Characterization of cinnamon essential oil and its application in Malva sylvestris seed mucilage edible coating to the enhancement of the microbiological, physicochemical and sensory properties of lamb meat during storage.

AIMS: Firstly, Cinnamomum zeylani essential oil (CZEO) was isolated and characterized. Secondly, CZEO was used in Malva sylvestris mucilage (MSM) coating and its antioxidant and antimicrobial effects on lamb meat slices were evaluated in 10 days at 4°C. METHODS AND RESULTS: The main chemical compounds and functional groups of the CZEO were identified and quantified by a gas chromatograph coupled to a mass spectrometer and by an Fourier transform infrared spectrometer respectively. The total phenol and flavonoid contents of CZEO were determined by the Folin-Ciocalteu reagent-based and aluminium chloride methods respectively. Various microbiological, physicochemical analyses and sensory evaluations were also utilized regarding the coated lamb meat slices. CZEO contains benzyl benzoate (40.93%), caryophyllene oxide (26.07%) and (E)-cinnamaldehyde (13.01%), with strong radical scavenging activity and antibacterial effect against investigated pathogenic microorganisms. The CZEO-loaded MSM edible coating greatly postponed the growth of microorganisms and extended the product life (>10 days). The pH value, moisture content and hardness of the samples were also preserved more efficiently when high concentrations of the essential oil were incorporated into the edible coating (p < 0.05). The CZEO-rich MSM coating was also able to possess considerable activity against lipid oxidation in lamb meat samples, and significantly decreased the production of primary and secondary oxidation products (p < 0.05). Moreover, sensory parameters of the samples were preserved more efficiently during cold storage when the CZEO-enriched edible coating, particularly MSM + 2% CZEO was used. CONCLUSIONS: The use of edible coating based on MSM and CZEO is therefore effective in reducing microbial growth and chemical reactions in lamb meat during the storage period. SIGNIFICANCE AND IMPACT OF THE STUDY: The importance of the results of this study is in order to increase the use of natural preservatives, maintain food safety and of course the health of the people in the community.

Biscuits Prepared with Enzymatically-Processed Soybean Meal Are Rich in Isoflavone Aglycones, Sensorially Well-Accepted and Stable during Storage for Six Months.

Soybean meal (SBM) is a co-product of the soybean oil industry that is rich in bioactive compounds, such as isoflavones. We aimed to study the effects of processing SBM by fermentation (Saccharomyces cerevisiae) (FSBM) and enzymatic hydrolysis (CelluMax C, a commercial cellulase) (ESBM) on its chemical composition, with emphasis on isoflavones. Fermentation increased protein content by 9%, ash content by 7%, dietary fiber by 11% and minerals by up to 38%, except for iron, which decreased by 26%. Fermentation completely removed oligosaccharides from SBM, while enzymatic processing decreased oligosaccharides by 45% in SBM. Both processes converted glycosylated isoflavones into the corresponding aglycones, the content of which increased by up to 7.7-fold. Biscuits containing SBM, FSBM and ESBM could be labeled as dietary sources of dietary fibers, potassium, phosphorous, calcium and zinc, as well as high in proteins, copper, iron, manganese and magnesium. While FSBM biscuits had lower sensory scores compared to SBM biscuits, ESBM biscuits had equivalent scores. During storage for 180 days at room temperature, the isoflavone profile of all biscuits remained stable. Moreover, storage did not impair microbiological and sensory qualities of any biscuits. Altogether, ESBM biscuits show great marketing potential.

Effect of the Addition of Lemongrass (Cymbopogon citratus) on the Quality and Microbiological Stability of Craft Wheat Beers.

