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Journal of the European Academy of... Nov 2019Phenoxyethanol, or 2-phenoxyethanol, has a large spectrum of antimicrobial activity and has been widely used as a preservative in cosmetic products for decades. It is... (Review)
Review
Phenoxyethanol, or 2-phenoxyethanol, has a large spectrum of antimicrobial activity and has been widely used as a preservative in cosmetic products for decades. It is effective against various Gram-negative and Gram-positive bacteria, as well as against yeasts, and has only a weak inhibitory effect on resident skin flora. According to the European Scientific Committee on Consumer Safety, phenoxyethanol is safe for all consumers - including children of all ages - when used as a preservative in cosmetic products at a maximum concentration of 1%. Adverse systemic effects have been observed in toxicological studies on animals but only when the levels of exposure were many magnitudes higher (around 200-fold higher) than those to which consumers are exposed when using phenoxyethanol-containing cosmetic products. Despite its widespread use in cosmetic products, phenoxyethanol is a rare sensitizer. It can be considered as one of the most well-tolerated preservatives used in cosmetic products.
Topics: Animals; Biological Availability; Carcinogens; Cosmetics; Dermatitis, Allergic Contact; Endocrine Disruptors; Ethylene Glycols; Humans; Nervous System Diseases; Preservatives, Pharmaceutical; Reproduction; Skin Absorption
PubMed: 31588615
DOI: 10.1111/jdv.15944 -
Drugs Jan 2018Glaucoma therapy-related ocular surface disease (OSD) is a serious pathology with a broad spectrum of insidious clinical presentations and complex pathogenesis that... (Review)
Review
Glaucoma therapy-related ocular surface disease (OSD) is a serious pathology with a broad spectrum of insidious clinical presentations and complex pathogenesis that undermines long-term glaucoma care. Preservatives, especially benzalkonium chloride (BAK), contained in topical intraocular pressure-lowering medications frequently cause or aggravate OSD in glaucoma. Management of these patients is challenging, and to date often empirical due to the scarcity of controlled long-term clinical trials. Most of the available data are extracted from case series and retrospective analysis. Preservative-free prostaglandins and prostaglandin/timolol fixed combinations are novel options developed to remove the harmful impact of preservatives, especially BAK, upon ocular tissues. Based on what is currently known on the value of preservative-free antiglaucoma therapies it is tempting to speculate how these new therapies may affect the future medical management of all glaucoma patients. This article provides a comprehensive and critical review of the current literature on preservative-free prostaglandins and preservative-free prostaglandin/timolol fixed combinations.
Topics: Adrenergic beta-Antagonists; Antihypertensive Agents; Benzalkonium Compounds; Drug Combinations; Glaucoma; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Ocular Hypertension; Preservatives, Pharmaceutical; Prostaglandins; Prostaglandins, Synthetic; Retrospective Studies; Timolol
PubMed: 29196953
DOI: 10.1007/s40265-017-0843-9 -
The Ocular Surface Jul 2011Benzalkonium chloride (BAK) is the principal preservative employed in topical ocular hypotensive medications, although alternative compounds recently have begun to be... (Review)
Review
Benzalkonium chloride (BAK) is the principal preservative employed in topical ocular hypotensive medications, although alternative compounds recently have begun to be employed or examined. Individual clinical trials have shown that exposure to BAK concentrations contained in ophthalmic solutions does not produce adverse sequelae in the majority of glaucoma patients, but concerns continue with regard to its long-term use. These concerns have resulted from an extensive research effort, including preclinical studies with in vitro and in vivo models, as well as recent clinical investigations dedicated specifically to this issue. The aim of this systematic literature review of both preclinical and clinical data was to determine the relevance of these findings to clinical practice. Most preclinical studies reported negative effects of BAK exposure, but with few exceptions, BAK concentrations and exposure times greatly exceeded those likely to be experienced by patients, given the normal physiological dilution by the tear film. In addition, consistent evidence of BAK-related toxicity did not emerge from our review of dedicated clinical investigations. Thus, taken together, current evidence supports the safety of BAK for most glaucoma patients, although subpopulations with abnormal tearing may benefit from alternative preservative compounds or preservative-free formulations. Further studies to identify these populations are needed.
