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AAPS PharmSciTech Jan 2018This review gives a brief overview about microbial contamination in pharmaceutical products. We discuss the distribution and potential sources of microorganisms in... (Review)
Review
This review gives a brief overview about microbial contamination in pharmaceutical products. We discuss the distribution and potential sources of microorganisms in different areas, ranging from manufacturing sites, pharmacy stores, hospitals, to the post-market phase. We also discuss the factors that affect microbial contamination in popular dosage forms (e.g., tablets, sterile products, cosmetics). When these products are contaminated, the microorganisms can cause changes. The effects range from mild changes (e.g., discoloration, texture alteration) to severe effects (e.g., changes in activities, toxicity). The most common method for countering microbial contamination is the use of preservatives. We review some frequently used preservatives, and we describe the mechanisms by which microorganisms develop resistance to these preservatives. Finally, because preservatives are inherently toxic, we review the efforts of researchers to utilize water activity and other non-preservative approaches to combat microbial contamination.
Topics: Bacteria; Cosmetics; Dosage Forms; Drug Contamination; Fungi; Preservatives, Pharmaceutical
PubMed: 29019083
DOI: 10.1208/s12249-017-0875-1 -
Der Hautarzt; Zeitschrift Fur... Mar 2020Preservatives in cosmetics are often suspected as contact sensitizers and hence frequently patch tested in dermatitis patients. Exposure in this field has changed over... (Review)
Review
BACKGROUND
Preservatives in cosmetics are often suspected as contact sensitizers and hence frequently patch tested in dermatitis patients. Exposure in this field has changed over the course of years.
OBJECTIVE
To describe the frequency of contact sensitization to various preservatives.
MATERIALS AND METHODS
Retrospective data analysis from the Information Network of Departments of Dermatology (IVDK) for the years 2009-2018.
RESULTS
Frequency of sensitization to methylisothiazolinone (MI) has increased from 2.0% in 2009 to 7.2% in 2013. Since 2014, the rate has been falling again. Increasing the patch test concentration of methyldibromo glutaronitrile (MDBGN) in 2016 has caused a sudden rise in positive patch test reactions from 2.0% to more than 4.5%. Allergic reactions to other preservatives occurred in less than 1% of the patients tested.
DISCUSSION
Since 2014, the worldwide "epidemic" of sensitization to MI has been subsiding in Central Europe, thanks to corresponding restrictions on use. Since 2008, there is no longer any widespread exposure to MDBGN; the new, higher test concentration elicits many false-positive test reactions and explains the sudden rise in positive patch test reactions since 2016. Despite widespread use, phenoxyethanol, benzoates, benzyl alcohol, parabens and sorbates rarely cause allergic reactions. Therefore, they can be recommended for cosmetics from the epidemiological-allergological point of view.
Topics: Allergens; Cosmetics; Dermatitis, Allergic Contact; Europe; Humans; Nitriles; Patch Tests; Predictive Value of Tests; Preservatives, Pharmaceutical; Retrospective Studies; Thiazoles
PubMed: 31792581
DOI: 10.1007/s00105-019-04517-x -
Dermatitis : Contact, Atopic,... 2015Parabens have been used as preservatives in foods, injectables, and topical preparations for nearly 10 decades. Present in nature, rapidly metabolized by skin and liver... (Review)
Review
Parabens have been used as preservatives in foods, injectables, and topical preparations for nearly 10 decades. Present in nature, rapidly metabolized by skin and liver enzymes, they have an excellent safety record. However, in the past 15 years, they have been under scrutiny for their alleged estrogenic and antiandrogenic effects, as well as their putative role in promoting cancerogenesis through endocrine disruption. Scientific articles supporting these assertions have led the European Community to ban or restrict the use of some parabens. Despite that methylparaben and ethylparaben have negligible endocrine disruption activity, the food, pharmaceutical, and cosmetic industries are under pressure from scare campaigns in the media and are responding by replacing parabens with other biocides that cause multiple cases, and even worldwide epidemics, of allergic contact sensitization. In the present review, we present a balanced account of the published literature about the metabolism and potential toxicology of parabens.
Topics: Androgen Antagonists; Androgens; Animals; Breast Neoplasms; Consumer Product Safety; Cosmetics; Estrogens; Female; Humans; Parabens; Preservatives, Pharmaceutical; Skin Absorption
PubMed: 26551603
DOI: 10.1097/DER.0000000000000147 -
Cutis Aug 2019Methylisothiazolinone (MI) is a preservative commonly used in water-based personal care products. Increases in the allowable concentration of MI alone in these products...
