Background Oral propranolol has been found successful in the treatment of infantile haemangiomas. Paediatric dosage forms of propranolol are not commercially available in our country.
Purpose To develop an extemporaneous oral dosage form of propranolol appropriate for children from 14 days to 24 months of age in hospital and an ambulatory care setting and to determinate its stability. The requirement for minimum excipients for the safety of targeted age group was considered.
Materials and Methods A solution of propranolol 2 mg/ml was prepared from the substance. We used citric acid or citrate- phosphate buffer to achieve the optimum stability of propranolol (pH about 3) and simple syrup to mask the bitter taste of the active ingredient. Two formulations (depending on the patient’s age) were developed – one using sodium benzoate as preservative and one preservative-free. The preservative-free solution was prepared aseptically with a limited expiry date. The stability of the preserved solution was evaluated for 180 days at room and reduced (2–8°C) temperatures using a validated HPLC method and pH measurements.
Results The formulation preserved with sodium benzoate was stable at both temperatures for 180 days. The concentration of propranolol varied between 98.2–102.5%, the pH value did not change significantly. The efficacy of antimicrobial preservation (Ph.Eur., 5.1.3) was proven for sodium benzoate 0.05%. A risk assessment of the formulation was undertaken (<100) and an appropriate quality assurance system was developed. A glass bottle with an oral syringe enabled the dose of propranolol to be given with flexibility and accuracy.
Conclusions The preparation of propranolol solution in the pharmacy enabled 23 paediatric patients aged 0.6–20.9 months to be treated successfully for haemangiomas by our hospital.
Acknowledgement This work was supported by the Ministry of Health of the Czech Republic as a project of conceptual development of research organisation 00064203 (University Hospital Motol, Prague, Czech Republic)
No conflict of interest.
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