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Biomedical subjects

J F Martinez

Publications and source records attributed to J F Martinez.

At least 19 recordsLinked to original sources
PubMed1998

Stability of cisatracurium besylate in vials, syringes, and infusion admixtures.

The stability of cisatracurium besylate was studied. Cisatracurium (as besylate) 2 mg/mL in 5- and 10-mL unopened vials and 10 mg/mL in 20-mL unopened vials, as well as 3 mL of solution from additional 2-mg/mL vials, repackaged in 3-mL sealed plastic syringes, was stored at 4 and 23 degrees C in the dark and in normal fluorescent room light. Admixtures of cisatracurium (as besylate) 0.1, 2, or 5 mg/mL in polyvinyl chloride (PVC) minibags of 5% dextrose injection or 0.9% sodium chloride injection were stored at 4 and 23 degrees C in normal fluorescent room light. Triplicate samples for each storage condition were taken initially and at 1, 3, 5, 7, 14, 21, and 30 days; samples from vials were also removed at 45 and 90 days. Solutions were stored in sterile vials at -70 degrees C and then thawed at room temperature before analysis of chemical stability by high-performance liquid chromatography. Physical stability was assessed as well. Cisatracurium besylate was physically stable in all samples throughout the study. Cisatracurium (as besylate) 2 mg/mL exhibited drug losses at 23 degrees C in vials at 45 days and in syringes at 30 days. Cisatracurium (as besylate) 0.1, 2, and 5 mg/mL in 5% dextrose injection and in 0.9% sodium chloride injection was stable for at least 30 days at 4 degrees C, but substantial drug losses occurred at 23 degrees C. Admixtures prepared with cisatracurium (as besylate) 0.1 mg/mL and with 5% dextrose injection exhibited the greatest losses. Cisatracurium besylate was stable in most samples for at least 30 days at 4 and 23 degrees C; admixtures containing cisatracurium (as besylate) 0.1 or 2 mg/mL exhibited substantial drug loss at 23 degrees C.

Atracurium↗
PubMed1997

Compatibility of doxorubicin hydrochloride liposome injection with selected other drugs during simulated Y-site administration.

The compatibility of doxorubicin hydrochloride liposome injection with selected other drugs during simulated Y-site administration was studied. Five milliliters of doxorubicin hydrochloride liposome injection 0.4 mg/mL in 5% dextrose injection was combined with 5 mL of each of 82 other drugs in 5% dextrose injection or, if necessary to avoid incompatibilities with the diluent, 0.9% sodium chloride injection. The combinations were examined with the unaided eye in fluorescent light and in high-intensity monodirectional light to enhance visualization of small particles and low-level turbidity. The turbidity of each combination was measured as well. Particle sizing and counting were performed on selected combinations. Evaluations were performed initially and at one and four hours. All combinations were stored at room temperature (approximately 23 degrees C). Most of the test drugs were compatible with doxorubicin hydrochloride liposome injection during the four-hour observation period. However, practitioners should be cautious in administering any drug simultaneously with doxorubicin hydrochloride liposome injection until the integrity of the liposomes can be verified. Eighteen drugs exhibited unacceptable increases or decreases in measured turbidity or particulate formation within four hours. During simulated Y-site administration, doxorubicin hydrochloride 0.4 mg/mL (as the liposomal injection) in 5% dextrose injection was compatible with 64 of 82 other drugs for four hours at approximately 23 degrees C and was incompatible with 18 of the test drugs.

Antibiotics, Antineoplastic↗
PubMed1997

Compatibility of remifentanil hydrochloride with selected drugs during simulated Y-site administration.

