Vanbillemont Brecht, De Beer Thomas
Laboratory of Pharmaceutical Process Analytical Technology (LPPAT), Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium.
Int J Pharm X. 2020 Oct 31;2:100057. doi: 10.1016/j.ijpx.2020.100057. eCollection 2020 Dec.
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 ( ) and dried layer resistance ( ) 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.
口服冻干制剂也称为口腔崩解片（ODTs），是一种对患者友好且方便的剂型。它们是通过将悬浮液装入泡罩杯中，然后对这些泡罩进行冷冻干燥来制造的，以获得多孔片剂，当置于舌上时能迅速崩解（<10秒）。本文提出了在冷成型泡罩中加工的这些口服冻干制剂一次干燥阶段的机理模型。回归了传热系数（ ）和干燥层阻力（ ），并将其应用于一次干燥阶段的动态优化。优化结果表明，对于基于聚醋酸乙烯酯（PVA）的制剂，超短升华时间是可能的，对于一片500毫克的对乙酰氨基酚片剂，一次干燥时间为3.68小时。
