Polyvinylpyrrolidone as excipient
What is Polyvinylpyrrolidone?
Polyvinylpyrrolidone, commonly known as PVP, is a versatile polymer that has found widespread applications across various industries, with a significant presence in the pharmaceutical sector. This water-soluble polymer is valued for its unique properties, making it an essential component in pharmaceutical formulations, among other uses.
Composition and properties of Polyvinylpyrrolidone
PVP is synthesized through the polymerization of vinylpyrrolidone monomers. The chemical formula of PVP is (C6H9NO)n, where ‘n’ represents the degree of polymerization.
Properties:
- Solubility: polyvinylpyrrolidone is highly soluble in water and polar solvents, making it suitable for various pharmaceutical applications.
- Hygroscopicity: It exhibits hygroscopic properties, absorbing moisture from the surroundings.
- Film-forming: PVP can form transparent and flexible films, making it ideal for coating applications.
- Compatibility: PVP is compatible with a wide range of pharmaceutical excipients and drug substances.
Excipient Characterization Services
Excipia offers fast and flexible hands-on polyvinylpyrrolidone quantification and characterization services to reveal and compare hidden polyethylene glycol properties like :
the presence of potential reactive impurities or functional groups, degradation products and related substances, just like molecular weight distributions, reducing power and many other featured characteristics.
In addition, we can help users of excipients to pick the most appropriate polyvinylpyrrolidone manufacturer, select the most suitable PVP grade for their finished dosage form, or define customized polyvinylpyrrolidone specifications to control product performance, quality and safety.
Polyvinylpyrrolidone manufacturing
Polyvinylpyrrolidone is synthesized through the polymerization of vinylpyrrolidone monomers. The production process involves free-radical polymerization, typically initiated by peroxides or other radical initiators. The synthesis of PVP involves the following steps:
- Monomer Production: Vinylpyrrolidone is typically produced by reacting acetylene with N-vinylformamide.
- Polymerization: Vinylpyrrolidone monomers undergo free-radical polymerization, forming the linear chain structure of PVP.
- Purification: The resulting polymer is then purified to remove any unreacted monomers and impurities.
Figure 1 Structural formula of polyvinylpyrrolidone
Pharmaceutical Applications of Polyvinylpyrrolidone
PVP has gained prominence in the pharmaceutical industry due to its exceptional properties, such as biocompatibility, solubility, and film-forming ability. It serves various functions, including:
- Binder: PVP acts as a binder in tablet formulations, enhancing the cohesiveness of the ingredients and ensuring the tablet’s structural integrity.
- Disintegrant: In oral solid dosage forms, PVP aids in the rapid disintegration of tablets, allowing for faster drug release and absorption.
- Stabilizer: PVP is utilized as a stabilizer for suspensions and emulsions, preventing the settling of particles and ensuring a uniform distribution of the active pharmaceutical ingredient.
- Film-former: PVP is employed to create thin films in pharmaceutical coatings, improving the appearance, taste masking, and controlled release of drugs.
- Solubilizer: It enhances the solubility of poorly water-soluble drugs, facilitating their absorption and bioavailability.
Stability and Degradation of Polyvinylpyrrolidone
PVP is generally stable under normal storage conditions. However, factors such as exposure to high temperatures, UV radiation, and oxidative conditions can lead to degradation. The degradation products are typically non-toxic, but monitoring storage conditions is crucial to maintain the integrity of pharmaceutical formulations.
Advantage and disadvantages of Polyvinylpyrrolidone
Advantages
- Versatility: PVP can be used in various pharmaceutical formulations, offering versatility in drug delivery.
- Biocompatibility: PVP is considered biocompatible and is well-tolerated in the human body.
- Enhanced Drug Solubility: Its ability to improve the solubility of poorly water-soluble drugs contributes to enhanced bioavailability.
- Film-forming Properties: PVP’s film-forming ability is valuable in coating applications, providing a protective layer for pharmaceutical dosage forms.
Disadvantages
- Hygroscopicity: PVP’s hygroscopic nature may lead to stability concerns in formulations with moisture-sensitive drugs.
- Sensitivity to UV Radiation: PVP can be sensitive to UV radiation, requiring appropriate packaging and storage conditions.
- Cost: The production of high-quality PVP can be cost-intensive, affecting the overall cost of formulations.
Be in control of your product!
PVP Characterization Services
Excipia is an independent contract service platform that focuses on the physicochemical characterization of pharmaceutical excipients and food ingredients like polyvinylpyrrolidone; as a pure substance, as a raw material or when processed into end products.
More than 25 years in the development of pharmaceutical formulations have taught us that the limited information available on an excipient Certificate of Analysis (CoA) often falls short of explaining observed product or excipient characteristics and that more in-depth knowledge of the actual chemical excipient composition is essential to meet and understand specific formulation challenges.
Over the past 15 years, Excipia analytical scientists have spent tens of thousands of hours establishing unique, specific analytical and physicochemical methods with ingenious sample preparation techniques to characterize polysaccharides and other pharmaceutical excipients.
In these years we have gained a lot of knowledge about many excipients, their properties and exact composition, the difference between batches, qualities, grades, and manufacturers, how to quantify them in medicines and how they can best be used in a formulation.
Excipia offers fast and flexible hands-on cellulose characterization services to reveal and compare hidden properties like:
- the presence of potential reactive impurities or functional groups,
- reducing power of excipients,
- degradation products and related substances,
- relative molecular weight distributions,
- and many other excipient characteristics.
In addition, Excipia can help users of excipients to pick the most appropriate manufacturer, select the most suitable grade for their finished dosage form, or define customized cellulose specifications to control product performance, quality and safety.
Welcome to Excipia, a service platform dedicated to the composition of quality of excipients and quantity of inactive ingredients in medicinal products.
Discover our unique services such as quantitative excipient analysis, identification, selection or specific formulation development support. Don’t forget to check out our case studies.
Try us. Feel free to contact us using the “Contact” button or by sending a message to Excipia@avivia.nl.
Menno Wiltink
Founder of Excipia.
