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Farmacia Hospitalaria : Organo Oficial... May 2024To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 and 10 mg/mL eye drops...
OBJECTIVE
To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 and 10 mg/mL eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome.
METHOD
The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5±3 °C), at room temperature (25±2 °C), and at 40 °C (±2 °C). In accordance with the USP (United States Pharmacopeia), physicochemical controls of the active ingredient content were carried out by HPLC-UV (High Performance Liquid Chromatography with Ultraviolet detection), together with controls of pH, osmolality, and visual examination. Microbiological sterility was also tested under refrigerated conditions up to 30 days in open containers and up to 90 days in closed ones.
RESULTS
The eye drops stored at 5 °C were the most stable; in the 1 mg/mL eye drops, degradation of the drug fell below 90% from day 21, and in the 10 mg/mL eye drops, from day 42. pH change did not vary by ≥1 unit in formulations stored at 5 °C, unlike the other formulations. Changes in osmolality did not exceed 5% on day 90 in any storage conditions. Samples of non refrigerate eye drops at 10 mg/mL, presented a white precipitate from day 14 and 28, respectively. Non-refrigerated 1 mg/mL eye drops presented suspended particles on day 90. There were no color changes. Microbiological analysis showed that sterility was maintained for over 90 days in the closed containers, although microbial contamination was detected from day 21 in the open containers.
CONCLUSIONS
1 mg/mL MTPSS eye drops show physicochemical and microbiological stability for 21 days under refrigeration, compared to 42 days for 10 mg/mL eye drops stored under the same conditions. However, since they do not include preservatives in their composition, they should not be used for more than 7 days after opening.
PubMed: 38782645
DOI: 10.1016/j.farma.2024.04.021 -
Analytical Chemistry Jun 2024Metabolites from feces provide important insights into the functionality of the gut microbiome. As immediate freezing is not always feasible in gut microbiome studies,... (Comparative Study)
Comparative Study
Metabolites from feces provide important insights into the functionality of the gut microbiome. As immediate freezing is not always feasible in gut microbiome studies, there is a need for sampling protocols that provide the stability of the fecal metabolome and microbiome at room temperature (RT). Here, we investigated the stability of various metabolites and the microbiome (16S rRNA) in feces collected in 95% ethanol (EtOH) and commercially available sample collection kits with specific preservatives OMNImet•GUT/OMNIgene•GUT. To simulate field-collection scenarios, the samples were stored at different temperatures at varying durations (24 h + 4 °C, 24 h RT, 36 h RT, 48 h RT, and 7 days RT) and compared to aliquots immediately frozen at -80 °C. We applied several targeted and untargeted metabolomics platforms to measure lipids, polar metabolites, endocannabinoids, short-chain fatty acids (SCFAs), and bile acids (BAs). We found that SCFAs in the nonstabilized samples increased over time, while a stable profile was recorded in sample aliquots stored in 95% EtOH and OMNImet•GUT. When comparing the metabolite levels between aliquots stored at room temperature and at +4 °C, we detected several changes in microbial metabolites, including multiple BAs and SCFAs. Taken together, we found that storing samples at RT and stabilizing them in 95% EtOH yielded metabolomic results comparable to those from flash freezing. We also found that the overall composition of the microbiome did not vary significantly between different storage types. However, notable differences were observed in the α diversity. Altogether, the stability of the metabolome and microbiome in 95% EtOH provided results similar to those of the validated commercial collection kits OMNImet•GUT and OMNIgene•GUT, respectively.
Topics: Ethanol; Feces; Metabolomics; Gastrointestinal Microbiome; Humans; Specimen Handling; RNA, Ribosomal, 16S; Temperature
PubMed: 38782403
DOI: 10.1021/acs.analchem.3c04436 -
International Journal of Food... Jul 2024In this study, 327 presumptive lactic acid bacteria (LAB) were isolated from goats' milk acid curds produced at a Sicilian dairy farm with the aim to identify potential...
Selection of starter lactic acid bacteria capable of forming biofilms on wooden vat prototypes for their future application in traditional Sicilian goat's milk cheese making.
