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1.
Int J Pharm Compd ; 16(1): 54-6, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-23050312

RESUMEN

Lawrence A. Trissel was awarded the 2011 Institute for Safe Medication Practices Lifetime Achievement Award. In this article, the author acknowledges his appreciation of being selected for this award, pays his respects to those who honored him, and discusses the future of pharmacy as it relates to drug stability and compatibility efforts.


Asunto(s)
Distinciones y Premios , Farmacia , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos
2.
Am J Health Syst Pharm ; 68(22): 2163-9, 2011 Nov 15.
Artículo en Inglés | MEDLINE | ID: mdl-22058102

RESUMEN

PURPOSE: The physical compatibility of ceftaroline fosamil with commonly used medications and diluents (a total of 73 drugs in 219 admixtures) during simulated Y-site administration was evaluated. METHODS: Duplicate 5-mL samples of ceftaroline fosamil (2.22 mg/mL) in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection were combined at a 1:1 ratio with samples of 73 drugs (diluted or undiluted). Visual examinations were performed with the unaided eye in fluorescent light and with the aid of a Tyndall beam; the turbidity and particulate content of each sample were also measured. The compatibility of ceftaroline fosamil with propofol was evaluated by visually inspecting for emulsion separation and particle formation after centrifugation. All evaluations were performed within 15 minutes of sample preparation and at one and four hours after preparation. RESULTS: Ceftaroline fosamil was physically compatible with 64 drugs in a combination of 196 admixtures for at least four hours, exhibiting color, clarity, turbidity, and microparticle content similar to those of control solutions. Signs of physical incompatibility, including visible precipitation, increased turbidity, and microparticle formation, were observed with 9 drugs in 23 admixtures during the four-hour observation period. CONCLUSION: Of the 73 drugs evaluated, 64 were compatible and 7 were incompatible with ceftaroline fosamil 2.22 mg/mL in 3 standard infusion solutions. Nine drugs in 23 admixtures were observed to exhibit signs of incompatibility with ceftaroline fosamil within four hours of mixing; those drugs should not be simultaneously administered via a Y-site with ceftaroline preparations.


Asunto(s)
Cefalosporinas/administración & dosificación , Incompatibilidad de Medicamentos , Antibacterianos/administración & dosificación , Antibacterianos/química , Cefalosporinas/química , Simulación por Computador , Solución Hipertónica de Glucosa , Humanos , Infusiones Intravenosas , Inyecciones Intravenosas , Soluciones Isotónicas , Solución de Ringer , Solución Salina Hipertónica , Ceftarolina
3.
Int J Pharm Compd ; 13(1): 78-80, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-23969967

RESUMEN

Palonosetron hydrochloride is a longer-acting, selective 5-HT3 receptor antagonist that has been approved for prevention of chemotherapy-induced nausea and vomiting and is being evaluated for prevention of postoperative nause and vomiting. The objective of this study was to evaluate the physical and chemical stablity of palonosetron hydrochloride 50 mcg/mL when mixed with undiluted propofol 1% during simulated Y-site administation. Duplicate samples of this mixture were tested. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by visual inspection. Chemical stability was assessed by high-performance liquid chromatographic analysis. All of the admixtures were opaque white when viewed in normal fluorescent room light and when viewed with a Tyndall beam. After centrifugation, no evidence of precipitation was found. The drug concentrations were essentially unchanged in all of the samples throughout the study. Palonosetron hydrochloride is physically and chemically stable when mixed with propofol as undiluted injections during simulated Y-site administration over 4 hours at ambient room temperature.