Lemongrass (Cymbopogon citratus) is a valuable source of vitamins, macro- and microelements, and essential oils. The purpose of this study was to compare the physicochemical properties, sensory properties, antioxidant activity, and microbiological stability of wheat beers enriched with varying additions of crushed lemongrass. Sensory evaluation showed that wheat beers enriched with 2.5% m/v lemongrass were characterised by balanced taste and aroma (overall impression). Physicochemical analysis of the wheat beers showed that increasing the concentration of lemongrass in the finished product negatively affected the ethanol content. Alcohol content in wheat beer enriched with 1% m/v lemongrass was on average 14.74% higher than wheat beer enriched with 2.5% m/v lemongrass and on average 17.93% higher than wheat beer enriched with 5% m/v addition of lemongrass. The concentration of lemongrass in the finished product also increased the acidity of the beers and affected the colour of the wheat beers compared to the control beer. The total polyphenol content and antioxidant activity of lemongrass-enriched wheat beers varied. Of the lemongrass-enriched beers analysed, the beer product with 5% m/v lemongrass was the most microbiologically stable. According to the study, crushed lemongrass-enriched wheat beer may represent a new trend in the brewing industry, but the brewing process still needs to be improved.

Effect of Ozonation on the Mechanical, Chemical, and Microbiological Properties of Organically Grown Red Currant (Ribes rubrum L.) Fruit.

Red currant fruits are a valuable source of micro- and macronutrients, vitamins, and chemical compounds with health-promoting properties, the properties of which change depending on the harvest date and the time and method of storage. This study analysed the effect of applying 10 ppm ozone gas for 15 and 30 min on the mechanical properties, chemical properties and microbiological stability of three organic-grown red currant fruit cultivars. Fruits harvested at the time of harvest maturity had significantly larger diameters and weights and lower water contents compared with fruits harvested seven days earlier, and the ozonation process, regardless of its harvesting date, reduced the physical parameters in question (diameter, weight, and water content). The ascorbic acid content of the ozonated fruit varied, with the highest decreases observed for fruit harvested 7 days before the optimal harvest date and stored for 15 days under refrigeration (an average decrease of 13.31% compared with the control fruit without ozonation). In general, the ozonation process had a positive effect on the variation of fruit antioxidant activity, with the highest average values obtained for fruit harvested 7 days before the optimum harvest date and stored for 15 days under refrigeration conditions; in addition, it also had an effect on reducing the development of microorganisms, including mesophilic aerobic bacteria, yeasts, and moulds, mainly for the cultivar 'Losan'.

Effects of Ozone Application on Microbiological Stability and Content of Sugars and Bioactive Compounds in the Fruit of the Saskatoon Berry (Amelanchier alnifolia Nutt.).

Saskatoon berry fruits are a valuable source of micro- and macronutrients, sugars, and compounds with health-promoting properties, the properties of which change during storage. This study presents the effects of applied gaseous ozone at 10 ppm for 15 and 30 min on microbiological stability, sugar content, and bioactive compounds for three cultivars and three clones of Saskatoon berry fruit. The ozonation process had a positive effect on reducing the microbial load of the fruit, which was observed on day 7 of storage for the two variants of ozonation time of 15 and 30 min compared to the control and also on the sugar profile of the "Thiessen" fruit, as well as clones no 5/6 and type H compared to the control sample, which was non-ozonated fruit. In the Saskatoon berry fruits analyzed, 21 polyphenolic compounds were identified, of which four belonged to the anthocyanin group whose main representative was the 3-O-glucoside cyanidin. The ascorbic acid content and antioxidant activity (determined by DPPH· and ABTS+· methods) varied according to the cultivar and clone of the Saskatoon berry fruits analyzed and the ozone exposure time.

Formulation and Administration of Biological Medicinal Products".

