Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma
<b>Background/Objectives</b>: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs....
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| author | Chiara Lacassia Annalisa Cutrignelli Flavia Maria la Forgia Sergio Fontana Antonio Lopalco Nunzio Denora Angela Assunta Lopedota |
| author_facet | Chiara Lacassia Annalisa Cutrignelli Flavia Maria la Forgia Sergio Fontana Antonio Lopalco Nunzio Denora Angela Assunta Lopedota |
| author_sort | Chiara Lacassia |
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| description | <b>Background/Objectives</b>: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs. Although oral propranolol therapy at a dosage of 3 mg/kg/die is effective, it can cause systemic adverse reactions. This therapy is not necessarily applicable to all patients. Topical skin applications could help maintain a high drug concentration at local sites and also represent a characteristically easy method of administration for pediatric patients. Because no topical propranolol dosage forms are commercially available, such formulations may be prepared at hospitals and pharmacies. <b>Methods</b>: In the present study, we identified a simple method for preparing topical propranolol hydrochloride formulations at 1% <i>w/w</i> with five commercial ready-to-use bases and evaluated the pharmaceutical profiles. The physical stability of the extemporaneous formulations was predicted by performing an accelerated centrifuge test and assessed by visual inspection after one month storage at 25 °C. The chemical stability of the drug in the five formulations was assessed by using a high-performance liquid chromatography (HPLC) method. In vitro drug-release and permeability experiments were conducted through synthetic membranes and the outer pavilion of a pig’s ear by utilizing Franz-type diffusion cells. <b>Results</b>: The results indicated that the release of the drug was significantly influenced by the internal structure and physicochemical properties of each base. <b>Conclusions</b>: Specifically, the formulations prepared with the hydrophilic bases could be easily prepared and yield satisfactory results, representing a potential effective therapy for IHs in pediatric patients. |
| format | Article |
| id | doaj-art-2742aba557dd4a9b820edf4ee7726e74 |
| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| series | Pharmaceutics |
| spelling | doaj-art-2742aba557dd4a9b820edf4ee7726e742025-01-24T13:45:53ZengMDPI AGPharmaceutics1999-49232025-01-011718310.3390/pharmaceutics17010083Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile HemangiomaChiara Lacassia0Annalisa Cutrignelli1Flavia Maria la Forgia2Sergio Fontana3Antonio Lopalco4Nunzio Denora5Angela Assunta Lopedota6Department of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 70125 Bari, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 70125 Bari, ItalyCentro Studi Ricerche “Dr. S. Fontana 1900–1982”, Farmalabor s.r.l., 76012 Canosa di Puglia, ItalyCentro Studi Ricerche “Dr. S. Fontana 1900–1982”, Farmalabor s.r.l., 76012 Canosa di Puglia, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 70125 Bari, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 70125 Bari, ItalyDepartment of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 70125 Bari, Italy<b>Background/Objectives</b>: Since 2008, following clinical studies conducted on children that revealed the ability of the β-adrenergic antagonist propranolol to inhibit capillary growth in infantile hemangiomas (IHs), its oral administration has become the first-line treatment for IHs. Although oral propranolol therapy at a dosage of 3 mg/kg/die is effective, it can cause systemic adverse reactions. This therapy is not necessarily applicable to all patients. Topical skin applications could help maintain a high drug concentration at local sites and also represent a characteristically easy method of administration for pediatric patients. Because no topical propranolol dosage forms are commercially available, such formulations may be prepared at hospitals and pharmacies. <b>Methods</b>: In the present study, we identified a simple method for preparing topical propranolol hydrochloride formulations at 1% <i>w/w</i> with five commercial ready-to-use bases and evaluated the pharmaceutical profiles. The physical stability of the extemporaneous formulations was predicted by performing an accelerated centrifuge test and assessed by visual inspection after one month storage at 25 °C. The chemical stability of the drug in the five formulations was assessed by using a high-performance liquid chromatography (HPLC) method. In vitro drug-release and permeability experiments were conducted through synthetic membranes and the outer pavilion of a pig’s ear by utilizing Franz-type diffusion cells. <b>Results</b>: The results indicated that the release of the drug was significantly influenced by the internal structure and physicochemical properties of each base. <b>Conclusions</b>: Specifically, the formulations prepared with the hydrophilic bases could be easily prepared and yield satisfactory results, representing a potential effective therapy for IHs in pediatric patients.https://www.mdpi.com/1999-4923/17/1/83propranolol hydrochlorideformulationtopicalhemangiomapediatriccompounding |
| spellingShingle | Chiara Lacassia Annalisa Cutrignelli Flavia Maria la Forgia Sergio Fontana Antonio Lopalco Nunzio Denora Angela Assunta Lopedota Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma Pharmaceutics propranolol hydrochloride formulation topical hemangioma pediatric compounding |
| title | Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma |
| title_full | Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma |
| title_fullStr | Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma |
| title_full_unstemmed | Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma |
| title_short | Evaluation of Five Ready-to-Use Bases for the Topical Administration of Propranolol Hydrochloride to Treat Infantile Hemangioma |
| title_sort | evaluation of five ready to use bases for the topical administration of propranolol hydrochloride to treat infantile hemangioma |
| topic | propranolol hydrochloride formulation topical hemangioma pediatric compounding |
| url | https://www.mdpi.com/1999-4923/17/1/83 |
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