Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug
Orodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children. Objectives: The aim of the study was to develop and characterize an optimal ODF formulation...
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MDPI AG
2025-01-01
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| author | Clément Boisseillier Lucas Demange-Labriet Dulanjalee Kariyawasam Pauline Marchadour Anne-Sophie Fauqueur Maxime Annereau Lucas Denis Camille Cotteret Salvatore Cisternino Arnaud Schweitzer-Chaput |
| author_facet | Clément Boisseillier Lucas Demange-Labriet Dulanjalee Kariyawasam Pauline Marchadour Anne-Sophie Fauqueur Maxime Annereau Lucas Denis Camille Cotteret Salvatore Cisternino Arnaud Schweitzer-Chaput |
| author_sort | Clément Boisseillier |
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| description | Orodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children. Objectives: The aim of the study was to develop and characterize an optimal ODF formulation containing equivalent hydrocortisone at 0.5 mg/cm<sup>2</sup> using the solvent-casting method. A stability-indicating assay for the simultaneous quantification of hydrocortisone and hydrocortisone 21-hemissucinate (HMS) was developed. ODFs were characterized by organoleptic properties and by testing for uniformity of mass, content, stability, thickness, and dissolution. Results: When optimized, ODF is thin, flexible, and transparent, making it suitable for production in hospital pharmacies using standard equipment. In contrast to the water-insoluble hydrocortisone, the HMS-loaded cast gel successfully satisfied the tests, including content uniformity. Disintegration appeared acceptable as compared to the commercial grade ondansetron ODF (Setofilm<sup>®</sup>). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm<sup>2</sup> is demonstrated for at least 84 days at 23 °C. Conclusion: The ODF formulated with the water-soluble hydrocortisone prodrug HMS allows accurate drug level to be achieved, thus opening up new opportunities for use in pediatric patients. |
| format | Article |
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| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | MDPI AG |
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| series | Pharmaceuticals |
| spelling | doaj-art-3ded63248dc14aa3b35b2fbbd5da03f22025-01-24T13:45:20ZengMDPI AGPharmaceuticals1424-82472025-01-011818610.3390/ph18010086Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate ProdrugClément Boisseillier0Lucas Demange-Labriet1Dulanjalee Kariyawasam2Pauline Marchadour3Anne-Sophie Fauqueur4Maxime Annereau5Lucas Denis6Camille Cotteret7Salvatore Cisternino8Arnaud Schweitzer-Chaput9Service Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService d’Endocrinologie, Diabétologie, Gynécologie Pédiatriques, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService Pharmacie, Institut Gustave Roussy, F-94800 Villejuif, FranceService Pharmacie, Institut Gustave Roussy, F-94800 Villejuif, FranceService Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceService Pharmacie, Hôpital Universitaire Necker-Enfants Malades, Assistance Publique des Hôpitaux de Paris (AP-HP), 149 Rue de Sèvres, F-75015 Paris, FranceOrodispersible thin film (ODF) is an innovative dosage form that allows for adjustable dosing and improved patient compliance. It is administered by mouth, where it dissolves, making it suitable for children. Objectives: The aim of the study was to develop and characterize an optimal ODF formulation containing equivalent hydrocortisone at 0.5 mg/cm<sup>2</sup> using the solvent-casting method. A stability-indicating assay for the simultaneous quantification of hydrocortisone and hydrocortisone 21-hemissucinate (HMS) was developed. ODFs were characterized by organoleptic properties and by testing for uniformity of mass, content, stability, thickness, and dissolution. Results: When optimized, ODF is thin, flexible, and transparent, making it suitable for production in hospital pharmacies using standard equipment. In contrast to the water-insoluble hydrocortisone, the HMS-loaded cast gel successfully satisfied the tests, including content uniformity. Disintegration appeared acceptable as compared to the commercial grade ondansetron ODF (Setofilm<sup>®</sup>). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm<sup>2</sup> is demonstrated for at least 84 days at 23 °C. Conclusion: The ODF formulated with the water-soluble hydrocortisone prodrug HMS allows accurate drug level to be achieved, thus opening up new opportunities for use in pediatric patients.https://www.mdpi.com/1424-8247/18/1/86adrenal hyperplasiadrug compoundinghydrocortisone21-hydroxylase deficiencypediatricspersonalized medicine |
| spellingShingle | Clément Boisseillier Lucas Demange-Labriet Dulanjalee Kariyawasam Pauline Marchadour Anne-Sophie Fauqueur Maxime Annereau Lucas Denis Camille Cotteret Salvatore Cisternino Arnaud Schweitzer-Chaput Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug Pharmaceuticals adrenal hyperplasia drug compounding hydrocortisone 21-hydroxylase deficiency pediatrics personalized medicine |
| title | Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug |
| title_full | Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug |
| title_fullStr | Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug |
| title_full_unstemmed | Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug |
| title_short | Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug |
| title_sort | development of a hydrocortisone orodispersible thin film containing its succinate prodrug |
| topic | adrenal hyperplasia drug compounding hydrocortisone 21-hydroxylase deficiency pediatrics personalized medicine |
| url | https://www.mdpi.com/1424-8247/18/1/86 |
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