Model-based optimization of the primary drying phase of oral lyophilizates
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 place...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-12-01
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| Series: | International Journal of Pharmaceutics: X |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590156720300190 |
| Summary: | 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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| ISSN: | 2590-1567 |