19
Pre-formulation studies (before making nanoparticles)
2 subtopics
20
Solubility screening plan: extract in organic phase; carrier in solvent; precipitation checks
21
Extract–polymer compatibility checks: FTIR/DSC concepts and practical interpretation
22
Core nanoprecipitation SOP (batch process)
5 subtopics
23
Prepare organic phase: polymer concentration, extract loading, and filtration strategy
24
Prepare aqueous phase: surfactant type/concentration, pH/ionic strength, and temperature
25
Nanoprecipitation step: addition method (dropwise/injection), mixing tool, and timing
26
Critical process controls: solvent fraction, total solids, phase ratio, and batch volume
27
Batch record essentials: documenting CPPs, deviations, and sample labeling for traceability
28
Formulation optimization using Design of Experiments (DoE)
3 subtopics
29
Define CQAs/CPPs: size, PDI, zeta, loading, residual solvent, and stability endpoints
30
DoE screening designs: selecting factors/ranges and avoiding confounding
31
Response surface optimization: building models and confirming the predicted optimum
32
Post-formation processing: solvent removal, purification, and concentration
3 subtopics
33
Purification methods: centrifugation, dialysis, ultrafiltration (choosing for your system)
34
Solvent removal approaches: evaporation under stirring, reduced pressure, and time planning
35
Residual solvent testing concepts: limits, sampling, and basic GC/alternative approaches
36
Solidification and storage: lyophilization and redispersion
3 subtopics
37
Cryoprotectant selection: sugars/polyols, concentration, and compatibility with surfactant
38
Freeze-drying basics: freezing, primary/secondary drying, and collapse risk
39
Redispersion testing: gentle mixing, time-to-disperse, and size recovery criteria