Monoclonal antibody (Mabs) containing medicinal products are widely used in clinical practice. Prior to parenteral administration, licensed Mab containing medicinal products are transferred to the ready-to-administer (RTA) forms. Reconstitution and/or preparation should follow the guidelines for Good Reconstitution/Good Preparation Practice. Preparation in the pharmacy must take place within the framework of a suitable quality management system. The responsible pharmacist must apply a risk assessment on the process to ensure the appropriate quality of the RTA preparation, especially because the extent of quality testing is limited by batch size (often one single unit) and time restraints. In these cases, appropriate quality is to be assured by means of qualification activities, environmental monitoring, process validation with growth medium and in-process controls. Correct labelling of the Mab containing RTA preparations includes a suitable storage advice and a defined shelf life. Physicochemical stability of a given Mab preparation can be assessed based on a specific stability study (supplied by the manufacturer in the SmPC or scientific journals, study published by an expert in a peer-reviewed scientific journal). Physicochemical stability studies require the use of various orthogonal physicochemical methods to detect accurately the degradation changes that may result from the deamidation, oxidation, disulfide formation, aggregation or fragmentation during storage. Complementary, biological activity can be measured. Compatibility studies of Mabs and devices used for preparation and administration are still scarce. Microbiological stability of Mab preparations is related to the complexity of the preparation process, the growth supporting nature of the preparation and the integrity of the container or container/closure combination. In use viability tests revealed that the potential of Mab preparations to support microbial growth was similar to that of the pure vehicle solutions used as control solutions. The enumerated microbial counts varied according to the species utilized and the type of Mab preparation. If sterility testing of the individual preparation is impossible, maximum permitted shelf life can be assessed empirically with regard to the maximum shelf lives defined in the USP <797> monograph. Finally, microbiological and physicochemical stability are to be considered concurrently when determining the shelf life of an individual Mab preparation. In each case, shelf life should be limited according to the shorter period of proven stability, either derived from the microbiological or physicochemical stability data.

Development and Stability Control of Pediatric Oral Tizanidine Hydrochloride Formulations for Hospital Use.

Tizanidine hydrochloride is a centrally acting skeletal muscle relaxant used in the treatment of spasticity. This drug is sold only as tablets or capsules, which highlights the need to develop oral liquid formulations that allow administration to children and adults with impaired swallowing. This study aim was to develop and improve tizanidine hydrochloride liquid formulations from raw material and to evaluate their stability. A stability-indicating high performance liquid chromatography method was validated for two formulations developed. Fifteen formulations were developed containing syrup and fifteen containing sodium carboxymethyl cellulose as vehicles, to select the two most suitable for stability testing. The formulations were prepared in triplicate and placed in amber polyethylene terephthalate and glass bottles, which were stored under three different conditions: at room temperature (15-30°C), under refrigeration (2-8°C), and at 40°C. The physicochemical and microbiological stability of formulations were evaluated, applying high performance liquid chromatography and microbiological count. The studied formulations at 15-30°C, 2-8°C, and 40°C can be used for a period of 70 days, and all parameters are inside of recommended specifications, enough to allow its use in the context for which it was developed, the application in hospital. The formulations developed in this work have simple components to avoid adverse reactions in vulnerable populations. Results of this study could be applied as a reference for hospital use; once it demonstrated the reliability of storage time interval and proper conditions for use.

Development of a novel physico-chemically and microbiologically stable oral solution of flecainide for pediatrics.

There is as yet no commercialized preparation for oral administration of flecainide acetate (FA) to children. In such cases, manipulation of commercial tablets is the usual practice in pharmacy services of hospitals and compounding pharmacies, to provide a suitable dosage form for this vulnerable pediatric population group. In this study, we have formulated FA as an oral solution, as an alternative to the suspension elaborated from commercial tablets. Due to this sensitivity of young patients, we have used the pure active pharmaceutical ingredient (API) and the lowest permitted levels of pediatric excipients. Despite being a highly soluble API, only one of the formulations appears as a transparent solution due to complete FA solubilization. The proposed formulation is physico-chemically and microbiologically stable and the mass and dose uniformity is appropriate for 30 days' storage at 25 °C.

Microbiological stability and quality of pulsed light treated cantaloupe (Cucumis melo L. reticulatus cv. Glamour) based on cut type and light fluence.

The aim of this study was to investigate the effect of cut type and pulsed light (PL) fluence on microbiological stability and quality of fresh-cut cantaloupes. Fresh-cut cantaloupes with various cut types (cuboid, triangular prism and sphere) were treated with PL technology at 6 J/cm(2). Samples were exposed to PL treatment at fluences of 2.7, 7.8, 11.7 and 15.6 J/cm(2) followed by storage at 4 ± 1 °C for 28 days. Microbiological quality, headspace composition, firmness, colour, pH, titratable acidity, total soluble solids, total phenolic content and ascorbic acid content of fresh-cut cantaloupes were determined. Spherical shape was found to be the most suitable shape for PL treatment of fresh-cut cantaloupes due to its significantly lowest (p ≤ 0.05) microbial counts before and after the PL treatment. No significant (p > 0.05) effect was observed for firmness, colour, total soluble solids and total phenolic content of fresh-cut cantaloupes throughout the storage study. Pulsed light treatment using 7.8 J/cm(2) was the best for extending shelf life of fresh-cut cantaloupes with extension of 8 days longer at 4 ± 1 °C compared to the control while maintaining the ascorbic acid content. In conclusion, PL treatment is a potential technique for extending the shelf life of fresh-cut cantaloupes by inactivating microorganisms without compromising the nutritional value.