The compatibility of remifentanil hydrochloride with 90 other drugs during simulated Y-site administration was studied. Five milliliters of remifentanil 25 and 250 micrograms/mL (as hydrochloride) in 0.9% sodium chloride injection or 5% dextrose injection was combined with 5 mL of each of 90 other drugs in 5% dextrose injection of 0.9% sodium chloride injection. Each combination was prepared in duplicate. The combinations were stored at approximately 23 degrees C under fluorescent light and examined with the unaided eye and in high-intensity monodirectional light during the first 15 minutes after preparation and at one and four hours. The turbidity of each combination was measured as well. Particle sizing and counting were performed for selected combinations. Most of the combinations exhibited no haze, turbidity, or color change throughout the study period. Remifentanil 25 micrograms/mL combined with chlorpromazine hydrochloride showed a small increase in haze within four hours. One of the combinations of remifentanil 250 micrograms/mL with cefoperazone sodium was unacceptably hazy within one hour. The combination of remifentanil 250 micrograms/mL with amphotericin B formed a gross precipitate upon mixing. Remifentanil 25 and 250 microgram/mL (as hydrochloride) in 0.9% sodium chloride injection was compatible for four hours at approximately 23 degrees C with all the drugs studied except chlorpromazine hydrochloride (with remifentanil 25 micrograms/mL), cefoperazone sodium (with remifentanil 250 micrograms/mL), and amphotericin B (with remifentanil 250 micrograms/mL in 5% dextrose injection).

Amphotericin B↗
PubMed1997

Compatibility of cisatracurium besylate with selected drugs during simulated Y-site administration.

The compatibility of cisatracurium besylate with 91 other drugs during simulated Y-site injection was studied. Five milliliters of cisatracurium 0.1, 2, and 5 mg/mL (as besylate) in 5% dextrose injection was combined with 5 mL of each of 91 drugs in 5% dextrose injection or 0.9% sodium chloride injection. All combinations were prepared in duplicate and stored at approximately 23 degrees C. Samples were visually examined under normal laboratory fluorescent light and, if there was no obvious visual incompatibility, under high-intensity monodirectional light. Turbidity was measured as well. Particle sizing and counting was performed for selected combinations. All evaluations were performed at intervals up to four hours. Cisatracurium besylate at all three concentrations was compatible with most of the drugs tested. However, one drug (cefoperazone) was incompatible with cisatracurium besylate at all three concentrations, 14 (including many cephalosporins) were incompatible with cisatracurium besylate 2 and 5 mg/ mL, and 12 were incompatible with cisatracurium 5 mg/ mL. During simulated Y-site administration, cisatracurium 0.1, 2, and 5 mg/mL (as besylate) in 5% dextrose injection was compatible with 64 of 91 drugs for four hours at approximately 23 degrees C. Twenty-seven drugs were incompatible with cisatracurium besylate at one or more concentrations.

Anti-Infective Agents↗
PubMed1997

Compatibility of propofol injectable emulsion with selected drugs during simulated Y-site administration.

The compatibility of a new formulation of injectable propofol with selected other drugs during simulated Y-site injection was studied. Two milliliters of undiluted propofol injectable emulsion was combined with 2 mL of each of 112 other drugs in 5% dextrose injection or 0.9% sodium chloride injection. The liquids were diluted with 6 mL of particle-free high-performance liquid chromatography (HPLC)-grade water and centrifuged for 20 minutes. A pipette connected to a vacuum line was used to remove the fat layer at the top and most of the aqueous phase. The remaining liquid was diluted with 9 mL of particle-free HPLC-grade water to facilitate visualization of any precipitate. The liquids were examined with the unaided eye in fluorescent light and with a Tyndall beam to enhance visualization of small particles. Samples were evaluated during the first 15 minutes and one hour after mixing. Propofol injectable emulsion was compatible with 98 of the 112 drugs testes. Fourteen drugs demonstrated incompatibilities, including precipitation, gel formation, and oiling out of cracked emulsions. During simulated Y-site injection, propofol injectable emulsion was compatible with most other drugs tested for one hour at approximately 23 degrees C

Anesthetics, Intravenous↗
PubMed1997

Compatibility of parenteral nutrient solutions with selected drugs during simulated Y-site administration.