Topics: Animals; Benzalkonium Compounds; Clinical Trials as Topic; Glaucoma; Humans; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 21791189
DOI: 10.1016/s1542-0124(11)70024-6 -
Current Microbiology Jun 2019This review reports cosmetic ingredients with antimicrobial activity including synthetic and natural (plant and microbial) origin as alternative for preservatives used... (Review)
Review
This review reports cosmetic ingredients with antimicrobial activity including synthetic and natural (plant and microbial) origin as alternative for preservatives used in cosmetics as well described mechanism of their action.
Topics: Anti-Infective Agents; Cosmetics; Preservatives, Pharmaceutical
PubMed: 29651551
DOI: 10.1007/s00284-018-1492-2 -
European Journal of Ophthalmology 2013To review and summarize the available literature on the effect of preservatives on the eye, to provide practical guidance for the clinical assessment of the ocular... (Review)
Review
PURPOSE
To review and summarize the available literature on the effect of preservatives on the eye, to provide practical guidance for the clinical assessment of the ocular surface in glaucoma patients, and to define patient populations that might benefit from preservative-free topical intraocular pressure (IOP)-lowering agents.
METHODS
This manuscript is based on a combination of a literature review on preservatives and the eye and expert opinion from glaucoma specialists with an interest in ocular surface disease.
RESULTS
There is an increasingly recognized association between eyedrop preservatives and ocular surface disease. Preservative-free therapy is now available for a wide range of active compounds, although there are still some misconceptions regarding their appropriate use. For patients treated topically for glaucoma or ocular hypertension, a rough estimate could be that 20% may need treatment with topical IOP-reducing agents that are free from preservatives.
CONCLUSION
This review provides an up-to-date account of the literature regarding preservatives and the eye, as well as suggestions and recommendations on to when to use preservative-free antiglaucoma treatment.
Topics: Antihypertensive Agents; Eye Diseases; Glaucoma; Humans; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 23483513
DOI: 10.5301/ejo.5000270 -
Eye & Contact Lens Apr 2022
Topics: Glaucoma; Humans; Preservatives, Pharmaceutical
PubMed: 35296624
DOI: 10.1097/ICL.0000000000000893 -
Expert Opinion on Drug Safety Apr 2021: Preservative-free (PF) medications represent a valuable treatment strategy in the lifelong management of glaucoma. By removing preservative toxicity, PF formulations... (Comparative Study)
Comparative Study Review
: Preservative-free (PF) medications represent a valuable treatment strategy in the lifelong management of glaucoma. By removing preservative toxicity, PF formulations provide tangible clinical benefits to glaucoma patients worldwide. They improve tolerability and adherence, leading to a positive impact in long-term intraocular pressure (IOP) control.: A critical review of the subject is provided, including selected evidence on the safety and tolerability of currently available topical PF formulations. Cumulative evidence confirms that topical PF medications are at least equally efficacious to their preserved equivalents. There is convincing short-term evidence for superior tolerability and safety of PF formulations compared to preserved medications. The long-term benefits and success of PF therapy requires further elucidation.: Successful stepwise administration of medical therapy for glaucoma remains elusive. There is a greater risk for ocular toxicity and therapy failure with preserved topical glaucoma therapy. Currently available and emerging PF therapy options potentially optimize lifelong stepwise glaucoma therapy and may enhance outcome. To avert complications from preservatives leading to poor adherence, ideally, future antiglaucoma therapy should become 100% PF. There are still key aspects of PF therapy that warrant further investigation.
