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Compatibility and stability of dexamethasone sodium phosphate and ketamine hydrochloride subcutaneous infusions in polypropylene syringes.

The stability of ketamine hydrochloride injection and dexamethasone sodium phosphate injection, when mixed and stored in polypropylene syringes, was studied. Formulations containing ketamine hydrochloride (50 mg or 600 mg) and dexamethasone sodium phosphate (1 mg) in 0.9% sodium chloride injection (to 14 ml) were prepared and stored at 4 degrees C, 23 degrees C, and 37 degrees C, under normal fluorescent light conditions, for 192 hours. The concentrations of the drugs were determined at 0, 2, 4, 8, 24, 48, 96, and 192 hours using a validated high-pressure liquid chromatography method. The pH, color, and visible particles of each solution were also assessed at each time point. All formulations tested maintained more than 98% of the initial concentrations of both drugs, and no degradation products were detected. The solutions remained clear and colorless and the pH varied within 0.05 units throughout 192 hours. The results indicate that, at the concentrations studied, combinations of ketamine hydrochloride and dexamethasone sodium phosphate in 0.9% sodium chloride injection were physically and chemically stable for at least 192 hours (8 days) when stored in polypropylene syringes.

Complex Mixtures↗

Shelf lives of aseptically prepared medicines--stability of hydrocortisone sodium succinate in PVC and non-PVC bags and in polypropylene syringes.

Parenteral aseptic preparations of hydrocortisone sodium succinate (HSS) are used frequently in hospitals, but little definitive stability information is available. The purpose of this study was to obtain ultimate shelf lives for typical formulations so that they may be prepared in bulk in appropriately licensed facilities. In the first study, the stability of HSS, 1mg/ml, was determined in polyvinyl chloride (PVC) bags and polyolefine (non-PVC) bags, in 0.9% (w/v) sodium chloride at 7 degrees C, 25 degrees C/60% relative humidity (RH) and room temperature in the light (RTL) with storage for up to 135 days. In the second study, the stability of HSS, 50 mg/ml was determined in polypropylene syringes at 5 degrees C and 25 degrees C/60%RH with storage for up to 120 days. Samples from each admixture were analysed by stability indicating high performance liquid chromatography (HPLC) and were monitored for pH, appearance of solution and container, and the rate of appearance of decomposition products. Shelf lives were calculated using the maximum rate method. HSS at a concentration of 1 mg/ml in PVC bags was stable for up to 41 days at 7 degrees C, 8 days at 25 degrees C and 7 days at RTL. It was stable in non-PVC bags for up to 48, 8 and 6 days, respectively. HSS in polypropylene syringes at a strength of 50 mg/ml was stable for up to 81 days at 5 degrees C and 6 days at 25 degrees C.

Asepsis↗

Stability of PO2, PCO2, and pH in fresh blood samples stored in a plastic syringe with low heparin in relation to various blood-gas and hematological parameters.

OBJECTIVE: To assess the stability of PO2, PCO2 and pH in fresh individual blood samples drawn in a plastic syringe with low heparin and stored at 22 degrees C or on ice in relation to various biochemical and hematological parameters of the samples. METHODS: PO2, PCO2, and pH were measured at determined times in samples kept at 22 degrees C or on ice. The magnitude of change in blood-gas parameters over time for each group of samples was determined. The change in PO2 was examined according to its initial value, the oxygen content (CaO2), the hemoglobin concentration, the leukocyte and platelet counts of each sample. RESULTS: The changes in PO2, PCO2, and pH over time were about three times lower in samples stored on ice than in the ones at 22 degrees C. Nevertheless, rapid increases in PO2 were observed for samples stored on ice with an initial PO2 between 50 and 250 mm Hg. Samples with PO2 over 250 mmHg exhibited a decrease in PO2 over time. No correlation was observed between the change in PO2 and the oxygen content, the hemoglobin concentration or the leukocyte and platelet counts for both groups of samples stored at 22 degrees C or on ice. CONCLUSION: PO2 in samples with an initial PO2 between 50 and 250 mm Hg stored on ice should be analyzed within 30 min. However, PCO2 and pH didn't exhibit clinically significant changes within 60 min under similar conditions. The magnitude of change in PO2 for samples kept on ice was dependent on their hemoglobin capacity for buffering oxygen, which is in converse relation with the oxygen saturation level of hemoglobin (SatHbO2). It is believed that the alteration in PO2 for samples stored on ice is produced predominantly by diffusion of oxygen through the plastic wall of the syringe, whereas it would be mainly of metabolic origin in samples at room temperature.