4.
Int J Pharm Compd ; 13(2): 162-5, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-23970009

RESUMEN

A new generation of VISIV polyolefin intravenous solution containers, made of a new and different proprietary polymer, were evaluated for sorption and leaching potential with a cadre of drugs known to exhibit those phenomena with polyvinylchloride containers. Sorption potential was evaluated for amiodarone hydrochloride, carmustine, regular human insulin, lorazepam, nitroglycerin, sufentanil citrate, and thiopental sodium. Leaching potential was evaluated for tacrolimus and teniposide as well as the vehicles of docetaxel and paclitaxel. Representative concentrations of the drugs in infusion solutions or undiluted were placed into the new generation of VISIV containers and left in contact for up to 24 hours at room temperature. High performance liquid chromatography was used to determine drug concentrations and the presence of plasticizer or other plastic components, if any. Only regular human insulin exhibited any substantial loss of concentration in the polyolefin containers that could be attirbuted to sorption. Other drugs' concentrations were consistent with their stabilities over the test periods. No evidence of leaching of plasiticizer or other plastic components was observed.

5.
Am J Health Syst Pharm ; 65(18): 1735-59, 2008 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-18769000

RESUMEN

PURPOSE: The physical and chemical compatibility of palonosetron hydrochloride with atropine sulfate, famotidine, heparin sodium, lidocaine hydrochloride, and potassium chloride during simulated Y-site administration were studied. METHODS: Test samples were prepared in duplicate by separately mixing 7.5-mL samples of undiluted palonosetron hydrochloride 50 microg/mL with 7.5-mL samples of atropine sulfate 0.4 mg/mL, famotidine 2 mg/mL, undiluted heparin sodium 100 units/mL, lidocaine hydrochloride 10 mg/mL, and potassium chloride 0.1 meq/mL diluted in 5% dextrose in colorless 15-mL borosilicate glass screw-cap culture tubes with polypropylene caps. Physical stability of the admixtures was assessed by visual examination and by measuring turbidity and particle size and content. Chemical stability of atropine sulfate, famotidine, heparin sodium, and lidocaine hydrochloride was assessed by stability-indicating high-performance liquid chromatography. Potassium chloride concentration was determined by indirect potentiometry using a potassiumion selective electrode. RESULTS: All of the samples of palonosetron hydrochloride with the test drugs were initially clear and colorless in normal fluorescent room light and when viewed with a Tyndall beam. Changes in turbidity for the samples were minor throughout the study. Measured particulates of 10 mum or larger were found to be few in number in all samples and remained so throughout the observation period. The admixtures remained colorless throughout the study. No loss of palonosetron hydrochloride occurred with any of the drugs over four hours. Similarly, little or no loss of the other drugs occurred in four hours. CONCLUSION: Palonosetron hydrochloride is physically and chemically stable with atropine sulfate, famotidine, heparin sodium, lidocaine hydrochloride, and potassium chloride during simulated Y-site administration.


Asunto(s)
Antieméticos/química , Isoquinolinas/química , Quinuclidinas/química , Antagonistas de la Serotonina/química , Atropina/química , Química Farmacéutica , Cromatografía Líquida de Alta Presión , Incompatibilidad de Medicamentos , Estabilidad de Medicamentos , Famotidina/química , Heparina/química , Infusiones Intravenosas , Lidocaína/química , Nefelometría y Turbidimetría , Palonosetrón , Soluciones Farmacéuticas , Cloruro de Potasio/química
6.
Am J Health Syst Pharm ; 65(16): 1545-51, 2008 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-18693210

RESUMEN

PURPOSE: The physical compatibility of the new cephalosporin ceftobiprole medocaril with 70 other drugs during simulated Y-site injection was studied. METHODS: Ceftobiprole was reconstituted with sterile water for injection. Dilutions of ceftobiprole 2 mg/mL (as ceftobiprole medocaril 2.67 mg/mL) were prepared in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection. For testing compatibility with the other drugs, a 5-mL sample of the ceftobiprole 2-mg/mL admixtures was combined with a 5-mL sample of the other drug either undiluted or diluted with one of the three vehicles. Each combination was prepared in duplicate, switching the order of drug addition, and kept at room temperature. At intervals up to four hours after preparation, samples were examined visually and with the aid of a Tyndall beam and measured with a turbidimeter and a particle sizer and counter. Compatibility with propofol was evaluated by checking for emulsion separation and particles after centrifugation. RESULTS: In all three vehicles, ceftobiprole was compatible with 31 other drugs and incompatible with 32. With 7 drugs, compatibility was dependent on the vehicle used. Signs of incompatibility included the presence of visible and subvisible particles, haze, and turbidity. No incompatibilities were related to the order of mixing. CONCLUSION: Of the 70 drugs evaluated for compatibility with ceftobiprole 2 mg/ mL (as medocaril) in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection, 31 were found to be compatible and 32 were found to be incompatible in all three of the infusion solutions. For 7 of the drugs, compatibility was dependent on which infusion solution was used. Ceftobiprole medocaril should not be simultaneously administered via a Y site with drugs with which it was shown to be incompatible.


