Identification and characterization of chemical and physical stability of insulin formulations utilizing degraded glycerol after repeated use and storage

Sun, Min-Fei; Xu, You-Fu; Yuan, Junjie; Fang, Wei-Jie

doi:10.1016/j.ejpb.2022.06.011

Cited by 4 publications

(4 citation statements)

References 39 publications

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Section: Resultsmentioning

confidence: 99%

“…As reported in the previous literature, the presence of glycerol in beclomethasone aerosol particles may reduce the dissolution rate of particles and subsequently alter the pharmacokinetics of the drug [27]. Additionally, chemical instabilities have been observed in captopril [28], cetirizine [29], and insulin [18] when glycerol was present. (e) Cbf-14-condensed impurities with 3-hydroxypropanal; (f) Cbf-14-condensed impurities with glyceraldehyde; (g) formulation with Cbf-14 and methylcellulose alone stored at 4 • C for 2 months; and (h) fresh-prepared Cbf-14 gel (with both glycerol and methylcellulose as excipients) (PDA extract at 220 nm).…”

Section: Analysis Of the Source Of Peptide Degradation Impuritiesmentioning

confidence: 92%

“…When stored appropriately, glycerol exhibits excellent stability. However, it is highly susceptible to degradation when subjected to repeated use [ 18 ]. A review of the literature reveals that glycerol degradation pathways can be categorized into anaerobic and aerobic processes.…”

Section: Introductionmentioning

confidence: 99%

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Compatibility Study of Peptide and Glycerol Using Chromatographic and Spectroscopic Techniques: Application to a Novel Antimicrobial Peptide Cbf-14 Gel

Yang,

Huo,

Jin

et al. 2023

Pharmaceutics

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The interactions between active pharmaceutical ingredients (APIs) and excipients may lead to API degradation, thereby affecting the safety and efficacy of drug products. Cbf-14 is a synthetic peptide derived from Cathelicidin-BF, showing potential for bacterial and fungal infections. In order to assess impurities in Cbf-14 gel, we developed a two-dimensional liquid chromatography coupled with quadrupole/time-of-flight mass spectrometric method. A total of eleven peptide degradation impurities were identified and characterized. Furthermore, the compatibility tests were conducted to evaluate the interactions of Cbf-14 with glycerol and methylcellulose, respectively. The results revealed that the impurities originated from condensation reactions between Cbf-14 and aldehydes caused by glycerol degradation. Several aldehydes were employed to validate this hypothesis. The formation mechanisms were elucidated as Maillard reactions between primary amino groups of Cbf-14 and aldehydes derived from glycerol degradation. Additionally, the compatibility of Cbf-14 with glycerol from different sources and with varying storage times was investigated. Notably, the interaction products in the gel increased with extended storage time, even when fresh glycerol for injection was added. This study offers unique insights into the compatibility study of peptides and glycerol, contributing to the ongoing quality study of Cbf-14 gel. It also serves as a reference for the design of other peptide preparations and excipients selections.

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Section: Resultsmentioning

confidence: 99%

Section: Analysis Of the Source Of Peptide Degradation Impuritiesmentioning

confidence: 92%

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Compatibility Study of Peptide and Glycerol Using Chromatographic and Spectroscopic Techniques: Application to a Novel Antimicrobial Peptide Cbf-14 Gel

Yang,

Huo,

Jin

et al. 2023

Pharmaceutics

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“…The therapeutic peptides usually have a size of less than 5000 Da with a specific sequence of amino acids. The significance of therapeutic peptides/proteins in the pharmaceutical industry started after the therapeutic success of the first-ever synthesized peptide, i.e., insulin, which was synthesized through recombinant DNA technology (Sun, Xu et al 2022).…”

Section: Introductionmentioning

confidence: 99%

Metallic Nanocarriers for Therapeutic Peptides: Emerging Solutions Addressing the Delivery Challenges in Brain Ailments

Rathnam,

Deepak,

Sahoo

et al. 2023

J Pharmacol Exp Ther

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Peptides and proteins have recently emerged as efficient therapeutic alternatives to conventional therapies. Although their advent a few decades back, extensive exploration of various ailments or disorders began recently. The drawbacks of current chemotherapies and irradiation treatments, such as drug resistance and damage to healthy tissues, have enabled the rise of peptides in the quest for better prospects. The chemical tunability and smaller size make them easy to design selectively for target tissues. Other remarkable properties include antifungal, antiviral, antiinflammatory, protection from hemorrhage stroke, and as therapeutic agents for gastric disorders, Alzheimer's, and Parkinson's diseases. Despite these unmatched properties, their practical applicability is often hindered due to their weak susceptibility to enzymatic digestion, serum degradation, liver metabolism, kidney clearance, and immunogenic reactions. Several methods are adapted to increase the half-life of peptides, such as chemical modifications, fusing with Fc fragment, change in amino acid composition, and carrier-based delivery. Among these, nanocarrier-mediated encapsulation not only increases the half-life of the peptides in vivo but also aids in the targeted delivery. Despite its structural complexity, they also efficiently deliver therapeutic molecules across the blood-brain barrier (BBB). Here, in this review, we tried to emphasize the possible potentiality of metallic nanoparticles to be used as an efficient peptide delivery system against brain tumors and neurodegenerative disorders.

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Recent advances in transdermal insulin delivery technology: A review

Li,

Shi,

Ding

et al. 2024

International Journal of Biological Macromolecules

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Identification and characterization of chemical and physical stability of insulin formulations utilizing degraded glycerol after repeated use and storage

Cited by 4 publications

References 39 publications

Compatibility Study of Peptide and Glycerol Using Chromatographic and Spectroscopic Techniques: Application to a Novel Antimicrobial Peptide Cbf-14 Gel

Compatibility Study of Peptide and Glycerol Using Chromatographic and Spectroscopic Techniques: Application to a Novel Antimicrobial Peptide Cbf-14 Gel

Metallic Nanocarriers for Therapeutic Peptides: Emerging Solutions Addressing the Delivery Challenges in Brain Ailments

Recent advances in transdermal insulin delivery technology: A review

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