Application of Quality by Design Principles to the Development of Oral Lyophilizates Containing Olanzapine

Oral lyophilizates are intended for application to the oral cavity or dispersing in water. The purposes of this research were: (i) set up quality by design approach development drug incorporation; and (ii) evaluate established comparing its outcomes with experimentally obtained results. Within knowledge space, properties about drugs, excipients, lyophilization process were acquired, followed determination critical attributes via risk identification. Risks assessed failure mode effective analysis, which recognized material attributes, i.e., type, concentration, particle size, solubility while as main parameters, cooling rate, shelf temperature, chamber pressure during drying pointed out. Additionally, space was using Minitab® 17 software valued an 88.69% coefficient determination. A detailed comparison between model experimental results revealed that proposed optimal compositions match total concentration excipients (6%, w/w) pre-lyophilized liquid formulation, among mannitol predominates. On other hand, a discrepancy regarding presence gelatin detected. conclusion represents suitable onset toward optimization drug-based development, preventing unnecessary investment time resources.