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Compatibility of amphotericin B with certain large-volume parenterals.
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Compatibility of azathioprine sodium with intravenous fluids.
The effects of storage containers, diluent, temperature, and illumination on the stability and compatibility of azathioprine sodium were studied. Reconstituted solutions were stored in the manufacturer's vial and a plastic syringe. Diluted solutions were stored in mini-bags mixed with standard intravenous solutions (5% dextrose injection, 0.9% sodium chloride injection, and 0.45% sodium chloride injection). Samples were stored at 4 degrees C in the dark and at 23 degrees C under constant illumination. Samples containing an internal standard, 6-methylmercaptopurine, were assayed by ion exchange chromatography at 0, 8, and 16 days. Accelerated decomposition studies at 70 degrees C also were performed to determine the chromatographic method's capability for separating azathioprine from its breakdown products. No solutions or admixtures differed significantly (p greater than 0.13) from initial concentrations after 16 days at 23 degrees C under constant illumination. Mixture with 5% dextrose injection caused precipitation by day 16. Azathioprine sodium reconstituted and stored in the manufacturer's vial or a plastic syringe at 4 degrees C formed a precipitate by day 4. Sterility is the limiting factor determining suitability for use of azathioprine solutions kept less than four days.
Cimetidine hydrochloride compatibility. II: room temperature stability in intravenous infusion fluids.
The visual compatibility and chemical stability of cimetidine hydrochloride diluted in 19 intravenous infusion fluids were investigated. Cimetidine hydrochloride injection was added aseptically to large-volume parenteral solutions at concentrations of 120 and 500 mg/100 ml. Cimetidine concentration was analyzed by high-pressure liquid chromatography initially and after storage periods of 24, 48, 72, and 168 hours at room temperature. Cimetidine hydrochloride in each of the dilutions remained visually compatible for one week, exhibiting no changes in color, clarity, or odor; pH values remained constant. The addition of cimetidine to Normosol-R pH 7.4 resulted in solutions having pH values of 6.3 and 6.0 at 120 and 500 mg/100 ml, respectively. Cimetidine remained chemically stable in each of the intravenous fluids studied. Cimetidine hydrochloride is visually and chemically stable for at least one week when added to the intravenous fluids studied at concentrations of 120 and 500 mg/100 ml and stored at ambient room temperature.
[Interactions between alkaloids of benzyl-isoquinoline structure and barbiturates. Interaction between papaverine hydrochloride an sodium phenobarbitol. I. Study of interactions by physical, chemical and biological methods].
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Cimetidine hydrochloride compatibility with preoperative medications.
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Stability of five catecholamines and terbutaline sulfate in 5% dextrose injection in the absence and presence of aminophylline.
The stability of dopamine hydrochloride, epinephrine hydrochloride, isoproterenol hydrochloride, methyldopate hydrochloride, norepinephrine bitartrate, and terbutaline sulfate in 5% dextrose injection with and without aminophylline was evaluated. Kinetic data were obtained from the stability-indicating, high-performance liquid chromatographic assay method for autoxidation of the five sympathomimetic catecholamines and terbutaline sulfate. The autoxidation of epinephrine hydrochloride, isoproterenol hydrochloride, norepinephrine, bitartrate, and terbutaline sulfate was much faster in the alkaline solutions (pH 7.7-8.1) containing aminophylline than in the acidic solutions (pH 3.9-4.5) without aminophylline. On a molar basis among beta 2 agonists, terbutaline sulfate was considerably more stable than epinephrine hydrochloride or isoproterenol hydrochloride. The autoxidation of terbutaline sulfate and the five catecholamines followed apparent zero-order kinetics. The rate constants and degradation times to fall 90% of original potency were determined for each drug. Visual inspection was found to be grossly inadequate for estimating the stability of catecholamines to autoxidation. Epinephrine hydrochloride, norepinephrine bitartrate, and isoproterenol hydrochloride should not be combined with aminophylline or similarly alkaline drugs in LVP solutions. The stability of very potent and life-saving drugs prepared for i.v. admixtures must be studied with stability-indicating assay methods.