In this study, 327 presumptive lactic acid bacteria (LAB) were isolated from goats' milk acid curds produced at a Sicilian dairy farm with the aim to identify potential starter cultures for traditional cheeses. All isolates were first processed by randomly amplified polymorphic DNA (RAPD)-PCR analysis. This approach identified 63 distinct strains which were evaluated for their acidifying capacity. Only 15 strains specifically stood out for their acidification capacity and were identified through 16S rRNA gene sequencing as Lactococcus lactis (11 strains) Enterococcus faecalis (three strains), and Ligilactobacillus animalis (one strain). Notably, all 15 LAB isolates produced bacteriocin-like inhibitory substances and anti-biofilm compounds, against both planktonic and biofilm forms of Listeria monocytogenes, Salmonella Enteritidis, Escherichia coli, and Staphylococcus aureus, albeit at varying levels. Among these 15 LAB, En. faecalis RGM25 and Lc. lactis RGM55, susceptible to five antibiotics tested, were put in contact with wooden vat prototypes, because all equipment used in traditional cheese production in Sicily are made of wood. Scanning electron microscopy and bacterial plate counts of the wooden vat prototypes showed the development of biofilms at levels of approximately 6.0 log CFU/cm. Overall, this study contributes to establishing a custom-made LAB starter cultures with bio-preservatives properties for Sicilian cheese productions.
Topics: Cheese; Animals; Biofilms; Goats; Milk; Wood; Food Microbiology; Sicily; Lactobacillales; RNA, Ribosomal, 16S; Anti-Bacterial Agents; Random Amplified Polymorphic DNA Technique; Listeria monocytogenes
PubMed: 38781647
DOI: 10.1016/j.ijfoodmicro.2024.110752 -
Microbiology Spectrum May 2024The lasso peptide microcin J25 (MccJ25) possesses strong antibacterial properties and is considered a potential effective component of bacterial disease treatment drugs...
UNLABELLED
The lasso peptide microcin J25 (MccJ25) possesses strong antibacterial properties and is considered a potential effective component of bacterial disease treatment drugs and safe food preservatives. Although MccJ25 can be heterologously expressed in as we have previously reported, its regulation and accumulation are yet to be understood. Here, we investigated the expression level and stability of MccJ25 in strains with disruption in peptidase genes , and . Oligoendopeptidase F (PepF) was found to be involved in reduction of the production of MccJ25 by degradation of its precursor peptide. In the mutant, the MccJ25 reached a concentration of 1.68 µM after a cultivation time exceeding 60 hours, while the wild-type strain exhibited a concentration of only 0.14 µM. Moreover, the production of MccJ25 in downregulated the genes associated with sporulation, and this may contribute to its accumulation. Finally, this study provides a strategy to improve the stability and production of MccJ25 in .
IMPORTANCE
MccJ25 displays significant antibacterial activity, a well-defined mode of action, exceptional safety, and remarkable stability. Hence, it presents itself as a compelling candidate for an optimal antibacterial or anti-endotoxin medication. The successful establishment of exogenous production of MccJ25 in provides a strategy for reducing its production cost and diversifying its utilization. In this study, we have provided evidence indicating that both peptidase PepF and sporulation are significant factors that limit the expression of MccJ25 in B. subtilis. The Δ and Δ mutants of express MccJ25 with higher production yield and enhanced stability. To sum up, this study developed several better engineered strains of , which greatly reduced the consumption of MccJ25 during the nutrient depletion stage of the host strain, improved its production, and elucidated factors that may be involved in reducing MccJ25 accumulation in .
PubMed: 38780256
DOI: 10.1128/spectrum.03748-23 -
Human Vaccines & Immunotherapeutics Dec 2024The surge in recommended vaccinations for child's has spurred the development of combination vaccines, notably hexavalent vaccines, which provide multiple immunizations... (Review)
Review
The surge in recommended vaccinations for child's has spurred the development of combination vaccines, notably hexavalent vaccines, which provide multiple immunizations in a single dose. These vaccines offer various advantages, such as streamlining vaccination schedules, minimizing injection-related pain and exposure to preservatives, expanding vaccine coverage, and reducing administration costs. However, the intricate and expensive development of these vaccines presents substantial challenges, requiring increased investment and healthcare provider education to optimize their utilization and sustain high vaccination rates. Turkey, known for its robust vaccine coverage, strategic geographic location, and the influx of refugees, is at a critical juncture for integrating hexavalent vaccines into national programs. This transition is especially relevant given the rising vaccine hesitancy and the potential resurgence of vaccine-preventable diseases. This review assesses the deployment of hexavalent vaccines, examining their benefits and challenges through clinical trials and global experiences, with a specific emphasis on Turkiye's public health context.
