Many emerging drug candidates suffer from poor aqueous solubility and heat sensitivity, making them difficult to formulate using conventional manufacturing techniques. These challenges are especially problematic for inhalation and nasal drug delivery, where fine particle size and chemical stability are essential for therapeutic performance.
Existing methods such as hot-melt extrusion require elevated temperatures that frequently degrade thermolabile ingredients, while spray drying depends on organic solvents that may not adequately dissolve the drug and often result in low yields and scalability limitations. Additional processing steps such as micronization further increase manufacturing complexity and cost. As pharmaceutical pipelines continue to shift toward complex and fragile molecules, the need for a rapid, solvent-free, and low-temperature process that can produce stable, finely dispersed powders without compromising chemical integrity has become increasingly urgent.
This technology uses the KinetiSol powder ejection process to produce stable pharmaceutical powders containing thermolabile and poorly soluble active pharmaceutical ingredients. The solid-state process rapidly forms nano- or microcrystalline API particles directly on carrier surfaces without melting the ingredients, enabling significant enhancement of apparent solubility while preserving chemical stability. The method is entirely solvent-free and eliminates downstream milling or micronization steps, generating inhalation- and nasal-ready powders in less than 90 seconds.
Analytical tools including LC-MS, WAXS, and SEM confirm both structural integrity and optimal particle morphology. Comparative evaluations show that traditional methods such as hot-melt extrusion cause substantial degradation of sensitive APIs, and spray drying often yields poor solubility and limited scalability. The KinetiSol process avoids these drawbacks by operating under mild, room-temperature conditions, delivering homogeneous dispersions with improved dissolution characteristics and a streamlined manufacturing pathway suitable for a broad range of challenging compounds.