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Annual Meeting Abstracts 2004<br />

FEATURE<br />

Conclusions: In a busy 1,000-bed teaching hospital,<br />

various physician orders for lymphoscintigraphy<br />

doses required organization. A nuclear pharmacy<br />

preparation guideline chart provides a useful<br />

guide to accurately dispense Tc-99m sulfur colloid<br />

for lymphoscintigraphy procedures.<br />

116—PREPARATION OF [C-11]-CFT FOR<br />

PET MEASUREMENT OF CEREBRAL<br />

DOPAMINE TRANSPORT ACTIVITY.<br />

Moerlein S, Perlmutter J, Patel P, Welch M,<br />

Washington University in St. Louis. E-mail:<br />

moerleins@mir.wustl.edu<br />

Objective: Positron emission tomography (PET)<br />

is used to assess changes in degenerative disorders<br />

such as Parkinson’s disease or Huntington’s disease.<br />

With the goal <strong>of</strong> developing a more sensitive tracer<br />

for measurement <strong>of</strong> these changes, we have optimized<br />

the preparation <strong>of</strong> carbon-11 labeled β-CFT<br />

[(-)-2-β-carbomethoxy-3-β-(4 fluoropheny)tropane]<br />

suitable for clinical application in human subjects.<br />

Methods: [C-11]Carbon dioxide was produced<br />

using the 16-MeV proton beam <strong>of</strong> a JSW 16/8 medical<br />

cyclotron. The target was emptied into a<br />

PETtrace MeI MicroLab. This microprocessor-controlled<br />

device catalytically converts [C-11]carbon<br />

dioxide to [C-11]methane, which is subsequently<br />

iodinated to yield [C-11]methyl iodide.<br />

Approximately 12 minutes after target emptying,<br />

the [C-11]methyl iodide is bubbled into a solution<br />

<strong>of</strong> 0.5 mg <strong>of</strong> (nor-methyl)β-CFT in 200 µL <strong>of</strong><br />

