Value
“Excipient toolbox” to rapidly lock a castable window balancing disintegration, mouthfeel, mechanics, and stability; water-first, hydroalcoholic when justified.
Toolbox (examples)
Bases: HPMC, PVA, Pullulan, PVP, CMC-Na, MC, HPC, HEC, gelatin, sodium alginate.
Plasticizers: glycerin, PEG-400, propylene glycol, sorbitol, triacetin.
Functionals: wetting/surfactants (polysorbates), mucoadhesives, permeation aids, antioxidants, pH buffers (citric/citrate/bicarbonate).
Preservatives (if needed): potassium sorbate/sodium benzoate per market.
Solvents: water preferred; water-ethanol/IPA with EX-proof & residual limits.
Operating Window
Solids 10–35%; 25 °C viscosity 500–5,000 mPa·s @ 10–100 s⁻¹; plasticizer 10–30% of solids; pH 4.0–7.5.
Compatibility & Sourcing
Non-GMO/allergen-controlled options; pharm/food grade; dual-sourcing for criticals.
Risks & Mitigations
Hygroscopicity/brittleness: tune plasticizer/polymer; target product moisture 3–7%.
Residual solvents: temp/airflow/dew-point controls; retains & third-party tests.
Bitterness/crystallization: masking & microencapsulation; co-evaluate dissolution & stability.
Client Inputs
API solubility/pKa, taste profile, target disintegration & t80%, restricted lists (allergens/GMO/region-specific bans).