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Biomedical subjects

F P Mitrano

Publications and source records attributed to F P Mitrano.

14 recordsLinked to original sources
PubMed1991

Parenteral nutrient admixtures as drug vehicles: theory and practice in the critical care setting.

Parenteral nutrient (PN) admixtures are the most complex, extemporaneously compounded formulations routinely prepared for hospitalized and home-based patients. In addition, drugs are added with increasing frequency to PN admixtures, thus presenting even greater physicochemical challenges to this highly complex pharmaceutical product. The continuous infusion of selected drugs may provide pharmacokinetic and therapeutic advantages over conventional, intermittent, bolus methods of administration. Fluid conservation, cost savings, and a possible decrease in the risk of infection through reduced catheter manipulation and simplification of therapy provide additional incentives to consider the use of PN admixtures. The many advantages of PN admixtures make them an attractive approach to cost-effective care, with special clinical benefits achieved in the critical care setting. This article reviews our clinical experience using PN admixtures as drug vehicles for selected drugs and presents some theoretical as well as actual benefits associated with this practice.

Aminophylline↗
PubMed1991

Chemical and visual stability of amphotericin B in 5% dextrose injection stored at 4 degrees C for 35 days.

The chemical and visual stability of amphotericin B in 5% dextrose injection under refrigeration was assessed. Three admixtures of amphotericin B 0.1 mg/mL in 5% dextrose injection and three admixtures of amphotericin B 0.25 mg/mL in 5% dextrose injection were aseptically prepared in polyvinyl chloride (PVC) bags. Immediately after preparation (at time zero), six 5-mL samples were aseptically transferred from each admixture to sterile collection tubes. Three of the samples from each admixture were quick-frozen for later assay by stability-indicating high-performance liquid chromatography (HPLC), and the other three were immediately assessed for pH. Each of the six admixtures was also assessed visually under fluorescent light and 2x magnification for color change, turbidity, gas evolution, and precipitation. The admixtures were stored in PVC bags at 4 degrees C and protected from light. Six 5-mL samples were withdrawn from each admixture at 10, 21, and 35 days. Three of the samples from each admixture were assessed for pH, and three were quick-frozen for subsequent HPLC assay. There was no substantial loss or deterioration of amphotericin B during the 35-day study. At no time was the mean concentration of amphotericin B in the samples less than 96.4% of the concentrations at time zero for the 0.1-mg/mL samples or less than 96.6% of the time zero concentrations for the 0.25-mg/mL samples. There were no appreciable changes in pH, and there was no visual evidence of instability in any of the samples.(ABSTRACT TRUNCATED AT 250 WORDS)

Amphotericin B↗
PubMed1991

Stability and compatibility of ganciclovir sodium in 5% dextrose injection over 35 days.

The stability and compatibility of ganciclovir sodium in 5% dextrose injection over 35 days were assessed. Nine admixtures of ganciclovir sodium 1, 5, and 10 mg/mL in 5% dextrose injection were aseptically prepared. Immediately thereafter, six samples were aseptically withdrawn from each admixture into sterile collection tubes. Three of the samples were frozen for stability-indicating high-performance liquid chromatographic (HPLC) assay at a later date, and the other three were immediately assessed for pH. Each admixture was also assessed visually for color change, turbidity, gas evolution, and precipitation. The admixtures were stored in the dark at 4-8 degrees C and sampled at 10 and 35 days. There was no significant loss of ganciclovir over the 35-day study period. No admixture at any time contained less than 93.4% or more than 103.7% of its initial ganciclovir concentration. There were no appreciable pH changes, and there was no evidence of visual incompatibility. Ganciclovir sodium 1, 5, and 10 mg/mL in 5% dextrose injection was stable for at least 35 days when stored in the dark at 4-8 degrees C.

Chromatography, High Pressure Liquid↗
PubMed1989

Home intermittent amrinone infusions in terminal congestive heart failure.

