Risks of dairy derived excipients in medications for lactose intolerant and cow milk protein allergic patients.

The use of lactose and cow milk protein (CMP) as potential allergens in pharmaceuticals and their ability to cause allergic reactions remains a significant concern in medicine. Lactose, a common pharmaceutical excipient due to its inert, inexpensive, and stable properties, is found in many prescription-only and over-the-counter medications. However, despite their widespread use, individuals with lactose intolerance (LI) or cow milk protein allergy (CMPA) may experience adverse reactions to these excipients. This study investigated the prevalence of lactose and other dairy-derived ingredients in pharmaceuticals marketed in Portugal. Using the Summary of Product Characteristics (SmPC) from the INFOMED database, various medications, including analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs), and antiasthmatics, were analyzed. Results showed a high prevalence of dairy-derived excipients, particularly in antiasthmatic drugs (62.6%) and NSAIDs (39%). Although CMP are not explicitly mentioned in SmPCs, the presence of lactose as an ingredient poses a risk of cross-contamination. The findings emphasize the need for healthcare professionals to be aware of potential allergens in medications and the importance of developing lactose-free alternatives to ensure the safety of patients with LI and CMPA. Further research is required to assess the safety and implications of lactose in medicines for these populations.

Food allergens in oral care products.

Food allergies are a growing concern, especially in Western societies and can dramatically impact the quality of life of affected individuals. In recent years, various food allergens have been introduced into the oral care industry to improve product properties and provide the best possible treatment. Since small doses of food allergens may be sufficient to trigger allergic reactions, the non-discrimination of the sources of certain excipients in the product composition can compromise the patient's health. Therefore, knowledge and awareness of allergies and product composition among health professionals are critical on behalf of patients' and consumers' health. This study aimed to ascertain the presence of dairy products (e.g., cow's milk proteins and lactose), cereals (e.g., gluten, soy, and oats), fruits, nuts, spices, shellfish, and additives as excipients in oral care products for outpatients and products for professional use in the Dental Office. Among the 387 surveyed products, the highest prevalence of food allergens was found in toothpaste, fluoride varnishes, and alginates, mostly in spices and fresh fruits. As food allergies may occur because of erroneous information or a lack of labeling on the allergen list, manufacturers should be more rigorous in declaring allergens on product labeling regarding the safety of consumers.

Food Supplements for Weight Loss: Risk Assessment of Selected Impurities.

Nowadays, food supplements are widely consumed, often without any medical supervision. In this study, 25 food supplements for weight loss, randomly purchased from five different suppliers in the European Union, were analysed by Wavelength Dispersive X ray Fluorescence spectrometry (WDXRF). The aim of this study was the risk assessment of trace elements and the mixture of elements present in food supplements for weight loss. The obtained Hazard Index (0.11) showed no potential risk of non-carcinogenic effects to human health. However, since humans are frequently exposed by different routes and/or sources to toxic metals, the additional consumption of these products may cause potential toxicological risks that cannot be ignored. In one analysed food supplement (FS), the simultaneous presence of Pb and Mn in high concentrations was detected. In two, FS chromium concentrations were above the reference daily dose. Unconformities were detected between the labelled and the detected values, which emphasises the misinformation of labels. This highlights the need for a deeper surveillance of food supplements.

Feasibility of wavelength dispersive X-ray fluorescence spectrometry for the determination of metal impurities in pharmaceutical products and dietary supplements in view of regulatory guidelines.

The aim of this study was to investigate the feasibility of Wavelength Dispersive X-ray Fluorescence (WDXRF) spectrometry for the measurement of As, Cd, Cr, Cu, Hg, Ir, Mn, Mo, Ni, Os, Pb, Pd, Pt, Rh, Ru and V impurities in pharmaceuticals and dietary supplements, in view of the requirements by EMA and USP for the measurement of elemental impurities in drug products and according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH guidelines). For that purpose, a 4 kW WDXRF spectrometer (S4 Pioneer, Bruker AXS) was used after system calibration. The linearity of the method was demonstrated by correlation coefficients in excess of 0.9 and by appropriate test of lack of fit, except for Cd, Hg, Pd, V and As, which were excluded from analysis. The calculated limits of detection and quantification were in the ranges 0.6-5.4 µg/g and 1.7-16.4 µg/g meeting defined acceptance criteria, except for Pb. The accuracy of the method, determined by the percent recovery (R) of known amounts of each element added to a selected drug, at 3 different concentration levels, was in the acceptance range 70-150% except for Os and Pt, in which case R was marginally outside that range. The repeatability of the method, assessed as the % residual standard deviation (%RSD) of 3 replicate measurements at 3 concentration levels, produced %RSD values lower than 20%, as required. These results show that the WDXRF method complies with the validation requirements defined by the European Pharmacopeia for Cu, Cr, Ir, Mn, Mo, Ni, Os, and Pt, and by the United States Pharmacopeia for Ir, Ni, Os and Pt. Therefore, it may be an alternative to the compendial analytical procedures recommended for such elements. The novelty of the present work is the application of WDXRF to final medicines and not only to active pharmaceutical ingredients and/or excipients.

Metallo-beta-lactamase VIM-2 in clinical isolates of Pseudomonas aeruginosa from Portugal.

Resistance to carbapenems is emerging, and it is a great problem to therapeutics. Three isolates of Pseudomonas aeruginosa from a Portuguese hospital identified in urine and sputum, in 1995, presented a high-level resistance to imipenem (> 32 mg/L). Afterward, one isolate of P. aeruginosa recovered from urine of an ambulatory patient in 1998 showed high resistance to imipenem and meropenem. The resistance to carbapenems in these strains was associated with the production of a class B beta-lactamase, as was demonstrated by imipenem hydrolysis and inhibition by EDTA. Using primers described for bla(IMP) and bla(VIM), the amplification of the latter was observed in all isolates and a VIM-2 metallo-enzyme was identified. The pulsed-field gel electrophoresis (PFGE) patterns of these isolates were indistinguishable, suggesting dissemination to the community of this VIM-2 producer.