Polyvinylpyrrolidone, commonly known as PVP, is a water-soluble polymer derived from the monomer N-vinylpyrrolidone. Among its various grades, PVP K90 stands out as a highly versatile and indispensable excipient in the pharmaceutical industry. Identified by CAS No. 9003-39-8, this grade is characterized by a K-value range that reflects its high molecular weight and resulting high viscosity in solution. It typically presents as a white to milky white powder, odorless or with a slight characteristic odor, and is notably hygroscopic, readily absorbing moisture from the atmosphere.

The physical properties of PVP K90 make it exceptionally useful in a wide array of pharmaceutical formulations. It is highly soluble in water, ethanol, isopropyl alcohol, and trichloromethane, which facilitates its incorporation into both aqueous and organic solvent-based processes. Conversely, its insolubility in solvents like acetone or ether highlights its specific solubility profile, important for certain manufacturing techniques.

The primary applications of PVP K90 in pharmaceuticals leverage its unique polymeric characteristics, particularly its binding and complex-forming capabilities. It is widely employed as a tablet binder, a crucial function in the manufacturing of solid dosage forms. In processes like wet granulation, PVP K90, when dissolved and added to the powder mix, forms a polymeric network upon drying. This network effectively binds the drug particles and other excipients together, yielding granules with improved flow properties and compressibility. This leads to the production of tablets with adequate hardness and low friability, ensuring their integrity during handling, packaging, and transport.

Beyond its role as a binder, PVP K90 serves as an effective dissolution enhancer, particularly for poorly soluble active pharmaceutical ingredients (APIs). By forming amorphous solid dispersions or molecular complexes with hydrophobic drugs, PVP K90 can improve their wettability and solubility in aqueous media. This enhanced solubility is critical for increasing the bioavailability of such drugs, allowing them to be absorbed more readily in the gastrointestinal tract. The high molecular weight of K90 contributes to the stability of these amorphous systems, preventing recrystallization of the drug.

Furthermore, PVP K90 functions as a reliable suspending agent in liquid pharmaceutical formulations. In suspensions, solid drug particles are dispersed in a liquid vehicle. Maintaining the uniformity of this dispersion over time and preventing sedimentation or caking of the solid phase is challenging. PVP K90 increases the viscosity of the liquid medium, thereby reducing the settling rate of the suspended particles. Its protective colloid properties also help to stabilize the dispersion, ensuring that the dose remains consistent throughout the shelf life of the product.

While other grades of PVP are often preferred as primary tablet disintegrants (like cross-linked PVP), PVP K90 is also listed for this function. Its role as a binder in wet granulation can still facilitate tablet disintegration, depending on the formulation design. It can also act as a secondary disintegrant or contribute to the overall break-up of the tablet matrix upon contact with water.

The quality and purity of pharmaceutical excipients like PVP K90 are paramount. Strict adherence to pharmacopoeial standards such as USP (United States Pharmacopeia), BP (British Pharmacopoeia), and EP (European Pharmacopoeia) is essential. These standards specify parameters including pH, water content, residue on ignition, and limits for various impurities such as aldehydes, 2-pyrrolidone, vinylpyrrolidinone, peroxides, formic acid, and hydrazine. Compliance with these stringent specifications ensures the safety, efficacy, and consistency of the final pharmaceutical product. The K-value itself is a critical specification, guaranteeing the molecular weight range appropriate for the intended application.

Proper storage conditions are also vital for maintaining the quality and stability of PVP K90. It should be stored in a cool, dry place, ideally below 30 degrees Celsius, and protected from excessive humidity and physical pressure. When stored correctly in its original packaging, typically a 25 kg fiber drum, it maintains a validity period of approximately two years.

In summary, Polyvinylpyrrolidone K90 (CAS 9003-39-8) is a multifaceted pharmaceutical excipient whose high molecular weight and viscosity confer significant advantages as a binder, dissolution enhancer, suspending agent, and contributing factor to disintegration. Its compliance with major pharmacopoeial standards underscores its reliability and suitability for use in a wide range of solid and liquid dosage forms, contributing significantly to the quality and performance of modern medicines.

For pharmaceutical companies seeking a dependable manufacturer and supplier of high-quality Polyvinylpyrrolidone K90 CAS 9003-39-8, exploring options from reputable sources is key. When planning to buy or purchase this essential excipient, it is advisable to inquire about detailed product specifications, quality control documentation, and price structures, especially for bulk orders. Securing a consistent supply from a trusted partner is crucial for maintaining uninterrupted production of pharmaceutical products.