Topics: Administration, Ophthalmic; Animals; Glaucoma; Humans; Intraocular Pressure; Medication Adherence; Preservatives, Pharmaceutical
PubMed: 33478284
DOI: 10.1080/14740338.2021.1873947 -
Pharmacotherapy May 2017For convenience, many pediatric hospitals are preparing solutions for continuous nebulized albuterol using the 0.5% 20-ml multidose albuterol dropper bottle. This... (Review)
Review
For convenience, many pediatric hospitals are preparing solutions for continuous nebulized albuterol using the 0.5% 20-ml multidose albuterol dropper bottle. This product contains benzalkonium chloride (BAC) that, by itself, produces bronchospasm that is dose dependent and cumulative. The bronchoconstrictive effects of BAC are greater in patients with more severe airway obstruction and increased airway responsiveness. Use of BAC-containing albuterol during severe acute asthma exacerbations may antagonize the bronchodilator response to albuterol, prolong treatment, and increase the risk of albuterol-related systemic adverse effects. Such a deleterious effect of BAC is difficult to detect because some patients improve slowly or may even worsen during treatment. We recommend that only preservative-free albuterol products be used.
Topics: Albuterol; Benzalkonium Compounds; Bronchoconstriction; Bronchodilator Agents; Dose-Response Relationship, Drug; Humans; Nebulizers and Vaporizers; Preservatives, Pharmaceutical; Randomized Controlled Trials as Topic
PubMed: 28349590
DOI: 10.1002/phar.1929 -
Eye (London, England) Feb 2022Preservatives in multidose formulations of topical ophthalmic medications are crucial for maintaining sterility but can be toxic to the ocular surface. Benzalkonium... (Review)
Review
Preservatives in multidose formulations of topical ophthalmic medications are crucial for maintaining sterility but can be toxic to the ocular surface. Benzalkonium chloride (BAK)-used in approximately 70% of ophthalmic formulations-is well known to cause cytotoxic damage to conjunctival and corneal epithelial cells, resulting in signs and symptoms of ocular surface disease (OSD) including ocular surface staining, increased tear break-up time, and higher OSD symptom scores. These adverse effects are more problematic with chronic exposure, as in lifetime therapy for glaucoma, but can also manifest after exposure as brief as seven days. Multiple strategies are available to minimize or eliminate BAK exposure, among them alternative preservatives, preservative-free formulations including sustained release drug delivery platforms, and non-pharmacological therapies for common eye diseases and conditions. In this paper, we review the cytotoxic and clinical effects of BAK on the ocular surface and discuss existing and emerging options for ocular disease management that can minimize or eliminate BAK exposure.
Topics: Antihypertensive Agents; Benzalkonium Compounds; Glaucoma; Humans; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 34262161
DOI: 10.1038/s41433-021-01668-x -
Molecules (Basel, Switzerland) Jun 2018Cosmetics, like any product containing water and organic/inorganic compounds, require preservation against microbial contamination to guarantee consumer’s safety and... (Review)
Review
Cosmetics, like any product containing water and organic/inorganic compounds, require preservation against microbial contamination to guarantee consumer’s safety and to increase their shelf-life. The microbiological safety has as main goal of consumer protection against potentially pathogenic microorganisms, together with the product’s preservation resulting from biological and physicochemical deterioration. This is ensured by chemical, physical, or physicochemical strategies. The most common strategy is based on the application of antimicrobial agents, either by using synthetic or natural compounds, or even multifunctional ingredients. Current validation of a preservation system follow the application of good manufacturing practices (GMPs), the control of the raw material, and the verification of the preservative effect by suitable methodologies, including the challenge test. Among the preservatives described in the positive lists of regulations, there are parabens, isothiasolinone, organic acids, formaldehyde releasers, triclosan, and chlorhexidine. These chemical agents have different mechanisms of antimicrobial action, depending on their chemical structure and functional group’s reactivity. Preservatives act on several cell targets; however, they might present toxic effects to the consumer. Indeed, their use at high concentrations is more effective from the preservation viewpoint being, however, toxic for the consumer, whereas at low concentrations microbial resistance can develop.
Topics: Anti-Infective Agents; Cosmetics; Preservation, Biological; Preservatives, Pharmaceutical
PubMed: 29958439
DOI: 10.3390/molecules23071571