Asunto(s)
Antibacterianos/química , Cefalosporinas/química , Antibacterianos/administración & dosificación , Cefalosporinas/administración & dosificación , Incompatibilidad de Medicamentos , Glucosa/química , Humanos , Infusiones Intravenosas , Soluciones Isotónicas/química , Tamaño de la Partícula , Vehículos Farmacéuticos/química , Solución de Ringer , Cloruro de Sodio/química , Factores de Tiempo
7.
Ann Pharmacother ; 42(9): 1247-51, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18614750

RESUMEN

BACKGROUND: Esomeprazole sodium (Nexium IV, AstraZeneca) is the S-isomer of omeprazole and acts as a proton pump inhibitor gastric antisecretory agent indicated for the short-term treatment of gastroesophageal reflux disease in patients with a history of erosive esophagitis. Currently, there is no information on the long-term stability of esomeprazole sodium in infusion solutions beyond 12 hours. OBJECTIVE: To evaluate the stability of esomeprazole sodium in 5% dextrose, 0.9% sodium chloride, and lactated Ringer's injection, at 2 concentrations, at room temperature and when refrigerated. METHODS: Triplicate samples of esomeprazole 0.4 and 0.8 mg/mL as the sodium salt were prepared in the solutions required. Stability evaluations were performed initially, over 2 days stored at 23 degrees C, and over 5 days stored at 4 degrees C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual observation. Chemical stability was evaluated by stability-indicating high-performance liquid chromatography. RESULTS: The samples in all 3 infusion solutions were physically stable throughout the study. None of the samples had evidence of visible haze or particulates. Most samples developed a slight yellow discoloration within 24 hours, but this discoloration was not accompanied by an excessive loss of drug content. The esomeprazole sodium samples in all 3 infusion solutions exhibited less than 7% loss over 2 days at 23 degrees C and over 5 days at 4 degrees C. CONCLUSIONS: Esomeprazole 0.4 and 0.8 mg/mL as the sodium salt in the infusion solutions tested is chemically and physically stable for at least 2 days at room temperature and 5 days under refrigeration.


Asunto(s)
Antiulcerosos/química , Esomeprazol/química , Estabilidad de Medicamentos , Almacenaje de Medicamentos , Glucosa/química , Humanos , Soluciones Isotónicas/química , Omeprazol/química , Cloruro de Polivinilo/química , Lactato de Ringer , Cloruro de Sodio/química , Soluciones/química , Factores de Tiempo
8.
Am J Health Syst Pharm ; 65(13): 1261-5, 2008 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-18574017

