Table 6.

Various challenges for making PLA particles for drug delivery [7].

General issues ○ Low drug loading capacity and low encapsulation efficiency ○ Low reproducibility between batches ○ Poor scalability of manufacturing process from laboratory to large scale production ○ Lack of compendial method for measurement of drug release rates ○ High initial burst release with incomplete release of the drug ○ Presence of residual organic solvents Physico-chemical characterization ○ Particle heterogeneity in shape and size ○ Unknown correlation between particle properties and in vivo behavior ○ Lack of reference particles for validation of tools and techniques ○ Lack of standardized test protocols. ○ Difficulty in characterizing residual solvents affecting particle properties Other issues ○ Difficulty in terminal sterilization of particles ○ No accelerated testing methods for long term stability studies ○ Little information on particle formulations for production of generic products