BASF says its new Soluplus excipient will help meet demand for solubilising agents that are compatible with hot melt extrusion (HME) manufacturing methods.
Fundamentally, HME manufacturing combines a drive and monitoring system with a rotating extrusion barrel and formation die through which the hot product is passed under high pressure.
While common in the production of plastics and foodstuffs since the 1930s, in recent times the approaches' efficiency, removal of the need for solvents and, most importantly, ability to improve the dispersion of active pharmaceutical ingredients (APIs) has attracted the attention of the drug industry.
BASF spokesperson Stefanie Hofmann told in-Pharmatechnologist about Soluplus’ hot melt applications, explaining that improving the solubility and bioavailability of drugs produced in this way through improved dispersion were the key drivers for the excipient's development.
“Many drug candidates are hard to solubilize and are poorly bioavailable. Hence BASF developed a new polymer with amphiphilic character, especially designed for hot melt extrusion techology, [which] is becoming more common in the formulation of poorly soluble actives.”
She added that: “Soluplus is especially designed for hot melt extrusion technology [and] we consider this fact to be a real innovation in the market.”
Hofmann went on to explain that the excipient, launched at CPhI in Madrid, Spain last week, is a "copolymer made from PEG 6000, vinylcaprolactam and vinylacetate. Thus it comprises of hydrophilic elements, lipophilic elements and sites for drug complexation.
“Due to its bifunctional character, Soluplus is able to act as a matrix polymer for solid solutions on the one hand, and, on the other hand, it is capable of solubilizing poorly-water soluble drugs in aqueous media.