Study of the inactivation of spoilage microorganisms in apple juice by pulsed light and ultrasound.

The aim of this study was to evaluate the effect of ultrasound (US) (600 W, 20 kHz and 95.2 µm wave amplitude; 10 or 30 min at 20, 30 or 44 ± 1 °C) and pulsed light (PL) (Xenon lamp; 3 pulses/s; 0.1 m distance; 2.4 J/cm(2)-71.6 J/cm(2); initial temperature 2, 30, 44 ± 1 °C) on the inactivation of Alicyclobacillus acidoterrestris ATCC 49025 spores and Saccharomyces cerevisiae KE162 inoculated in commercial (pH: 3.5; 12.5 °Brix) and natural squeezed (pH: 3.4; 11.8 °Brix) apple juices. Inactivation depended on treatment time, temperature, microorganism and matrix. Combination of these technologies led up to 3.0 log cycles of spore reduction in commercial apple juice and 2.0 log cycles in natural juice; while for S. cerevisiae, 6.4 and 5.8 log cycles of reduction were achieved in commercial and natural apple juices, respectively. In natural apple juice, the combination of US + 60 s PL at the highest temperature build-up (56 ± 1 °C) was the most effective treatment for both strains. In commercial apple juice, US did not contribute to further inactivation of spores, but significantly reduced yeast population. Certain combinations of US + PL kept on good microbial stability under refrigerated conditions for 15 days.

Prolonging the stability of cetuximab (Erbitux®) and panitumumab (Vectibix®): An orthogonal assessment of physicochemical, biological and microbiological properties of original opened glass vials and diluted saline preparations.

The two anti-epidermal growth factor receptor monoclonal antibodies (mAbs) cetuximab and panitumumab are the pillars for the treatment of EGFR-positive, KRAS wild-type metastatic colorectal cancers. However, stability data of these mAbs are generally missing or incomplete. Here, we report for the first time an orthogonal analysis of the stability of cetuximab (Erbitux®) and panitumumab (Vectibix®), either undiluted vial leftovers or saline dilutions in polyolefin/polyamide infusion bags. All samples were stored at 2-8 °C protected from light, according to their summary of product characteristics (SmPCs). Alternatively, opened vials and preparations were maintained at 25 °C for 15 h, and then stored again at 2-8 °C protected from light to mimic a temporary interruption of the cold chain. Vial leftovers proved stable up to 180 days when stored according to their SmPCs, while compounded preparations in infusion bags maintained their physiochemical, biological and microbiological stability up to 30 days. Additionally, no changes were detected up to 30 days for the same samples undergoing a thermal excursion. Our results provide additional rationale to the SmPCs, crucial especially in the case of reassignment and pre-preparation of bags. This information will allow hospitals to achieve significant cost savings, and better organization of the entire therapeutic process.

The unique chemical and microbiological signatures of an array of bottled drinking water.

