Feasibility of amlodipine besylate, chloroquine phosphate, dapsone, phenytoin, pyridoxine hydrochloride, sulfadiazine, sulfasalazine, tetracycline hydrochloride, trimethoprim and zonisamide in SyrSpend ® SF PH4 oral suspensions

Ferreira, Anderson O; Polonini, Hudson; Silva, Sharlene L; Patrício, Fernando B.; Brandão, Marcos Antônio Fernandes; Raposo, Nádia Rezende Barbosa

doi:10.1016/j.jpba.2015.10.032

Cited by 32 publications

(20 citation statements)

References 5 publications

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“…No detectable change was observed in the prepared suspensions. The suspension showed more stability at 4°C than 25°C (91 days and 56 days respectively) [14].…”

Section: Amlodipine Besylate Suspensionmentioning

confidence: 91%

“…In ambered plastic bottles the suspension was placed in room temperature for 90 days. The sample was analyzed using HPLC at different time interval (14,28,56, and 90 days). Results revealed that the drug showed up to 90% stability at 90 th day in both the preparations and there were significant physical or chemical changes were observed neither any microbial growth was detected [8].…”

Section: Rufinamide Oral Suspensionmentioning

confidence: 99%

See 1 more Smart Citation

An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension

Naveed¹,

Akhtar²,

Khan³

2017

J Bioequiv Availab

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“…No detectable change was observed in the prepared suspensions. The suspension showed more stability at 4°C than 25°C (91 days and 56 days respectively) [14].…”

Section: Amlodipine Besylate Suspensionmentioning

confidence: 91%

Section: Rufinamide Oral Suspensionmentioning

confidence: 99%

An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension

Naveed¹,

Akhtar²,

Khan³

2017

J Bioequiv Availab

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“…Specificity, precision, accuracy, linearity and limits of detection and quantification were determined following a protocol described in a previous study 36. In this protocol, during specificity determination a stressing test was also conducted (acid, alkaline, ultraviolet light, heat and oxidising stresses).…”

Section: Methodsmentioning

confidence: 99%

“…Occurrence of physical phenomena (precipitation, turbidity, macroscopically visible crystal growth, odour generation, phase separation, flocculation or caking) was checked. A detailed protocol is described by Ferreira et al 36 Samples were withdrawn at 0 (baseline), 7, 14, 30, 60 and 90 days (T=0, 7, 14, 30, 60 or 90) and assayed six times at each time point.…”

Section: Methodsmentioning

confidence: 99%

Compatibility of proton pump inhibitors in a preservative-free suspending vehicle

Polonini¹,

Silva²,

Loures³

et al. 2016

Eur J Hosp Pharm

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ObjectivesTo evaluate the microbiological and physicochemical compatibility of commonly used proton pump inhibitors (PPIs) esomeprazole, lansoprazole, omeprazole and pantoprazole compounded at a single concentration using SyrSpend SF Alka and stored at refrigerated temperatures (omeprazole was also stored at room temperature because it has the most widespread use).MethodsCompatibility was assessed by measuring the per cent recovery at varying time points throughout a 90-day period. Quantification of the APIs was performed by a validated high performance liquid chromatography (HPLC-UV) method. This same assay was also used to determine the dosage content uniformity of the suspensions. Microbiological stability (‘test in use’) was assessed during 60 days and total aerobic microbial count (TAMC), total combined yeasts and moulds count (TYMC), detection of Escherichia coli and pH determination were performed. Antimicrobial effectiveness testing was determined following European Pharmacopoeia guidelines.ResultsBeyond-use dates of maximum 60 days for omeprazole (5 mg/mL), pantoprazole (3 mg/mL) and esomeprazole (3 mg/mL) were established. All suspensions that met the physicochemical criteria for stability also met the content uniformity criteria. The suspensions showed no antimicrobial efficiency against bacteria, yeasts and moulds as SyrSpend SF Alka is an unpreserved vehicle, but the ‘test in use’ showed that the suspensions can remain microbiologically stable for up to 60 days.ConclusionsSyrSpend SF Alka can be used to compound palatable (taste-masking properties) preservative-free oral suspensions with almost all commonly used PPIs.

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“…Compatibility results with SyrSpend SF have been published for more than 70 different APIs. [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] In all of these studies, the compatibility was assessed by measuring the percentage recovery at varying time points throughout a 90-day period at controlled room and/or at controlled refrigerated temperature. The majority of the compatibility studies have been performed with raw pharmaceutical APIs.…”

mentioning

confidence: 99%

Limited Influence of Excipients in Extemporaneous Compounded Suspensions

Dijkers¹,

Nanhekhan²,

Thorissen³

et al. 2017

Hosp Pharm

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The objective of this study was to identify whether compounding oral suspensions with SyrSpend SF based on tablets or capsules is a suitable alternative for using raw pharmaceutical materials. Suspensions based on 5 different tablets and capsules were studied in SyrSpend SF. The summary of product characteristics of these different tablets and capsules were obtained from the manufacturer. Our hypothesis was that, if the maximum beyond-use date of the study was reached, the excipient did not seem to have an influence on the stability of the active pharmaceutical ingredient (API) within the studied time frame. All excipients used in flecainide acetate, labetalol HCl, and tiagabine HCl tablets as well as in celecoxib and oseltamivir capsules did not seem to influence the beyond-use date of the overall suspension based on SyrSpend SF. Although using raw materials as API sources is preferred, oral suspensions with SyrSpend SF prepared from crushed tablets or opened capsules could be a possible alternative. Based on this study, a wide range of different excipients does not seem to impact the beyond-use date of different APIs compounded in SyrSpend SF.

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Feasibility of amlodipine besylate, chloroquine phosphate, dapsone, phenytoin, pyridoxine hydrochloride, sulfadiazine, sulfasalazine, tetracycline hydrochloride, trimethoprim and zonisamide in SyrSpend ® SF PH4 oral suspensions

Cited by 32 publications

References 5 publications

An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension

An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension

Compatibility of proton pump inhibitors in a preservative-free suspending vehicle

Limited Influence of Excipients in Extemporaneous Compounded Suspensions

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