Surge Dose<sup>®</sup> Formulations of NSAIDs Provide for Ultra-Rapid and Consistent Drug Absorption in Both the Fasted and Fed State as Predicted by Physiologically Based Biopharmaceutics Modelling
<b>Background/Objectives:</b> This paper describes the use of physiologically based biopharmaceutics modelling (PBBM) to predict the effect of food on diclofenac and ibuprofen absorption from ultra-rapid-release Surge Dose<sup>®</sup> tablets. <b>Methods:</b> Fast...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-05-01
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| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/17/6/708 |
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| Summary: | <b>Background/Objectives:</b> This paper describes the use of physiologically based biopharmaceutics modelling (PBBM) to predict the effect of food on diclofenac and ibuprofen absorption from ultra-rapid-release Surge Dose<sup>®</sup> tablets. <b>Methods:</b> Fasted-state diclofenac pharmacokinetics (PK) were used with published IV data and biorelevant dissolution data for the diclofenac tablets to develop a mechanistic PBBM model which could be used to predict absorption. <b>Results:</b> The resultant model that best fitted the PK data showed that, in vivo, the ultra-rapid-release tablets behaved like a solution with a median time to peak plasma concentration (T<sub>max</sub>) of 20 min. Incorporating a well-established model for gastric emptying in the fed state, the fed T<sub>max</sub> for these tablets was predicted to be 21 min, similar to that seen in fasted subjects. Use of a PBBM model to predict absorption of ibuprofen in the fasted and fed states again showed that ultra-rapid-release tablets produced fast and consistent absorption independent of the presence of food. Predicted mean T<sub>max</sub> values were 31.8 and 35.4 min in the fasted and fed states, respectively. <b>Conclusions:</b> Therefore, even if Surge Dose<sup>®</sup> formulations are taken after food, as frequently recommended for NSAIDs, the speed of absorption and subsequent onset of action should not be impacted. |
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| ISSN: | 1999-4923 |