A review of the literature on antimicrobial preservatives: Definition, properties, classification, safety, side effects and antimicrobial effectiveness testing
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Antimicrobial preservatives, microbes, excipientsResumen
Antimicrobial preservatives are excipients that are utilized in both sterile & non-sterile pharmaceutical products that are given in several doses. Antimicrobial preservatives are mainly utilized to prevent the growth of germs that may arise throughout the course of a product's uses. It is necessary to determine the efficiency of antimicrobial preservatives in the case of certain excipients. It is discussed in this article the most important aspects to consider when selecting preservatives, the principles of the preservative effectiveness test, and the relevance of regulatory requirements for preservative effectiveness testing in the practice of medicine. Antimicrobial effectiveness testing is required to establish the efficacy of preservative systems in multidose products that are carried out by the manufacturer.
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Moreton C. Functionality and Performance of Excipients in a Quality-by-Design World: Part VII. Explor Investig Discov. 2010:32-5.
Fassihi RA. Preservation of medicines against microbial contamination. Disinfect Steriliz Preserv Philadelphia Lea Febiger. 1991;871–86.
Ahmed N, Singh J, Kour H, Gupta P. Naturally occurring preservatives in food and their role in food preservation. Int J Pharm Biol Arch. 2013;4:22–30.
Anand SP, Sati N. Artificial preservatives and their harmful effects: looking toward nature for safer alternatives. Int J Pharm Sci Res. 2013;4(7):2496–501.
Council of Europe. European pharmacopoeia: Efficacy of Antimicrobial Preservation. European Directorate for Quality of Medicines, Strasbourg, France. 2010.
Sutton SVW, Porter D. Development of the antimicrobial effectiveness test as USP chapter <51>. PDA J Pharm Sci Technol. 2002;56(6):300–11.
Gabel LF. The relative action of preservatives in pharmaceutical preparations. J Am Pharm Assoc. 1921;10(10):767–8.
World Health Organization, UNICEF. Good practices guidance handbook for national TB surveys: how to apply good clinical and good data management practices for national TB surveys. 2022.
ICH Expert Working Group. Stability data package for registration applications in climatic zones III and IV Q1F. EMEA, London. 2003;4.
Barr M, Tice LF. The preservation of aqueous sorbitol solutions. J Am Pharm Assoc (Scientific ed). 1957;46(4):221–3.
Shaikh SM, Doijad RC, Shete AS, Sankpal PS. A Review on: Preservatives used in Pharmaceuticals and impacts on Health. PharmaTutor. 2016;4(5):25–34.
Chiori CO, Ghobashy AA. A potentiating effect of EDTA on the bactericidal activity of lower concentrations of ethanol. Int J Pharm. 1983;17(2–3):121–8.
Rowe RC, Sheskey PJ, Quinn, ME. Handbook of pharmaceutical excipients. Sixth Edition. Pharmaceutical Press & American Pharmacists Association; 2009.
Krzyzaniak JF, Raymond DM, Yalkowsky SH. Lysis of human red blood cells 2: effect of contact time on cosolvent induced hemolysis. Int J Pharm. 1997;152(2):193–200.
Grissom CB, Chagovetz AM, Wang Z. Use of viscosigens to stabilize vitamin B12 solutions against photolysis. J Pharm Sci. 1993;82(6):641–3.
Akers MJ. Considerations in selecting antimicrobial preservative agents for parenteral product development. Pharm Technol. 1984;8:36–46.
Rafiee-Tehrani M, Mehramizi A. In vitro release studies of piroxicam from oil-in-water creams and hydroalcoholic gel topical formulations. Drug Dev Ind Pharm. 2000;26(4):409–14.
Karabit MS. Studies on the evaluation of preservative efficacy V. Effect of concentration of micro-organisms on the antimicrobial activity of phenol. Int J Pharm. 1990;60(2):147–50.
Denyer SP, Baird RM. Guide to microbiological control in pharmaceuticals. Vol. 11. Ellis Horwood Chichester; 1990.
Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical Excipients 2004. Japan Pharmaceutical Excipients Council; 2004.
Nishijo J, Yonetani I. Interaction of theobromine with sodium benzoate. J Pharm Sci. 1982;71(3):354–6.
Joint FAO/WHO Expert Committee on Food Additives. Toxicological evaluation of certain food additives with a review of general principles and of specifications: seventeenth report of the Joint FAO/WHO Expert Committee on Food Additives, Geneva, 25 June-4 July 1973. World Health Organization; 1974.
Radus TP, Gyr G. Determination of antimicrobial preservatives in pharmaceutical formulations using reverse-phase liquid chromatography. J Pharm Sci. 1983;72(3):221–4.
Smolinske SC. CRC handbook of food, drug, and cosmetic excipients. CRC press; 2018.
Mahuzier P-E, Altria KD, Clark BJ. Selective and quantitative analysis of 4-hydroxybenzoate preservatives by microemulsion electrokinetic chromatography. J Chromatogr A. 2001;924(1–2):465–70.
Lund W. The pharmaceutical codex: principles and practice of pharmaceutics. 12th Edition. The Pharmaceutical Press, London; 1994.
Bando H, Mohri S, Yamashita F, Takakura Y, Hashida M. Effects of skin metabolism on percutaneous penetration of lipophilic drugs. J Pharm Sci. 1997;86(6):759–61.
Jian L, Po ALW. Ciliotoxicity of methyl?and propyl?p?hydroxybenzoates: a dose?response and surface?response study. J Pharm Pharmacol. 1993;45(10):925–7.
Krinsky D. Handbook of non-prescription drugs. Medicine (Baltimore). 2015;1(1):45.
Abdelaziz AA, El?Nakeeb MA. Sporicidal activity of local anaesthetics and their binary combinations with preservatives. J Clin Pharm Ther. 1988;13(4):249–56.
Parkin JE. The decomposition of phenylmercuric nitrate in sulphacetamide drops during heat sterilization. J Pharm Pharmacol. 1993;45(12):1024–7.
Chowhan M, Lang JC, Missel P. Ophthalmic preparations. Remington. 2012;541–64.
Tan M, Parkin JE. Route of decomposition of thiomersal (thimerosal). Int J Pharm. 2000;208(1–2):23–34.
Adejare A. Remington: the science and practice of pharmacy. Academic Press; 2020.
Radford JR, Beighton D, Nugent Z, Jackson RJ. Effect of use of 0.05% cetylpyridinium chloride mouthwash on normal oral flora. J Dent. 1997;25(1):35–40.
Beasley R, Fishwick D, Miles JF, Hendeles L. Preservatives in nebulizer solutions: risks without benefit. Pharmacother J Hum Pharmacol Drug Ther. 1998;18(1):130–9.
Meyer BK, Ni A, Hu B, Shi L. Antimicrobial preservative use in parenteral products: past and present. J Pharm Sci. 2007;96(12):3155–67.
The European Agency for the Evaluation of Medicinal Products. Note for Guidance on Excipients, Antioxidants and Antimicrobial Preservatives in the Dossier for Application for Marketing Authorisation of a Medicinal Product [Internet]. 2003 [cited 2023 Dec 10]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-note-guidance-excipients-antioxidants-and-antimicrobial-preservatives-dossier-application-marketing-authorisation-medicinal-product-superseded-nov-2006-version_en.pdf
Penha FM, Rodrigues EB, Maia M. Retinal and ocular toxicity in ocular application of drugs and chemicals—part II. Retin Toxic Curr new drugs. 2010:44(4):205–24.
Cartwright AC. The British pharmacopoeia, 1864 to 2014: medicines, international standards and the state. Routledge; 2016.
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