TY - JOUR
T1 - Development of a Hydrocortisone Orodispersible Thin Film Containing Its Succinate Prodrug
AU - Boisseillier, Clément
AU - Demange-Labriet, Lucas
AU - Kariyawasam, Dulanjalee
AU - Marchadour, Pauline
AU - Fauqueur, Anne Sophie
AU - Annereau, Maxime
AU - Denis, Lucas
AU - Cotteret, Camille
AU - Cisternino, Salvatore
AU - Schweitzer-Chaput, Arnaud
N1 - Publisher Copyright:
© 2025 by the authors.
PY - 2025/1/1
Y1 - 2025/1/1
N2 - 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/cm2 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®). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm2 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.
AB - 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/cm2 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®). The physicochemical stability of the active ingredients (i.e., HMS, hydrocortisone) contained in the ODF at 0.5 mg/cm2 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.
KW - 21-hydroxylase deficiency
KW - adrenal hyperplasia
KW - drug compounding
KW - hydrocortisone
KW - pediatrics
KW - personalized medicine
KW - pharmacy service
UR - http://www.scopus.com/inward/record.url?scp=85216796010&partnerID=8YFLogxK
U2 - 10.3390/ph18010086
DO - 10.3390/ph18010086
M3 - Article
AN - SCOPUS:85216796010
SN - 1424-8247
VL - 18
JO - Pharmaceuticals
JF - Pharmaceuticals
IS - 1
M1 - 86
ER -