Example Of Low-Dose Amiodarone Capsules - PubMed

Trang chủ » Chimie H&m » Example Of Low-Dose Amiodarone Capsules - PubMed

Có thể bạn quan tâm

Full text links CiteDisplay options Display options Format AbstractPubMedPMID

Abstract

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.

Keywords: amiodarone; drug compounding; drug-excipient interaction; microcrystalline cellulose; stability.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.

Figure 1.

Forced degradation study, amiodarone.

Figure 1.

Forced degradation study, amiodarone.

Figure 1. Forced degradation study, amiodarone.
Figure 2.

Figure 2.

Influence of diluent and of…

Figure 2.

Influence of diluent and of amiodarone content on degradation product P1 increase.

Figure 2. Influence of diluent and of amiodarone content on degradation product P1 increase.
See this image and copyright information in PMC

References

    1. Nahata MC. Stability of amiodarone in an oral suspension stored under refrigeration and at room temperature. Ann Pharmacother. 1997;31:851-852. doi: 10.1177/106002809703100707 - DOI - PubMed
    1. Geiger CM, Sorenson B, Whaley P. Stability assessment of 10 active pharmaceutical ingredients compounded in SyrSpend SF. Int J Pharm Compd. 2015;19:420-427. - PubMed
    1. Helin-Tanninen M, Autio K, Keski-Rahkonen P, Naaranlahti T, Järvinen K. Comparison of six different suspension vehicles in compounding of oral extemporaneous nifedipine suspension for paediatric patients. Eur J Hosp Pharm. 2012;19:432-437. doi: 10.1136/ejhpharm-2012-000159 - DOI
    1. Ernst JA, Williams JM, Glick MR, Lemons JA. Osmolality of substances used in the intensive care nursery. Pediatrics. 1983;72:347-352. - PubMed
    1. Shah DD, Kuzmov A, Clausen D, et al. Osmolality of commonly used oral medications in the neonatal intensive care unit. J Pediatr Pharmacol Ther. 2021;26:172-178. doi: 10.5863/1551-6776-26.2.172 - DOI - PMC - PubMed
Show all 29 references

LinkOut - more resources

  • Full Text Sources

    • Europe PubMed Central
    • Ovid Technologies, Inc.
    • PubMed Central

Từ khóa » Chimie H&m