Blood Gas Analysis↗

[Characterization by thin layer chromatography of benzothiazole derivatives and beta-sitosterol leached by disposable syringes].

A thin-layer chromatographic study of 2-mercaptobenzothiazole, 2-(methylthio)benzothiazole, 2-(2-hydroxy-ethylthio)benzothiazole, 2-hydroxybenzothiazole, zinc 2-mercaptobenzothiazolate, mercaptobenzothiazole disulfide, and beta-sitosterol with three developing solvents and eleven spray reagents is reported. A simple method is described which highlights the leaching of 2-mercaptobenzothiazole and 2-(2-hydroxy-ethylthio)benzothiazole from the rubber plunger-seals of disposable syringes: contact of rubber with bidistilled water, extraction of this liquid with chloroform, chromatography on silica gel with the solvents previously studied and spraying with N-chloro-2,6-dichloro-p-benzoquinone monoimine. The method may also be used to discriminate those syringes sterilized with ethylene oxide, the only ones able to leach 2-(2-hydroxy-ethylthio)benzothiazole, from those sterilized by irradiation. Owing to the beta-sitosterol traces leached, it may also be used to investigate whether the plunger-seals are made of natural rubber. The toxic effects of the compounds leached are briefly reported.

Chemistry, Pharmaceutical↗

A miniature syringe pump for continuous administration of drugs and hormones: The Mill Hill infuser.

A miniature syringe pump has been developed for intravenous or subcutaneous infusion of the many drugs and hormones which produce better therapeutic responses when continuously delivered at a controlled rate than by repeated separate injections. The infuser uses disposable plastic syringes and is designed for precise tamper-proof delivery of 2 ml/24 h or 2 ml/8 h with quartz-crystal control, unaffected bt the dose-rate can be precisely determined by prescribing solutions of appropriate strength.

Hormones↗

Development of an instrument to assess expectations of and preference for an insulin injection pen compared with the vial and syringe.

BACKGROUND: Before using a product, patients form expectations regarding the extent of a product's desirable attributes. These expectations can be used to understand their preference and anticipate potential satisfaction with the product. OBJECTIVE: The aim of this study was to produce a valid and reliable data collection instrument (the Insulin Injection Preference questionnaire [IIP-q]) to measure expectations of and preference for the insulin injection pen compared with the vial and syringe. METHODS: This study was initiated at the University of Mississippi (University, Mississippi). The IIP-q was developed to determine the extent to which respondents' prepurchase expectations of a product's attributes relate to preference for an insulin injection pen compared with the vial and syringe. Instrument development began with item generation related to product attributes important to patients who inject insulin. Items originated from an extensive search of the peer-reviewed Internet-based literature, marketing reports, clinical studies, and existing instruments. Content validity also was assessed using expert panel and focus group review. The resultant instrument (the IIP-q) was mailed to 1200 patients known to have type 1 or type 2 diabetes mellitus who either did or did not use insulin. Subscales were identified through exploratory factor analysis. Reliability and validity were assessed using Cronbach alpha for subscale items. Product-moment correlations between subscale dimensions and 2 global measures of preference were used to test the relationship between attribute expectations and preference. RESULTS: Seventeen of the questionnaires were returned as undeliverable, leaving 1183 in the sample population. Questionnaires were received from 302 individuals, 55 of whom failed to complete > or = 85% of the items and thus were not included in the final analysis. Of the 247 respondents (135 women, 112 men; mean [SD] age, 52.4 [13.2] years (range, 18-83 years]), 99 (40.1%) were current insulin users and 143 (57.9%) were not using insulin. Exploratory factor analysis resulted in a 13-item solution (Cronbach alpha = 0.92), accounting for 73.6% of the total explained variance. Ease of use, activity interference, and social acceptability emerged as expectation subscales from exploratory factor analysis. Cronbach alpha for items comprising the subscales ranged from 0.82 to 0.92. The 3 subscales were significantly correlated with patient preference (ease of use, r = 0.520, P < 0.001; activity interference, r = 0.570, p < 0.001; social acceptability, r = 0.602, p < 0.001). CONCLUSIONS: The results of the present study provide support for the IIP-q as a reliable and valid instrument to assess patient expectations of product attributes and preference. This instrument can be modified for use in clinical trials to determine the role of patient expectations and preference in their judgments regarding satisfaction with insulin delivery devices.

