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At least 199 records · Page 11Linked to original sources
PubMed2004

Stability and compatibility of tegaserod from crushed tablets mixed in beverages and foods.

PURPOSE: The stability and compatibility of tegaserod from crushed tablets in selected beverages and foods were studied. METHODS: Suspensions of tegaserod maleate tablets containing 6 mg of the drug base were prepared by crushing the tablets and mixing the powder with tap water, apple juice, orange juice, milk, applesauce, yogurt, and chocolate-hazelnut spread. Drug stability, drug comparability, suspension homogeneity, and completeness of a dose were measured by high-performance liquid chromatography at intervals up to three days at 20-25 degrees C and 5 degrees C. In vitro dissolution profiles were determined for crushed tegaserod tablets in water, apple juice, orange juice, and applesauce. RESULTS: Tegaserod from crushed tablets was stable in and compatible with water, apple juice, orange juice, and applesauce, and the suspensions were homogeneous. The complete dose was delivered with these media. The dissolution profiles of crushed tegaserod tablets in water and in apple juice were comparable to those of intact tablets; the dissolution profiles in orange juice and applesauce were not comparable with those of intact tablets. The results with milk, yogurt, and chocolate-hazelnut spread as vehicles were inconclusive. The suspension in milk was not homogeneous, and the dose was incomplete. CONCLUSION: Tegaserod from crushed tablets was stable in and compatible with water, apple juice, orange juice, and applesauce, but the dissolution profile in orange juice or applesauce was not acceptable. Apple juice may be the preferred vehicle because it masks the drug's taste.

Beverages↗
PubMed1992

Bacteriology, drug stability and exchange of percutaneous delivery systems and antibacterial filters in long-term intrathecal infusion of opioid drugs and bupivacaine in "refractory" pain.

OBJECTIVE: To provide a basis for recommendations on the exchange of containers (syringes and cassettes) and antibacterial filters, and for choice of administration device in patients with "refractory" pain treated with long-term percutaneous intrathecal (IT) infusions of opioid (morphine or buprenorphine) and bupivacaine mixtures. DESIGN: Prospective, cohort, nonrandomized control trial-case series, with consecutive sample, no standard criterion, and cost-benefit analysis. SETTING: Tertiary care center, institutional practice as well as hospitalized and ambulatory care. PATIENTS: Eighty-nine (51 women and 38 men); 81 with malignant pain and 8 with benign "refractory" pain. INTERVENTIONS: (a) The chemical stability of the drugs in the containers during 30 days. (b) The results of bacteriologic culture of the residual volumes of the analgesic mixtures from used and reused (1-16 times) syringes (n = 135) and cassettes (n = 258), and of 5 ml of sterile isotonic saline filtered through the used Millipore filters (n = 149). The bacteriologic samples from the 89 patients were taken after 1-40 (median = 7), 1-86 (median = 20), and 5-78 (median = 31) days of IT treatment, respectively. MAIN OUTCOME MEASURES: Chemical stability: buprenorphine and bupivacaine concentrations-liquid chromatography; morphine concentrations--gas chromatography. Bacteriologic cultures: standard laboratory procedures. The hypothesis (repeated use of the infusion systems and their exchange once a month does not significantly affect drug concentrations or increase the infection risk) was elaborated before data collection began. RESULTS: The bupivacaine-opioid mixtures were found to be chemically stable within 3-10% of the original doses up to 30 days. Seventeen cultures (from five syringes, six cassettes, and six filters) in 13 patients (having no signs of meningeal infection) were found to be colonized with Staphylococcus aureus (n = 4), coagulase negative staphylococci (n = 7), viridans streptococci (n = 3), Neisseria sp (n = 4), Corynebacterium sp (n = 4), Enterobacter sp (n = 2), Klebsiella sp (n = 3), gram-negative bacilli (n = 1), and yeasts (n = 2). The place of IT treatment, its duration, and patient-related infection risk factors (age; malignancy; diabetes; presence of a colostomy, pyelostomy, or indwelling urinary catheter; and the presence and location of infection foci) were not related to the results of the cultures. However, 9 of the 17 positive cultures came from patients with skin ulcers, a notable incidence. The positive cultures had no connection with the cultured item, its in-use duration, the number of times of reuse, the analgesic drugs used, their concentrations or the presence of preservatives (sodium metabisulfite and sodium edetate), or the antiseptic agent (70% ethanol or 0.5% chlorhexidine gluconate) used during bacteriologic sampling. The bacterial growth was sparse in 14 and massive in 3 of the 17 positive cultures. One item (filter) from one patient with meningitis was sterile. CONCLUSIONS: In our population, exchange of the infusion systems when they are empty (within 1 month) and of the antibacterial filters once a month does not appear to affect the concentrations of, or increase the infection risk from, the opioid-bupivacaine mixtures. The risk of bacterial contamination/colonization of the syringes from syringe drivers does not seem to be higher than that of cassettes from external portable pumps.

Adolescent↗
PubMed1989

A critical review of continuous infusion H2 receptor therapy.

Recent studies suggest that continuous infusions of H2-receptor antagonists may be more effective than intermittent iv therapy to control gastric pH for the prevention of stress ulcers. Infusions of cimetidine, ranitidine, and famotidine have been shown either to have a beneficial clinical effect, to control gastric acid secretion, to maintain gastric pH greater than 4, or to have pharmacokinetic properties similar to intermittent doses. In addition, some evidence suggests that continuous infusions may permit the use of lower doses, leading to cost savings. However, as yet there have been no trials that directly compare continuous and intermittent regimens and show improved outcomes with a continuous regimen. Since candidates for parenteral administration of H2-receptor antagonists are most common in the ICU, several practical issues must be addressed. Patients who receive total parenteral nutrition (TPN) may be suitable candidates for continuous infusions of H2-blockers since these agents can be given in the same container as TPN solutions. These patients also usually have a parenteral access site and infusion pump dedicated to TPN administration. In other patients, drug incompatibilities, limited iv access lines, or a lack of infusion pumps may require frequent interruptions of the infusion in order to administer additional medications, which may lead to a loss of gastric pH control. In most patients, administration of an H2-blocker regimen which maintains consistent pH control after intermittent administration may be the most practical method by which to administer these agents.

