Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework.

Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%-70% of the population experiences incontinence with most studies suggesting 25%-45% of the population. Varying definitions of UI (e.g., stress, urgency, mixed) exist, and inconsistent symptom assessment tools, age, and gender can affect the estimate of incidence. Disposable Adult Incontinence products were first introduced into the market in the late 1970s and initially were used mostly in nursing homes and hospitals. However, during the 1980s, the market for incontinence products via retail outlets dramatically increased as awareness of the benefits of the products grew and stigma about their use declined. Today's products that manage urine loss have an extensive history and have evolved with time. Always products were introduced into the market in 2014 and are designed to meet the needs of women of all ages. Considered medical devices in some countries, regional regulations and global guidelines require clear planning, thorough assessment, and concise documentation of clinical safety. This manuscript will briefly review the regulatory landscape with a specific focus on European Union regulations. As previously published, the iterative, risk assessment framework used to assess the safety of Always incontinence products confirms that these products are compatible with skin and can be used safely. This manuscript will expand on the current literature highlighting additional steps that help assure the safety and compliance of the products from quality assurance programs through comprehensive post-market safety surveillance. Recommendations to help ensure several of the key regulatory requirements are met are outlined in the context of a risk assessment framework used to assure safety.

Safety evaluation of superabsorbent baby diapers.

Superabsorbent disposable baby diapers are sophisticated, well-engineered products that provide many benefits including convenience, comfort, exceptional leakage protection, improved hygiene and skin care benefits compared with cloth diapers. Safety assurance is an integral part of the diaper development process at Procter & Gamble, with the goal of ensuring safety for both caregivers and babies. A systematic, stepwise approach to safety assessment starts with a thorough evaluation of new design features and materials, using the principles of general risk assessment including, as appropriate, controlled trials to assess clinical endpoints or independent scientific review of safety data. The majority of the diaper materials are polymers that are safe and do not have inherent toxicity issues. Trace amounts of non-polymeric materials, such as colorants, are assessed based on their skin contact potential. New materials or design features are introduced in marketed products only if they have been shown to be safe under the conditions of recommended or foreseeable use. The product safety continues to be confirmed after launch by means of in-market monitoring. This article provides a broad overview of human safety exposure-based risk assessment used at Procter & Gamble for absorbent hygiene products.

Characterization and determination of piperine and piperine isomers in eggs.

A new analytical method for the determination of piperine and its isomers in egg yolk and albumen is described here. All four isomers were separated by HPLC and detected using UV, DAD and electrochemical detection. The absolute detection limit (UV detection, S/ N=3) of a standard solution of piperine was 370 pg piperine. The correlation coefficients for the linear calibration graphs (concentration range: c=100 ng-10 micro g piperine isomer/mL) are generally better than 0.996. The piperine isomers were characterized and identified by spectroscopy (MS, (1)H-NMR, FT-IR). The method was successfully applied to the determination of piperine deposits in eggs (egg yolk and albumen) after feeding hens with piperine-spiked feed. The detection limit for piperine (24.8(+/-0.2) ng/g egg yolk and 37.9(+/-4.9) ng/g albumen) and the recoveries (70.3(+/-7.7)% (egg yolk) and 75.7(+/-1.9)% (albumen)) of piperine were determined.