Methylisothiazolinone (MI) is a preservative commonly used in water-based personal care products. Increases in the allowable concentration of MI alone in these products has led to an epidemic of allergic contact dermatitis (ACD). Although personal care products are the most common source of MI contact allergy, other novel exposures include household products, industrial chemicals, paint, slime, and adhesive agents. Other isothiazolinones such as benzisothiazoline (BIT) and octylisothiazolinone (OIT) are uncommon in personal care products but have been found in leather products, glue, industrial chemicals, paints, and cleaning products. There may be cross-reactivity between OIT and MI, and a minority of patients who are allergic to MI are cosensitized to BIT. In this article, we review MI and related isothiazolinone chemicals.
Topics: Cosmetics; Cross Reactions; Dermatitis, Allergic Contact; Humans; Preservatives, Pharmaceutical; Thiazoles
PubMed: 31603959
DOI: No ID Found -
Cells Apr 2023Cosmetic products contain preservatives to prevent microbial growth. The various types of preservatives present in skincare products applied on the skin induce many side...
Cosmetic products contain preservatives to prevent microbial growth. The various types of preservatives present in skincare products applied on the skin induce many side effects. We tested several types of preservatives such as phenoxyethanol, methyl paraben, propyl paraben, imidazolidinyl urea (IU), the composition of gluconolactone and sodium benzoate (GSB), diazolidinyl urea (DU), and two grapefruit essential oils, one of which was industrially produced and a second which was freshly distilled from fresh grapefruit peels. This study aimed to find the relationship between preservative concentration, cell growth, collagen secretion, and cell viability. We hypothesized that these products induced a decrease in collagen secretion from human dermal fibroblasts. Our research, for the first time, addressed the overall effect of other preservatives on skin extracellular matrix (ECM) by studying their effect on metalloproteinase-2 (MMP-2) activity. Except for cytotoxicity and contact sensitivity tests, there are no studies of their effect on skin ECM in the available literature. These studies show potential antimicrobial activity, especially from the compounds IU and DU towards reference bacteria and the compounds methyl paraben and propyl paraben against reference fungi. The MTS test showed that fibroblasts are more sensitive to the tested group of preservatives than keratinocytes, which could be caused by the differences between the cells' structures. The grapefruit oils exhibited the most cytotoxicity to both tested cell lines compared to all considered preservatives. The most destructive influence of preservatives on collagen synthesis was observed in the case of IU and DU. In this case, the homemade grapefruit oil turned out to be the mildest one. The results from a diverse group of preservatives show that whether they are natural or synthesized compounds, they require controlled use. Appropriate dosages and evaluation of preservative efficacy should not be the only aspects considered. The complex effect of preservatives on skin processes and cytotoxicity is an important topic for modern people.
Topics: Humans; Parabens; Matrix Metalloproteinase 2; Preservatives, Pharmaceutical; Cosmetics; Allergens
PubMed: 37048149
DOI: 10.3390/cells12071076 -
Dermatitis : Contact, Atopic,... 2017Allergic contact dermatitis related to cosmetic use can result from allergens not routinely evaluated by standard patch test protocols. Propyl, octyl, and dodecyl... (Review)
Review
Allergic contact dermatitis related to cosmetic use can result from allergens not routinely evaluated by standard patch test protocols. Propyl, octyl, and dodecyl gallates are commonly used antioxidant preservatives with reports of associated allergic contact dermatitis in the literature. The objectives of this review were to investigate the role of gallates in allergic contact dermatitis and to explore products containing these preservatives. A systematic review of the literature through April 2016 was performed to explore cases of reported gallate allergy. Food and cosmetic product databases were searched for products containing gallates. Seventy-four cases of gallate contact allergy have been reported. In addition, a variety of commercially available cosmetic products and foods contain gallate chemicals. Propyl gallate is the most commonly reported gallate contact allergen and often causes facial and/or hand dermatitis.
Topics: Antioxidants; Cosmetics; Dermatitis, Allergic Contact; Gallic Acid; Humans; Patch Tests; Preservatives, Pharmaceutical; Propyl Gallate
PubMed: 28169852
DOI: 10.1097/DER.0000000000000263 -
Molecular Aspects of Medicine Oct 2023Glaucoma is one of the leading causes of irreversible blindness. Progression is halted with a reduction in intraocular pressure (IOP), which is most often achieved with... (Review)
Review
Glaucoma is one of the leading causes of irreversible blindness. Progression is halted with a reduction in intraocular pressure (IOP), which is most often achieved with eye drops. A major challenge in the topical treatment of glaucoma patients is the many side effects and the resulting reduced adherence. Side effects may of course be due to the molecular properties of the active pharmaceutical ingredients (APIs). There are currently six different APIs available: prostaglandin analogues, β-adrenergic inhibitors, α-adrenergic agonists, carbonic anhydrase inhibitors, rho-kinase inhibitors and muscarinic 3 agonists. But the additives used in eye drops are also known to cause damage to the ocular surface and to some extent also to the deeper tissues. Said additives are considered inactive molecular components and are added to secure for instance viscosity and pH value, and to prevent contamination. There has been an increasing focus on the harmful effects of preservatives, with the most commonly used preservative benzalkonium chloride (BAK) being particularly controversial. BAK has long been recognized as a toxin that increases the risk of ocular discomfort. This can affect the adherence and ultimately result in lack of disease control. Other issues include the addition of certain buffers, such as phosphates, and varying pH values. This review will address the different molecular components of the IOP-lowering eye drops and what to be aware of when prescribing topical glaucoma treatment.