dimethylformamide cooled in an ice bath. The reaction<br />

mixture is heated at 70º C for 3 minutes. The<br />

crude product mixture is diluted with 4 mL <strong>of</strong> HPLC<br />

solvent and purified using semipreparative HPLC<br />

(Partisil 10 ODS-3; acetonitrile/10 mM monobasic<br />

potassium phosphate (40/60); 5 mL/min). The product<br />

fraction is diluted with 150 mL <strong>of</strong> 4 µM sodium<br />

hydroxide, and passed through a SepPak C18<br />

extraction cartridge, which is then rinsed with 10<br />

mL Sterile Water for Injection, USP. The radiopharmaceutical<br />

is eluted from the SepPak with 1.1<br />

mL <strong>of</strong> Ethyl Alcohol, USP, through a 0.2 µ<br />

Acrodisc filter into a 10 mL sterile empty vial. The<br />

solution is diluted with 10 mL <strong>of</strong> Saline for<br />

Injection, USP to give the reformulated [C-11]β-<br />

CFT in a 10% ethanolic solution.<br />

Results: Batch yields <strong>of</strong> [C-11]β-CFT prepared<br />

in this manner are 28.3 ± 10.1 mCi (N = 41), with<br />

specific activity >1000 Ci/mmol and radiochemical<br />

purity >97%, and are sterile and apyrogenic. The<br />

overall preparation time is 60 minutes EOB.<br />

Conclusions: This methodology is a reliable<br />

method for the clinical production <strong>of</strong> [C-11]β-CFT<br />

for PET studies <strong>of</strong> human subjects.<br />

117—QUALITY CONTROL OF [F-<br />

18]FACBC: A NON-NATURAL AMINO ACID<br />

TUMOR IMAGING AGENT. Crowe R, Yu W,<br />

Goodman M, Emory University. E-mail:<br />

ronald_crowe@emoryhealthcare.org<br />

Objective: FACBC, anti-1-amino-3-[F-18]fluorocyclobutyl-1-carboxylic<br />

acid, is a non-natural<br />

amino acid that has shown promise for PET tumor<br />

imaging. An improved method <strong>of</strong> synthesis has been<br />

reported that demonstrates high stereoselectivity<br />

and possible suitability for larger scale preparation.<br />

Determine and develop potential quality control<br />

(QC) methods to ensure safe intravenous administration<br />

and begin data collection in anticipation <strong>of</strong><br />

IND submission.<br />

Methods: Design: FACBC was synthesized<br />

using an automated chemical process control unit<br />

(CPCU) with a computer interface (CTI, Inc.). Upon<br />

completion <strong>of</strong> synthesis, the FACBC is purified by<br />

passage through an Ion Retard column assembly<br />

and 0.22-µm sterilizing filter before collection. The<br />

QC <strong>of</strong> FACBC included analysis for sterility, pyrogenicity,<br />

pH, clarity, and purity. Purity is evaluated<br />

using TLC with radiometric detection, GC analysis,<br />

and timed radioactive decay. Sterility is evaluated<br />

per USP guidelines, and PET is performed using the<br />

LAL gelclot method. Setting: All procedures performed<br />

in a licensed radiopharmacy laboratory.<br />

Patients: Limited to patients presenting probable<br />

metastatic brain carcinoma and referred by neurosurgery<br />

services <strong>of</strong> the Emory Healthcare System.<br />

Results: For all lots <strong>of</strong> FACBC, radiochemical<br />

and radionuclidic purity have been greater than<br />

99%. Sterility and endotoxin testing have been negative.<br />

pH range has been 5.5–6.0. GC analysis has<br />

shown only trace amounts <strong>of</strong> organic solvents.<br />

FACBC has been used in 12 people at Emory with<br />

no local, neurologic, or systemic toxicities<br />

observed. Additional QC testing procedures have<br />

been identified as potential requisites for release.<br />

Conclusions: QC results have exceeded established<br />

in-house limits <strong>of</strong> acceptability. However,<br />

more investigation into the characterization <strong>of</strong><br />

major nonradioactive species present and evaluation<br />

<strong>of</strong> the potential toxicity <strong>of</strong> FACBC must be completed<br />