RESUMEN

PURPOSE: The compatibility of doripenem diluted for infusion with 82 other drugs during simulated Y-site administration was studied. METHODS: Five-milliliter samples of doripenem 5 mg/mL in 5% dextrose injection and separately in 0.9% sodium chloride injection were combined with 5 mL of 82 other drugs, undiluted or diluted in 5% dextrose injection or 0.9% sodium chloride injection. Visual examinations were performed with the unaided eye in fluorescent light and using a Tyndall beam to enhance visualization of small particles and low-level turbidity. The turbidity of each sample was measured, and particulate content was evaluated. Samples were inspected initially and one and four hours after preparation. RESULTS: Of the drugs tested, doripenem 5 mg/mL in 5% dextrose injection and in 0.9% sodium chloride injection was incompatible with diazepam, potassium phosphates, and undiluted propofol. Doripenem 5 mg/mL in 0.9% sodium chloride injection but not in 5% dextrose injection was incompatible with amphotericin B-containing drugs due to the diluent. Doripenem was found to be compatible when combined with the other 75 drugs for at least four hours. CONCLUSION: Doripenem 5 mg/mL in 5% dextrose injection or in 0.9% sodium chloride injection was physically compatible for four hours at room temperature with 75 drugs during simulated Y-site administration. Three drugs combined with doripenem in 5% dextrose injection or 0.9% sodium chloride injection and 7 drugs combined with doripenem in 0.9% sodium chloride injection resulted in unacceptable precipitation or an increase in measured haze and should not be simultaneously administered with doripenem admixtures.


Asunto(s)
Carbapenémicos/administración & dosificación , Incompatibilidad de Medicamentos , Antibacterianos/administración & dosificación , Doripenem , Inyecciones Intravenosas , Nefelometría y Turbidimetría/métodos
9.
Int J Pharm Compd ; 12(2): 156-60, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-23969608

RESUMEN

Palonosetron hydrochloride is a longer-acting selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting and is being evaluated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50 mcg/mL when mixed with any of the neuromuscular blocking drugs cisatracurium besylate 0.5 mg/mL, rocuronium bromide 1 mg/mL, succinylcholine chloride 2 mg/mL, and vecuronium bromide 1 mg/mL during simulated Y-site administration. Triplicate samples of palonosetron hydrochloride with each of the neuromuscular blocking drugs were tested. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by high-performnace liquid chromatography. All of the admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the study. The drug concentration was unchanged in all of the samples tested. Palonosetron hydrochloride is physically and chemically stable with cisatracurium besylate, rocuronium bromide, succinylcholine chloride, or vecuronium bromide at the concentrations tested during simulated Y-site administration over 4 hours at ambient room temperature.

10.
Int J Pharm Compd ; 12(2): 170-3, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-23969611

RESUMEN

Palonosetron hydrochloride is a relatively long-acting selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting and is being evaluated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50 mcg/mL when mixed with gentamicin sulfate 5 mg/mL, metronidazole 5 mg/mL, or vancomycin hydrochloride 5 mg/mL during simulated Y-site administration. Duplicate samples of palonosetron hydrochloride with each of the anti-infectives were tested. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by high-performance liquid chromatography. All of the admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the study. The drug concentration was unchanged in all of the samples tesed. Palonosetron hydrochloride is physically and chemically stable with gentamicin sulfate, metronidazole, or vancomycin hydrochloride at the concentrations tested during simulated Y-site administration over 4 hours at ambient room temperature.

11.
Int J Pharm Compd ; 12(3): 276-8, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-23969719

RESUMEN

The physical compatibility of caspofungin acetate injection with selected other drugs during simulated Y-site coadministration was evaluated by visual observation and turbidity measurement. Five-milliliter samples of caspofungin acetate 0.7 mg/mL in 0.9% sodium chloride injection were combined with 5 mL of 67 other drugs including antineoplastics,analgesics, anti-infectives, and supportive care drugs, undiluted or diluted in 0.9% sodium chloride injection or 5% dextrose injection, and with a parenteral nutrition admixture. Visual examinations were performed with the unaided eye in normal laboratory fluorescent light and with a Tyndall beam (high-intensity monodirectional light beam) to enhance visualization of small particles and low-level turbidity. The turbidity of each sample was measured as well. The sample mixtures were evaluated immediately and at 1 and 4 hours after preparation. Nineteen of the drugs tested and the parenteral nutrition admixture were incompatible with caspofungin acetate 0.7 mg/mL during the 4-hour observation period. The remaining drugs were compatible for at least 4 hours. Gross precipitation or turbidity changes visible in normal diffuse room light with the unaided eye occurred with 18 drugs and with the parenteral nutrition admixture. Microprecipitation of particulates not visible with the unaided eye occurred with cytarabine. The measured turbidity of the caspofungin acetate control solutions and the compatible test samples remained essentially unchanged throughout the observation period. In combination with caspofungin acetate, 48 drugs and a parenteral nutrition admixture were considered to be physically compatible. In contrast, 19 drugs with the parenteral nutrition admixture exhibited frank precipitation or microparticulate formation within 4 hours and should not be simultaneously administered via Y-site with caspofungin acetate.

