Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet - An industrial case study of attempting to comply with EU regulation 2022/63.

Recently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the food industry, and it is anticipated that the same will happen in the pharmaceutical industry. For this reason, pharmaceutical manufacturers have to consider the possible impact of removing TiO2 from the film coating of tablets. In this paper, we present a case study of a commercially produced tablet where the film coating containing TiO2 was replaced with a coating using calcium carbonate (CaCO3) or with a transparent coating. The performance of the coatings was compared by measuring the moisture absorption rate and the dissolution profile of the tablets. In these regards, there were negligible differences between the coating types. The tablets contained a highly photosensitive drug, the ability of the coatings to protect the drug was evaluated through environmental stability and photostability measurements. The HPLC results showed that the inclusion of TiO2 does not provide additional benefits, when humidity and thermal stress is applied, however its role was vital in protecting the drug from external light. There were several decomposition products which appeared in large quantities when TiO2 was missing from the coating. These results imply that photosensitivity is an issue, replacing TiO2 will be challenging, though its absence can be tolerated when the drug does not need to be protected from light.

A semi-nested PCR method with increased sensitivity for the specific, direct detection of Salmonella enterica strains in poultry ectoparasites.

The darkling beetle, Alphitobius diaperinus, and the poultry red mite, Dermanysuss gallinae are among the most common pests of poultry farms. Both pests can be carriers and reservoirs of various pathogens including zoonotic ones like Salmonella. Salmonellosis is one of the most common foodborne diseases reported in the EU. We developed a semi-nested PCR method for the direct detection of Salmonella enterica. When testing the specificity of the novel PCR, we successfully detected various S. enterica strains, whereas Escherichia coli and Citrobacter strains gave negative results. The authenticity of the PCR products was confirmed by DNA sequencing. The sensitivity of the semi-nested PCR was tested on serial dilution of bacterial cultures and extracted DNA. We found our new method more sensitive than the previous PCRs. We also screened ectoparasite samples, collected from a poultry farm in Hungary, and three out of the eight samples were positive for S. Enteritidis. This novel PCR seems suitable for the detection of S. enterica strains in poultry ectoparasites without the need of sample pre-enrichment.

Noncovalent Interaction of Tilmicosin with Bovine Serum Albumin.

Tilmicosin is a widely used antibiotic in veterinary applications. Its antimicrobial activity is ranged from Gram-positive and some Gram-negative bacteria towards activities against Mycoplasma and Chlamydia. Adsorption affinity of tilmicosin antibiotics towards bovine serum albumin was investigated by both spectroscopic (UV-vis, Photoluminescence) and calorimetric methods. The interaction was determined on the basis of quenching of albumin by tilmicosin. Results confirm noncovalent binding of tilmicosin on bovine serum albumin with 1:1 stoichiometry associated with pK = 4.5, highlighting possible removal of tilmicosin molecules from the albumin surface through exchange reactions by known competitor molecules. Calorimetric measurements have confirmed the weak interaction between tilmicosin and albumin and reflect enhanced denaturation of the albumin in the presence of tilmicosin antibiotic. This process is associated with the decreased activation energy of conformational transition of the albumin. It opens a new, very quick reaction pathway without any significant effect on the product by noncovalent binding the tilmicosin molecules to the protein molecules. Results highlight the medical importance of these investigations by considerable docking of the selected antibiotic molecules on serum albumins. Although the binding may cause toxic effects in living bodies, the strength of the binding is weak enough to find competitor molecules for effective removals from their surface.

Exhaled breath condensate pH decreases following oral glucose tolerance test.

Exhaled breath condensate (EBC) pH is a widely measured non-invasive marker of airway acidity. However, some methodological aspects have not been thoroughly investigated. The aim of the study was to determine the effect of oral glucose tolerance test (OGTT) on EBC pH in attempt to better standardize its measurement. Seventeen healthy subjects (24 ± 2 years, 6 men, 11 women) participated in the study. EBC collection and capillary blood glucose measurements were performed before as well as 0, 30, 60 and 120 min after a standardized OGTT test. The rate of respiratory droplet dilution and pH were evaluated in EBC. Blood glucose significantly increased at 30 min and maintained elevation after 60 and 120 min following OGTT. Compared to baseline (7.99 ± 0.25) EBC pH significantly decreased immediately after OGTT (7.41 ± 0.47); this drop sustained over 30 (7.44 ± 0.72) and 60 min (7.62 ± 0.44) without a significant difference at 120 min (7.78 ± 0.26). No change was observed in the rate of respiratory droplet dilution. There was no relationship between blood glucose and EBC pH values. Sugar intake may significantly decrease EBC pH. This effect needs to be considered when performing EBC pH studies. Further experiments are also warranted to investigate the effect of diet on other exhaled biomarkers.

