Beyond-Use Dates Assignment for Pharmaceutical Preparations: Example of Low-Dose Amiodarone Capsules
| Autor: | Patrice Vanelle, Christophe Jean, Edouard Lamy, Julie Broggi, Christophe Curti, Pierre Bertault-Peres, Damien Brun, Guillaume Tintori |
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| Přispěvatelé: | Laboratoire d'Informatique de l'Université du Mans (LIUM), Le Mans Université (UM), Assistance Publique - Hôpitaux de Marseille (APHM), Aix Marseille Université (AMU), Institut des Sciences du Mouvement Etienne Jules Marey (ISM), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service Pharmacie [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Institut de Chimie Radicalaire (ICR), Aix Marseille Université (AMU)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS) |
| Rok vydání: | 2021 |
| Předmět: |
Drug compounding
drug-excipient interaction Traditional medicine Chemistry Low dose Pharmaceutical Science Research Reports stability Amiodarone law.invention Microcrystalline cellulose chemistry.chemical_compound Compounding law medicine drug compounding [SDV.IB]Life Sciences [q-bio]/Bioengineering Pharmacopoeia amiodarone microcrystalline cellulose medicine.drug |
| Zdroj: | J Pharm Technol The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians, 2021, 37 (4), pp.178--185. ⟨10.1177/87551225211015566⟩ |
| ISSN: | 8755-1225 |
| DOI: | 10.1177/87551225211015566⟩ |
| Popis: | Background: Beyond-use dates (BUDs) in compounding practice are assigned from stability studies. The United States Pharmacopoeia (USP 42 NF 37) suggested to assign a 6 months BUD for dry oral forms. A new pediatric formula of amiodarone capsules was implemented in our hospital, with 3 dosages (5 mg, 20 mg, and 50 mg). Objective: BUD of these new formulas had to be determined by stability study. Methods: The method for the determination of amiodarone content was validated to be stability indicating, and a stability study was performed. Different excipients commonly used for capsule compounding were compared. Results: We found that, with microcrystalline cellulose as excipient, 50 mg amiodarone capsules were stable for 1 year, whereas 5 mg and 20 mg capsules were not. This difference was studied, and lactose or mannitol were found to be better excipients for 5 mg amiodarone capsules, despite their potential side effects. A potential drug-excipient interaction between microcrystalline cellulose and amiodarone hydrochloride is described. Conclusion: Amiodarone hydrochloride/microcrystalline cellulose capsules have a BUD of 1 month for 5 mg capsules, 6 months for 20 mg, and 1 year for 50 mg. |
| Databáze: | OpenAIRE |
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