Formulation R&D

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The formulation platforms at 2Y-Chem support R&D for oral solid dosage forms, oral solutions, semi-solid topical/transdermal products, and injectable dosage forms. Our experienced team specializes in developing sustained- and controlled-release systems, as well as formulations for low-solubility compounds.

 

Drug Product R&D Services

Pre-formulation Studies:
    • pH-solubility profile
    • Solid-state and solution stability
    • Intrinsic dissolution rate assessment
    • Excipient compatibility screening
    • Moisture adsorption/desorption
    • Crystallinity evaluation
    • Material flowability tests

Formulation Development:
    • Alignment of TPP and QTPP
    • Prototype formulation design and screening
    • Formulation optimization
    • Formula robustness evaluation
    • Solubility/Dissolution enhancement
    • API micronization
    • Amorphous solid dispersion
    • Immediate release tablet/capsule/granule/powder formulations
    • Sustained/controlled release tablet/capsule/pellet formulations
    • Orally disintegrating tablet/sublingual tablet
    • Semi-solid cream, gel, ointment, emulsion formulations

Primary Package Development:
    • Package development for moisture/oxidation sensitive APIs