Physical Stability of Amorphous Formulations

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Representative Special Dosage Forms for Oral Delivery of Poorly Soluble Drugs Solid Dispersions ‣Solid dosage form ‣Low chemical stability ‣Low physical stability ‣Difficult to handle in manufacturing process ‣Special manufacturing facility Nanosuspensions ‣Solid/liquid dosage form ‣Low physical stability ‣Special manufacturing facility Self-emulsifying Formulations ‣Liquid dosage form ‣Simple formulation/process design ‣Low chemical stability ‣Large formulation volume
Case Study of Liquid-filled Capsule ‣ BCS class II compound ‣ Aqueous solubility 19.5 mg/mL、No ionizable groups ‣ Highest solubility in oil 72.6 mg/mL ‣ Highest dose required 1800 mg ‣ Administration volume: 25 mL => 18 Capsules! Typical disadvantage of LFC/S(M)EDDS
Page 1: Physical Stability of Amorphous For
Page 5 and 6: Amorphous Formulation Feature of Am
Page 7 and 8: Heat Flow (W/g) Heat Flow (W /g) Is
Page 9 and 10: Memory before Amorphization Cryo-mi
Page 11 and 12: Miscibility of Amorphous Formulatio
Page 13 and 14: Heat Flow (Exotherm Up) Melting Poi
Page 15 and 16: Heat Flow (Exotherm Up) Time-depend
Page 17 and 18: Heat Flow Relationship b/w Phase Se
Page 19 and 20: Relationship b/w Relaxation & Cryst
Page 21 and 22: Preclinical Development Timeline
Page 23 and 24: Electrospray Deposition Electrospra
Page 25 and 26: Coaxial Electrospray Coaxial electr
Page 27: Acknowledgements National Institute

Physical Stability of Amorphous Formulations

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