The prevalence of congestive heart failure (CHF) and its progressive degenerative course continue to generate pressure for alternative, more effective means of treatment. A confluence of factors, including the number of Americans with CHF, the spiraling costs of hospital care, and increasing interest in cost-effective home care, contribute to the current efforts to develop an effective, nontoxic therapy that effectively increases myocardial contractility and output and can be administered within the confines of the home. Given that preliminary clinical trials in the hospital setting with amrinone have produced positive results, the transition of this therapy to the home, when administered intermittently via central venous catheter and infusion pump, was undertaken. In order to prolong and increase quality of life in terminal CHF patients, intermittent amrinone infusions were provided at home to four patients as part of our pilot program. All four patients met the criteria for New York Heart Association (NYHA) functional class IV heart failure, and none had responded to conventional therapy suitable for outpatient maintenance. The patients also shared strong family support and an intense desire to improve the quality of remaining life. All four patients and designated family members were trained in the specifics of aseptic technique, medication dose preparation, central venous catheter care, and operation of an infusion pump. An ambulatory pump was used in three of the four patients. Subsequent to the initiation of intermittent home amrinone infusions, all four patients had greater tolerance to limited exercise and/or ambulation secondary to increased cardiac output and diuresis. Patients survived 8, 10, 47, and 56 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1987

Drug stability guidelines for a continuous infusion chemotherapy program.

Recent technological advances in ambulatory infusion pumps, the development of safe long-term venous access devices, and the clinical advantages of the continuous infusion of chemotherapeutic agents have facilitated the delivery of ambulatory infusion chemotherapy. This method of therapy provides chemotherapeutic drug infusions over a period of several days, weeks, or months. Therefore, the antineoplastic drugs used must be chemically stable for the duration of the infusion. However, an extensive compilation of extended stability (greater than 24 hours) data of intravenous solutions containing antineoplastic drugs is lacking, and as such, pharmacy concerns have been significant. We have accumulated extended chemical stability data (greater than or equal to 90% of time zero concentration) based on literature surveys and manufacturer written correspondence. The accumulated data, presented herein, support the following minimum stability limits (in days) with regard to single and multiple drug admixtures stored in 60-ml polyvinylchloride (PVC) reservoir bags (Cormed, Medina, NY) at room temperature: cytarabine (8), cyclophosphamide (6), doxorubicin (14), epidoxorubicin (14), floxuridine (8), fluorouracil (14), methotrexate, mitomycin-C (14), cisplatin (14), thiotepa (7), vinblastine (8), methotrexate/fluorouracil (14), doxorubicin/vinblastine (8), doxorubicin/cyclophosphamide (7), fluorouracil/cyclophosphamide (7), and doxorubicin/vincristine (14).

Antineoplastic Agents↗
PubMed1986

Microbial contamination potential of solutions in prefilled disposable syringes used with a syringe pump.

The sterility of trypticase soy broth (TSB) that was frozen and thawed in disposable plastic syringes and infused via syringe pump was studied to determine whether ambient air or personnel-transferred contaminants compromised the sterility of the solution. Samples of TSB (10, 20, 30 mL) were prepared aseptically in syringes of three different brands--150 samples for each volume (50 for each manufacturer). The syringes were placed in zip-lock bags, stored for 24 hours at -15 to -20 degrees C, and thawed for three hours. Both positive and negative controls were used. For the test samples, infusion sets were connected to the syringes under aseptic conditions, and the solution was infused via syringe pump in ambient air into polyvinyl chloride minibags before incubation. The remaining samples were prepared in the same manner as the test solutions except that they were intentionally challenged with Bacillus subtilis introduced distal to the plunger. All samples were inspected visually for turbidity after a 14-day incubation period. There was no growth in any of the test infusion samples or in samples that were intentionally contaminated. The negative controls showed no growth; all of the positive controls showed growth. The sterility of solutions frozen in disposable plastic syringes does not appear to be compromised by touch contamination of the plunger shaft or by airborne microorganisms settling on the infusion system.

Bacteria↗
PubMed1985

Microbial contamination potential of sterile disposable plastic syringes.