Topics: Humans; Glaucoma; Intraocular Pressure; Eye; Preservatives, Pharmaceutical; Ophthalmic Solutions
PubMed: 37459821
DOI: 10.1016/j.mam.2023.101195 -
Journal of Pharmaceutical Sciences Jun 2021Small angle neutron scattering (SANS) studies of a model pharmaceutical formulation reveal how formulation stability depends on the compatibility of individual...
Small angle neutron scattering (SANS) studies of a model pharmaceutical formulation reveal how formulation stability depends on the compatibility of individual components. Solutions of two common protein formulation excipients, polysorbate 80 (PS80), a nonionic surfactant that prevents aggregation, and m-cresol, an antimicrobial agent for multi-dose injectable formulations, are investigated. The addition of m-cresol to PS80 solutions leads to solution turbidity and irreversibly alters PS80 micelle morphology. This slow preservative-induced destabilization of PS80 micelles progresses over days or even weeks, which highlights the essential role that aggregation kinetics plays in preservative-surfactant interactions. The temperature-dependence of PS80 micelle growth kinetics is quantified by SANS in the presence of m-cresol. Aggregation is a two-step process, where initial formation of small aggregates is followed by a period of monotonic power-law growth, providing evidence for the mechanism. Total aggregate mass stays constant after initial aggregate formation, and addition of a pH-regulating citrate buffer dramatically accelerates aggregation kinetics.
Topics: Excipients; Micelles; Polysorbates; Preservatives, Pharmaceutical; Surface-Active Agents
PubMed: 33387597
DOI: 10.1016/j.xphs.2020.12.030 -
International Journal of Pharmaceutics Jul 2022Food-processing and pharmaceutical industries share a lot of stability issues against the same physical, chemical, and microbiological phenomena. They also share some... (Review)
Review
Food-processing and pharmaceutical industries share a lot of stability issues against the same physical, chemical, and microbiological phenomena. They also share some solutions to improve the stability as the use of preservatives and packaging. Ecological concerns lead to the development of tremendous innovations in food. Some of these innovations could also be beneficial in the pharmaceutical domain. The objective of this review is to evaluate the potential application of these findings in the pharmaceutical field and the main limits in terms of toxicity, environmental, economic and regulatory issues. The principal factors influencing the shelf-life were highlighted through the description of the stability studies usually performed in the pharmaceutical industry (according to European guidelines). To counter those factors, different solutions are currently available as preservatives and specific packaging. They were described and debated with an overview of recent food innovations in each field. The limits of the current solutions in the pharmaceutical field and the innovation in the food field have inspired a critical pharmaceutical outlook. The active and intelligent packaging for active pharmaceutical ingredients of the future is imagined.
Topics: Drug Industry; Food; Food Packaging; Food Preservation; Preservatives, Pharmaceutical
PubMed: 35680111
DOI: 10.1016/j.ijpharm.2022.121881 -
Current Drug Safety 2023Preservatives are the ingredients that are utilized in order to improve the shelf life of products (Medicines, food). These tend to slow down or stop the degradation or... (Review)
Review
Preservatives are the ingredients that are utilized in order to improve the shelf life of products (Medicines, food). These tend to slow down or stop the degradation or decomposition processes, therefore, enhance the shelf life of the products. These agents either interfere with the chemical reaction or check the growth of microorganisms in the products. Preservatives are classified according to the mode of action or source or chemical nature. The preservation efficacy can be affected by various factors, e.g., interaction with other components, nature of preservatives, type of containers, type of micro-organism, and pH. Despite being vital for various types of products, these chemicals are not safe, if not used appropriately. The review will provide an updated detail of different types of preservatives along with their safety aspect. This review also highlighted the maximum safe concentration of preservatives that can be required to develop a formulation with maximum safety and low toxicity.
Topics: Humans; Cosmetics; Preservatives, Pharmaceutical
PubMed: 36121087
DOI: 10.2174/1574886317666220919121532