Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend<sup>®</sup> SF PH4

Bonnaure, Anne-Claire; Bellay, Romain; Rault, Pauline; Lester, Marie-Antoinette; Boivin, P

doi:10.1515/pthp-2018-0001

Cited by 2 publications

(1 citation statement)

References 4 publications

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“…In an effort to standardize formulations and operating procedures, an increasing number of studies related to the development of compounded oral liquid formulations is now available. Some formulations include commercial vehicles for oral use as excipients [ 21 , 22 , 23 , 24 , 25 ]. However, the composition of commercial vehicles is not fully described by suppliers, and modifications in the nature and proportion of the components may occur, raising issues for previous stability studies conducted using these products.…”

Section: Discussionmentioning

confidence: 99%

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

et al. 2023

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Nicardipine hydrochloride is an anti-hypertensive drug that is used off-label to treat hypertension in children. A previous oral formulation of nicardipine hydrochloride was developed using a commercial vehicle as an excipient. However, ready-to-use vehicles are prone to supply shortages, and their composition may undergo substantial modifications. The aim of this study was to propose a new oral formulation of nicardipine hydrochloride 2 mg/mL using simple excipients. The formulation included hydroxypropylmethylcellulose, simple syrup, polysorbate 80, sodium saccharin, citrate buffer, strawberry flavor and 0.2% potassium sorbate. The uniformity of content was maintained before and after agitation. Nicardipine hydrochloride concentration assessed by HPLC-MS/MS remained above 90% for 365 days before opening and for 28 days after opening. pH and osmolality were maintained throughout the study, and no microbial contamination was observed. The uniformity of mass of the delivered doses was evaluated using four different devices. A new oral formulation of nicardipine hydrochloride 2 mg/mL was developed using simple and safe excipients. Pharmacological and clinical parameters remain to be assessed and compared with those of the previous formulation.

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Section: Discussionmentioning

confidence: 99%

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

et al. 2023

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Physicochemical stability of 20 mg/mL amiodarone hydrochloride oral suspension in SyrSpend^® SF PH4 (liquid)

Adoum

Faisant

et al. 2022

Pharmaceutical Technology in Hospital Pharmacy

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Objectives Amiodarone hydrochloride is a class III antiarrhythmic drug indicated for the treatment of ventricular and supraventricular tachycardias. Oral amiodarone is only available in a tablet dosage form, which is not suitable for pediatric use. The stability of amiodarone hydrochloride suspension at 5 mg/mL was assessed in SyrSpend® SF PH4 (liquid) but oral amiodarone is typically given as a loading dose of 10–15 mg/kg/day for 4–10 days and then reduced to a maintenance dose of 5 mg/kg/day, making the 20 mg/mL concentration a better option. A hospital preparation of 20 mg/mL amiodarone hydrochloride oral suspension was developed. The purpose of this study was to determine the physicochemical stability of a 20 mg/mL amiodarone hydrochloride oral multidose suspension in a commercial compounding excipient, SyrSpend® SF PH4 (liquid) at ambient temperature and under dark conditions. Methods Three batches of oral suspension were prepared using amiodarone hydrochloride powder and SyrSpend SF PH4 (liquid). The suspensions were stored at room temperature and protected from light (amber glass vials). A sample was withdrawn from each bottle immediately after preparation and at 1, 2, 5, 10, 15, 30, 60, and 90 days. After additional dilution to an expected concentration of 100 μg/mL with methanol, the samples were assayed in triplicate using a stability-indicating high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection. The physicochemical properties (pH, osmolality, amiodarone concentration, macroscopic changes) were assessed over 90 days at each day of analysis. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point and defined as retention of at least 95% of the initial concentration of amiodarone hydrochloride. Results After 90 days, the study showed that amiodarone hydrochloride concentrations did not go below 95% of the initial drug concentration. Neither degradation products nor changes of physicochemical properties were detected. Conclusions Compounded oral suspensions of 20 mg/mL amiodarone hydrochloride in SyrSpend® SF PH4 (liquid) were stable for at least 90 days when stored in amber glass bottles at room temperature.

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Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend^® SF PH4

Cited by 2 publications

References 4 publications

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

Physicochemical stability of 20 mg/mL amiodarone hydrochloride oral suspension in SyrSpend^® SF PH4 (liquid)

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Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend® SF PH4

Cited by 2 publications

References 4 publications

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension

Physicochemical stability of 20 mg/mL amiodarone hydrochloride oral suspension in SyrSpend® SF PH4 (liquid)

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Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend^® SF PH4

Physicochemical stability of 20 mg/mL amiodarone hydrochloride oral suspension in SyrSpend^® SF PH4 (liquid)