Model-based optimization of the primary drying phase of oral lyophilizates

Autor: Brecht Vanbillemont, Thomas De Beer
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: International Journal of Pharmaceutics: X, Vol 2, Iss , Pp 100057- (2020)
Druh dokumentu: article
ISSN: 2590-1567
DOI: 10.1016/j.ijpx.2020.100057
Popis: Oral lyophilizates also called orally disintegrating tablets (ODTs) are a patient friendly and convenient dosage form. They are manufactured by dosing a suspension in blister cups and subsequently freeze-drying these blisters to achieve porous tablets that disintegrate quickly (< 10 s) when placed upon the tongue. This paper proposes a mechanistic model of the primary drying phase of these oral lyophilizates processed in cold-form blisters. A heat transfer coefficient (Kv) and dried layer resistance (Rp) are regressed and applied in a dynamic optimization of the primary drying phase. The optimization exercise showed the possibility of ultra-short sublimation times for polyvinyl acetate (PVA) based formulations with a primary drying time of 3.68 h for a 500 mg acetaminophen tablet.
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