The Concept of Chirality and its Association with Drug Safety: Traditional Review

BAHAR, Ayfer; SONMEZ, Neriman Ipek KIRMIZI; VIZDIKLAR, Caner; AYDIN, Volkan; AKICI, Ahmet

doi:10.5336/pharmsci.2022-88233

J Lit Pharm Sci

2022

DOI: 10.5336/pharmsci.2022-88233

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The Concept of Chirality and its Association with Drug Safety: Traditional Review

Ayfer BAHAR¹,

Neriman Ipek KIRMIZI SONMEZ²,

Caner VIZDIKLAR³

et al.

Abstract: Biyolojik sistemlerde nesnelerin önemli geometrik özelliklerinden birisi olan kiralite, bir maddenin ayna görüntüsü ile örtüşmemesi veya üst üste çakışmamasıdır. Moleküldeki atomların 3 boyutlu düzenlenmelerinin doğada pek çok farklı örneği ile karşılaşılır. İlaçların yanı sıra amino asitlerden, kar-

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2023

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The impact of chiral switch on drug labeling in Turkey: indication, posology, and adverse effects

KIRMIZI SONMEZ,

VIZDIKLAR,

AYDIN

et al. 2023

Marmara Medical Journal

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Objective: Chiral switch, which involves replacing racemic drugs to market them as pure enantiomers, is presumed to improve efficacy and safety. Data on how chiral switch-related changes are represented in summary of product characteristics (SmPC) is scarce. We aimed to compare the indication, posology, and safety expressions in SmPCs of racemates and their pure enantiomers. Materials and Methods: We examined SmPCs of nine drug pairs (racemate/pure enantiomer) that underwent chiral switching among top 100 utilized active substances throughout Turkey. We evaluated the expressions in “indications”, “posology”, and “adverse effects” (AE) subheadings. Daily doses were examined based on “Defined Daily Dose” (DDD) metric. Results: We detected indication differences in four drug pairs, including absence of “peptic ulcer” in dexlansoprazole and “prevention of depression relapses” in escitalopram. DDDs of pure enantiomers decreased in most of the pairs. Recommended daily doses of esomeprazole and dexibuprofen per DDD were lower than their racemates. Cautions about use in renal and/or hepatic insufficiency varied in three pairs. AE expressions differed in seven drug pairs, mainly citalopram/escitalopram. Conclusion: This study demonstrated few indication differences in SmPCs of the drug pairs frequently used in Turkey and underwent chiral switching. However, dose reductions and distinctions in safety expressions were remarkable.

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The impact of chiral switch on drug labeling in Turkey: indication, posology, and adverse effects

KIRMIZI SONMEZ,

VIZDIKLAR,

AYDIN

et al. 2023

Marmara Medical Journal

View full text Add to dashboard Cite

show abstract

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The Concept of Chirality and its Association with Drug Safety: Traditional Review

Cited by 1 publication

References 38 publications

The impact of chiral switch on drug labeling in Turkey: indication, posology, and adverse effects

The impact of chiral switch on drug labeling in Turkey: indication, posology, and adverse effects

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