The contamination potential of sterile disposable plastic syringes was evaluated after subjecting the syringes to both simulated in-use conditions and an intentional microbial challenge. Lots of 20 Luer-lock syringes in 10 or 12-cu cm and 20- or 30-cu cm sizes from three manufacturers were tested. Sampling was conducted using 30-ml vials of sterile aerobic culture media containing 14C-labeled substrates. Microbial contamination was confirmed by both visual observation of the turbidity caused by colonization and instrumental detection of 14CO2 caused by the microbial metabolism of 14C-substrates. No contamination of 120 samples was found after the ribbed plunger shaft was grasped by a bare, unprepared dry hand during five cycles of filling and injecting the medium into the vials without removing the needles from the stoppers. When this sampling technique was applied to the syringes inoculated on the upper piston surface with Bacillus subtilis suspension, a 100% contamination rate was observed in 120 samples each under both positive and negative in-vial pressure. Grasping the ribbed plunger shaft of disposable plastic syringes with a dry bare hand did not compromise the sterility of the syringe contents in this study; however, this practice should be avoided when possible. Personnel should absolutely avoid introducing fluid-borne microbial contaminants into the distal barrel end of these syringes because the contents are readily labile to contamination under these conditions.

Bacillus subtilis↗
PubMed1982

Factors affecting insulin adherence to type I glass bottles.

Some physicochemical factors that could account for insulin adherence to type I glass bottles from admixtures of insulin with 5% dextrose (D5W) and 0.9% sodium chloride (NS) injections were studied. Samples of three volumes of NS or D5W containing insulin I 125 were mixed in three sizes of bottles to test the effect of surface area and volume. Appropriate volumes of insulin were combined with insulin I 125 and D5W or NS to yield solutions containing nine concentrations of insulin to test the effect of insulin concentration. Appropriate volumes of KCl injection to yield six concentrations were combined with insulin I 125 and NS or D5W to test the effect of KCl concentration. All samples were assayed by gamma scintillation. In general, there was a direct relationship between the percentage of insulin adhering and the container surface area. In D5W admixtures, as the fill volume at constant insulin I 125 concentration was doubled and quadrupled, the adherence of insulin decreased in all three bottle sizes (200, 250, and 500 ml). In NS admixtures, however, this effect was seen only with the 250-ml bottle. Increasing insulin concentrations over the range of 50-300 units/liter in D5W and 0-50 units/liter in NS resulted in decreased adherence. The addition of 1-60 meq/liter of KCl resulted in a significant decrease of insulin adhering from D5W and an insignificant decrease from NS admixtures. The percentage of insulin adhering to type I glass surfaces may be reduced to 25% or less by preparing i.v. admixtures in full bottles of D5W or NS at insulin concentrations of 25 to 300 units/liter. The addition of KCl, when therapeutically appropriate, will further decrease the extent of insulin adherence.

Adsorption↗
PubMedDate not supplied

Stability and compatibility of cimetidine hydrochloride and aminophylline in dextrose 5% in water injection.

A controlled study was conducted to assess the physical compatibility of cimetidine hydrochloride (HCl) and aminophylline and the chemical stability of an admixture of the two medications in dextrose 5% in water (D5W) injection, over 48 hours at room temperature. Three one-liter admixtures were prepared, each containing cimetidine HCl 1200 mg and aminophylline 500 mg in D5W. One liter of only cimetidine HCl 1200 mg in D5W and one liter of only aminophylline 500 mg in D5W served as controls. Samples drawn from the five admixtures and immediately frozen were analyzed for cimetidine and theophylline content at times 0, 1, 6, 24, and 48 hours using high-performance liquid chromatography. Chemical stability of each drug was assessed relative to its time-zero concentration. Samples were also drawn from each test and control solution at every time interval to assess the pH. Admixtures were stored at room temperature out of direct sunlight for the duration of the study, and were visually inspected for color change, turbidity, cloudiness, and precipitation. Recovery of cimetidine and theophylline at all test intervals, pH assessments, and visual inspections of the admixtures showed that cimetidine HCl and aminophylline are both chemically stable and physically compatible for 48 hours at room temperature in one liter of D5W.

Aminophylline↗