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Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates)

Author(s):  Brandin Thibaut, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice

Issue:  Mar/Apr 2022 - Volume 26, Number 2
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Abstract:  Fludrocortisone acetate is a drug used to treat adrenal insufficiencies which can be prescribed to hospitalized or ambulatory pediatric patients at dosages not commercially available. For these patients, 10-µg fludrocortisone capsules are currently compounded from a pre-compounded titrated powder (powder triturate). Fludrocortisone stability studies were carried out to ensure a valid beyond-use date. First, a stability-indicating fludrocortisone acetate dosing method was validated. Then fludrocortisone acetate 10-µg capsules and 1% fludrocortisone acetate titrated powders (powder triturates) were realized. Finally, stability studies were performed. The fludrocortisone acetate titrated powders (powder triturates) were stable for one year at controlled ambient temperature and protected from light, whereas 10-µg fludrocortisone acetate capsules were stable for six months. One year after, even if the fludrocortisone content remained conformed, an increase in product degradation was noted. Our work allowed us to determine a six-month beyond-use date for fludrocortisone acetate titrated powder (powder triturate) with the three most commonly used excipients for capsule compounding. We also confirmed the sixmonth theoretical stability for capsules.

Related Keywords: Thibault Brandin, BsC, Maya Wasilewski, BsC, Camille Panuccio, BsC, Cyrielle Bouguergour, BsC, Nicolas Primas, PharmD, PhD, Edouard Lamy, PharmD, PhD, Christophe Jean, PharmD, Pierre Bertault-Peres, PharmD, Pascal Rathelot, PharmD, PhD, Christophe Curti, PharmD, PhD, Patrice Vanelle, PharmD, PhD, fludrocortisone acetate, stability, adrenocortical insufficiency, adrenal deficiency, excipients, titrated powders, powder triturates, children

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, ALLERGY/IMMUNOLOGY/INFLAMMATION, DOSAGE FORMS/DRUG CARRIERS, ENDOCRINOLOGY/HORMONES/ MENOPAUSE/ANDROPAUSE

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