<abstract xmlns="http://www.w3.org/1999/xhtml">Aim: Sildenafil citrate is a drug used to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). As for both clinical applications, the only available dosage form is tablets; there is a clear need for a safe oral liquid, especially for children. The objective of this study was to determine the stability of sildenafil citrate in SyrSpend® SF PH4, a suspending agent containing neither sorbitol nor alcohol.Material/Methods: The studied sample was compounded into a 2.5-mg/mL suspension and stored in low-actinic plastic bottles at temperatures between 2 and 8°C and at room temperature conditions. Six samples were assayed at each time point out to 92 days by a high-performance liquid chromatography (HPLC) method. The method was validated for its specificity through forceddegradation studies.Results: The samples remained within 90–110% of the initial concentration throughout the course of the study. Conclusions: On the basis of the data collected, the beyond-use date of this product is at least 92 days when protected from light at both refrigerated and room temperature storage conditions.</abstract>

Aim: Sildenafil citrate is a drug used to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). As for both clinical applications, the only available dosage form is tablets; there is a clear need for a safe oral liquid, especially for children. The objective of this study was to determine the stability of sildenafil citrate in SyrSpend® SF PH4, a suspending agent containing neither sorbitol nor alcohol.Material/Methods: The studied sample was compounded into a 2.5-mg/mL suspension and stored in low-actinic plastic bottles at temperatures between 2 and 8°C and at room temperature conditions. Six samples were assayed at each time point out to 92 days by a high-performance liquid chromatography (HPLC) method. The method was validated for its specificity through forceddegradation studies.Results: The samples remained within 90–110% of the initial concentration throughout the course of the study. Conclusions: On the basis of the data collected, the beyond-use date of this product is at least 92 days when protected from light at both refrigerated and room temperature storage conditions.

Stability Of Sildenafil Citrate Oral Suspension With Syrspend® Sf

European Pharmaceutical Journal

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Stability Of Sildenafil Citrate Oral Suspension With Syrspend Sf

Aim: Sildenafil citrate is a drug used to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). As for both clinical applications, the...

Stability Of Sildenafil Citrate Oral Suspension With Syrspend^® Sf

Data publikacji: 20 lip 2018

Zakres stron: 31 - 35

Otrzymano: 22 cze 2016

Przyjęty: 19 lip 2016

DOI: https://doi.org/10.2478/afpuc-2018-0007

Słowa kluczowe
Compatibility, Stability, Compounding, Oral suspension, SyrSpend, Sildenafil

© 2018 Geiger Ch. M. et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Stability Of Sildenafil Citrate Oral Suspension With Syrspend® Sf

Data publikacji: 20 lip 2018

Zakres stron: 31 - 35

Otrzymano: 22 cze 2016

Przyjęty: 19 lip 2016

DOI: https://doi.org/10.2478/afpuc-2018-0007

Słowa kluczoweCompatibility, Stability, Compounding, Oral suspension, SyrSpend, Sildenafil

© 2018 Geiger Ch. M. et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Stability Of Sildenafil Citrate Oral Suspension With Syrspend^® Sf

Słowa kluczowe
Compatibility, Stability, Compounding, Oral suspension, SyrSpend, Sildenafil