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Spray Drying of Chitosan Acid Salts: Process Development, Scaling Up and Physicochemical Material Characterization
Nilia de la Paz1, Mirna Fernández2, Orestes López3
1Center for Drug Research and Development (CIDEM), Ave 26 No.1605, e/ Boyeros and Puentes Grandes, Plaza de la Revolución, Havana City CP 10400, Cuba.
Marine Drugs
|July 2, 2021
Summary
Spray drying creates water-soluble chitosan (CH) salts from marine lobster chitin for pharmaceutical use. This reproducible process yields amorphous CH salts with consistent physicochemical properties, suitable for excipient applications.
Area of Science:
- Materials Science
- Polymer Chemistry
- Pharmaceutical Technology
Background:
- Chitosan (CH), a high molecular weight polysaccharide derived from chitin, possesses valuable properties but limited water solubility for pharmaceutical applications.
- Developing water-soluble derivatives of CH is crucial for expanding its utility as a pharmaceutical excipient.
- Marine-derived chitin from *Panulirus argus* lobster was utilized as the source for chitosan.
Purpose of the Study:
- To investigate and optimize a spray drying process for producing water-soluble chitosan (CH) acid salts.
- To evaluate the effects of organic acids (acetic and lactic) and varying air temperatures on the spray drying outcomes.
- To confirm the reproducibility and physicochemical uniformity of the spray-dried CH salts at both laboratory and industrial scales.
Main Methods:
- Spray drying of chitosan acetate and chitosan lactate solutions.
- Characterization of spray-dried powders using particle size analysis, X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), 1H nuclear magnetic resonance (NMR), and Fourier transform infrared (FT-IR) spectroscopy.
- Optimization of process parameters including inlet/outlet air temperatures and atomizer disk speed.
Main Results:
- Spray-dried CH salt yields ranged from 50% to 99%.
- The resulting powders comprised spherical agglomerated particles with mean diameters of 36.2 ± 7.0 µm (acetate) and 108.6 ± 11.5 µm (lactate).
- Dispersed CH salt particles exhibited mean sizes of 31.4–44.2 nm (acetate) and 100.8–121.8 nm (lactate).
- Optimal conditions identified: 160°C inlet, 100°C outlet air temperature, and 18,200 rpm atomizer speed.
- XRPD and DSC confirmed an amorphous state; NMR and FT-IR verified the integrity of the polymer backbone.
Conclusions:
- Spray drying is a reproducible method for preparing water-soluble chitosan acid salts at both laboratory and industrial scales.
- The physicochemical properties of the spray-dried chitosan acetate and lactate salts are uniform.
- The optimized spray drying process yields amorphous chitosan salts suitable for pharmaceutical excipient applications.