Follow up of lung transplant recipients using an electronic nose.

Lung transplantation is the only available treatment for some end-stage lung diseases. However, patients following lung transplantation need tight control to prevent serious complications, but mainly invasive techniques are available. An electronic nose is a non-invasive way to measure exhaled volatiles. In this study we investigated the potential of electronic nose measurements in lung transplant patients and compared the 'breathprint' with clinical parameters. Sixteen patients with lung transplant and 33 healthy subjects participated in the study. Exhaled breath was collected; laboratory tests and lung function measurements were carried out. Breath samples were processed by an electronic nose, analysed using principal component analysis and compared to blood (CRP, tacrolimus) and lung function parameters. Significant differences were found in exhaled breath volatile compound pattern between healthy subjects and lung transplant recipients. The plasma level of tacrolimus showed significant relationship with 'breathprint' in lung transplanted patients. Patients living with transplanted lungs can be discriminated from healthy subjects by exhaled breath volatile organic compounds' profile. Treatment after lung transplantation needs to be taken into consideration when using an electronic nose as medication may have profound influence on breathprints.

[Complex psycho-social intervention program complementing conventional antitumor therapy -- promising results]. / A hagyományos daganatterápiát kiegészíto komplex életmód és pszichoszociális intervenciós program - igen biztató eredményekkel.

The aim of the research was to assess the effectiveness of a comprehensive, complex psycho-social intervention program, operating on different levels of spiritual plane, life management and behavioural health, among women with breast cancer. The general objective of the study was to help in coping, promote cognitive and emotional processing, encourage psychological and spiritual growth, improve the quality of life, and reduce the chances of remission. The research has been carried out in Budapest at the Radiology Diagnostic Department of the National Oncology Institute, involving 173 women treated for malignant breast tumour (C50) (experimental group: n=86, control group: n=87). Thirty-four women from the experimental group participated in the complex intervention program. We carried out two tests: one before the start and one after the end of the program. Research tools: Shortened Beck Depression Inventory, Quality of Life Questionnaire (EORTC QLQ-C30, QLQ-BR23), Spielberger's State-Trait Anxiety Inventory (STAI-T), the Revised Illness Perception Questionnaire (IPQ-R), the Posttraumatic Growth Inventory, and the Benefit Finding Questionnaire. The women participating the experimental program showed a significant positive change in comparison to the control group: in anxiety F (1, 65)=6.021, p=0.017; in depression: F(1, 72)=4.347, p=0.041; in experience of personal control: F(1, 69)=7.346, p=0.008; in EORTC General Health/Quality of Life Subscale F(1, 78)=7.531, p=0.008; in EORTC physical functioning F(1, 78)=4.874, p=0.014; in EORTC fatigue F(1, 78)=15.060, p=0.000; in BR23 body-image F(1, 79)=8.828, p=0.004; in BR23 arm symptoms F(1, 78)=7.229, p=0.009; in benefit finding F(1, 80)=21.171, p=0.000, and in posttraumatic growth F(1, 31)=24.186, p=0.000). The program has proven effective, its widespread use in practice is recommended.

Exhaled breath volatile alterations in pregnancy assessed with electronic nose.

CONTEXT: Pregnancy-linked accelerated metabolism and oxidative stress may alter the exhaled volatile compound pattern ("breathprint"). Electronic noses can distinguish "breathprints" associated with different disorders. OBJECTIVE: This is the first study assessing alterations in "breathprint" during gestation. MATERIAL AND METHODS: 130 women participated in our study (78 pregnant vs. 52 non-pregnant). Breath samples were processed by an electronic nose and analyzed using principal component analysis. RESULTS: Significant differences were found in exhaled breath pattern between pregnant and non-pregnant women (p = 0.001). CONCLUSION: Pregnancy-induced changes in exhaled gases need to be considered when pregnant women with respiratory disorders carry out breath tests.