to obtain regulatory approval for extensive<br />

human use. The Emory FACBC study is a pilot<br />

study to determine subsequent broad study feasibility<br />

and generate pilot data and is under the oversight<br />

<strong>of</strong> the Emory Radioactive Drug Research<br />

Committee.<br />

118—RADIOPHARMACISTS’ SATISFAC-<br />

TION WITH THEIR EDUCATION/TRAIN-<br />

ING, JOB SATISFACTION, AND PROFES-<br />

SIONAL PRACTICE PATTERNS: RESULTS<br />

OF A NATIONAL SURVEY. Wittstrom K,<br />

Norenberg J, Borrego M, University <strong>of</strong> New<br />

Mexico. E-mail: aaaaa@unm.edu<br />

Objective: This study assessed radiopharmacists’<br />

satisfaction with their radiopharmacy training and<br />

education (T&E) and job satisfaction. The study<br />

also identified factors that have influenced radiopharmacists’<br />

decision to enter, continue, or exit this<br />

specialty practice.<br />

Methods: A 20-item, self-administered survey<br />

was developed and pilot-tested using a convenient<br />

sample <strong>of</strong> practicing radiopharmacists. The study<br />

sample included all U.S. radiopharmacists identified<br />

through databases <strong>of</strong> licensed pharmacists, radiopharmacy<br />

continuing education program subscribers,<br />

and alumni records (N = 789). Follow-up<br />

surveys were mailed to nonrespondents.<br />

Results: Overall usable response rate was 41%<br />

(N = 327). Of those respondents practicing radiopharmacy,<br />

64% were Board Certified Nuclear<br />

<strong>Pharmacists</strong> (BCNPs), 81% were men, 64% listed<br />

BS Pharmacy as their highest degree, and 54%<br />

received their T&E through a certificate program.<br />

Respondents trained in an academic setting felt<br />

more prepared to perform radiopharmacy practice<br />

functions, compared with those completing a certificate<br />

program. Board certification did not influence<br />

preparedness to perform radiopharmacy practice<br />

functions. Overall, most radiopharmacists were satisfied<br />

with their current position. Of the respondents<br />

practicing pharmacy, the most frequently cited reasons<br />

for leaving radiopharmacy practice, included<br />

family reasons, difficult hours, and management<br />

issues.<br />

Conclusions: The results <strong>of</strong> the survey provide<br />

information regarding radiopharmacists´ satisfaction<br />

with their T&E, and job satisfaction with their<br />

current radiopharmacy position. Results <strong>of</strong> this<br />

study can be used to improve existing radiopharmacy<br />

educational program curricula and to develop<br />

new continuing radiopharmacy education programs<br />

to address perceived T&E deficiencies.<br />

119—STABILITY OF FILTERED TC-99M<br />

SULFUR COLLOID. Ponto J, University <strong>of</strong> Iowa.<br />

E-mail: james-ponto@uiowa.edu<br />

Objective: Filtered Tc-99m sulfur colloid has<br />

recently gained popularity for use in lymphoscintigraphic<br />

mapping <strong>of</strong> lymphatic flow and identification<br />

<strong>of</strong> sentinel lymph nodes. This study was undertaken<br />

to evaluate the stability <strong>of</strong> filtered Tc-99m<br />

sulfur colloid stored in glass vials over a period <strong>of</strong> 8<br />

hours.<br />

Methods: About 100 mCi <strong>of</strong> routinely prepared<br />

Tc-99m sulfur colloid was passed through a 0.1-<br />

micron filter (Millex-VV, Millipore Corp, Bedford,<br />

Mass.). The filtrate was collected in a sterile glass<br />

vial (Hollister-Stier, Spokane, Wash.) and diluted to<br />

a concentration <strong>of</strong> about 4 mCi/mL. Samples were<br />

withdrawn from this stock vial at 2-hour intervals<br />

and subjected to the following testing: (1) thin-layer<br />

chromatography to assess radiochemical purity; (2)<br />

measurement <strong>of</strong> specific activity (mCi/gram) as<br />

assayed in a dose calibrator and weighed on an analytical<br />

balance, to indirectly assess<br />

sedimentation/adsorption to container walls; and (3)<br />

measurement <strong>of</strong> specific activity (mCi/gram) following<br />

re-filtration through another 0.1-micron filter<br />

to indirectly assess changes in particle size (e.g.,<br />

aggregation or clumping). This procedure was<br />

repeated on a total <strong>of</strong> ten separate preparations <strong>of</strong><br />

filtered Tc-99m sulfur colloid.<br />

Results: Results are expressed as mean (range)<br />

values. (1) Radiochemical purity <strong>of</strong> the filtered Tc-<br />

99m sulfur colloid in the stock vial decreased slightly<br />

from 99.3% (98.7–99.7%) at the time <strong>of</strong> preparation<br />

to 98.6% (98.3–99.5%) at 8 hours. (2) The specific<br />

activity <strong>of</strong> filtered Tc-99m sulfur colloid in the<br />

stock vial decreased slightly to 97% (94–101%) <strong>of</strong><br />

its original value at 8 hours. (3) The specific activity<br />

<strong>of</strong> refiltered samples decreased slightly to 94%<br />

2004 Abstracts <strong>of</strong> Contributed Papers<br />

Vol. 44, No. 2 March/April 2004 www.japha.org <strong>Journal</strong> <strong>of</strong> the <strong>American</strong> <strong>Pharmacists</strong> <strong>Association</strong> 255<br />

<strong>Downloaded</strong> From: http://japha.org/ on 01/25/2014

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