Cimetidine↗
PubMed1995

Chemical compatibility of inotropic and vasoactive agents delivered via a multiple line infusion system.

OBJECTIVES: To determine the chemical compatibility of three different triple drug admixtures diluted with either 5% dextrose in water or 0.9% NaCl solution when administered via a multiple line infusion system (Omni-Flow 4000, Abbott Laboratories, Abbott Park, IL). The triple drug admixtures were: a) dobutamine, dopamine, and norepinephrine; b) nitroglycerin, sodium nitroprusside, and dobutamine; and c) nitroglycerin, dopamine, and dobutamine. DESIGN: Two phase in vitro compatibility study. SETTING: Pharmaceutical laboratory. SUBJECTS: None. INTERVENTIONS: Phase I assessed chemical stability when the triple drug admixture was placed in a single container. In phase II, individual drug components of the admixtures were infused via the multiple line infusion system. Samples were collected at time 0, 1 hr, 2 hrs, 4 hrs, 12 hrs, and 24 hrs. All samples were frozen and stored at -70 degrees C until assayed. MEASUREMENTS AND MAIN RESULTS: Samples were assayed using stability-indicating high performance liquid chromatography. The triple drug admixtures were considered to be chemically stable if there was < or = 10% loss of stated potency over 24 hrs. In phase I, chemical stability was observed for all triple drug admixtures at 24 hrs. In phase II, dobutamine, dopamine, norepinephrine, and sodium nitroprusside showed chemical stability at 24 hrs. Nitroglycerin showed a two-fold increase in concentration at 24 hrs compared with the initial concentration through the test infusion system; however, this amount was still one third lower than originally anticipated. CONCLUSIONS: All triple drug admixtures were chemically stable when placed in single containers. Dobutamine, norepinephrine, and sodium nitroprusside showed chemical stability when delivered via a multiple line infusion system. The reduced recovery of nitroglycerin from the test infusion system may result from adsorption of the nitroglycerin to the polyvinyl chloride plastic cassette and tubing during infusion.

Chromatography, High Pressure Liquid↗
PubMed2005

Compatibility and stability of Imexon in infusion devices and its in vitro biocompatibility.

Imexon is an investigational anti-cancer agent, pharmaceutically formulated as a lyophilized solid for i.v. infusion requiring reconstitution and subsequent dilution in infusion fluid before infusion. Imexon contains a highly reactive aziridine ring in its structure, which limits its stability in aqueous solutions. In the present study, several in vitro studies were conducted to determine the administration parameters for use in the forthcoming phase I clinical trial. The stability of Imexon in the reconstituted solution and infusion solutions was investigated, including its tendency to degrade to its main degradation product BM41.209, and to its hydroxy and chloride adducts. The compatibility of the infusion solution with glass, low-density polyethylene and freeflex polyolefin containers, and its potency to cause vascular irritation and hemolysis upon i.v. infusion were investigated. Imexon was found to be stable for 8 h in the reconstituted product and for 2 h after dilution to infusion solution concentrations in normal saline. The infusion solution was compatible with the freeflex polyolefin container and polyvinylchloride infusion lining, showing no sorption of Imexon during a 15-min infusion duration and no release of the plasticizer diethylhexyl phthalate. Furthermore, Imexon infusion solution showed no indication for vascular irritation or hemolysis upon i.v. infusion, as measured with a static in vitro model with incubation with whole blood. In conclusion, Imexon should be administered using a freeflex polyolefin infusion container within 2 h after preparation and a 15-min infusion duration. The results obtained with an in vitro model show that no vascular irritation or hemolysis is expected upon i.v. infusion.

Antineoplastic Agents↗
PubMed1996

The effect of the addition of lignocaine on propofol emulsion stability.

The stability of propofol emulsion following the addition of various amounts of lignocaine solution was investigated. The investigations used were macroscopic and microscopic observations and electroacoustic determination of both droplet size and zeta potential. Evidence of emulsion instability was present following the addition of even small amounts of lignocaine. Resultant changes are unlikely to be clinically important following the addition of less than 20 mg of lignocaine to 200 mg of propofol (20 ml of propofol emulsion). It is recommended, however, that anaesthetists consider the possibility of destabilisation of propofol emulsion when adding larger doses of lignocaine, or when there is a delay between formulation and administration of the propofol-lignocaine mixtures.

Anesthetics, Intravenous↗
PubMed1982

The compatibility of diazepam with infusion fluids and their containers.

A significant interaction exists between diazepam and infusion fluid containers constructed of PVC plastics. This is attributed to absorption of the drug into the PVC matrix and should preclude the use of this type of container prior to or during infusion of diazepam admixtures. Infusions containing diazepam injection either as a solution (in dextrose 5% or sodium chloride 0.9%) or oil-in-water emulsion (in dextrose 5%) exhibit no significant interaction over 48 h when prepared in polyethylene (Polyfusor) containers. No data were obtained regarding the physical stability of diluted emulsion. The inert nature of polyethylene and an absence of plasticizers or other additives account for a good compatibility with the drug additive. Therefore, diazepam dilutions may be prepared in polyethylene containers as an alternative to glass. However, the interaction with administration sets should not be overlooked when considering these solutions for infusion.

Chemical Phenomena↗