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

Sylva Klovrzová, Lukáš Zahálka, Ludmila Matysová

    Ceska a Slovenska Farmacie : Casopis Ceske Farmaceuticke Spolecnosti a Slovenske Farmaceuticke Spolecnosti
    |April 13, 2013
    PubMed

    Insights

    This study developed a stable propranolol hydrochloride (PRO) oral solution for pediatric use. The extemporaneous preparation demonstrated good stability for infantile haemangioma and hypertension treatment.

    Area of Science:

    • Pharmaceutical Sciences
    • Pediatric Pharmacology

    Background:

    • Pediatric oral solutions require careful formulation for stability and palatability.
    • Propranolol hydrochloride (PRO) is used for infantile haemangioma and hypertension.
    • Extemporaneous preparation of pediatric medications is crucial.

    Purpose of the Study:

    • To formulate an extemporaneous pediatric oral solution of propranolol hydrochloride (PRO) at 2 mg/ml.
    • To evaluate the stability of the PRO oral solution in pediatric patients (1 month to school children).
    • To assess palatability and preservative efficacy.

    Main Methods:

    • Formulation of PRO oral solution using citric acid or citrate-phosphate buffer at pH 3.
    • Stability testing of PRO solutions stored at 5°C and 25°C for 180 days.
    • Quantification of PRO and sodium benzoate using a validated High-Performance Liquid Chromatography (HPLC) method.

    Main Results:

    • All PRO preparations remained stable at both storage temperatures (5°C and 25°C) with pH values between 2.8-3.2.
    • Sodium benzoate (0.05% w/v) proved effective as a preservative, meeting pharmacopoeial requirements.
    • The citrate-phosphate buffer formulation exhibited better palatability compared to the citric acid formulation.

    Conclusions:

    • An extemporaneous pediatric oral solution of propranolol hydrochloride (PRO) 2 mg/ml was successfully formulated and demonstrated stability.
    • The developed PRO oral solution is suitable for treating infantile haemangioma or hypertension in pediatric patients.
    • The citrate-phosphate buffer formulation offers improved palatability for pediatric administration.
    Abstract

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