Development of methodology for the study of API sensitivity to hydrolytic degradations at different pH conditions in solid-state

Petřík, Jakub; Heřt, Jakub; Řezanka, Pavel

doi:10.1007/s11696-021-01630-x

Chem. Pap.

2021

DOI: 10.1007/s11696-021-01630-x

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Development of methodology for the study of API sensitivity to hydrolytic degradations at different pH conditions in solid-state

Jakub Petřík

Jakub Heřt²,

Pavel Řezanka

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2024

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Cited by 4 publications

(1 citation statement)

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“…Additionally, Petrit et al reported bisoprolol reactivity to hydrolytic degradation at different pH conditions, Ghauch et al and Prachi et al reported bisoprolol sensitivity to oxidative degradation conditions, Marothu et al reported isothermal stress testing of bisoprolol fumarate. [3][4][5][6] In literature, Pandey et al reported thermal degradation of bisoprolol in stability indicating method. 7 Combination of bisoprolol with other drugs are used in hypertension treatment.…”

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confidence: 99%

Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development

Chandramore,

Sonawane

2023

IJPQA

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The stability of bisoprolol in tablet and bulk form was developed and validated using chromatographic methods. The bisoprolol was exposed to oxidizing agents like hydrogen peroxide, heat (dry and wet) and photolytic conditions, acid, alkali, and water hydrolysis. However, considerable degradation was observed in acid, alkali, oxidative, and wet heat thermal conditions. The drug’s stability under photolytic and dry heat conditions was established. The drug and its degradation products were separated on ODS C-18 with the specification of (250 mm × 4.6 mm, 5 μm) and the mobile phase containing acetonitrile and phosphate buffer (20 mM, pH 8) (60:40, v/v). According to ICH Q2 (R1) all method validation parameters are verified. Determination of the active pharmaceutical ingredient was not interfered by excipients or degradation products. In the 6–14 μg/mL range, the response was shown to be linear. One degradation product’s LC-MS m/z values and fragmentation patterns matched an impurity mentioned in the drug’s European Pharmacopoeia monograph. The remaining three were unidentified degradation products. LC-MS fragmentation experiments were used to characterize the products. The findings may lead to the suggestion of a more thorough drug degradation mechanism. The Toxtree software (Version 3.1.1) was then used to forecast the toxicity of the degradation products. Additional toxicity determination was carried out by using in-silico method.

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confidence: 99%

Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development

Chandramore,

Sonawane

2023

IJPQA

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Drug administration via feeding tubes—a procedure that carries risks: systematic identification of critical factors based on commonly administered drugs in a cohort of stroke patients

Sommerfeldt,

Sartorius,

von Sarnowski

et al. 2024

Eur J Clin Pharmacol

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Purpose Drug administration via feeding tubes is considered a process with many uncertainties. This review aimed to give a comprehensive overview of data available on feeding tube application and to carry out risk assessments for drug substances commonly administered to stroke patients. Methods Drugs frequently administered via feeding tubes were identified through a retrospective analysis of discharge letters from a stroke unit. Physicochemical, pharmacokinetic, and stability properties of these drugs and data on drug-enteral nutrition interactions were systematically searched for in the European Pharmacopoeia, Hagers Handbook of Pharmaceutical Practice, Birchers clinical-pharmacological data compilation, and the Martindale Complete Drug Reference, as well as from databases including DrugBank, DrugDex, PubChem, Google Scholar, and PubMed. Results Of the drugs most commonly administered via feeding tubes in the present stroke patient cohort, bisoprolol, candesartan, and ramipril could be considered the least critical due to their overall favourable properties. Acetylsalicylic acid, amlodipine, hydrochlorothiazide, omeprazole and esomeprazole, simvastatin, and torasemide pose risks based on pH or light-dependent instability or proposed food effects. The most critical drugs to be administered via feeding tubes are considered to be furosemide, levodopa, and levothyroxine as they show relevant instabilities under administration conditions and substantial food effects; the latter two even possess a narrow therapeutic index. However, little information is available on drug-tube and drug-formula interactions. Conclusion Feeding tube administration of medications turned out to be a highly complex process with several unmet risks. Therefore, investigations that systematically assess these risk factors using clinically relevant model systems are urgently needed.

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Enhance the anti-scaling performance of conductive heating vacuum membrane distillation by carbon nanotube-based electroactive membrane

Han

Mao²,

Wang³

2022

Journal of Environmental Chemical Engineering

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Development of methodology for the study of API sensitivity to hydrolytic degradations at different pH conditions in solid-state

Cited by 4 publications

References 25 publications

Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development

Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development

Drug administration via feeding tubes—a procedure that carries risks: systematic identification of critical factors based on commonly administered drugs in a cohort of stroke patients

Enhance the anti-scaling performance of conductive heating vacuum membrane distillation by carbon nanotube-based electroactive membrane

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