Cross-Sectional Studies↗

[A new model electric syringe: sequential injector for anesthesia].

A new type of syringe injector has been studied. Its major characteristic was the ability to compute the time and drug doses required for induction of anaesthesia, as well as those doses required for its maintenance. The staggering of induction time (from 1 to 9 min) should help reduce the severity of anaphylactoid reactions and the cardiovascular effects of anaesthetic induction in critically ill patients. Because of its computerized system, all types of syringes (5 to 60 ml) could be used with this new electrical injector.

Adolescent↗

Efficacy of a self-aspirating syringe.

Several self-aspirating syringes have been introduced into dentistry during the last decade. The efficacy of such a self-aspirating system, the EVERS-syringe, has been tested in relation to varying liquid pressure and diameter of the needle. It was found that the EVERS system was able to secure aspiration, irrespective of pressure and needle diameter. The passive back-flow of liquid through the needle, however, did depend on pressure and needle diameter. 3 different brands of local analgetics were evaluated, and it was found that the degree of self-aspiration was identical, regardless of brand and thereby cartridge type.

Anesthesia, Dental↗

Clinical experience in oral surgery with 2 different automatic aspirating syringes.

The efficacy of 2 designs of automatic aspirating syringe was investigated in 440 patients receiving regional block anaesthesia in the mandible. The incidence of positive aspiration was significantly different between operators and between syringes. Positive aspiration was achieved in 18.9% of patients at some stage during administration of the local anaesthetic solution.

Anesthesia, Dental↗

Stability of sufentanil and levobupivacaine solutions and a mixture in a 0.9% sodium chloride infusion stored in polypropylene syringes.

We have evaluated the chemical and microbiological stability of sufentanil citrate, levobupivacaine hydrochloride and a mixture in a 0.9% sodium chloride infusion in order to provide background information on the storage of a sufentanil-levobupivacaine mixture in polypropylene (PP) syringes. Chemical assays were performed by HPLC on days 0, 1, 2, 3, 8, 14, 23, 28 and 30 after storage at 4, 21, and 36 degrees C. Microbiological stability was evaluated under aseptic conditions using a laminar air flow station, with a grade A environment and a B background. The samples taken for microbiological analysis were collected immediately after preparation of the solutions and then after 7, 14, 21 and 28 days storage. At 4 degrees C the sufentanil citrate solution was stable for 23 days. At 21 degrees C the sufentanil citrate solution maintained chemical stability for 3 days, but thereafter the concentration of sufentanil decreased 15% from day 3 to day 8. At 36 degrees C a similar decrease was noticed from day 1 to day 3. On the contrary, the levobupivacaine hydrochloride solution maintained chemical stability for 28 days at 4 and 21 degrees C and for 23 days at 36 degrees C. The sufentanil-levobupivacaine mixture maintained chemical stability for 28 days at 4, 21 and 36 degrees C. The sufentanil and levobupivacaine solutions and the mixture studied maintained microbiological stability for 28 days. According to the chemical and microbiological stability studies, the sufentanil-levobupivacaine mixture in PP syringes could be stored for 28 days at 4 and 21 degrees C.

Anesthetics, Intravenous↗

Evaluation of canal cleanliness and smear layer removal after the use of the Quantec-E irrigation system and syringe: a comparative scanning electron microscope study.