12.
Int J Pharm Compd ; 12(4): 368-71, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-23969774

RESUMEN

The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron hydrochloride 50 mcg/mL when mixed with undiluted glycopyrrolate 0.2 mg/mL and neostigmine methylsulfate 0.5 mg/mL during simulated Y-site administration. Duplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of glycopyrrolate and neostigmine methylsulfate injections. Physical stability was assessed by using a multi-step evaluation procedure that included both turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by using a multi-step evalutation procedure that included both turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatography analytical techniques based on the determination of drug concentrations. Evaluations were perfromed initially upon mixing and 1 and 4 hours after mixing. The samples were clear and colorless when viewed with a Tyndall beam. Measured turbidity remained unchanged and particulate content was low and exhibited little change. High-performance liquid chromatography analysis found palonosetron hydrochloride and both glycopyrrolate and neostigmine methylsulfate remained stable throughout the 4-hour test with no drug loss. Palonosetron hydrochloride is physically compatible and chemically stable with glycopyrrolate and neostigmine methylsulfate during simulated Y-site administration.

13.
Int J Pharm Compd ; 12(5): 460-2, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-23969872

RESUMEN

Palonosetron hydrochloride is a longer-acting, selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting ad is being evaluated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50mcg/mL when mixed with Lactated Ringer's injection, 6% hetastarch in lactated electrolyte injection, or 15% mannitol injection during simulated Y-site administration. Duplicate samples of each admixture were tested. The samples were stored and evaluated for 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements, and by visual inspection. Chemical stability was assessed by using high-performance liquid chromatography. All of the admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the observation period. Palonosetron hydrochloride concentration was unchanged in any of the samples throughout the study period. Palonosetron hydrochlorie is physically and chemically stable with Lactated Ringer's injection, 6% hetastarch in lactated elecrolyte injection, or 15% mannitol injection during simulated Y-site administration over 4 hours at ambient room temperature.

14.
Int J Pharm Compd ; 12(6): 524-8, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-23969930

RESUMEN

United States Pharmacopeia Chapter 797 provides guidelines and standards that deal with the preparation, compounding, and labeling of compounded sterile preparations. These standards ensure patient care and safety by defining safe practice. The Chapter gives instructions on determining beyond-use dates for the different risk categories associated with compounded preparations. Each of these categories has specific aspects of environmental personnel, and situational deterrents that Chapter 797 requires to be taken into account. By following the standards of Chapter 797, compounding pharmacists can alleviate danger to the patient and themselves in any situation.

15.
Am J Health Syst Pharm ; 64(11): 1209-13, 2007 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-17519464

RESUMEN

PURPOSE: The physical and chemical compatibility of palonosetron hydrochloride with fentanyl citrate, hydromorphone hydrochloride, meperidine hydrochloride, morphine sulfate, and sufentanil citrate during simulated Y-site administration was studied. METHODS: Test samples were prepared in triplicate by mixing 7.5-mL samples of undiluted palonosetron 50 microg/mL (of palonosetron) with 7.5-mL samples of fentanyl citrate 50 microg/mL, morphine sulfate 15 mg/mL, hydromorphone hydrochloride 0.5 mg/mL, meperidine hydrochloride 10 mg/mL, and sufentanil citrate 12.5 microg/mL (of sufentanil) per milliliter individually in colorless 15-mL borosilicate glass screw-cap culture tubes with polypropylene caps. Physical stability of the admixtures was assessed by visual examination and by measuring turbidity and particle size and content. Chemical stability was assessed by stability-indicating high-performance liquid chromatography. Evaluations were performed immediately and one and four hours after mixing. RESULTS: All of the admixtures were initially clear and colorless in normal fluorescent room light and when viewed with a high-intensity monodirectional light (Tyndall beam) and were essentially without haze. Changes in turbidity were minor throughout the study. Particulates measuring 10 microm or larger were few in all samples throughout the observation period. The admixtures remained colorless throughout the study. No loss of palonosetron hydrochloride occurred with any of the opiate agonists tested over the four-hour period. Similarly, little or no loss of the opiate agonists occurred over the four-hour period. CONCLUSION: Palonosetron hydrochloride was physically and chemically stable with fentanyl citrate, hydromorphone hydrochloride, meperidine hydrochloride, morphine sulfate, and sufentanil citrate during simulated Y-site administration.


