Evaluating preservative efficacy in pharmaceutical and cosmetic products

by K. E. Moore

Written in English

Published: 1978 Downloads: 526

Edition Notes

Thesis(Ph.D.) - Loughborough University of Technology 1978.

ID Numbers
Statement	by K.E. Moore.
Open Library	OL20030326M

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The panel books presented to the Expert Panel for Cosmetic Ingredient Safety contain safety assessments and other materials related to the ingredient or ingredients being considered. 40 Years of CIR For 40 years the Cosmetic Ingredient Review has worked with FDA, the cosmetics industry, and consumers to help keep cosmetics safe. A composition for and methods of preserving a topical cosmetic, toiletry or pharmaceutical formulation against microbiological contamination or growth are described in which the compositions used herein include at least one hydroxamic acid, salt or complex thereof, and the methods include addition of an effective amount of such compounds to a cosmetic, toiletry or pharmaceutical formulation. In March , FDA revised the Compliance Policy Guide (CPG) Sec. on Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to . Given that the effectiveness of many preservatives is pH dependent, the specifications for such products should usually also include requirements for pH which will ensure preservative efficacy (the limits should have been justified on the basis of preservative efficacy studies over the shelf life).

Products formulated to contain preservatives to inhibit microbial growth should be monitored throughout their shelf life to assure the effectiveness of the preservative system. The aim of this study was to statistically evaluate the influence of the concentration of the co-solvent propylene glycol on the preservative efficacy of a complex pharmaceutical suspension-emulsion formulation containing methyl- and propylparaben. Cosmetic Products Compliance Requirements SCOPE This guide addresses the compliance requirements for basic cosmetics and soap. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body. Emerging Technologies and the Future of Cosmetic Science, Preservative Efficacy Testing: Accelerating the Process, The Regulatory Interface: When is it a Cosmetic and When a Drug? Correlating Porosity and Tensile Strength of Chemically Modified Hair, In Vivo Quantitative Evaluation of Gloss, Evaluating Shampoo s: 7.

Connolly P, et al. The use of impedance for preservative efficacy testing of pharmaceuticals and cosmetic products. J. Appl. Bacteriol. , PubMed: Wnendt S, et al. Molecular cloning, sequence analysis and expression of the gene encoding an antifungal-protein from Aspergillus giganteus. Curr. Genet. , The growth of this market is mainly driven by the increasing use of surface disinfectants and preservatives in pharma, biopharma, and cosmetics industries for . Contacts. Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call For U.S./CAN Toll Free Call For GMT Office. The growth of this market is mainly driven by the increasing use of surface disinfectants and preservatives in pharma, biopharma, and cosmetics industries for contamination control and product.

Recent

Evaluating preservative efficacy in pharmaceutical and cosmetic products by K. E. Moore Download PDF EPUB FB2

Evaluation of preservative efficacy in pharmaceutical products: the use of psychrotolerant, low-nutrient preferring microbes in challenge tests. Charnock C(1), Otterholt E. Author information: (1)Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, St. Olavs plass, Oslo, Norway.

[email protected] by: 1. Evaluation of preservative efficacy in pharmaceutical products: the use of psychrotolerant, low‐nutrient preferring microbes in challenge tests C. Charnock PhD Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, St.

Olavs plass, Oslo, NorwayCited by: 1. A sodium benzoate‐sorbic acid preservative system of a pharmaceutical product was proved effective against a wild strain of Pseudomonas cepacia, following the official method of the Italian and British r, this preservative system was ineffective against a challenge of Ps.

cepacia wild strain cells grown in the unpreserved pharmaceutical product and on culture media Cited by: Preservative efficacy testing (PET) or antimicrobial effectiveness testing (AET) is required for the assessment of the antimicrobial preservatives in multiple-use cosmetic and pharmaceutical products.

Antimicrobial preservatives are substances added to products to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subsequent. The objective of this work was to evaluate the preservative effectiveness of liquid crystalline systems containing retynil palmitate (RP) by the challenge test (CT) and D-value.

A system was developed containing water, silicon glycol copolymer, and polyether functional siloxane with 1% RP added. The analyses were carried out by methods in the U.S. Pharmacopeia ( ) using the microorganisms Escherichia coli Cited by: 3. International Journal of Pharmaceutics, 60 () Elsevier IJP Studies on the evaluation of preservative efficacy V.

Effect of concentration of micro-organisms on the antimicrobial activity of phenol Mufid Shamil Karabit Department of Pharmaceutics, Uppsala Biomedical Center, BoxS 23 Uppsala (Sweden) (Received 25 August ) (Accepted 30 October.

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.

In recent years, there is a considerable interest in the development of preservative-free or self-preserving cosmetics. The aim of our work was to develop new cosmetic formulations by replacing chemical preservatives with ingredients with antimicrobial properties that are not legislated as preservatives according to Annex VI of Commission Directive 76//EEC.

Parabens are used as preservati ves in many thousands of cosmetic, food, and pharmaceutical products to which the human population is exposed. Though recent reports of. ORA, Version DATE: t U ha ni t t e ar d e S n t ot specifically addressed in the microbi serve as a at te e c s h P ni ha cal rm r a e c f o er p e e n.