Topics: Humans; Immunization Programs; Immunization Schedule; Turkey; Vaccination; Vaccination Coverage; Vaccination Hesitancy; Vaccine-Preventable Diseases; Vaccines, Combined
PubMed: 38780074
DOI: 10.1080/21645515.2024.2345493 -
Journal of Cytology 2024kit (DiaPath S.p.A.) offers a major advantage compared to other commercially available kits available for the screening of cervical cancer, as it does not require...
CONTEXT
kit (DiaPath S.p.A.) offers a major advantage compared to other commercially available kits available for the screening of cervical cancer, as it does not require additional equipment for sample processing. Using this methodology, collected epithelial cells are immersed in a preservative liquid before setting as a thin layer on a slide via gravity sedimentation.
AIMS
To evaluate the suitability of the kit for the processing of cervical samples, detection of pre-neoplastic lesions, and nucleic preservation and extraction for HR-HPV diagnosis.
MATERIALS AND METHODS
A total of 242 self-sampled cervical specimens were utilized, with 192 collected in vials and 50 collected and processed using the for comparative analysis. The samples underwent processing, Papanicolaou staining, and microscopic evaluation for morphological parameters. The extracted nucleic acids were assessed for purity and integrity, and the detection of high-risk human papillomavirus (HR-HPV) was carried out using the Alinity HR HPV system kit (Abbott Laboratórios Lda).
RESULTS
Both methods demonstrated effective performance, enabling the morphological assessment of the cervical epithelium. Statistical analysis indicated that yielded significantly better results in terms of cellularity. Conversely, exhibited superior performance in terms of the quantity of extracted DNA and its degree of purification. Concerning the time consumed during processing, both methods were comparable, with the methodology standing out for its cost-effectiveness, as it does not necessitate additional instruments and consumables.
CONCLUSIONS
The novel methodology proves effective in preserving both nucleic acids and cell morphology characteristics, two crucial features for cervical cancer screening.
PubMed: 38779609
DOI: 10.4103/joc.joc_108_23 -
Biological & Pharmaceutical Bulletin 2024Patch tests are often used in safety evaluations to identify the substance causing skin irritation, but the same substance can sometimes give positive or negative...
Patch tests are often used in safety evaluations to identify the substance causing skin irritation, but the same substance can sometimes give positive or negative results depending on the test conditions. Here, we investigated differences in the skin penetration of two test compounds under different application conditions. We studied the effects of the anionic surfactant sodium dodecyl sulfate (SDS) and the nonionic surfactant polysorbate 80 (PS) on skin penetration of the preservatives methylisothiazolinone (MT) and methylchloroisothiazolinone (MCT), which are used in cosmetics such as shampoos. The skin permeation of MT was enhanced by SDS but was unchanged by PS. Skin impedance decreased in the presence of SDS whereas PS had the same effect as the control aqueous solution, suggesting that SDS reduction of the barrier function of skin affects the permeation of MT, a hydrophilic drug. Application of a mixture of MCT and MT in the presence of SDS did not affect the skin permeation of MCT whereas the permeation of MT was enhanced by SDS, indicating that the skin permeation of MCT is less affected by SDS than is MT. Thus, attention should be paid to the possible effect of co-solutes, especially hydrophilic drugs.
Topics: Thiazoles; Surface-Active Agents; Skin Absorption; Polysorbates; Sodium Dodecyl Sulfate; Skin; Animals; Preservatives, Pharmaceutical; Swine; Cosmetics; Electric Impedance; Permeability
PubMed: 38777759
DOI: 10.1248/bpb.b24-00127 -
Food Chemistry Sep 2024Food preservatives are crucial in fruit production, but fungal resistance is a challenge. The main objective was to compare the sensitivity of Neosartorya spp. isolates...
The role of food preservatives in shaping metabolic profile and chemical sensitivity of fungi - an extensive study on crucial mycological food contaminants from the genus Neosartorya (Aspergillus spp.).