The bottled drinking water market has seen significant growth and diversification, yet the selection criteria lack scientific basis, as all must adhere to stringent health standards. Prior studies predominantly focused on chemical quality, with limited assessments of microbial quality using methods prone to underestimation. Moreover, insufficient research explores the impact of packaging materials and temperatures optimal for mesophilic growth on microbial quality. To understand the unique characteristics and justify the distinction among different types of bottled waters, a comprehensive analysis encompassing both chemical and microbiological aspects is imperative. Addressing these gaps, our study examines 19 diverse bottled water brands comprising purified, mineral, artesian, and sparkling water types from Saudi Arabia and abroad. Our findings reveal distinct chemical compositions among bottled waters, with notable variations across types. Flow cytometry analysis reveals significant differences in bacterial content among water types, with natural mineral waters having the highest concentrations and treated purified waters the lowest. Bacterial content in plastic-bottled mineral water suggests it may be higher than in glass-bottled water. Flow cytometry fingerprints highlight separate microbial communities for purified and mineral waters. Additionally, temperatures favorable for mesophilic growth reveal varying microbial responses among different types of bottled waters. Some variation is also observed in mineral water bottled in plastic versus glass, suggesting potential differences that warrant further investigation. 16S rRNA gene sequencing identifies unique microbial taxa among different mineral waters. Overall, our study underscores that all bottled waters meet health regulations. Furthermore, the combined chemical and microbial profiles may serve as authenticity indicators for distinct bottled water types. This study can serve as a basis for future research on the environmental impact of bottled water transportation, suggesting that locally produced water may offer a more sustainable option.

Alicyclobacillus spp. in fruit-based products: Isolation, identification, quantitative assessment (SPME/GC-MS) of spoilage compounds and spore's resistance to thermal shocks.

Alicyclobacillus spp. is the cause of great concern for the food industry due to their spores' resistance (thermal and chemical) and the spoilage potential of some species. Despite this, not all Alicyclobacillus strains can spoil fruit juices. Thus, this study aimed to identify Alicyclobacillus spp. strains isolated from fruit-based products produced in Argentina, Brazil, and Italy by DNA sequencing. All Alicyclobacillus isolates were tested for guaiacol production by the peroxidase method. Positive strains for guaiacol production were individually inoculated at concentration of 103 CFU/mL in 10 mL of orange (pH 3.90) and apple (pH 3.50) juices adjusted to 11°Brix, following incubation at 45 °C for at least 5 days to induce the production of the following spoilage compounds: Guaiacol, 2,6-dichlorophenol (2,6-DCP) and 2,6-dibromophenol (2,6-DBP). The techniques of micro-solid phase extraction by headspace (HS-SPME) and gas-chromatography with mass spectrometry (GC-MS) were used to identify and quantify the spoilage compounds. All GC-MS data was analyzed by principal component analysis (PCA). The effects of different thermal shock conditions on the recovery of Alicyclobacillus spores inoculated in orange and apple juice (11°Brix) were also tested. A total of 484 strains were isolated from 48 brands, and the species A. acidocaldarius and A. acidoterrestris were the most found among all samples analyzed. In some samples from Argentina, the species A. vulcanalis and A. mali were also identified. The incidence of these two main species of Alicyclobacillus in this study was mainly in products from pear (n = 108; 22.3 %), peach (n = 99; 20.5 %), apple (n = 86; 17.8 %), and tomato (n = 63; 13 %). The results indicated that from the total isolates from Argentina (n = 414), Brazil (n = 54) and Italy (n = 16) were able to produce guaiacol: 107 (25.8 %), 33 (61.1 %) and 13 (81.2 %) isolates from each country, respectively. The PCA score plot indicated that the Argentina and Brazil isolates correlate with higher production of guaiacol and 2,6-DCP/2,6-DBP, respectively. Heatmaps of cell survival after heat shock demonstrated that strains with different levels of guaiacol production present different resistances according to spoilage ability. None of the Alicyclobacillus isolates survived heat shocks at 120 °C for 3 min. This work provides insights into the incidence, spoilage potential, and thermal shock resistance of Alicyclobacillus strains isolated from fruit-based products.

High-Pressure Processing Effects on Microbiological Stability, Physicochemical Properties, and Volatile Profile of a Fruit Salad.