The compatibility of 102 drugs with parenteral nutrient (PN) solutions during simulated Y-site administration was studied. Five milliliters of each of four representative PN solutions was combined in duplicate in a 1:1 ratio with 5-mL samples of solutions of 102 drugs in 5% dextrose injection or 0.9% sodium chloride injection. Visual examinations were performed in fluorescent laboratory light and under high-intensity monodirectional light, and turbidity was measured. Particle sizing and counting were performed for selected solutions. All evaluations were performed at intervals up to four hours; storage was at 23 degrees C. Most of the drugs tested were compatible with the PN solutions. However, 20 drugs exhibited various incompatibilities with one or more of the PN solutions. During simulated Y-site administration, four PN solutions were compatible with 82 of 102 drugs for four hours at 23 degrees C. Twenty drugs were incompatible with one or more of the PN solutions.

Drug Incompatibility↗
PubMed1997

Compatibility of granisetron hydrochloride with selected drugs during simulated Y-site administration.

The compatibility of granisetron hydrochloride with selected other drugs during simulated Y-site administration was studied. Five milliliters of granisetron 50 micrograms/mL (as the hydrochloride) in 5% dextrose injection was combined with 5 mL of each of 91 secondary additives, including antineoplastics, anti-infectives, and supportive care drugs, in 5% dextrose injection or (if necessary to avoid incompatibility with the diluent) 0.9% sodium chloride injection. Visual examinations were performed with the unaided eye in fluorescent light and in high-intensity monodirectional light to enhance visualization of small particles and low-level turbidity. The turbidity of each solution was measured as well. Particle sizing and counting were performed for selected solutions. Evaluations were performed initially and at one and four hours. Nearly all the test drugs were compatible with granisetron during the four-hour observation period. The granisetron-amphotericin B combination had an unacceptable increase in turbidity upon being mixed. During simulated Y-site administration, granisetron 50 micrograms/mL (as the hydrochloride) in 5% dextrose injection was compatible with 90 of 91 drugs and combination drugs for four hours at room temperature; the exception was amphotericin B.

Antiemetics↗
PubMed1997

Rapid loss of fentanyl citrate admixed with fluorouracil in polyvinyl chloride containers.

OBJECTIVE: To study the physical compatibility and chemical stability of fluorouracil 1 and 16 mg/mL with fentanyl citrate 12.5 micrograms/mL in dextrose 5% and in sodium chloride 0.9% injection. DESIGN: Test solutions of the drugs in dextrose 5% injection and in sodium chloride 0.9% injection were prepared in triplicate and stored at -20, 4, 23, and 32 degrees C. Samples were removed immediately and at various times over 7 days and stored at -70 degrees C until analyzed. Physical compatibility was assessed visually and by measuring turbidity with a color-correcting turbidimeter; particle content was measured with a light-obscuration particle sizer and counter. Chemical stability was determined by measuring the concentration of each drug in the test solutions in duplicate with stability-indicating HPLC. RESULTS: Fentanyl citrate was rapidly lost when admixed with fluorouracil in polyvinyl chloride (PVC) containers, losing about 25% in the first 15 minutes and about 50% in the first hour. The loss of fentanyl citrate was so rapid that accurate time zero determinations were not possible. The extent of fentanyl loss increased with time and occurred more rapidly at the higher temperatures (i.e., 23, 32 degrees C). Losses of 70% or more occurred in all samples within 24 hours. Fentanyl underwent rapid sorption to the containers at the high pH (9.0-9.5) of the fluorouracil admixtures. Adjusting the pH of a fentanyl citrate solution (containing no fluorouracil) in PVC containers to pH 9 with sodium hydroxide also resulted in rapid sorption loss. Fentanyl citrate sorption did not occur when admixtures were prepared in polyethylene containers. Fluorouracil remained stable for at least 7 days at all temperatures. There were no visual or subvisual changes in turbidity or particle content in any of the test solutions at any time. CONCLUSIONS: When admixed with fluorouracil 1 and 16 mg/mL in dextrose 5% injection and sodium chloride 0.9% injection, fentanyl citrate 12.5 micrograms/mL underwent rapid and extensive loss due to sorption to the PVC containers, making the combination unacceptable within minutes of mixing. The sorption results from the alkaline pH of the admixture and, presumably, could occur from the admixture of fentanyl citrate with any sufficiently alkaline drug.