Food preservatives are crucial in fruit production, but fungal resistance is a challenge. The main objective was to compare the sensitivity of Neosartorya spp. isolates to preservatives used in food security applications and to assess the role of metabolic properties in shaping Neosartorya spp. resistance. Sodium metabisulfite, potassium sorbate, sodium bisulfite and sorbic acid showed inhibitory effects, with sodium metabisulfite the most effective. Tested metabolic profiles included fungal growth intensity and utilization of amines and amides, amino acids, polymers, carbohydrates and carboxylic acids. Significant decreases in the utilization of all tested organic compound guilds were observed after fungal exposure to food preservatives compared to the control. Although the current investigation was limited in the number of predominately carbohydrate substrates and the breadth of metabolic responses, extensive sensitivity panels are logical step in establishing a course of action against spoilage agents in food production being important approach for innovative food chemistry.
Topics: Food Preservatives; Food Contamination; Neosartorya; Metabolome
PubMed: 38772305
DOI: 10.1016/j.foodchem.2024.139583 -
Frontiers in Nutrition 2024Essential oils have been recognized for their strong antibacterial property, making them an innovative approach for preserving meat. However, their chemical instability...
Essential oils have been recognized for their strong antibacterial property, making them an innovative approach for preserving meat. However, their chemical instability and direct impact on meat proteins limit their application. To overcome these limitations, various loading systems have been explored. This study aimed to compare the effect of cinnamon essential oil (CEO) loaded in a liposome and emulsion system on the proteolysis of minced pork and to evaluate the advantages of each delivery system in preventing microorganism-induced quality deterioration of meat. Minced pork treated with CEO-liposomes exhibited lower pH, total volatile basic nitrogen (TVB-N), and total viable count (TVC) values than CEO-emulsions and provided better protection against microorganisms. SDS-polyacrylamide gel electrophoresis (PAGE) analysis confirmed that CEO-liposome was more effective in protecting proteins from degradation. Moreover, CEO-liposome produced lower amount of bitter amino acids and harmful biogenic amines. Antibacterial mechanisms indicated that CEO-liposome exhibited a stronger inhibitory effect against major spoilage bacteria in meat products by increasing cell membrane permeability. The membrane damage was further supported by an increase in conductivity and the leakage of nucleic acids. Compared to the CEO-emulsion system, CEO-liposome emerged as an effective preservative for minced pork. These results provided important theoretical support for using a bioactive compound delivery system to prevent microorganism-induced quality deterioration in meat.
PubMed: 38765811
DOI: 10.3389/fnut.2024.1341827 -
International Journal of Burns and... 2024In this experimental study, we aimed to determine whether platelet-rich plasma (PRP) is a suitable preservative for dermo-epidermal grafts. An additional objective was...
OBJECTIVE
In this experimental study, we aimed to determine whether platelet-rich plasma (PRP) is a suitable preservative for dermo-epidermal grafts. An additional objective was to investigate how long grafts can be stored without biological degradation.
METHODS
We compared pig skin graft preservation using PRP versus saline solution and crystalloid Custodiol, which is used for hypothermic preservation of organs for transplantation. Grafts (10 × 10 mm) were placed on gauze impregnated with one of the tested solutions, and stored for 3, 7, 11, and 15 days at a constant temperature of 4°C. We evaluated a total of 240 pig skin samples: 120 by histopathology and 120 by fluorescence optical microscopy.
RESULTS
Overall, Custodiol solution appeared to be the best medium for preservation of dermo-epidermal grafts, with beneficial properties manifested on days 7 and 11. Although we expected PRP to be a better preservative than saline, this was not confirmed by our results, as we found no significant difference between these two media. In fact, by day 3, the histopathological results were better with standard saline solution than with PRP. On day 15, with each tested solution, some samples showed histological changes that are incompatible with graft viability.
CONCLUSION
Overall, Custodiol appears to be the best medium for dermo-epidermal graft preservation. Moreover, the present findings suggest a maximum graft storage time of 11 days in all of the tested solutions. We do not recommend using grafts stored for 15 days, due to isolated signs of graft biodegradation with all solutions.
PubMed: 38764893
DOI: 10.62347/MLIW4300