Nanoparticles are very useful when oral bioavailability is limited by the dissolution rate of the active pharmaceutical ingredient. The commercial utility is expressed by the multiple products approved in the market over the last decades. Hovione particle design tool box includes both “Top Down” and “Bottom up” technologies to produce nanoparticles of active ingredients.

How it works
In top down processes, nanoparticles are produced by wet milling processes. On the other hand, in bottom up processes crystalline or amorphous nanoparticles can be obtained by crystallization or precipitation processes, respectively. Nanoparticle isolation or microencapsulation can then be achieved by spray drying.

Applications

• Overcome solubility limitations of BCS class 2 and 4 drugs -  oral administration as capsules, tablets or suspensions
• Sustained release formulations  e.g. in ocular delivery
• Injectable formulations

Strenghts

• Tailor made particle size distribution assures tunable performance
• Can enable the handling of heat-sensitive materials
• Free flowable powders when isolated / microencapsulated by spray drying
• Precise control of the polymorphic form

Limitations

• Top down approach may not lead to sufficiently small sizes – product dependent
• Ostwald ripening needs to be carefully managed to avoid size increase
• In bottom up processes the need to find a solvent system that is miscible with the antisolvent
• Addition of stabilizers / surfactants is key to maintain product self-life