Analgesics, Opioid↗
PubMed1997

Compatibility and stability of paclitaxel combined with cisplatin and with carboplatin in infusion solutions.

OBJECTIVE: To evaluate the physical compatibility and chemical stability of paclitaxel at concentrations of 0.3 and 1.2 mg/mL with cisplatin 0.2 mg/mL in NaCl 0.9% injection and with carboplatin 2 mg/mL in NaCl 0.9% injection and dextrose 5% injection over 7 days at 4, 23, and 32 degrees C. DESIGN: The test samples were prepared in polyolefin bags of the infusion solutions at the required drug concentrations. Evaluations were performed initially and after 4 hours, and 1, 3, 5, and 7 days of storage at temperatures of 4, 23, and 32 degrees C for physical and chemical stability. Physical stability was assessed by using visual observation in normal light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the three drugs was evaluated by using three stability-indicating HPLC analytical techniques. RESULTS: All samples were physically stable through 1 day. However, microcrystalline precipitation of paclitaxel occurred in 3 days in some samples and within 5 days in all samples. Paclitaxel concentrations remained above 90% in all samples throughout the study. Cisplatin admixtures exhibited paclitaxel concentration-dependent decomposition with cisplatin losses of approximately 5-8% in 4 hours and approximately 20% in 1 day at 23 and 32 degrees C in the paclitaxel 1.2 mg/mL admixtures. With paclitaxel 0.3 mg/mL in the admixtures, cisplatin losses were about 10% in 7 days at these temperatures. Carboplatin in admixtures with both concentrations of paclitaxel was stable for 7 days at 4 degrees C, but sustained losses of about 10% and 12% in 3 days at 23 and 32 degrees C, respectively. CONCLUSIONS: Admixtures of paclitaxel 0.3 and 1.2 mg/mL with cisplatin and carboplatin are limited in their utility time by both paclitaxel microcrystalline precipitation and decomposition of cisplatin and carboplatin. The admixture of paclitaxel 1.2 mg/mL with cisplatin 0.2 mg/mL in NaCl 0.9% injection exhibits unacceptable cisplatin loss in 24 hours. All other combinations were physically and chemically stable for at least 24 hours at 4, 23, and 32 degrees C.

Antineoplastic Agents↗
PubMed1996

Stability of thiotepa (lyophilized) in 5% dextrose injection at 4 and 23 degrees C.

The stability of thiotepa (lyophilized) 0.5 and 5 mg/mL in 5% dextrose injection was studied. Vials of lyophilized thiotepa were reconstituted with sterile water for injection to yield a solution with a nominal 10-mg/mL drug concentration. The reconstituted solution was filtered and diluted in 5% dextrose injection in polyvinyl chloride and polyolefin bags to nominal thiotepa concentrations of 0.5 and 5 mg/mL. Triplicate test admixtures were prepared and stored at 4 or 23 degrees C in normal fluorescent light. Initially and after four and eight hours and 1, 3, 7, and 14 days, samples were removed for visual evaluation, turbidimetry, and stability-indicating high-performance liquid chromatography. No incompatibilities were observed. Admixtures containing thiotepa 0.5 mg/mL retained at least 90% of the initial drug concentration for eight hours at either temperature in either type of container; after 24 hours, losses ranged from 10% to 17%. Thiotepa in the 5-mg/mL admixtures was stable for 3 days at 23 degrees C and 14 days at 4 degrees C in both container types. Thiotepa (lyophilized) 0.5 mg/mL in 5% dextrose injection was stable for eight hours at 4 or 23 degrees C. Thiotepa (lyophilized) 5 mg/mL in 5% dextrose injection was stable for 3 days at 23 degrees C and 14 days at 4 degrees C.