Nowadays, consumers are more aware of the effects of their diet on their health, and thus demand natural or minimally processed food products. Therefore, research has focused on processes that assure safe products without jeopardizing their nutritional properties. In this context, this work aimed to evaluate the effects of high-pressure processing (550 MPa/3 min/15 °C, HPP) on a fruit salad (composed of melon juice and pieces of Golden apple and Rocha pear) throughout 35 days of storage at 4 °C. For the physicochemical properties analysed (browning degree, polyphenol oxidase activity, antioxidant activity (ABTS assay), and volatile profile), a freshly made fruit salad was used, while for the microbiological tests (total aerobic mesophiles, and yeast and moulds) spoiled melon juice was added to the fruit salad to increase the microbial load and mimic a challenge test with a high initial microbial load. It was determined that processed samples were more microbiologically stable than raw samples, as HPP enabled a reduction of almost 4-log units of both total aerobic mesophiles and yeasts and moulds, as well as an almost 1.5-fold increase in titratable acidity of the unprocessed samples compared to HPP samples. Regarding browning degree, a significant increase (p < 0.05) was observed in processed versus unprocessed samples (roughly/maximum 68%), while the addition of ascorbic acid decreased the browning of the samples by 29%. For antioxidant activity, there were no significant differences between raw and processed samples during the 35 days of storage. An increase in the activity of polyphenol oxidase immediately after processing (about 150%) was confirmed, which was generally similar or higher during storage compared with the raw samples. Regarding the volatile profile of the product, it was seen that the compounds associated with melon represented the biggest relative percentage and processed samples revealed a decrease in the relative quantity of these compounds compared to unprocessed. Broadly speaking, HPP was shown to be efficient in maintaining the stability and overall quality of the product while assuring microbial safety (by inactivating purposely inoculated microorganisms), which allows for longer shelf life (7 versus 28 days for unprocessed and processed fruit salad, respectively).

Stability of Opened Durvalumab (IMFINZI) Vials. The Beginning of the End of Costly Product Wastage?

Durvalumab is a monoclonal antibody approved for the treatment of lung, urothelial and biliary tract cancers. Durvalumab is supplied in vials as a solution containing no preservatives. Monographs recommend single use of durvalumab vials, and that any leftovers be discarded within 24 h. Thus, significant portions of unused product from opened vials are wasted on a daily basis, generating considerable financial losses. The objective of the present study was to assess the physicochemical and microbiological stability of durvalumab vials kept at 4 °C or room temperature, at 7 and 14 days after opening. Following pH and osmolality measurements, turbidity and submicronic aggregation of durvalumab solution were evaluated by spectrophotometry and dynamic light scattering, respectively. Moreover, steric exclusion high performance liquid chromatography (SE-HPLC), ion exchange HPLC (IEX-HPLC) and peptide mapping HPLC were used to respectively assess aggregation/fragmentation, charge distribution and primary structure of durvalumab. Microbiological stability of durvalumab was evaluated by incubation of vial leftovers on blood agar. All experiments showed physicochemical and microbiological stability of durvalumab vial leftovers for at least 14 days when aseptically handled and kept at either 4 °C or at room temperature. These results suggest the possible extension of utilization of durvalumab vial leftovers well beyond 24 h.

Multivariate Analysis of the Influence of Microfiltration and Pasteurisation on the Quality of Beer during Its Shelf Life.

Gas chromatography-mass spectrometry (GC-MS), physicochemical and microbiological analyses, sensory descriptive evaluation, and multivariate analyses were applied to evaluate the efficiencies of microfiltration and pasteurization processes during the shelf life of beer. Samples of microfiltered and pasteurised beer were divided into fresh and aged groups. A forced ageing process, which consisted of storing fresh samples at 55° C for 6 days in an incubator and then keeping them under ambient conditions prior to analysis, was applied. Physicochemical analysis showed that both microfiltered and pasteurised samples had a slight variation in apparent extract, pH, and bitterness. The samples that underwent heat treatment had lower colour values compared with those that were microfiltered. Chromatographic peak areas of vicinal diketones increased in both fresh and aged samples. The results of the microbiological analysis revealed spoilage lactic acid bacteria (Lactobacillus) and yeasts (Saccharomyces and non-Saccharomyces) in fresh microfiltered samples. In the GC-MS analysis, furfural, considered by many authors as a heat indicator, was detected only in samples that underwent forced ageing and not in samples that were subjected to thermal pasteurisation. Finally, sensory analysis found differences in the organoleptic properties of fresh microfiltered samples compared with the rest of the samples.

Properties of Sound Absorption Composite Materials Developed Using Flax Fiber, Sphagnum Moss, Vermiculite, and Sapropel.

