AFFINISOL™ hydroxypropyl methylcellulose (HPMC) is a water-soluble cellulosic polymer that can help optimize solubility enhancement by maintaining stable solid dispersions and inhibiting API crystallization.
More sophisticated drug discovery techniques have led to pipeline compounds that require solubility enhancement to be therapeutically effective. Solid dispersions are one of the key technologies for formulating oral solid dosage forms containing APIs with bioavailability challenges. AFFINISOL™ HPMC has been specifically designed for generating solid dispersions via spray-drying (SDD) or hot-melt extrusion (HME).
AFFINISOL™ HPMC HME offers hot melt-extrusion process flexibility in choosing a polymer viscosity for optimization of both solubility enhancement and drug release profiles. The polymer’s added organosolubility further creates advantages for employing HPMC in solvent spray-drying applications.
Designing a polymer based on over half a century of cellulosics expertise
- AFFINISOL™ HPMC HME is hydroxypropyl methylcellulose designed with a polymer substitution architecture that enables thermal processability. Thus, it has excellent utility in manufacturing methods such as HME to create stable amorphous solid dispersions (ASDs) with poorly soluble APIs.
- HME is a solvent-free, continuous manufacturing process with proven applicability to the pharmaceutical industry for solubility enhancement.
- It is uniquely suited to form stable ASDs which can result in solubility enhancement and a subsequent increase in bioavailability for both immediate release (IR) and controlled release (CR) formulations.