A Review on Forced Degradation Strategies to Establish the Stability of Therapeutic Peptide Formulations

Patel, Shikha; Vyas, Vivek K.; Mehta, Priti

doi:10.1007/s10989-023-10492-8

Cited by 5 publications

(3 citation statements)

References 159 publications

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“…There is neither a practical protocol nor any specification limits defined for the worthwhile forced degradation study of peptides. However, it is accepted that stress conditions for peptide drugs should be set to achieve 5–20% degradation, identically to those for small molecule drugs [ 19 ].…”

Section: Analytical Tools For Peptide Drugs Examinationmentioning

confidence: 99%

Metabolism and Chemical Degradation of New Antidiabetic Drugs: A Review of Analytical Approaches for Analysis of Glutides and Gliflozins

Gumieniczek

Berecka‐Rycerz

2023

Biomedicines

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The drug metabolism and drug degradation pathways may overlap, resulting in the formation of similar constituents. Therefore, the metabolism data can be helpful for deriving safe levels of degradation impurities and improving the quality of respective pharmaceutical products. The present article contains considerations on possible links between metabolic and degradation pathways for new antidiabetic drugs such as glutides, gliflozins, and gliptins. Special attention was paid to their reported metabolites and identified degradation products. At the same time, many interesting analytical approaches to conducting metabolism as well as degradation experiments were mentioned, including chromatographic methods and radioactive labeling of the drugs. The review addresses the analytical approaches elaborated for examining the metabolism and degradation pathways of glutides, i.e., glucagon like peptide 1 (GLP-1) receptor agonists, and gliflozins, i.e., sodium glucose co-transporter 2 (SGLT2) inhibitors. The problems associated with the chromatographic analysis of the peptide compounds (glutides) and the polar drugs (gliflozins) were addressed. Furthermore, issues related to in vitro experiments and the use of stable isotopes were discussed.

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Section: Analytical Tools For Peptide Drugs Examinationmentioning

confidence: 99%

Metabolism and Chemical Degradation of New Antidiabetic Drugs: A Review of Analytical Approaches for Analysis of Glutides and Gliflozins

Gumieniczek

Berecka‐Rycerz

2023

Biomedicines

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“…The solution was left at room temperature for 1 hour. After 1 hour, the solution was neutralized with 0.1N NaOH and diluted to volume with diluents, ensuring thorough mixing (Patel et al, 2023).…”

Section: Untreated Testmentioning

confidence: 99%

Forced degradation and stability assessment of Tenofovir alafenamide

Kumar,

Malik

2023

DPSA

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This study presents a comprehensive evaluation of an analytical method for the quantification and identification of Tenofovir Alafenamide (TAF) and its related impurities in pharmaceutical formulations. The method exhibited outstanding performance, with exceptional sensitivity demonstrated through low limits of detection (LOD) and quantification (LOQ) values for TAF and various impurities. The LOD and LOQ values for TAF were determined to be 0.001% and 0.004%, respectively, underscoring the method's capability to detect minute concentrations. System suitability assessments, including LOD verification, linearity studies, relative response factor (RRF) determination, and accuracy assessments, provided a comprehensive understanding of the method's reliability and precision. The method showed a strong linear relationship between concentration and peak area, along with accurate recovery of added compound amounts at various concentration levels. Forced degradation studies further validated the method's specificity and robustness, with degradation peaks distinct from TAF and its specified impurities. Peak purity analysis confirmed the method's ability to accurately determine TAF in both untreated and treated test preparations. Additionally, system precision, method precision, and intermediate precision evaluations showcased the method's consistent and reproducible performance under various conditions and across different analysts. Stability assessments of the analytical solution, standard preparation, and mobile phase revealed the method's resilience to variations in flow rate and column oven temperature, with most parameters remaining within acceptable limits. In conclusion, this analytical method is a reliable tool for the precise quantification and identification of TAF and related impurities, meeting stringent acceptance criteria. Its robustness, precision, and specificity make it suitable for pharmaceutical quality control and research applications.

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“…Then 50mL of 0.1 M HCl was added and sonicated for 15 minutes. Then volume was made with 0.1M HCl [16].…”

Section: Sample Solution-2 (01m Hcl)mentioning

confidence: 99%

Forced Degradation and Stability Indicating Studies for Clomifene Citrate Tablet

Khan,

Yaseen,

Ali

et al. 2023

AJOCS

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Pharmaceutical medications must be stable to preserve their efficacy and safety over the period of their shelf lives. Studies on force degradation are crucial for identifying probable degradation pathways and identifying extreme stresses that may lead to the breakdown of the pharmaceutical product. This report offers a thorough analysis of the force degradation tests performed on Clomifene citrate tablets. Evaluation of the effects of several stress factors, including temperature, humidity, light, and mechanical forces, on the stability of clomifene citrate is the main goal. To replicate actual storage and handling situations, the study used stress testing criteria specified by the International Conference on Harmonization (ICH). According to the study, temperature and humidity have the biggest roles in the degradation of Clomifene citrate tablets. In this article the FDS was performed by using a stainless-steel column (250 mm x 4.6 mm) packed with Butylsilane C4 (5µm) L26, detector 233nm, mobile phase; mobile Phase was prepared by mixing 550 volumes of methanol, 450 volumes of water and 3 volumes of triethylamine. Then adjust the pH to 2.5 with phosphoric acid. Flow rate; 1 mL/mint. The quantification and hyphenation of the instrumental analysis were successfully accomplished using the developed method.

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A Review on Forced Degradation Strategies to Establish the Stability of Therapeutic Peptide Formulations

Cited by 5 publications

References 159 publications

Metabolism and Chemical Degradation of New Antidiabetic Drugs: A Review of Analytical Approaches for Analysis of Glutides and Gliflozins

Metabolism and Chemical Degradation of New Antidiabetic Drugs: A Review of Analytical Approaches for Analysis of Glutides and Gliflozins

Forced degradation and stability assessment of Tenofovir alafenamide

Forced Degradation and Stability Indicating Studies for Clomifene Citrate Tablet

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