Characterization of Controlled Release Microspheres Using FIB-SEM and Image-Based Release Prediction.
AAPS PharmSciTech
; 21(5): 194, 2020 Jul 14.
Article
en En
| MEDLINE
| ID: mdl-32666160
ABSTRACT
For polymer-based controlled release drug products (e.g. microspheres and implants), active pharmaceutical ingredient distribution and microporosity inside the polymer matrix are critical for product performance, particularly drug release kinetics. Due to the decreasing domain size and increasing complexity of such products, conventional characterization and release test techniques are limited by their resolution and speed. In this study, samples of controlled release poly(lactic-co-glycolic acid) microspheres in the diameter range of 30-80 µm are investigated with focused ion beam scanning electron microscope imaging at 20 nm or higher resolution. Image data is quantified with artificial intelligence-based image analytics to provide size distributions of drug particles and pores within the microsphere sample. With an innovative image-based numerical simulation method, release profiles are predicted in a matter of days regardless of the designed release time. A mechanistic understanding on the impact of porosity to the interplays of drug, formulation, process, and dissolution was gained.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Microscopía Electrónica de Rastreo
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Preparaciones de Acción Retardada
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Copolímero de Ácido Poliláctico-Ácido Poliglicólico
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Microesferas
Tipo de estudio:
Prognostic_studies
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Risk_factors_studies
Idioma:
En
Año:
2020
Tipo del documento:
Article