Antineoplastic Agents, Alkylating↗
PubMed1996

Compatibility of thiotepa (lyophilized) with selected drugs during simulated Y-site administration.

The compatibility of lyophilized thiotepa injection with selected other drugs during simulated Y-site injection was evaluated. Five-milliliter samples of thiotepa (lyophilized) 1 mg/mL in 5% dextrose injection were combined with 5 mL each of 100 other drugs, including antineoplastics, anti-infectives, and supportive care drugs, in 5% dextrose injection or 0.9% sodium chloride injection. The combinations were stored at room temperature (approximately 23 degrees C) under constant fluorescent light. Visual examinations were performed immediately and at one and four hours with the unaided eye and, if there was no obvious incompatibility, with a high-intensity mono-directional light beam to enhance visualization of small particles and low-level turbidity. The turbidity of each combination was measured as well. Particle sizing and counting were performed on selected solutions. Most of the test drugs were compatible with thiotepa 1 mg/mL during the observation period. Two drugs exhibited incompatibilities with thiotepa. The thiotepa-cisplatin combination developed turbidity in four hours, and the thiotepa-minocycline hydrochloride combination developed a bright yellow-green discoloration in one hour. All the test drugs except cisplatin and minocycline hydrochloride were compatible with thiotepa 1 mg/mL (prepared from the lyophilized formulation) for at least four hours at room temperature.

Alkylating Agents↗
PubMed1995

Compatibility and stability of aztreonam and vancomycin hydrochloride.

The physical compatibility and chemical stability of aztreonam and vancomycin hydrochloride when combined at clinically used high and low concentrations were studied. Admixtures consisting of aztreonam 4 mg/mL and vancomycin 1 mg/mL (as the hydrochloride salt) in 5% dextrose injection, aztreonam 4 mg/mL and vancomycin 1 mg/mL in 0.9% sodium chloride injection, aztreonam 40 mg/mL and vancomycin 10 mg/mL in 5% dextrose injection, and aztreonam 40 mg/mL and vancomycin 10 mg/mL in 0.9% sodium chloride injection were prepared in triplicate in polyvinyl chloride containers. Three containers of each type of admixture were stored at 4, 23, and 32 degrees C. Samples were removed immediately and at various time points over 31 days. Compatibility was assessed by visual examination, with a turbidimeter, and with a particle sizer-counter. Stability was determined by stability-indicating high-performance liquid chromatography (HPLC). All the admixtures initially appeared clear to the unaided eye after the disappearance of a transient white swirl in the high-concentration admixtures (aztreonam 40 mg/mL and vancomycin 10 mg/mL). However, the high-concentration admixtures immediately developed unacceptable levels of a microcrystalline precipitate when viewed with a high-intensity fiber-optic light source. Easily visible gross turbidity and precipitation formed after various periods but often within 24 hours. HPLC showed aztreonam 4 mg/mL and vancomycin 1 mg/mL in 5% dextrose injection to be a stable combination for 7 days at 32 degrees C, 14 days at 23 degrees C, and 31 days at 4 degrees C. In 0.9% sodium chloride injection, the drugs in the low-concentration admixtures were stable for 7 days at 32 degrees C and for 31 days at 4 and 23 degrees C. Stability of the combination in the high-concentration admixtures was maintained for 3 days at 23 and 32 degrees C and for 14 days at 4 degrees C. Aztreonam and vancomycin hydrochloride were considerably less compatible and stable in the high-concentration admixtures than in the low-concentration ones.

Anti-Bacterial Agents↗
PubMed1995

Compatibility of amifostine with selected drugs during simulated Y-site administration.