[Introduction to the discussion theme drug interactions].
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Thiamine destruction by sodium bisulfite in infusion solutions.
The degree of degradation of thiamine hydrochloride in sodium bisulfite-containing infusion solutions was investigated. Two amino acid and one electrolyte infusion solution containing sodium bisulfite and four infusion solutions (5 and 10% dextrose, Lactated Ringer's, and 0.9% sodium chloride injections) without sodium bisulfite were obtained in 500-ml glass or plastic containers. Three thiamine sources, two commercial multivitamin preparations, and one investigational multivitamin product were added to the infusion solutions. The percentage of added thiamine remaining after storage was determined in four experiments: (1) The investigational product was added to the infusion solutions with bisulfite, and the determinations were made after 24 hours of storage at room temperature (RT) under both light and dark conditions; (2) the two commercial multivitamin preparations were mixed with an amino acid solution containing bisulfite and the determination was made after 24 hours of storage at RT under dark conditions; (3) the investigational product was added to the infusion solutions with bisulfite, and the determinations were made after 2, 4, 6, 8, and 24 hours storage at 7 degrees C and following four hours at RT under dark conditions; and (4) the investigational product was added to the four infusion solutions without bisulfite, and the determinations were made after 24 hours of storage at RT under both light and dark conditions. In the infusion solutions containing bisulfite, the stability of thiamine was inversely related to the pH. In an amino acid solution at a pH of 6.5, only 3-8% of the added thiamine was found after 24 hours storage at RT, and only 37% was found after 24 hours at 7 degrees C. In the electrolyte solution with bisulfite (pH = 5), the percentages of thiamine remaining after 24 hours RT and 7 degrees C storage were 50 and 69%, respectively. Light exposure was not found to affect the stability of thiamine in the solutions containing bisulfite. In the infusion solutions without bisulfite, a minimal loss of thiamine occurred even though the pH range was 4.7-5.6. The degradation effect of light exposure was greater for the solutions stored in plastic than in glass. Infusion solutions containing bisulfite were found to be unsuitable vehicles for the administration of vitamin formulations containing thiamine. If a patient must receive multivitamins in infusion solutions with bisulfite, the solutions should be used immediately after their preparation, and the patient should be monitored for signs of thiamine deficiency.
Stability and compatibility of antitumor agents in glass and plastic containers.
The stability of methotrexate, fluorouracil, cytarabine, dactinomycin, doxorubicin, bleomycin sulfate, mitomycin, mithramycin, vincristine sulfate, vinblastine sulfate, cyclophosphamide, dacarbazine, carmustine, and leucovorin calcium in underfilled plastic and glass administration containers was determined. Drugs were reconstituted according to manufacturers' instructions and added to 5% dextrose injection 50 ml in both polyvinyl chloride bags and glass partial-fill bottles. In addition, mitomycin was added to 0.9% sodium chloride injection 50 ml in both polyvinyl chloride bags and glass partial-fill bottles. All admixtures were stored at room temperature, not protected from light. Stability was determined over 24 hours (48 hours for doxorubicin and fluorouracil) by high-pressure liquid chromatography, except for cyclophosphamide (analyzed by mass spectrometry) and carmustine (analyzed by spectrophotometry). Methotrexate, leucovorin calcium, cytarabine, dactinomycin, mithramycin, vinblastine sulfate, cyclophosphamide, and dacarbazine were equally stable (10% or less change in concentration over 24 hours) in glass and plastic containers. Doxorubicin and fluorouracil were more stable in plastic containers than glass containers. The T90 value for doxorubicin in glass was 40 hours; there was no apparent decrease in plastic even after 48 hours. The T90 value for fluorouracil in glass was seven hours and in plastic, 43 hours. Vincristine sulfate, bleomycin sulfate, and carmustine were more stable in glass than plastic. The T90 value for vincristine sulfate in plastic was 10 hours. The T90 value for bleomycin sulfate in plastic was 0.7 hour. The T90 value for carmustine in plastic was 0.6 hour. Mitomycin dissolved in 0.9% sodium chloride injection was more stable in plastic. Mitomycin dissolved in 5% dextrose injection was not stable. Carmustine and bleomycin sulfate should be administered only in glass containers. Continuous infusions of doxorubicin and fluorouracil are more completely delivered from plastic containers. Mitomycin should not be dissolved in 5% dextrose injection.
