spheroidisatie

Spheroidisation is a process used in the production of pharmaceuticals, particularly in the formulation of tablets. It involves the transformation of a powdered drug substance into spherical particles, known as spheroids. This process aims to improve the physical properties of the drug, such as flowability, compressibility, and dissolution rate, which are crucial for the efficacy and stability of the final tablet.

The spheroidisation process typically begins with the mixing of the drug powder with a suitable binder, such as polyvinylpyrrolidone (PVP) or hydroxypropylmethylcellulose (HPMC). The mixture is then subjected to a spheroidisation technique, which can include methods such as fluid bed granulation, spray granulation, or high-shear granulation. These techniques involve the application of mechanical forces to the mixture, causing the particles to coalesce and form spheroids.

The resulting spheroids have a more uniform size and shape compared to the original powder, which enhances their flow properties and makes them easier to handle during the tablet manufacturing process. Additionally, the increased surface area of the spheroids can improve the dissolution rate of the drug, leading to faster and more consistent drug release.

Spheroidisation is particularly beneficial for drugs that are poorly soluble or have a low dissolution rate, as it can significantly enhance their bioavailability. It is also useful for drugs that are prone to segregation or caking, as the spheroids are less likely to form aggregates or adhere to each other.

In summary, spheroidisation is a valuable technique in pharmaceutical formulation, offering several advantages in terms of drug properties and tablet manufacturing. It plays a crucial role in improving the efficacy, stability, and manufacturability of pharmaceutical products.