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Amorphous Solid Dispersions Layered onto Pellets-An Alternative to Spray Drying?

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Spray drying creates amorphous solid dispersions (ASDs) powders, but ASD pellets offer superior yield and are ready for use. ASD pellets are a promising alternative for early-stage formulation development.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Spray drying is a common method for producing amorphous solid dispersions (ASDs).
  • Fine powders from spray drying often need additional processing for oral dosage forms.

Purpose of the Study:

  • To compare the properties and performance of spray-dried ASDs with ASDs coated onto neutral starter pellets.
  • To evaluate ASD-layered pellets as an alternative manufacturing process.

Main Methods:

  • Preparation of binary amorphous solid dispersions (ASDs) with Ketoconazole or Loratadine and pH-dependent polymers.
  • Characterization using differential scanning calorimetry, X-ray powder diffraction, and infrared spectroscopy.
  • Assessment of physical stability and dissolution performance.

Main Results:

  • Single-phased ASDs were successfully prepared and showed physical stability for six months.
  • Both manufacturing methods yielded ASDs with a linear relationship between surface area and solubility enhancement.
  • ASD-layered pellets demonstrated a superior yield (>98%) and were ready for further processing.

Conclusions:

  • ASD-layered pellets are a viable alternative to spray-dried powders, especially for early formulation development with limited drug substance.
  • This method offers advantages in yield and immediate usability for creating multiple unit pellet systems.