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(Charecterisation (Dissolution (Water, Release of Polymer, Release of…
Charecterisation
Dissolution
Water
Release of Polymer
Release of Surfactant
Polymer in media Vs Polymer in product
Surfactant in media Vs. surfactant in product
10 micron filter (Quantify Dispersion)
0.45 micron Filter (Quantify Solution)
Solubility
API Crystalline
API Amorphous
API Physical Mixture
API + Polymer
API + Surfactant
API+ Polymer + Surfactant
Stability of SD
Low Volume
pH
Ionic Condition
Glucose Solution
DOE
Low vs. high Polymer
Low vs. high surfactant
Impact of other excipients
Tg
Tg of Premix < than MP of Drug
Tg of Premix ~ to MP of Drug
Granule PSD
Crystal
(Hard/Brittle/Glassy State)
Ionic (NaCl)
Metalic (Cu)
Molecular (Ice)
Network Covalent (Diamond)
Amorphous
(Soft/Flexible/Rubbery/Viscoelastic State)
Stability
Glass Transition Temperature (Tg)
No of Hydrogen Bonds :
No of ring structures
Maximum sigma Fukui index
Increase with higher MW
Increase with rigid chain
Increase with bulk steric hindrance
Increase with increase crystalization
Increase with increased crosslinking
Change in production method
Rate of amorphous to crystalline transformation
Glass Forming Ability
MW
">" 300 (Glass Formers)
< 200 Non Glass Formers
:check: Intermolecular Hydrogen Bonding Capacity
:no_entry: Rigidity
:no_entry: Aromaticity
:no_entry: No of Benzene Rings
Amorphous Solbility
Liquid-Liquid Phase Separation (Drug Rich AmorphousPhase)
Spinodal decomposition
drug-saturated water-rich solution
water-saturated drug-rich amorphous phase
Nucleation & Growth
Crystalization
High Molecular weight API less prone to recrystallization from supersaturation
