ABSTRACT:
Insoluble Drug Delivery technology, which has been successfully, addressed the problem of water-insoluble drug delivery. Water-insoluble drugs pose intricate problems in their formulation and delivery. Poorly water-soluble drugs traditionally have been formulated for oral administration through their micronization. Micronization increases their in vivo dissolution rates by reducing particle size and increasing surface area with a concomitant gain in bioavailability. New approaches in formulating poorly soluble drugs, such as the use of surface stabilized nano or microparticles, inclusion in polymer or lipophilic matrices such as nanospheres, hydrophobic carrier systems, self-dispersible systems, and molecular complexation with agents suitable for lipophilic drugs, have demonstrated significant improvements. Hydrophobic carrier systems or self-dispersible systems can be employed only for those drugs that are sufficiently soluble in the carrier. Similarly, a matrix-inclusion system can be employed if the extent of drug loading and the drug release profile within the gastrointestinal tract are acceptable. Insoluble Drug Delivery technology formulations have displayed high drug payload, low amount of free drug in the continuous phase, almost all of the drug present in the dispersed particulate phase, no chemical change in the drug caused by the formulation process, absence of drug-vehicle interaction, narrow particle size distribution with well-defined particle morphology, a variety of suspensions and solid dosage forms, excellent bioavailability when required, and long formulations shelf-lives.