Below is a list of the 5 most common types of preservatives used in cosmetics, along with some examples, uses, and pros and cons of each to assist cosmetic and personal care producers in the decision of the most appropriate preservatives for their products. Formerly, there were no validated tests for cosmetic preservative efficacy (9), although the test for pharmaceutical preservative efficacy in the U.S.

Pharmacopeia (2) or the cosmetic test in the. Like the majority of cosmetic products having an aqueous phase, wipes are susceptible to microbial contamination and require the addition of preservatives.

The efficacy of such preservatives can be evaluated using a standard challenge test performed on the wetting liquid but this test cannot be regarded as representative for this new type of. EVALUATION OF PRESERVATIVES The evaluation of preservatives has traditionally involved time-consuming tests: Pharmacopoeial antimicrobial effectiveness tests (AET) Preservative efficacy tests (PET).

These are required for the assessment of the antimicrobial preservation of multiple-use pharmaceutical products 38 The use of impedance for preservative efficacy testing of pharmaceuticals and cosmetic products.

Connolly P(1), Bloomfield SF, Denyer SP. Author information: (1)Department of Pharmacy, King's College London, UK. Impedance was investigated for its applicability to preservative efficacy testing of pharmaceuticals and cosmetics.

and cosmetic products is a crucial parameter in evaluating. used as an antimicrobial preservative in pharmaceutical and. Microbial Stability of Pharmaceutical and Cosmetic Products. In book: Recent Trends in Malaysia Medicinal Plants Research (pp) pharmaceutical, food and textile indus try.

The presence of preservatives in cosmetic products is. obviously. An Antimicrobial Effectiveness Test (AET), also called a Preservative Efficacy Test (PET), provides product safety and product stability information to manufacturers of pharmaceutical, cosmetic and health and beauty care products.

Preservative content (for example antioxidant or anti-microbial preservative. Functionality tests (for example, a dose delivery system) Include any in-use conditions, for example, the stability of opened packages in multi-dose products.

Sunscreen products help in protecting the body from UV rays and treating sunburns. The evaluation tests for the lipsticks are as follows: 1. Text book of Cosmetic Formulations. Preservation of cosmetics Need for adding preservatives to cosmetics In addition to their principal ingredients of oil and water, cosmetics often also contain such substances as glycerin and sorbitol which provide a source of carbon for microorganisms, and such substances as amino acid derivatives and proteins which provide a source of nitrogen for them.

The following review provides a comprehensive summary of antimicrobial preservatives that are commonly used in licensed parenteral products to date. The information reviewed includes the general properties of the preservatives, the doses and frequency of their use, the classes of the preserved produ.

The Preservative efficacy test is a laboratory test that determines the level of antimicrobial activity of a product and to evaluate how well a product withstands microbial contamination during use.

Preservative efficacy test is an important parameter for both pharmaceutical and food products where there is a higher risk of microbial. In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics.

back to t op. When liquid cosmetics are evaluated, it is easy to obtain homogeneity between the inoculum and the sample, but for a powder sample it cannot be guaranteed. In this context, freeze-dried microorganisms could be used to help the homogenization.

In this research, the preservative efficacy is evaluated using a powdered eye shadow. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines.

Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity. The aim of the study was to compare the preservative effectiveness of plant extracts (Matricaria chamomilla, Aloe vera, Calendula officinalis) and essential oils (Lavandulla officinalis, Melaleuca alternifolia, Cinnamomum zeylanicum) with methylparaben in cosmetic emulsions against skin microflora during 2 months of application by volunteers.

Cosmetic emulsions with extracts ( %. The efficacy of the preservative systems of two cosmetic products, tested against standard micro-organisms (Staphylococcus aureus ATCC and Pseudomonas aeruginosa ATCC ) and two isolates from cosmetics in this study (S.

epidermidis and P. putida), satisfied the Cosmetics, Toiletries, and Fragrance Association and Official Italian Pharmacopeia criteria, while only one tested cosmetic.

Abstract. To ensure safety and efficacy, cosmetic products are regulated and controlled worldwide. However, the alignment of laws dealing with cosmetics is far from being achieved, and regulatory frameworks vary greatly between countries, making it practically impossible for a global industry to sell the same product on all markets and generating difficulties for trading.

The preservative efficacy of ZnO was assessed by challenge testing in three different formulations: an oil-in-water emulsion; a water-in-oil emulsion and a dry powder. The addition of ZnO in complex formulations significantly improved the microbiological quality of the products, in spite of the presence of other ingredients that modulate the.

Cosmetic Toiletry (12), McCarthy, T. J. () Formulated Factors Affecting the Activity of Preservatives. Cosmetic and Drug Preservation. Marcel Dekker. Inc., New York, pp. Orth, D. () Preservative efficacy testing of cosmetic products. Cosmetic Toiletry 97(5), Orth, D.

() Evaluation of Preservatives in.Part 4 Microbiological control - methods and standards: preservative efficacy testing of pharmaceuticals, cosmetics and toiletries and its limitations; challenge tests and their predictive ability; new methodology for microbial quality assurance; microbial contamination of manufactured products - official and unofficial limits.Even though the synthetic preservatives may offer a high antimicrobial efficacy, they are commonly related to adverse reactions and regarded as having potentially harmful effects caused by chronic consumption.

The development of natural preservatives provides a way of reducing the amount of synthetic preservatives normally used in pharmaceutical and cosmetic preparations.