Healthcare

Amorphous Solid Dispersion (ASD)

Solubility enhancement of poorly soluble APIs.

Amorphous solid dispersion is a technology for solubility enhancement of drugs. Solubility of a large number of APIs is limited by their crystalline nature which results in poor solubility. If the absorption in the GI tract is acceptable, these compounds are classified as BCD class II. By dispersing the drug on a molecular level in a polymeric carrier, an amorphous state of the API is maintained in the drug product overcoming solubility issues. Shin-Etsu AQOAT® HPMCAS is the leading excipient in solubility enhancement by amorphous solid dispersion technology. Also PHARMACOAT® and HPMCP show good results in solubility enhancement.

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    Solvent free methods (HME)

    Hot melt extrusion is an example of a solvent free process for the preparation of amorphous solid dispersion. The polymer is blended with the API and fed into an hot melt extruder. The carrier polymer is melting and the API dissolves in the polymer during the process. Kneading elements in the extruder add additional shear and energy to the system to create a homogenous extrudate. The extrudate is pelletized or milled and filled into capsules or compressed into tablets. Another option is to extrude filaments for 3D-printing and the tablet is printed.

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    Solvent methods

    Amorphous solid dispersions are also accessible by dissolving API and polymer carrier in a common organic solvent. Upon removal of the solvent, the dry product contains polymer with molecular dispersed, amorphous API. Processes examples utilizing organic solvents are spray drying, spray coating or co-precipitation.

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    Leading polymers for amorphous solid dispersion

    • Shin-Etsu AQOAT® HPMCAS
    • PHARMACOAT® and TYLOPUR® low viscosity hypromellose
    • HPMCP

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