title: Production and characterization of rapidly dissolving cryopellets.
abstract: The procedure described in this study provides a platform technology for rapidly dissolving, single-dosed cryopellets. The different steps during cryopellet production were investigated, covering droplet generation, droplet freezing in liquid nitrogen (LN₂) as well as cryopellet properties. With the setup developed, uniform droplets between 4 and 14 μL were produced. The freezing behavior was similar to approaches reported in the literature. A weight loss reported for droplets frozen in LN₂ could not be confirmed. Mechanical stability as observed with texture analysis as well as dissolution time increased with increasing solid content. All cryopellets immediately disintegrated when in contact with the dissolution medium. The dissolution times of amorphous sucrose and trehalose-based cryopellets at different solid content levels were comparable. Crystalline mannitol cryopellets showed in general a higher dissolution time. The formation of δ-mannitol potentially makes the cryopellets suitable as an intermediate product for tableting.
authors: Division of Pharmaceutics, Friedrich - Alexander University Erlangen - Nürnberg, Erlangen, 91058, Germany.
authors: Matthias
authors: M
authors: Erber
authors: Geoffrey
authors: G
authors: Lee
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004343:Drug Implants / Q000138:chemical synthesis* / Q000378:metabolism; D005612:Freeze Drying / Q000379:methods*; D008353:Mannitol / Q000138:chemical synthesis / Q000378:metabolism; D012995:Solubility; D013997:Time Factors; D014961:X-Ray Diffraction
chemical_list: D004343:Drug Implants; D008353:Mannitol
keywords: dissolution; excipients; lyophilization; mechanical properties; physical characterization; solid dosage form