Development of a Hydroxypropyl-β-Cyclodextrin-Based Liquid Formulation for the Oral Administration of Propranolol in Pediatric Therapy
Articolo
Data di Pubblicazione:
2023
Citazione:
Development of a Hydroxypropyl-β-Cyclodextrin-Based Liquid Formulation for the Oral Administration of Propranolol in Pediatric Therapy / M. Cirri, P. Mura, S. Benedetti, S. Buratti. - In: PHARMACEUTICS. - ISSN 1999-4923. - 15:9(2023), pp. 2217.1-2217.16. [10.3390/pharmaceutics15092217]
Abstract:
Propranolol (PPN) is widely used in children to treat various cardiovascular diseases. The
availability of a suitable PPN solution should avoid recourse to extemporaneous preparations of
unknown/limited stability, as commonly made in hospital pharmacies. However, the development of pediatric PPN solutions is hindered by their instability to light and stability at pH 3, bitter taste,
and the need to improve palatability and avoid co-solvents, flavoring agents, or preservatives that
are potentially toxic. In this study, cyclodextrin (CD) complexation has been exploited to develop a safe, stable, and palatable oral pediatric solution of PPN. An initial screening among various CDs allowed us to select HP CD for its good complexing ability and no toxicity. Drug-HP CD physical mixtures or co-ground systems (1:1 or 1:2 mol:mol) were used to prepare 0.2% w/v drug solutions.
Photo stability studies evidenced the protective effect of HP CD, revealing a reduction of up to 75%
in the drug degradation rate after 1 h of exposure to UV radiation. Storage stability studies showed unchanged physical–chemical properties and almost constant drug concentration after 6 months and under accelerated conditions (40 °C), despite the less aggressive pH ( 5.5) of the solution. The
electronic tongue test proved that the HP CD taste-masking properties improved the formulation palatability, with a 30% reduction in drug bitterness.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
propranolol; pediatric solutions; hydroxypropyl-β-cyclodextrin; photo stability; storage stability; electronic tongue
Elenco autori:
M. Cirri, P. Mura, S. Benedetti, S. Buratti
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