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RE: I-131 capsules
John:
I can speak to how I-123 diagnostic capsules are made, and I believe that I-131 capsules are made the same way. I helped to get the IND for company's I-123 product - being involved in the research, development and FDA application. Later I helped to run the production line and I set-up the distribution process (and about three other hats! It was a small company).
It's quite simple: A gelatin capsule is filled with sugar, then a specific quantity of stabilized NaI in water is dropped into the sugar. You can try adding a drop of water to table sugar and you will see that the sugar clumps pretty hard. The capsule cap is then inserted over the capsule.
It doesn't sound like the manufacturer seals the capsule halves together - we didn't. We occasionally got a batch of capsules where the caps would come off pretty easily and QC would reject them. The biggest QC problem was if the specific activity was low, thus the volume of liquid high, then the gelatin would get soggy and deform. So we used very high specific activity, and of course there are the HP problems associated with high specific activity. There was never a dull moment.
In your scenario, as long as the sugar remains in the lower half of the capsule, which it should as the wetted sugar will usually bind a little with the gelatin, then the potential for contamination is fairly small, but not out of the question.
PS: Things you can do with rejected gelatin capsules.
- play table soccer at the local bar (boy, we did this a lot)
- spill them on the ground in front of a cop.
- give them to your cat to bat around.
- see how many you can stuff in your mouth (I think the bar also had something to do with this)
- replace all of your mom's prescription drugs
- replace your buddy's illegal drugs (be prepared to run)
- fill a jar and have a fund raiser "guess how many" contest. Keep the money.
Larry Grimm, Senior HP
UCLA EH&S/ Radiation Safety Division
* lgrimm@admin.ucla.edu Phone:310/206-0712 Fax: 310/206-9051
Cell: 310/863-5556 Pager:1-800-233-7231ext93569
* On Campus: 501 Westwood Plaza, 4th Floor, MS 951605
* Off Campus: UCLA Radiation Safety Div, 501 Westwood Plaza 4th
Fl, Box 951605, Los Angeles, CA 90095-1605
* If this email is not RSD business, the opinions are mine, not
UCLA's.
-----Original Message-----
From: Jacobus, John (NIH/OD/ORS) [mailto:jacobusj@ors.od.nih.gov]
Sent: Friday, December 13, 2002 8:20 AM
To: 'Medical Physics List Server'; 'RadSafe'; 'HPS Medical Physic
Section'
Subject: I-131 capsules
During a recent administration of sealed capsules for a cancer ablation, the
top of the I-131 pill popped off. No kidding.
1. Has this ever happened to anyone else?
2. Has anyone had experience with the material coming out of a capsule?
3. How are the capsules made? Does the manufacturing process preclude the
NaI from coming out of a capsule?
-- John
John P. Jacobus, MS, CHP
Health Physicist
National Institutes of Health
Radiation Safety Branch
21 Wilson Drive, MSC 6780
Bethesda, MD 20892-6780
USA
Ph. -- 301-496-5774
FAX -- 301-496-3544
e-mail: jjacobus@mail.nih.gov
jacobusj@ors.od.nih.gov
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