The Role of Titanium Dioxide (E171) and the Requirements for Replacement Materials in Oral Solid Dosage Forms: An IQ Consortium Working Group Review.

Titanium dioxide (in the form of E171) is a ubiquitous excipient in tablets and capsules for oral use. In the coating of a tablet or in the shell of a capsule the material disperses visible and UV light so that the contents are protected from the effects of light, and the patient or caregiver cannot see the contents within. It facilitates elegant methods of identification for oral solid dosage forms, thus aiding in the battle against counterfeit products. Titanium dioxide ensures homogeneity of appearance from batch to batch fostering patient confidence. The ability of commercial titanium dioxide to disperse light is a function of the natural properties of the anatase polymorph of titanium dioxide, and the manufacturing processes used to produce the material utilized in pharmaceuticals. In some jurisdictions E171 is being considered for removal from pharmaceutical products, as a consequence of it being delisted as an approved colorant for foods. At the time of writing, in the view of the authors, no system or material which could address both current and future toxicological concerns of Regulators and the functional needs of the pharmaceutical industry and patients has been identified. This takes into account the assessment of materials such as calcium carbonate, talc, isomalt, starch and calcium phosphates. In this paper an IQ Consortium team outlines the properties of titanium dioxide and criteria to which new replacement materials should be held.

Work-related Helicobacter pylori infection among sewage workers in municipal wastewater treatment plants in Belgium.

INTRODUCTION: Most studies among sewage workers of wastewater treatment plants (WWTPs) have found a higher prevalence of gastrointestinal symptoms than among non-sewage exposed workers. Waterborne transmission of Helicobacter pylori (H pylori) has been hypothesised, as the bacteria can survive into an aqueous environment and has been detected in sewage. A health and hygiene questionnaire has demonstrated a higher prevalence of peptic ulcers among Belgian WWTP operators and maintenance workers than among non-sewage exposed colleagues. OBJECTIVES: To assess the seroprevalence of H pylori infection in Belgian sewage workers at municipal WWTPs, and to determine whether sewage exposure is an important risk factor for acquisition of H pylori and the possible association with gastrointestinal symptoms. METHODS: A seroprevalence study of H pylori antibodies was conducted among 317 WWTP employees (operators, maintenance workers, laboratory personnel, other job). Information about demographic variables, possible H pylori risk factors, working history, and history of current gastrointestinal symptoms during last 3 months was obtained by a questionnaire. The presence of H pylori IgG was investigated with an ELISA. The results were compared with those of 250 employees of a pharmaceutical company (operators, maintenance workers, laboratory personnel). RESULTS: The prevalence of H pylori IgG antibodies among sewage workers was 16.7% (95% CI 12.6 to 20.8%) compared to 13.6% (95% CI 9.4 to 17.8%) among the control group. In a logistic regression model with controlling for age and educational levels, OR study/control group was 1.02 (95% CI 0.58 to 1.80 with p=0.93). No significant associations were found between the H pylori status and gastrointestinal symptoms, occupational exposures in different tasks, nor with hygienic practices. CONCLUSIONS: Our results do not suggest that H pylori infection is a probable cause of part of gastrointestinal symptoms among Flemish municipal sewage workers of WWTPs.