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Biomedical subjects

L A Trissel

Publications and source records attributed to L A Trissel.

13 recordsLinked to original sources
PubMed1992

Turbidimetric assessment of the compatibility of taxol with selected other drugs during simulated Y-site injection.

The compatibility of taxol in 5% dextrose injection with each of 17 other drugs during simulated Y-site injection was studied through visual and turbidimetric assessment. A 4-mL sample of taxol 1.2 mg/mL in 5% dextrose injection was combined with a 4-mL sample of each of 17 drugs at concentrations that are used clinically. Each combination was prepared in duplicate, with the order of mixing reversed between the two samples. The samples were inspected visually in normal fluorescent light, in high-intensity light, and against light and dark backgrounds with a 3-diopter magnification lens initially and at 30 minutes, one hour, and four hours. A turbidimeter was used to measure the turbidity of each drug combination in triplicate initially and at one and four hours after mixing. None of the drug combinations resulted in visual evidence of precipitation, color change, or gas production, and the turbidity was essentially unchanged over the four-hour observation period. Taxol 1.2 mg/mL in 5% dextrose injection exhibited no visual or turbidimetric evidence of incompatibility when combined with each of 17 other drugs during simulated Y-site injection. However, drug combinations for which no visual or turbidimetric incompatibility is apparent may not be chemically stable; therefore, practitioners should be cautious in applying these findings to the clinical setting.

Alkaloids↗
PubMed1991

Stability, compatibility, and plasticizer extraction of taxol (NSC-125973) injection diluted in infusion solutions and stored in various containers.

The stability of taxol (NSC-125973) in various diluents and containers was determined, and the extent of leaching of di(2-ethylhexyl) phthalate (DEHP) from polyvinyl chloride (PVC) bags caused by the taxol formulation was measured. A taxol formulation consisting of a 6-mg/mL solution of taxol in 50% polyoxyethylated castor oil and 50% dehydrated ethanol was added to 50- and 100-mL glass bottles, PVC infusion bags, and polyolefin containers containing 5% dextrose injection or 0.9% sodium chloride injection to give initial nominal taxol concentrations of 0.3, 0.6, 0.9, and 1.2 mg/mL. The containers were maintained at 20-23 degrees C for 12-24 hours. Samples were assayed by stability-indicating high-performance liquid chromatography, and clarity was determined visually. An experiment was run to ascertain whether DEHP would leach from a PVC administration set during a simulated infusion. There was no substantial loss of taxol over 24 hours. Filtration through a membrane resulted in no loss of taxol. All the solutions initially appeared hazy. Solutions stored in PVC bags became more hazy with time than solutions stored in glass or polyolefin containers. The haze seen in PVC bags was traced to leaching of DEHP. Agitation had no effect on the extent of leaching. Leaching was also seen during simulated delivery through PVC administration sets. No DEHP was detected when solutions were stored in glass or polyolefin containers and infused through polyethylene-lined sets. At the dilutions studied, taxol was visually and chemically stable for up to 24 hours.(ABSTRACT TRUNCATED AT 250 WORDS)

Alkaloids↗
PubMed1991

Design and implementation of an electronic investigational drug accountability system.

A software system designed to maintain protocol-specific investigational drug accountability records is described. The University of Texas M. D. Anderson Cancer Center and Cygnus Systems Development, Inc., worked together to create an electronic investigational drug accountability system (IDRx), which meets the requirements of the National Cancer Institute. This system performs record keeping, stores information on drugs and protocols, and generates standard and customized reports. On-screen assistance makes it easy to use. Security is achieved by granting access only to authorized users, and an audit trail is automatically generated. Systematic implementation at M. D. Anderson, initially in the investigational drug control area and subsequently in the satellite pharmacies, has resulted in increased accuracy and efficiency, and few problems have been encountered. The IDRx software package is useful for keeping records, generating reports, and tracking and evaluating data associated with an investigational drug accountability system.

Cancer Care Facilities↗
PubMed1989

Stability of pibenzimol hydrochloride in commonly used infusion solutions and after filtration.

The stability of pibenzimol hydrochloride was evaluated after reconstitution, after addition to several intravenous fluids, and after filtration. Vials containing pibenzimol hydrochloride 50 mg were reconstituted with 2.5 mL of 0.9% sodium chloride injection to 20 mg/mL. For determination of drug stability in intravenous fluids, vial contents were further diluted to 0.15 mg/mL by injection into glass containers and polyvinyl chloride (PVC) bags containing 250 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection. Pibenzimol concentrations were determined immediately after preparation and at various intervals after storage at 4-6 degrees C or 25 degrees C by means of a stability-indicating, high-performance liquid chromatographic technique. Vial contents were inspected visually for color changes, and pH was measured. Determinations were also made of the stability of pibenzimol 0.15 mg/mL in 0.9% sodium chloride injection after simulated infusions using a 0.22-micron filter set at 25 degrees C. All study solutions and admixtures retained more than 90% of the initial pibenzimol concentration. The greatest loss of drug (6-7%) occurred after 24 hours in lactated Ringer's injection in both glass and PVC containers and in 0.9% sodium chloride injection in PVC bags. No drug loss occurred as a result of filtration. Reconstituted pibenzimol hydrochloride and admixtures of pibenzimol in 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection in glass or PVC containers are stable for at least 24 hours at 25 degrees C. Filtration has no effect on stability.

Benzimidazoles↗
PubMed1978

Pharmaceutical assessment of amygdalin (Laetrile) products.

The National Cancer Institute (NCI) recently acquired a large supply of formulated products of amygdalin manufactured by Cyto Pharma of Mexico, for possible use in a clinical trial in the US. Tablets for oral administration and ampules of the injectable produce were obtained. Both forms were extensively analyzed and evaluated by several analytic and pharmaceutical laboratories under contract with the NCI. Analytic test procedures were developed to determine the chemical integrity and quantitative composition of the formulated products. Routine physical and biologic tests were also performed to evaluate the manufacturing quality of both dosage forms. The results indicate that both the oral and injectable forms of amygdalin were substandard by US criteria for manufactured pharmaceutical products. All samples were determined to be chemically subpotent, mislabeled, and of poor manufacturing quality. More than 20 samples of the ampules were found by visual inspection to contain microbial contamination. Other samples were found to be pyrogenic. Based on the results of the testing performed, both tablet and ampule forms of amygdalin manufactured by Cyto Pharma of Mexico are considered unfit for use in man.

Administration, Oral↗