China
Africa
Explore chapters and articles related to this topic
Allergic Contact Dermatitis to Ingredients other than the Active Drug
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
In cases of allergic contact dermatitis from topical pharmaceuticals, the allergenic culprit may be either the active drug or one or more of the other components, for example vehicle ingredients, preservatives, antioxidants, fragrances or other chemicals present in the topical drug product. Such reactions to non-drug components are far from rare. In eye drops, for example, many allergic reactions have been reported to the preservatives thimerosal and benzalkonium chloride. In creams and ointments, especially those used for herpes simplex (acyclovir), fungal infections (ketoconazole), and in topical corticosteroids, propylene glycol was often found to be the allergenic culprit. It should be realized, though, that these chemicals tend to cause irritant patch test reactions, and there can be no doubt that a number of the ‘allergic’ reactions reported have, in fact, been false-positive.
Preservatives and Preservation
Published in Philip A. Geis, Cosmetic Microbiology, 2020
Effective preservation is the most compelling element of cosmetic microbiological safety. In this role, the preservative serves the unique role as the only cosmetic ingredient added exclusively for a safety purpose. As biologically active chemicals, preservatives can potentially impact human safety and therefore are used at low concentrations establishing relative limited antimicrobial capacity. By comparison, cosmetic preservatives fail to achieve in a month efficacy required of a disinfectant in less than ten minutes. As even 70% ethanol and hospital-grade disinfectants can suffer microbial contaminated (18,123), it is clear that preservation alone cannot ensure quality in the context of all potential manufacture scenarios, for example, significant Gram-negative bacterial contamination of purified water systems. Similarly, effective in the context of relevant package and consumer use, preservation will not ensure quality if the product is abused such as dilution with bacteria-laden tap water. Despite these limitations, preservatives and preservation offer the single element for quantitative assessment, and every cosmetic should include an appropriate formulation. Industry best practice directs the use of systems composed of multiple preservatives effective against the range of microbes as well as a chelator.
Bayesian Methods for the Design and Analysis of Stability Studies
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
Tonakpon Hermane Avohou, Pierre Lebrun, Eric Rozet, Bruno Boulanger
Once a batch of drug is produced, it starts aging, waiting in a warehouse or in pharmacies for its final destination. For the patient, it is however critical that the drug he will take is still fully potent and not toxic at the time of medication, despite degradation(s) that might occur during this aging process. Interestingly, the drug product stability or instability during the time depends upon the ways the manufacturer has designed its process, the drug formulation (excipients, preservatives…). It also depends upon how the manufacturer is able to control appropriate raw materials at reception, and finally how storage conditions are defined and controlled. Hence, for the manufacturer, in turn, the drug stability will be an ultimate control of drug consistency, from release to shelf-life. Degradation might occur naturally, but all (the quality attributes of) commercial batches are expected to degrade the same way during the time a drug is fit for consumption, i.e. during its labelled shelf-life. It should reach and remain a satisfactory level of efficacy and safety. This means a drug substance stored under the recommended conditions is expected to remain within its approved specifications. The role of stability studies is to demonstrate exactly this.
Screening the immunotoxicity of different food preservative agents on the model organism Galleria mellonella L. (Lepidoptera: Pyralidae) larvae
Published in Drug and Chemical Toxicology, 2023
Emine Duman Erbaş, Rehemah Gwokyalya, Hülya Altuntaş, Bilal Kutrup
The increase in the world population pauses significant challenges to the welfare of the people by compromising the quality of human nutrition. Ensuring food safety from agricultural areas to the final consumers is a crucial step in solving these problems. Ensuring food safety can be achieved via proper food storage and preservation, extending the shelf life of food products, and protecting stored foods from damage. Preservatives (E200–285, E330), also known as food additives, protect the quality and taste of foods by preventing them from being affected by biological agents (Erkan 2010). Today, sulfur dioxide and several other sulfides, sorbic acids and their salts, nitrite and nitrate compounds, propionic acids and their salts, acetic acid, benzoic acid and its salts are among the most popular preservatives used during food processing (Wibbertmann et al. 2000, Russell and Grahame 2003, Rangan and Barceloux 2009).
Impact of Topical Cyclosporine-A or Topical Chloroquine on Post-LASIK Ocular Surface Stability – A Randomized Controlled Trial
Published in Current Eye Research, 2023
Jeewan Singh Titiyal, Ananya Goswami, Manpreet Kaur, Namrata Sharma, Prafulla Kumar Maharana, T. Velpandian, R. M. Pandey
Group I received standard treatment (routine postoperative regimen prescribed at our centre) which included topical moxifloxacin 0.5% three times a day for 1-month, topical prednisolone acetate 1% four times a day gradually tapered over 1 month and topical carboxymethyl cellulose eyedrop 0.5% four times a day for three months. Group II received topical cyclosporine-A 0.05% twice daily for three months in addition to standard treatment. Group III received topical chloroquine phosphate 0.03% twice daily for three months in addition to standard treatment. After three months, all the groups received carboxymethyl cellulose eyedrops 0.5% four times daily for further three months. All the medications were dispensed as unims in a preservative-free formulation. Cyclosporine A (0.05%) and Chloroquine Phosphate 0.03% are both commercially available. Preservative free cyclosporine A 0.05% ophthalmic emulsion single-use vials were used, with inactive ingredients including glycerin, castor oil, polysorbate 80, carbomer copolymer type A, purified water and sodium hydroxide to adjust pH (Brand name: Restasis, Allergan Inc, CA, USA). Unims of chloroquine phosphate 0.03% in aqueous buffered vehicle were used [Brand name- UV Lube, FDA Ltd, India). Only the left eye of each patient was included for analysis. The same eye was evaluated at each follow-up.
Ocular Surface Disease and Anti-Glaucoma Medications: Various features, Diagnosis, and Management Guidelines
Published in Seminars in Ophthalmology, 2023
Sowmya Andole, Sirisha Senthil
While AGM is the mainstay of treatment in the management of glaucoma, one needs to thoroughly assess the ocular surface, tolerability, and likely adverse effects of these medications before prescribing them. Choosing combination medications, preservative-free medications can decrease the dosing as well as preservative exposure and their side effects. Periodic follow-up is necessary not just to assess the efficacy of the medications in terms of IOP control but to assess the compliance and the adverse effects of medications if any. In case adverse effects are noted, changing to a different class of medication, use of short course of anti-inflammatory agents like corticosteroids, lubricants, and reducing exposure to preservatives may help decrease the inflammation and subsequent scarring. This would also improve compliance and persistence with medication, a better quality of life, and preserve vision.