Compatibility of mephentermine sulfate with hydrocortisone sodium succinate or aminophylline in 5% dextrose injection.
The compatibility and stability of mephentermine sulfate with hydrocortisone sodium succinate or aminophylline in 5% dextrose injection were studied. Mephentermine sulfate injection (equivalent to mephentermine 300 mg) was added to both hydrocortisone sodium succinate injection (equivalent to hydrocortisone 100 mg--admixture I) and aminophylline injection 250 mg (admixture II), each in 5% dextrose injection 400 ml. The solutions were stored in sealed USP type I containers and stored at 0-4 degrees C, 30 +/- 2 degrees C, and 45 +/- 1 degree C. Aliquots were drawn initially and at 4 and 24 hours for pH, drug content, and degradation product determinations. Mephentermine sulfate content was analyzed by a spectrophotometric method involving ion-pair extraction with tropaeolin 00. Hydrocortisone sodium succinate and aminophylline were analyzed by color reaction with isoniazid and UV spectrophotometry, respectively. The content of mephentermine and total hydrocortisone showed no change in admixture I under all test conditions. Hydrocortisone sodium succinate ester hydrolyzed slowly, but not more than 5% after 24 hours at 45 degrees C. There was no appreciable loss of mephentermine sulfate or aminophylline potency in admixture II. The pH of the solutions did not change over the period of study. The results indicate that both admixtures were compatible and stable under the tested storage conditions for at least 24 hours.
Cimetidine hydrochloride compatibility. I: Chemical aspects and room temperature stability in intravenous infusion fluids.
The visual and chemical stabilities of cimetidine hydrochloride in solution with frequently prescribed large-volume parenteral fluids were studied. Cimetidine hydrochloride was added aseptically to each of 22 intravenous fluid products in glass or polyvinyl chloride containers to final concentrations of 120 and 500 mg/100 ml. The solutions were stored at approximately 25 degrees C. At 0, 24, 48, 72, and 168 hours (1 week) after mixing, the solutions were examined for color, odor, and clarity; pH values were measured; and the cimetidine contents were determined by high-pressure liquid chromatography. The solutions showed no changes in odor, color, or clarity. The pH values remained relatively invariant, except for slight increases in the 5% dextrose and in the Aminosyn 3.5% M solutions (120 mg/100 ml) and the 10% Travert Injection (500 mg/100 ml). Cimetidine content remained steady in all solutions. Cimetidine hydrochloride is visually and chemically stable for at least one week at ambient temperatures when combined with commonly used intravenous fluids in concentrations of 120 and 500 mg/100 of solution.
Stability of carmustine in the presence of sodium bicarbonate.
The stability of carmustine in 5% dextrose injection and 0.9% sodium chloride injection, with and without added sodium bicarbonate, was studied at room temperature. Solutions of carmustine (0.1 mg/ml) in dextrose or saline with and without added sodium bicarbonate (1 meq/ml) were prepared. After 0, 15, 30, 60, and 90 minutes, aliquots of each test solution were analyzed for carmustine using the Bratton-Marshall test with absorbance at 540 nm. There was no significant decomposition of carmustine in dextrose or saline alone. However, the addition of sodium bicarbonate increased carmustine degradation; after 90 minutes, approximately 73% of the active drug remained. It is recommended that carmustine be neither admixed with nor administered piggyback with parenteral infusion solutions containing sodium bicarbonate.
