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Development of preservative systems
Published in R. M. Baird, S. F. Bloomfield, Microbial quality assurance in cosmetics, toiletries and non-sterile Pharmaceuticals, 2017
It is important to recognize when considering in vitro test methods that correlation between them is not always obtained since they often measure different parameters and employ different test conditions. Furthermore, extrapolation of the results to the product has to be made with caution since the formulation can further influence the characteristics of a preservative system. To illustrate these points, an example from studies to enhance the preservative effect of a fixed concentration of sorbic acid (0.2%) in an existing acidic cream formulation (Denyer, Hugo and Cavill, unpublished observations) is given in Table 9.3 and Figs 9.3 and 9.4. Here both candidates (chlorhexidine and dehydroacetic acid), showing promise in the agar diffusion approach against Staphylococcus aureus (Table 9.3), showed equivalent promise in the chessboard method (Fig. 9.3). Significantly, however, when chlorhexidine and dehydroacetic acid were introduced at bactericidal concentrations into the formulation, both increased the preservative efficacy as measured by a modification of the test in the British Pharmacopoeia, Addendum (Anon. 1982) test but they did so in the reverse order to that expected (Fig. 9.4).
Contact Urticaria Caused by Preservatives and Disinfectants
Published in Ana M. Giménez-Arnau, Howard I. Maibach, Contact Urticaria Syndrome, 2014
Sorbic acid is commonly used as a preservative in foods, but may also be used in personal care products such as topical creams and hair products. It is a well-recognized cause of nonimmunological CoU. Cases in the literature describe localized CoU without systemic symptoms.
Antibacterial Activity of Seaweeds and their Extracts
Published in Leonel Pereira, Therapeutic and Nutritional Uses of Algae, 2018
Rodríguez-Martínez et al. (2016) formulated a new, active biodegradable film based on polylactic acid and brown seaweed. An extrusion process was used to incorporate 8% dried Fucus spiralis seaweed extract and 0.5% natural sorbic acid into a polylactic acid based biodegradable film. The migration values of the film components into food simulants were found to be generally within the maximum acceptable EU limit. It was concluded that the film was suitable for further development as a packaged food protectant and for shelf-life extension. F. spiralis was selected because it showed the greatest inhibition in disc diffusion assays of the foodborne bacteria Staphylococcus aureus, Bacillus cereus, Bacillus subtilis, Pseudomonas fluorescens, Escherichia coli, Klebsiella pneumoniae, Aeromonas hydrophila, Vibrio alginolyticus, and Vibrio parahaemolyticus, when compared to other seaweed genera, Ascophyllum and Bifurcaria, among others. A concentration of only 10 pg mL−1 of F. spiralis was required to exert zones of inhibition up to 15 mm (for B. subtilis). Although sorbic acid has antimicrobial properties against fungi and bacteria, the addition of F. spiralis extract reduces the amount required, and broadens the scope of antibacterial activity. Sorbic acid was first isolated from mountain ash berries, and has antimicrobial action mainly against yeasts and molds, but is selective against bacteria (Lück and Jager 2012). It can also be detected as an acrid taste by some consumers. The addition of small amounts of dried seaweeds, or antibacterial extracts of marine algal compounds to active food-films could minimize the volume of traditional preservatives required. This could reduce costs and bring concomitant nutritional benefits.
The Association between the Preservative Agents in Foods and the Risk of Breast Cancer
Published in Nutrition and Cancer, 2019
Fardin Javanmardi, Jamal Rahmani, Fatemeh Ghiasi, Hadi Hashemi Gahruie, Amin Mousavi Khaneghah
Sorbic acid prevents the growth of microorganisms over an extensive range of pH, particularly above 6 (53). This organic acid is widely used in cheeses, bakery goods, beverages, and other dairy products. According to various studies owing to the rapid metabolizing pathway of sorbic acid, it could pose low toxic effects (54). Catabolizing pathway of sorbate is similar to other fatty acids (54,55). However, this acid can interfere owing to further interactions with other preservatives and dietary ingredients which consequently can produce free radicals. Despite the DNA damaging agents produced by sorbate, based on in vitro investigations, it can result in the immune activity by IFN-γ induction (16,19). In this context, JECFA has established an ADI of 0–25 mg/kg for sorbic acid and the related salts (52).
Cytotoxicities and wound healing effects of contact lens multipurpose solution on human corneal epithelial cell
Published in Clinical and Experimental Optometry, 2022
Su Hwan Park, Sung Hee Park, Hak Sun Yu, Jonghoon Shin, Su Jin Kim, Ji Eun Lee
The effect of borate buffer on corneal epithelial cell viability has been described previously,10,37 and the associated potential cytotoxic effects have been elucidated both in vitro and in vivo.38 Sorbic acid is widely used as antimicrobial preservatives in food and pharmaceutical industries, and dose-dependent cytotoxicity to human lymphocytes was also reported.39 It could be speculated that the combination of borate and PHMB might have contributed to the synergistic cytotoxic effect on integrin expression.33 In the present study, buffers such as borate and sorbate seemed to have synergistically contributed to the cytotoxicity along with the main components of the disinfecting agent.
Stability study of a clonidine oral solution in a novel vehicle designed for pediatric patients
Published in Pharmaceutical Development and Technology, 2018
Arnaud Potier, Julien Voyat, Alain Nicolas
NAS treatment without narcotics is made possible by the use of clonidine, its superiority to morphine having even been demonstrated in a recent study (Bada et al. 2015). We report here the first stability study of a 10 µg/mL clonidine hydrochloride oral solution in Inorpha®, prepared from active substance powder. Inorpha® was the only vehicle tested for ease of supply and manufacturing of the preparation. It was chosen because it is particularly suitable and it can be used with confidence in neonates. Inorpha® contains glycerol and potassium sorbate as excipient having a noticeable effects. It does not contain parabens neither sodium benzoate and its low osmolality allows a good digestive tolerability. It contains sucralose as non-cariogenic sweetener. The efficacy of the antimicrobial preservative has been demonstrated with Inorpha® through the test described in Ph. Eur. Chapter 5.1.3. ‘Efficacy of antimicrobial preservation’ (Guilli et al. 2012), and was checked throughout our study. A large-scale study showed that parabens are administered in 43% of newborns, while their effects such as the occurrence of hyperbilirubinemia, hypersensivity and estrogenic effects in the case of propylparaben are well-documented (Nellis et al. 2015). Eleven percent of neonates are exposed to sodium benzoate, responsible of hypersensitivity, metabolic acidosis, seizures, gasping or fatal toxic syndrome in premature infants. The European Food Safety Authority (EFSA) noted that there was no evidence of genotoxic activity for sorbic acid or potassium sorbate and toxicity studies did not show any adverse effects (EFSA ANS Panel 2015). Its content should not exceed 0.6% in ready-to-use preparations and the maximum daily dose is 25 mg/kg in children. The concentration of potassium sorbate in Inorpha® is 0.3% corresponding to a daily dose of 1–2 mg/kg.