JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2013, 62(1):35-39

Pediatric oral solutions with propranolol hydrochloride for extemporaneous compounding: the formulation and stability study

Sylva Klovrzová1, Lukáš Zahálka3, Ludmila Matysová3, Petr Horák1, Zdenka Šklubalová2,*
1 University Hospital Motol, Hospital Pharmacy, Prague, Czech Republic
2 Charles University in Prague, Faculty of Pharmacy, Department of Pharmaceutical Technology, Hradec Králové, Czech Republic
3 Charles University in Prague, Faculty of Pharmacy, Department of Analytical Chemistry, Hradec Králové, Czech Republic

The aim of this study is to formulate an extemporaneous pediatric oral solution of propranolol hydrochloride (PRO) 2 mg/ml for the therapy of infantile haemangioma or hypertension in a target age group of 1 month to school children and to evaluate its stability. A citric acid solution and/or a citrate-phosphate buffer solution, respectively, were used as the vehicles to achieve pH value of about 3, optimal for the stability of PRO. In order to mask the bitter taste of PRO, simple syrup was used as the sweetener. All solutions were stored in tightly closed brown glass bottles at 5 ± 3 °C and/or 25 ± 3 °C, respectively. The validated HPLC method was used to evaluate the concentration of PRO and a preservative, sodium benzoate, at time intervals of 0-180 days. All preparations were stable at both storage temperatures with pH values in the range of 2.8-3.2. According to pharmacopoeial requirements, the efficacy of sodium benzoate 0.05 % w/v was proved (Ph.Eur., 5.1.3). The preparation formulated with the citrate-phosphate buffer, in our experience, had better palatability than that formulated with the citric acid solution.

Keywords: propranolol hydrochloride; pediatric preparation; extemporaneous preparation; solution; stability testing; HPLC
Grants and funding:

Supported by the project of the Ministry of Health of the Czech Republic for conceptual development of research organization 00064203 (University Hospital Motol, Prague, Czech Republic) and Student Grants SVV-2012265 002 and SVV-2012265 001. The publication is co-financed by the European Social Fund and the state budget of the Czech Republic. TEAB, project no. CZ.1.07/2.3.00/20.0235.

Received: December 3, 2012; Accepted: January 10, 2013; Published: January 1, 2013  Show citation

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Klovrzová S, Zahálka L, Matysová L, Horák P, Šklubalová Z. Pediatric oral solutions with propranolol hydrochloride for extemporaneous compounding: the formulation and stability study. Čes. slov. farm. 2013;62(1):35-39.
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