Systems for lipophilic drugs 4. OBJECTIVES Nanotechnology based and lipid based approaches are being widely investigated to improve the solubility profile of BCS class II/IV drugs. Nanosizing is a classical approach based on Noyes-Whitney equation wherein the dissolution rate and saturation solubility of drugs could be increased. • For BCS class 1 products, a single point dissolution specification of Q=80% in 30 minutes. • For BCS class 3 products, a single point dissolution specification of Q=80% in 15 minutes. BCS class 3 products that meet the more stringent specifications will better ensure that the bioavailability of the.