OBJECTIVE: The purpose of this study was to evaluate canal cleanliness and smear layer removal after use of the Quantec-E irrigation system and to compare the system with traditional irrigation. STUDY DESIGN: Forty anterior teeth were randomly assigned to 4 groups. Group A consisted of 15 teeth that were instrumented with .12, .10, .08, .06 and .04 tapered rotaries while simultaneously irrigated via the Quantec-E irrigation pump with 12 mL of 5.25% NaOCl, followed by 6 mL EDTA 17% in crown-down fashion, with a final flush with 4 mL 5.25% NaOCl. Group B consisted of 15 teeth that were instrumented with the same instrument sequence, and irrigated with the same volumes via traditional needle and syringe. Group C consisted of 5 teeth that were sectioned and examined under a scanning electron microscope (SEM) without any instrumentation and served as a negative control. Group D consisted of 5 teeth that were instrumented dry, without any irrigation, and served as a positive control. All teeth were sectioned buccolingually and examined with SEM at 700x magnification in the apical, middle, and coronal portions of the canals. Analysis of SEM images was performed by 5 independent examiners using a 4-point scoring system. RESULTS: Irrigation with the Quantec-E irrigation pump resulted in cleaner canal walls, less debris, and more complete removal of the smear layer within the coronal one third, when compared with syringe irrigation. However, no difference was observed in the middle and apical one thirds of the root canal. CONCLUSION: There was no significant difference between the 2 irrigation systems.

Dental Pulp Cavity↗

Large scale purification of human blood CD34+ cells from cryopreserved peripheral blood stem cells, using a nylon-fiber syringe system and immunomagnetic microspheres.

Isolation of large numbers of human peripheral blood CD34+ cells could lead to therapeutic applications, including purging of malignant cells from blood cell transplantations, purging of T cells from allogeneic bone marrow, and even blood cell transplantation. This procedure has limitations if there are not sufficient numbers of progenitor cells in the leukapheresis concentrates available for selection after detection of tumor cells in apheresis products. Use of frozen/thawed peripheral blood mononuclear cell (PBMC) samples would make feasible pooling of two or even more stem cell harvests collected at different time points and the total number of CD34+ progenitor cells available would increase. We established an efficient method for purification of CD34+ cells from cryopreserved apheresis products, using a nylon-fiber syringe system and immunomagnetic microspheres. We compared purity, recovery rate and clonogenicity of CD34+ cells purified from fresh (n = 22) and cryopreserved apheresis products (n = 14), using a nylon-fiber syringe system and immunomagnetic microspheres. The purity of CD34+ cells from cryopreserved products was less than that from fresh products (85.9 +/- 14.4% vs 94.6 +/- 10.0%), but the recovery rate of CD34+ cells and colony-forming cells was comparable between fresh and cryopreserved products. One patient underwent grafting with peripheral blood CD34+ cells selected after freezing, with good success. Therefore, these cells are capable of rapidly reconstituting hematopoiesis after high-dose chemotherapy. Bone Marrow Transplantation (2000) 26, 787-793.

Antigens, CD34↗

The 50-millilitre syringe as an inexpensive training aid in the application of cricoid pressure.

A recent study in our department demonstrated that depressing the plunger of a 50-mL syringe was reliably and linearly related to the force applied between 20 N and 50 N. Using a 50-mL syringe we constructed a simple device to help train anaesthetic assistants to apply cricoid pressure correctly. We then tested anaesthetists, operating department practitioners (non-physicians) and nurses in our hospital to see if they could correctly apply forces of 20 and 40 N. All subjects were then trained using this apparatus and once confident were retested immediately afterwards, and again 1 week and 1 month later. The results show a wide variation in the force applied with only 30% of subjects applying appropriate force at 20 N, and 40% at 40 N. Training leads to a significant improvement in performance (P < 0.005 at 20 N and P < 0.001 at 40 N) which is maintained for 1 week for both 20 N (P < 0.05) and 40 N (P < 0.05) but not for 1 month. Therefore training should be practised on a weekly basis. This is an inexpensive and simple device that we believe to be useful in helping anaesthetic assistants to apply effective cricoid pressure.