The compatibility of amifostine for injection with selected other drugs during simulated Y-site injection was evaluated. Five-milliliter samples of amifostine 10 mg/mL in 5% dextrose injection were combined with 5 mL each of 100 other drugs, including antineoplastics, anti-infectives, and supportive care drugs, in 5% dextrose injection or 0.9% sodium chloride injection. The combinations were stored under fluorescent light at 23 degrees C. The combinations were evaluated initially and at one and four hours after preparation. Visual examinations were performed in fluorescent light with the unaided eye and using a high-intensity monodirectional light beam to enhance visualization of small particles and low-level turbidity. The turbidity of each sample was measured. Particle sizing and counting were performed on selected samples. Most of the test drugs were compatible with amifostine 10 mg/mL for the observation period. However, 10 drugs exhibited various incompatibilities, including turbidity, particulate formation, precipitation, and color change. These drugs were acyclovir sodium, amphotericin B, cefoperazone sodium, chlorpromazine hydrochloride, cisplatin, ganciclovir sodium, hydroxyzine hydrochloride, miconazole, minocycline hydrochloride, and prochlorperazine edisylate. Amifostine 10 mg/mL in 5% dextrose injection was compatible with most of the 100 drugs tested for four hours at 23 degrees C. However, 10 drugs exhibited incompatibility with amifostine.

Amifostine↗
PubMed1995

Compatibility of aztreonam with selected drugs during simulated Y-site administration.

The compatibility of aztreonam injection with selected other drugs during simulated Y-site injection was evaluated. A 5-mL sample of aztreonam 40 mg/mL in 5% dextrose injection was combined with 5 mL of each of 100 other drugs including antineoplastics, anti-infectives, and supportive care drugs in 5% dextrose injection or 0.9% sodium chloride injection. The combinations were stored under fluorescent light at 23 degrees C. The combinations were evaluated initially and at one and four hours after preparation by examination with the unaided eye and with a high-intensity light beam, turbidity measurement, and particle sizing and counting. Most of the test drugs were compatible with aztreonam 40 mg/mL for the observation period. However, aztreonam combinations with 12 drugs exhibited incompatibilities including turbidity, particulate formation, precipitation, and color change. These drugs were acyclovir sodium, amphotericin B, chlorpromazine hydrochloride, daunorubicin hydrochloride, ganciclovir sodium, lorazepam, metronidazole, miconazole, mitomycin, mitoxantrone hydrochloride, prochlorperazine edisylate, and streptozocin. Aztreonam 40 mg/mL in 5% dextrose injection was compatible with most of the drugs tested for up to four hours at 23 degrees C. However, 12 drugs exhibited incompatibility with aztreonam.

Anti-Infective Agents↗
PubMed1995

Incompatibility of fluorouracil with leucovorin calcium or levoleucovorin calcium.

The physical compatibility of fluorouracil mixed with leucovorin calcium or levoleucovorin calcium, undiluted and modestly diluted with 5% dextrose injection, was evaluated. Fluorouracil 50 mg/mL was combined in duplicate with leucovorin or levoleucovorin 20 mg/mL (as the calcium salt) in 250-mL polyvinyl chloride (PVC) portable-pump reservoirs in six volume ratios, either undiluted or diluted with 5% dextrose injection (to a final volume 25% greater than the drug volume). Duplicate reservoirs of each combination were stored for seven days at 4, 23, or 32 degrees C. Samples were evaluated visually with a high-intensity monodirectional light beam to observe development of particulates. Turbidimetry and light-obscuration particle counting and sizing also were used to evaluate compatibility. Small amounts of tiny crystalline particles developed in most of the combinations, usually by four days. In some cases, the particles could be seen in normal diffuse room light. Particle content was greater with higher leucovorin concentrations and over longer storage periods. Storage temperature did not play a consistent role in particle development. Fluorouracil and leucovorin calcium or levoleucovorin calcium were not compatible when stored in PVC reservoirs at 4, 23, or 32 degrees C.

Chemical Precipitation↗