Stability of Dexamethasone in Extemporaneously Prepared Oral Suspensions

ABSTRACT Objective: To evaluate the stability of 0.5 and 1.0 mg/mL dexamethasone suspensions in a vehicle consisting of equal parts of Ora-Sweet and Ora-Plus after storage at 4°C and 25°C for up to 91 days. Methods: Suspensions of dexamethasone sodium phosphate 4 mg/mL injection solution in a 1:1 mixture of Ora-Sweet and Ora-Plus were prepared in 40-mL amber plastic bottles; final concentrations of dexamethasone were 0.5 and 1.0 mg/mL. Three bottles of each suspension were stored at 4°C (refrigerated), and 3 were stored at 25°C (room temperature). Physical characteristics, including pH, colour, odour, viscosity, precipitation, and ease of resuspension, were observed weekly for 91 days. Aliquots were removed from each bottle weekly for 91 days and stored at –84°C until analysis by a validated high-pressure liquid chromatography method. A suspension was considered stable if it maintained 90% of its initial concentration. Results: No change in pH was observed in suspensions of either concentration after storage at 4°C or 25°C for 91 days. Changes in colour and odour were slight. Viscosity was constant. Precipitates were easily resuspended, and there was no caking or clumping of material. Suspensions of both concentrations of dexamethasone maintained at least 90% of initial concentration at both temperatures throughout the 91-day period. Conclusions: Dexamethasone suspensions of both 0.5 and 1.0 mg/mL in a 1:1 mixture of Ora-Sweet and Ora-Plus were physically and chemically stable for a period of up to 91 days, with or without refrigeration. The expiry date for these products can therefore be set at 91 days. RESUME Objectif : Evaluer la stabilite de suspensions de dexamethasone a des concentrations de 0,5 et 1,0 mg/mL dans un excipient liquide compose a parts egales d’Ora Sweet et d’Ora Plus, apres entreposage a 4 °C et 25 °C pendant une periode allant jusqu’a 91 jours. Methodes : Les suspensions de phosphate sodique de dexamethasone a raison de 4 mg/mL de solution pour injection dans un melange 1:1 d’Ora-Sweet et d’Ora-Plus ont ete preparees dans des flacons de plastique ambre de 40 mL; les concentrations finales de dexamethasone etaient de 0,5 et 1,0 mg/mL. Trois flacons de chaque suspension ont ete entreposes a 4 °C (au refrigerateur) et trois autres a 25°C (a la temperature ambiante). Les caracteristiques physiques, don le pH, la couleur, l’odeur, la viscosite, la precipitation et la facilite de remise en suspension ont ete examinees a chaque semaine pendant les 91 jours. Les aliquotes ont ete retirees de chaque flacon a toutes les semaines, pendant les 91 jours, et refrigerees a –84 °C avant d’etre analysees par une methode validee de chromatographie liquide a haute pression. La suspension etait consideree stable lorsqu’elle conservait 90 % de sa concentration initiale. Resultats : Aucun changement du pH n’a ete observe dans l’une ou l’autre des suspensions aux deux concentrations, apres leur entreposage a 4 °C ou 25 °C pendant 91 jours. Une legere alteration de la couleur et de l’odeur est cependant survenue. La viscosite etait stable et les precipites ont ete facilement remis en suspension, sans agglomeration ni agglutination de la matiere. Les suspensions des deux concentrations de dexamethasone ont conserve au moins 90 % de leur concentration initiale aux deux temperatures pendant la periode d’etude de 91 jours. Conclusions : Les suspensions de dexamethasone aux concentrations de 0,5 et 1 mg/mL dans un melange 1:1 d’Ora Sweet et d’Ora Plus ont montre une stabilite physique et chimique pendant une periode allant jusqu’a 91 jours, avec ou sans refrigeration. La date de peremption de ces produits peut par consequent etre etablie a 91 jours.

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