Asunto(s)
Analgésicos Opioides/química , Antieméticos/química , Isoquinolinas/química , Quinuclidinas/química , Química Farmacéutica , Cromatografía Líquida de Alta Presión , Incompatibilidad de Medicamentos , Estabilidad de Medicamentos , Infusiones Intravenosas , Nefelometría y Turbidimetría , Palonosetrón , Tamaño de la Partícula , Soluciones Farmacéuticas , Receptores Opioides/agonistas
16.
Am J Health Syst Pharm ; 64(8): 837-41, 2007 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-17420200

RESUMEN

PURPOSE: Using a multiple-step testing medium-risk-level compounding test procedure, the evaluation of two work-practice changes to determine if the changes could effectively reduce the potential for contamination occurrence was conducted. SUMMARY: Along with training and evaluation of aseptic sterile compounding techniques, each individual pharmacist and pharmacy technician at M. D. Anderson Cancer Center must successfully demonstrate aseptic preparation competency annually by performing the complicated multistep aseptic transfers of growth medium with no resulting growth of microorganisms. The multistep aseptic transfers are designed to simulate manual compounding of the most complicated medium-risk-level preparations anticipated as specified in the United States Pharmacopeia's chapter 797. An evaluation of two modest and simple work-practice changes was conducted: The use of bare hands and nonsterile gloves with only initial disinfection with 70% isopropyl alcohol (IPA) during years 1 and 2 (group A) was compared with the use of nonsterile chemotherapy gloves with initial and repeated disinfection with IPA for year 3 (group B) and the use of sterile gloves with initial and repeated disinfection with IPA for year 4 (group C). The process involved multiple discrete manipulations, including reconstitution of dry-growth medium; transfers of growth medium from vials and ampules using syringes, needles, a dispensing pin, and a filter straw; and transfers to an empty plastic i.v. bag. For groups B and C, significant reductions in contaminated samples were found compared with group A. CONCLUSION: The use of protective chemotherapy gloves that were repeatedly disinfected with IPA decreased the contamination rate of pharmacy-compounded sterile preparations.


Asunto(s)
Asepsia/métodos , Composición de Medicamentos/normas , Contaminación de Medicamentos/prevención & control , Ambiente Controlado , Servicio de Farmacia en Hospital/normas , 2-Propanol , Desinfectantes , Desinfección/métodos , Composición de Medicamentos/métodos , Guantes Protectores , Humanos , Preparaciones Farmacéuticas/normas , Farmacéuticos , Farmacopeas como Asunto/normas , Técnicos de Farmacia , Control de Calidad , Esterilización
17.
Int J Pharm Compd ; 11(1): 82-5, 2007.
Artículo en Inglés | MEDLINE | ID: mdl-23974489