Bretylium tosylate intravenous admixture compatibility. I: Stability in common large-volume parenteral solutions.
The stability of bretylium tosylate in 11 common large-volume parenteral solutions was studied. Two containers of each solution, one glass and one plastic (except for mannitol and sodium bicarbonate solutions, which were available in glass only), were stored at each of the following conditions: intense light (1400-2000 foot candles), ambient room temperature with normal light, 40 degrees C, and 4 degrees C. All samples were tested at 0 and 24 hours; some samples were also tested at 48 hours and 7 days. Testing included measurement for optical density at 4000 and 600 nm, pH level, and bretylium content as determined by HPLC. The admixtures remained clear and colorless, except that mannitol precipitated out of mannitol solutions stored at 4 degrees C. No appreciable changes in pH were observed. HPLC assays showed no significant changes in bretylium tosylate concentrations. Bretylium tosylate is compatible with each of the 11 common intravenous solutions chosen for investigation under the storage conditions studied. Admixtures with mannitol should not be refrigerated, because mannitol crystallizes from solution at refrigerator temperatures.
Drug interactions in clinical practice.
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Compatibility and stability of ondansetron hydrochloride with morphine sulfate and with hydromorphone hydrochloride in 0.9% sodium chloride injection at 4, 22, and 32 degrees C.
The physical compatibility and chemical stability of ondansetron hydrochloride 0.1 and 1 mg/mL with morphine sulfate 1 mg/mL and with hydromorphone hydrochloride 0.5 mg/mL in 0.9% sodium chloride injection were studied. Test solutions of the drugs in 0.9% sodium chloride injection were prepared in triplicate and stored at 4, 22, and 32 degrees C. Samples were removed immediately and at various time points over 31 days and stored at -70 degrees C until analyzed. Physical compatibility was assessed visually and by measuring turbidity with a color-correcting turbidimeter and particle content with a light-obscuration particle sizer and counter. Chemical stability was determined by measuring the concentration of each drug in duplicate with stability-indicating high-performance liquid chromatography. There were no visual or subvisual changes in turbidity or particle content in any of the test solutions at any of the time points. There was little or no loss of any of the drugs. When admixed in 0.9% sodium chloride injection, ondansetron hydrochloride 0.1 and 1 mg/mL plus morphine sulfate 1 mg/mL or hydromorphone hydrochloride 0.5 mg/mL were compatible and stable for at least 7 days at 32 degrees C and for at least 31 days at 4 and 22 degrees C.
[Physicochemical compatibility and stability of a solution containing strophanthin K and korazol].
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[Physicochemical compatibility of 5-fluorouracil (new french preparation) and folinic acid].
The potentiation of 5-fluorouracil (5FU) cytotoxicity by folinic acid (FA) is based on strong experimental basis. This experimental concept has been prolonged in the clinical setting where 5FU-FA combination has demonstrated its superiority in comparison to 5FU alone for the chemotherapeutic treatment of advanced colorectal cancer. A justified question concerns the stability for 5FU (new French preparation, with sodium hydroxyde, by Roche)-FA admixtures studied in clinically compatible conditions. We have presently undertaken this study. Based on drug concentrations corresponding to current 5FU-FA chemotherapeutic protocols, we have tested the influence of various factors like the vials, diluents and the type of FA preparation (Lederfoline versus Elvorine). The mixture between 5FU and FA leads to the formation of a precipitate which is influenced by the contact time between 5FU and FA (threshold at 24 hr), by the relative concentration of each drug in mixture and its seems necessary to avoid the mixture between undiluted 5FU and FA (d,1 preparation, Lederfoline). Cassettes or plastic bags are preferable to glass recipients. Finally and above all, the use of pure lFA form (Elvorine) does not lead to the formation of a precipitate seen with the d'1 FA form (Lederfoline) at equal concentration of active folate (1 form). These data carry practical importance for the security and the quality of 5FU-FA protocols and particularly when using portable pumps during prolonged periods necessitating the use of small volume of injectable drug solutions.