Effects of polyol excipient stability during storage and use on the quality of biopharmaceutical formulations

Sun, Min-Fei; Liao, Jia-Ning; Jing, Zhen-Yi; Gao, Han; Shen, Bin-Bin; Xu, You-Fu; Fang, Wei-Jie

doi:10.1016/j.jpha.2022.03.003

Cited by 11 publications

(2 citation statements)

References 45 publications

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“…The stability of glycerol on aquafeeds is yet to be addressed; however, in a biopharmaceutical context, it is considered chemically inert and for this reason often used as an excipient. 42 In this scenario, active impurities resulting from glycerol degradation were only detected after repeated use and improper storage (at 40 C for 6 weeks), 43 which should be unrealistic for aquafeed.…”

Section: Glycerol In Aquafeeds: Properties and Intakementioning

confidence: 97%

Glycerol supplementation in farmed fish species: A review from zootechnical performance to metabolic utilisation

Coelho,

Palma,

Tavares

et al. 2024

Reviews in Aquaculture

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Glycerol, an abundant by‐product of biodiesel production, has gained attention due to its price and availability for potential commercial applications, and thus utilisation as an animal feed ingredient. This article comprehensively reviews glycerol utilisation in fish and its potential as a dietary ingredient for aquaculture. While dietary inclusion of glycerol may offer cost‐effective energy and metabolic intermediates, studies report inconsistent results regarding its effects on nutrient digestibility, zootechnical performance, and product quality. Recent studies however have demonstrated that dietary glycerol supplementation in fish induces metabolic shifts, such as alterations to gluconeogenesis and/or lipogenesis, modifying energy utilisation. Additionally, glycerol has been proposed to reduce protein catabolism, minimising nitrogen excretion and its environmental impact, but its influence on protein retention remains uncertain. Nevertheless, it is important to carefully consider the balance between feed palatability and these potential metabolic alterations when incorporating glycerol in aquafeeds. This review highlights the need for more studies to expand our understanding of glycerol metabolism in fish, since it does not seem to be metabolised by carnivorous species as much as omnivorous. Future research should explore the effects of glycerol supplementation on fish with different feeding habits and in developmental stages, as well as diverse environmental salinities and temperatures. Insight into the impact of impurities and the optimisation of glycerol inclusion in aquafeeds are recommended to support sustainable aquaculture practices and the utilisation of glycerol as a valuable resource.

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Section: Glycerol In Aquafeeds: Properties and Intakementioning

confidence: 97%

Glycerol supplementation in farmed fish species: A review from zootechnical performance to metabolic utilisation

Coelho,

Palma,

Tavares

et al. 2024

Reviews in Aquaculture

View full text Add to dashboard Cite

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“…Due to complexity and fragility of the BP structures, a wide variety of compounds are used in their formulation, such as: amino acids (AAs), sugars, alcohols, and vitamins (Sun et al, 2022;Wang, Ohtake, 2019).…”

Section: Introductionmentioning

confidence: 99%

Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application

Souza,

Angelino,

Ornella

et al. 2024

Braz. J. Pharm. Sci.

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A simple, rapid, precise, accurate and sustainable spectrofluorimetric method (SFM) was developed, validated and applied for the determination of 4-aminobenzoic acid and aromatic amino acids (phenylalanine, tryptophan and tyrosine). These compounds are used in biopharmaceutical formulations and therefore must be analyzed by quality control laboratories to meet the criteria established in pharmacopoeias. In general, potentiometric titration (PT) is described in the compendia as the official analytical technique. However, this method showed low sensitivity and selectivity, and moreover was performed with a non-aqueous solvent (acetic acid), which led to higher consumption of reagents and consequently to the formation of residues. Therefore, the SFM was developed in aqueous medium at pH 7.2 using phosphate buffer. It was successfully validated according to the ICH guidelines and showed good linearity range (r > 0.999), specificity, accuracy and precision (within and between days) and robustness. The test results were compared between the SFM and PT using raw material samples, while according to the F-and t-tests at 95% confidence level, no statistical difference was found between the methods.

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Physical Unclonable Functions with Hyperspectral Imaging System for Ultrafast Storage and Authentication Enabled by Random Structural Color Domains

Lin,

Li,

Tang

et al. 2024

Advanced Science

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Physical unclonable function (PUF) is attractive in modern encryption technologies. Addressing the disadvantage of slow data storage/authentication in optical PUF is paramount for practical applications but remains an on‐going challenge. Here, a highly efficient PUF strategy based on random structural color domains (SCDs) of cellulose nanocrystal (CNC) is proposed for the first time, combing with hyperspectral imaging system (HIS) for ultrafast storage and authentication. By controlling the growth and fusion behavior of the tactoids of CNC, the SCDs display an irregular and random distribution of colors, shapes, sizes, and reflectance spectra, which grant unique and inherent fingerprint‐like characteristics that are non‐duplicated. Based on images and spectra, these fingerprint features are used to develop two sets of PUF key generation methods, which can be respectively authenticated at the user‐end and the manufacturer‐front‐end that achieving a high coding capacity of at least 22304. Notably, the use of HIS greatly shortens the time of key reading and generation (≈5 s for recording, 0.5–0.7 s for authentication). This new optical PUF labels can not only solve slow data storage and complicated authentication in optical PUF, but also impulse the development of CNC in industrial applications by reducing color uniformity requirement.

show abstract

Effects of polyol excipient stability during storage and use on the quality of biopharmaceutical formulations

Cited by 11 publications

References 45 publications

Glycerol supplementation in farmed fish species: A review from zootechnical performance to metabolic utilisation

Glycerol supplementation in farmed fish species: A review from zootechnical performance to metabolic utilisation

Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application

Physical Unclonable Functions with Hyperspectral Imaging System for Ultrafast Storage and Authentication Enabled by Random Structural Color Domains

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