an effective binder, improving tablet hardness and reducing friability, thereby enhancing the physical quality of tablets. For instance, studies have shown that increasing PVP K30 concentration from 1.5% to 2.5% significantly reduces friability and improves hardness in herbal extract tablets. A major benefit is its ability to enhance the oral bioavailability of poorly soluble drugs by maintaining supersaturation and inhibiting crystallization. In one study, a PVP K30-based supersaturated system increased quercetin bioavailability 10-fold compared to a suspension, achieving an absolute bioavailability of 36.05% versus approximately 3.6%. It also facilitates the production of porous lactose carriers, which improves the dissolution rates of insoluble active ingredients like curcumin. These improvements in drug dissolution and bioavailability are significant, with effects observed immediately upon formulation and pharmacokinetic improvements within hours post-administration in vivo.
How it works
PVP K30 is not pharmacologically active and does not interact with biological targets. Its mechanism of action is purely physicochemical. It interacts with drug molecules primarily through hydrogen bonding and steric hindrance, which prevents the crystallization of poorly soluble drugs, thereby maintaining their supersaturated state in aqueous environments, such as the gastrointestinal tract. This inhibition of crystallization and maintenance of supersaturation significantly enhances the dissolution rate and subsequent absorption of co-administered drugs. As a binder, it forms a polymeric matrix within tablets, providing structural integrity and improving mechanical strength. PVP K30 is poorly absorbed by the body, acting mainly within the gastrointestinal tract to facilitate drug release and absorption, rather than exerting systemic effects itself.
Side effects
PVP K30 is generally recognized as safe (GRAS) and has an excellent safety profile, being widely used in pharmaceuticals and cosmetics. Animal toxicity studies consistently support its safety, and it shows no significant dermal irritation or sensitization when used as a powder. In clinical use as an excipient, no common side effects (occurring in >5% of users) have been reported. Uncommon side effects (1-5%) are rare; however, irritant contact dermatitis has been reported with povidone-iodine formulations, which contain PVP, but not with PVP K30 alone. Very rare side effects (<1%) include localized sarcomas reported in animals following subcutaneous particulate implants, but this is not relevant to its typical oral or topical use in humans. There are no known intrinsic drug interactions with PVP K30 itself, though it may alter the release profiles of co-administered drugs. No contraindications are known, and its inert nature suggests broad safety across special populations.
Dosage
The dosage of PVP K30 is highly dependent on its specific application in formulation. For its role as a tablet binder, minimum effective concentrations typically range from 1.5% to 2.5% w/w of the tablet formulation, which is sufficient to improve hardness and reduce friability. Optimal dosage ranges can vary; higher amounts may be incorporated in formulations designed for solubility enhancement, where it helps maintain supersaturation of poorly soluble drugs. There is no explicitly defined maximum safe dose for PVP K30, as it is used at low concentrations in formulations and is not typically administered in high doses. As an excipient, it is incorporated during the manufacturing process, so there are no timing considerations for administration by the end-user. It can be used as a powder or in solution during manufacturing, and its inclusion in spray-dried formulations has been shown to improve the properties of porous carriers. PVP K30 is not absorbed, and therefore, absorption factors do not apply to the excipient itself, but rather to the active pharmaceutical ingredient it is formulated with. No specific cofactors are required for its function.
FAQs
Is PVP K30 pharmacologically active?
No, PVP K30 is an inert excipient, meaning it has no pharmacological activity. Its purpose is to improve the physical and chemical properties of drug formulations.
Is it safe for human consumption?
Yes, PVP K30 is extensively used in approved pharmaceutical products and has a strong safety record, being generally recognized as safe (GRAS).
Can it improve drug absorption?
Yes, by maintaining drug supersaturation and enhancing the dissolution of poorly soluble drugs, PVP K30 can significantly improve their absorption and bioavailability.
Does it cause allergic reactions?
Allergic reactions to PVP K30 are very rare. It is generally considered non-sensitizing, though rare cases of contact dermatitis have been noted with povidone-iodine.
How is it used in supplements?
In supplements, PVP K30 is primarily used as a binder to hold tablet ingredients together or as a solubility enhancer to improve the absorption of active compounds in tablet or capsule formulations.
Research Sources
- https://proceeding.thesich.org/index.php/sich/article/download/28/15 – This experimental formulation study investigated the effect of PVP K30 concentration on the physical properties of herbal extract tablets. It found that increasing PVP K30 from 1.5% to 2.5% significantly improved tablet hardness and reduced friability, demonstrating its effectiveness as a binder.
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8228188/ – This pharmaceutical development study explored the use of PVP K30 as a templating agent in spray-dried porous lactose carriers. The research showed that PVP K30 improved the properties of these carriers and enhanced the dissolution rate of insoluble actives like curcumin, highlighting its role in improving drug release.
- https://pubmed.ncbi.nlm.nih.gov/38421545/ – This pharmacokinetic study in rodents evaluated a PVP K30-based supersaturated system for quercetin delivery. The findings indicated a 10-fold increase in quercetin's absolute bioavailability compared to a suspension, demonstrating PVP K30's significant potential in enhancing the absorption of poorly soluble drugs.
- https://www.cir-safety.org/sites/default/files/PVP_RR.pdf – This safety assessment from the Cosmetic Ingredient Review (CIR) Expert Panel provides a comprehensive review of the safety of PVP and its copolymers. It concludes that PVP K30 is safe for use in cosmetic and pharmaceutical products, supporting its generally recognized as safe (GRAS) status.
- https://proceeding.thesich.org/index.php/sich/article/view/28 – This article, related to the Andaririt 2024 study, further details the methodology and results concerning the impact of PVP K30 concentration on the physical characteristics of herbal extract tablets, reinforcing its role in improving tablet quality.