RESUMEN

The objective of this study was to evaluate the physical and chemical stability of mixtures of undiluted palonosetron hydrochloride 50 micrograms/mL with undiluted metoclopramide hydrochloride 5 mg/mL and with promethazine hydrochloride 2 mg/mL diluted in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of the undiluted metoclopramide hydrochloride and, separately, with the promethazine hydrochloride dilution. Physical stability was assessed using a multistep evaluation procedure that included both turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatographic analytical techniques based on the determination of drug concentrations. Evaluations were performed initially upon mixing and 1 and 4 hours after mixing. The samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidities remained unchanged; particulate contents were low and exhibited little change. High-performance liquid chromatographic analysis revealed that palonosetron hydrochloride and both metoclopramide hydrochloride and promethazine hydrochloride remained stable throughout the 4-hour test with no drug loss. Palonosetron hydrochloride is physically compatible and chemically stable with undiluted metoclopramide hydrochloride and also with promethazine hydrochloride diluted in 5% dextrose injection during simulated Y-site adminstration.

18.
Int J Pharm Compd ; 11(6): 520-4, 2007.
Artículo en Inglés | MEDLINE | ID: mdl-23994813

RESUMEN

Palonosetron hydrochloride is a relatively long-acting selective 5-HT3 receptor antagonist that has been approved for the prevention of chemotherapy-induced nausea and vomiting and is being ealuated for the prevention of postoperative nausea and vomiting. The objective of this study was to evaluate the physical and chemical stability of palonosetron hydrochloride 50 mcg/mL with the B-lactam antibiotics cefazolin sodium 20 mg/mL, cefotetan disodium 20 mg/mL, and the combination ampicillin sodium-sulbactam sodium 20 mg/mL and 10 mg/mL, respectively, during simulated Y-site administration. The effects of each of the antibiotics on palonosetron hydrochloride in these admixtures were tested in triplicate. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by high-performnace liquid chromatography. All of the admixtures were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the study . The drug concentration was unchanged in all of the samples tested. Palonosetron hydrochloride is physically and chemically stable in admixtures with cefazolin sodium, cefotetan disodium and the combination ampicillin sodium-sulbactam sodium at the concentrations tested during simulated Y-site administration over 4 hours at ambient room temperature.

19.
Bethesda; American Society of Health-System Pharmacists; 14 ed; 2007. 1720 p. tab, graf.
Monografía en Inglés | Coleciona SUS | ID: biblio-927009
20.
Am J Health Syst Pharm ; 63(23): 2379-82, 2006 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-17106012

RESUMEN

PURPOSE: The compatibility of new polyolefin (VISIV) containers with seven drugs that have exhibited sorption to polyvinyl chloride (PVC) containers and sets and an additional four drugs that have exhibited leaching of plasticizer or other polymer matrix components from PVC containers and sets was studied. METHODS: For the sorption portion of the study, amiodarone hydrochloride, carmustine, regular human insulin, lorazepam, nitroglycerin, sufentanil citrate, and thiopental sodium and their respective reference standards were used. For the leaching portion of the study, docetaxel, paclitaxel, tacrolimus, teniposide, and diethylhexyl phthalate (DEHP) reference standard, were used. A 350-mL quantity of each test admixture was prepared, and 100-mL aliquots were transferred into three of the VISIV containers. The containers were stored at ambient temperature and exposed to fluorescent light. Samples for analysis were taken initially and after 24 hours for all drugs except carmustine, which was evaluated for only 6 hours because of its limited stability. High-performance liquid chromatography was used to evaluate each test solution. RESULTS: Of the seven drugs subject to sorption to PVC, only insulin showed a substantial loss in the VISIV containers. Carmustine exhibited a loss consistent with the drug's known chemical stability. None of the drugs that are known to leach plastic components, such as DEHP plasticizer, from PVC equipment exhibited any leached components in the VISIV containers. CONCLUSION: Of the drugs tested, only insulin exhibited sorption to the new VISIV polyolefin containers. No leaching of plastic components, such as plasticizer, from the containers was found with any of the surfactant-containing drugs.


Asunto(s)
Embalaje de Medicamentos , Estabilidad de Medicamentos , Preparaciones Farmacéuticas/química , Polienos/química , Adsorción , Cromatografía Líquida de Alta Presión , Plastificantes/química , Cloruro de Polivinilo/química , Tensoactivos/química
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