Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance

Cromoglycate (SCG) is widely used for allergy processes, and inflammatory states acting as a mast cell membrane stabilizer that inhibits the histamine and mediator release. Currently, SCG topical extemporaneous compounding formulations are prepared in hospitals and community pharmacies, as no indust...

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Main Authors: Olga González-González, Enrique Leal, Mercedes Martín-Martínez, Liliana Bautista, Maria Paloma Ballesteros, Juan J. Torrado, Dolores R. Serrano
Format: Article
Language:English
Published: MDPI AG 2023-05-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/15/6/1609
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author Olga González-González
Enrique Leal
Mercedes Martín-Martínez
Liliana Bautista
Maria Paloma Ballesteros
Juan J. Torrado
Dolores R. Serrano
author_facet Olga González-González
Enrique Leal
Mercedes Martín-Martínez
Liliana Bautista
Maria Paloma Ballesteros
Juan J. Torrado
Dolores R. Serrano
author_sort Olga González-González
collection DOAJ
description Cromoglycate (SCG) is widely used for allergy processes, and inflammatory states acting as a mast cell membrane stabilizer that inhibits the histamine and mediator release. Currently, SCG topical extemporaneous compounding formulations are prepared in hospitals and community pharmacies, as no industrial fabricated medicines are available in Spain. The stability of these formulations is unknown. Additionally, there are no clear guidelines on which concentration and vehicle are more suitable to enhance permeation across the skin. In this work, the stability of commonly prescribed topical SCG formulations in clinical practice was evaluated. Different vehicles commonly employed by pharmacists daily for formulating topical SCG were investigated (Eucerinum, Acofar Creamgel, and Beeler’s base) at different concentrations, ranging from 0.2 to 2%. The stability of topical extemporaneous compounded SCG formulations can be extended for up to three months at room temperature (25 °C). Creamgel 2% formulations significantly improved the topical permeation of SCG across the skin, being 4.5-fold higher than formulations prepared with Beeler’s base. The reason attributed to this performance can be related to the lower droplet size formed upon dilution in aqueous media combined with a lower viscosity, which facilitates its application and extensibility on the skin. The higher the SCG concentration in Creamgel formulations, the higher the permeability across both synthetic membranes and pig skin (<i>p</i>-value < 0.05). These preliminary results can be used as a guide to prompt a rational prescription of topical SCG formulations.
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spelling doaj.art-e6ec4cd6fb9740d8b91f3ffd758bdf082023-11-18T12:03:53ZengMDPI AGPharmaceutics1999-49232023-05-01156160910.3390/pharmaceutics15061609Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical PerformanceOlga González-González0Enrique Leal1Mercedes Martín-Martínez2Liliana Bautista3Maria Paloma Ballesteros4Juan J. Torrado5Dolores R. Serrano6Departamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, SpainCommunity Pharmacy, 140 Canillas Road, 28043 Madrid, SpainInstituto de Química Medica, Juan de la Cierva, 28006 Madrid, SpainDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, SpainDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, SpainDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, SpainDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, SpainCromoglycate (SCG) is widely used for allergy processes, and inflammatory states acting as a mast cell membrane stabilizer that inhibits the histamine and mediator release. Currently, SCG topical extemporaneous compounding formulations are prepared in hospitals and community pharmacies, as no industrial fabricated medicines are available in Spain. The stability of these formulations is unknown. Additionally, there are no clear guidelines on which concentration and vehicle are more suitable to enhance permeation across the skin. In this work, the stability of commonly prescribed topical SCG formulations in clinical practice was evaluated. Different vehicles commonly employed by pharmacists daily for formulating topical SCG were investigated (Eucerinum, Acofar Creamgel, and Beeler’s base) at different concentrations, ranging from 0.2 to 2%. The stability of topical extemporaneous compounded SCG formulations can be extended for up to three months at room temperature (25 °C). Creamgel 2% formulations significantly improved the topical permeation of SCG across the skin, being 4.5-fold higher than formulations prepared with Beeler’s base. The reason attributed to this performance can be related to the lower droplet size formed upon dilution in aqueous media combined with a lower viscosity, which facilitates its application and extensibility on the skin. The higher the SCG concentration in Creamgel formulations, the higher the permeability across both synthetic membranes and pig skin (<i>p</i>-value < 0.05). These preliminary results can be used as a guide to prompt a rational prescription of topical SCG formulations.https://www.mdpi.com/1999-4923/15/6/1609cromoglycateextemporaneous compounding formulationsstabilityskin permeability
spellingShingle Olga González-González
Enrique Leal
Mercedes Martín-Martínez
Liliana Bautista
Maria Paloma Ballesteros
Juan J. Torrado
Dolores R. Serrano
Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
Pharmaceutics
cromoglycate
extemporaneous compounding formulations
stability
skin permeability
title Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
title_full Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
title_fullStr Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
title_full_unstemmed Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
title_short Guiding Clinical Prescription of Topical Extemporaneous Formulations of Sodium Cromoglycate Based on Pharmaceutical Performance
title_sort guiding clinical prescription of topical extemporaneous formulations of sodium cromoglycate based on pharmaceutical performance
topic cromoglycate
extemporaneous compounding formulations
stability
skin permeability
url https://www.mdpi.com/1999-4923/15/6/1609
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