Anesthesiology↗

Compatibility and stability of fentanyl admixtures in polypropylene syringes.

OBJECTIVE: To determine the physicochemical stability of fentanyl in combination with midazolam and either hyoscine butylbromide or metoclopramide, and stored in 30 ml polypropylene syringes. METHODS: Solutions containing approximately 40 microg/ ml of fentanyl in combination with midazolam (approximately 600 microg/ml) and either metoclopramide (approximately 700 microg/l) or hyoscine (approximately 850 microg/ml) were prepared from commercial ampoules of the drugs. The solutions were stored, in triplicate, in the dark at 32 degrees C (to simulate usage conditions) for 10 days, and the concentration of each constituent drug was periodically determined using a stability-indicating high-performance liquid chromatography assay. RESULTS: The combinations were relatively stable, with all drugs maintaining over 90% of their initial chemical potency for at least 1 week. There were no evident changes in either the physical appearance or pH values of the solutions over the course of the study. CONCLUSIONS: On the basis of physicochemical stability, polypropylene syringes containing fentanyl with midazolam and either hyoscine butylbromide or metoclopramide can be safely prepared and stored at or below 32 degrees C for periods of up to 1 week prior to use by palliative care patients receiving the drugs via a portable subcutaneous infusion device.

Adjuvants, Anesthesia↗

Initial worker evaluation of a new safety syringe.

A prospective evaluation of a new safety syringe requiring a one-step activation was carried out at the University of California, San Diego Medical Center. Only 59.5% of 390 syringes were activated, and user acceptance and satisfaction were unfavorable. The development of safety devices should incorporate passive activation and take end-user satisfaction into consideration.

California↗

Effect of syringe-assisted liposuction on activation of cascade systems and circulating cells when using the superwet or tumescent technique.

Although liposuction is considered to be a relatively safe procedure, several deaths and nonfatal serious complications such as sepsis, toxic shock syndrome, thromboembolic disease, fat emboli, and adult respiratory distress syndrome have been reported. In the present study, we have investigated a wide variety of components belonging to the coagulation, fibrinolytic, plasma kallikrein-kinin, and complement systems in 22 patients undergoing syringe-assisted liposuction using the superwet or tumescent technique. In spite of a relatively high mean aspirate volume (2,648 ml), only small changes over time well within the normal range were found for the different parameters. In nine randomly selected patients, we also measured interleukin 6 and tumor necrosis factor-alpha. The size of the interleukin-6 peaks was found to be of the same order of magnitude as those measured in patients undergoing hernia repair or percutaneous cholecystectomy but lower than those in patients undergoing open cholecystectomy, breast reduction, or breast reconstruction. Tumor necrosis factor-alpha was not detected in any sample in any of the patients. We conclude that syringe-assisted liposuction with the present aspirate volumes using the superwet or tumescent technique represents a small to moderate surgical trauma without clinical significant activation of the cascade systems.

Adipose Tissue↗

Reductions in finger doses for radiopharmaceutical dispensing afforded by a syringe shield and an automatic dose dispenser.

A gamma extremity monitoring system (GEMS) has been used to measure finger doses during radio-nuclide dispensing procedures. GEMS uses a small semi-conductor probe that can be attached to a finger from which a continuous read-out can be obtained that is related to dose rate. The pattern of dose accumulation can be analysed to allow doses received from individual operations within a procedure to be evaluated. GEMS has been used to compare the radiation dose reduction afforded by a syringe shield and an automatic dose dispenser. Dispensing procedures were simulated using 10% of the activity normally administered in order to avoid problems with detector saturation. Results show that the syringe shield and the automatic dose dispenser reduced finger doses by more than a factor of 10 for the procedures tested. The disadvantages of the automatic dispenser tested were a failure to transfer activity in 10% of cases and a longer time taken for the dispensing process. GEMS has the potential to facilitate greater optimization of finger doses through analysis of finger dose patterns.

Dispensatories as Topic↗