To address the need to reduce consumption and pollution in the industrial sector, composite materials were created using a new type of raw materials-organic lake sediments (sapropel) as a binder; sphagnum moss, flax fiber, and vermiculite as a filler. The main application of these composite materials is for sound absorption and moisture buffering, but since they contain bio-based binders and fillers, they also work as carbon storage. Within the framework of this work, a total of 100 samples of composite materials were created. Fungicides-a biocide quaternary ammonium compound and its natural substitute montmorillonite mineral material were also added to the materials to improve microbiological stability. The mechanical sound absorption and microbiological properties of materials were investigated and compared to similar environmentally friendly materials, such as hemp-lime concrete (FHL), hemp magnesium oxychloride composite (MOC), and hemp magnesium phosphate cement (MPC). The results showed that sound absorption and mechanical and microbial properties of the created composite materials are sufficient for their intended use, with flax fiber and vermiculite composites showing more stable mechanical, sound absorbing, and microbiological stability properties than materials containing flax fiber and moss.

Stability study of extemporaneously compounded nitrofurantoin oral suspensions for pediatric patients.

AIM: To evaluate the stability of nitrofurantoin suspended in different extemporaneously compounded vehicles after storage at 4°C and at 25°C. To formulate an effective, readily available vehicle that can guarantee extended stability and precise dosing.

Influence of Emulsifying Salts on the Growth of Bacillus thuringiensis CFBP 3476 and Clostridium perfringens ATCC 13124 in Processed Cheese.

Processed cheese is a dairy product with multiple end-use applications, where emulsifying salts play a fundamental role in physicochemical changes during production. Moreover, some of these salts may be a strategy to control spoilage and pathogenic microorganisms, contributing to safety and shelf life extension. This study aimed to evaluate the in vitro inhibitory activity of two emulsifying salts (ESSP = short polyP and BSLP = long polyP) against Bacillus thuringiensis CFBP 3476 and Clostridium perfringens ATCC 13124, and to compare the in situ effects of two emulsifying salts treatments (T1 = 1.5% ESSP and T2 = 1.0% ESSP + 0.5% BSLP) in processed cheeses obtained by two different methods (laboratory- and pilot-scales), during 45-day storage at 6 °C. C. perfringens ATCC 13124 growth was not affected in vitro or in situ (p > 0.05), but both of the treatments reduced B. thuringiensis CFBP 4376 counts in the tested condition. Counts of the treatments with B. thuringiensis CFBP 3476 presented a higher and faster reduction in cheeses produced by the laboratory-scale method (1.6 log cfu/g) when compared to the pilot-scale method (1.8 log cfu/g) (p < 0.05). For the first time, the inhibitory effect of emulsifying salts in processed cheeses obtained by two different methods was confirmed, and changes promoted by laboratory-scale equipment influenced important interactions between the processed cheese matrix and emulsifying salts, resulting in B. thuringiensis CFBP 4376 growth reduction.

Physicochemical and microbiological stability of insulin eye drops in an artificial tear vehicle used in the treatment of refractory neurotrophic keratopathy.

Neurotrophic keratopathy (NK) is a degenerative corneal disease with a loss of corneal sensitivity and impairment of corneal healing. Low dose insulin eyedrops have been shown to be a simple and effective treatment for refractory NK when the response to the usual treatment is incomplete. At present, there are no commercially available forms, and there is no data regarding the stability of these products as prepared by compounding pharmacies. In this work, we studied the physicochemical and microbiological stability of an insulin ophthalmic formulation obtained by mixing insulin lispro in artificial tears with a polyethylene and propylene glycol base. The stability of this 1IU/mL insulin ophthalmic formulation was analysed for 12 months in low-density polyethylene (LDPE) multidose eye droppers at 4°C. The studied parameters of physicochemical stability were: visual inspection, turbidity, UV spectral absorption, osmolality and pH. In addition, insulin and m-cresol concentrations and quantification of impurities (insulin covalent aggregates and insulin fragments) were studied thanks to the development of a new Size Exclusion Chromatographic method. For unopened eye droppers, all tested physicochemical parameters remained stable for 12 months at 4°C, and excellent microbiological stability was obtained. In conditions of simulated use, these parameters also remained stable for one month at 4°C, and no impact of potential temperature rises on the insulin and m-cresol concentrations in the insulin eyedropper was observed.