Cold Kits

The concept reconstitution of a kit is erroneous, because radiolabeling is an active process by which a new chemical compound (a Tc pharmaceutical) is formed involving chemical reactions, in any case the reduction of pertechnetate, and in most cases complex formation, which might need heating in a boiling water bath. Moreover, a kit may be perfectly reconstituted (dissolved) but labeling might be inadequate. 

The instructions given by the manufacturer of the kit should be strictly followed, particularly with respect to the maximum activity and volume of Tc eluate that is transferred to the kit for labeling. The labeled product is a sterile, pyrogen-free solution suitable for intravenous injection. Any abnormality observed by visual inspection of the injection solution is a cause to reject the preparation. Tc radiopharmaceuticals have a short shelf-life (generally 6 h) they are used right after preparation. 

Cold kits are prepacked sets of sterile ingredients designed for the preparation of a specific radiopharmaceutical. Kits are fully tested to verify the specific characteristics, which are guaranteed by the producer. 

In fact, the stability of kits had been of considerable concern until freeze-drying was applied to kit production. Exact filling of the sterilized vials is performed automatically by a sterile dispensing/stoppering device, whereby a certain volume (1 ml) of the kit formulation is delivered and subjected to lyophilization. When closing the vial, nitro- 

Cold kits may also be prepared in a radiopharmacy similar to other medicinal products prepared in a pharmacy. The radiopharmacist then functions as the qualified person responsible for preparation of an official formula (formulation, pharmaceutical requirements, stability, etc.) 

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The composition of radiopharmaceuticals is not constant as it varies with time as the radionuclide disintegrates. Very often, the half-life of the labeled molecule is so short that it must be readily prepared just before its administration to the patient. This implies in many cases the use of semimanufactured , such as radionuclide generators, precursors, and cold kits that are also considered a medicinal product according to directive 2001/83/EC. 

Labeling and Packaging of Light-Sensitive Cold Kits.180... 

Light-sensitive cold kits and radiopharmaceuticals. USP 27-NF 22 is sometimes not in agreement with the light sensitivity cautionary statement listed in the package insert. Because the author s primary work is specialization in nuclear pharmacy, the examples mentioned in this chapter will be strictly related to the radiopharmaceuticals (i.e., radioactive drugs) used in nuclear pharmacy and nuclear medicine. 

If the reagents in the cold kit are light sensitive, is the radiopharmaceutical prepared from the light-sensitive cold kit also prone to photolytic degradation If... 

LABELING AND PACKAGING OF LIGHT-SENSITIVE COLD KITS 8.4.1 Labeling Light-Sensitive Cold Kits... 

An additional note should be emphasized with regard to the storage of the Neurolite cold kit. Each outer box contains two sets of cold kits for Neurolite ,... 

Figure 8.1 Left vial A of the Neurolite cold kits. Protect from light is stated on the vial label (lower right line) right the back side of the outer box for the Neurolite cold kits. Cautionary statement for light sensitivity now can be found on the labels of the outer box.

It is also interesting to note that the Hepatolite reaction vials are stored in a so-called convenience pack carton. This 30-vial convenience pack has six 12-mm diameter circular openings for checking for reorder point of the cold kit supply without the need to open the outer box (Figure 8.2). In addition, the convenience pack has an 11- x 3-cm round rectangular opening for retrieval of the Hepatolite ... 

Figure 8.2 The convenience pack for Hepatolite cold kits.

Figure 8.3 The lead container tor the storage of technetium Tc 99m labeled radiopharmaceutical (middle) and the lead container tor the storage ot technetium Tc 99m pertechnetate injection (right) tor the radiolabelling of the cold kit (left).

The author would like to thank Ms. Vicki S. Krage for her patience and assistance in the preparation of this chapter, which was presented in part in the following three articles Photolytic degradation of drugs, Am. J. Hosp. Pharm., 49,2704-2705,1992 Photochemical considerations of light-sensitive cold kits and radiopharmaceuticals,... 

Table 3.1. Content of stannous chloride and calculated Sn-to-Tc ratios in selected commercially available cold kits...

The preparatiou of Tc pharmaceuticals is greatly facilitated by the availability of couunercial cold kits coutaining the chemical ingredients as a lyophilized formulation ready for labeling with Tc-pertechnetate. 

The preparation of any Tc pharmaceutical is performed by using a commercial cold kit and adding the required Tc activity in a certain volume of " Tc eluate (pertech-netate). Kits offer couveuieuce aud ease of preparation for ad hoc labeling. 

Cold kits are considered as semimanufactured products, which ueed marketing authorization as medicinal products (European Economic Community 1998). Cold kits are commonly produced at the industrial level. The preparation of a Tc pharmaceutical by a uuclear mediciue facility or a nuclear pharmacy by adding Tc eluate to an... 

The industrial producer of a radiopharmaceutical product (radiopharmaceuticals ready for use, generators, radionuclide precursors, cold kits) must be authorized as pharmaceutical laboratory. 

In vivo labeling of red blood cells (RBC) with sodium Tc-pertechnetate (Callahan et al. 1982) is performed subsequent to pretreatment of RBC in vivo with a stannous reducing agent, using stannous pyrophosphate cold kits (TechneScan PYP, AngioCis) as well as Amerscan Stannous Agent. 

Kits containing tin-pyrophosphate as a sterile, nonpyrogenic formulation are either reconstituted with sterile saline or with sterile sodium Tc-pertechnetate solution. 99mrpc-pYp jjas been used for imaging myocardial infarction the cold kits serve as stannous agent for in vivo labeling of RBC. No bacteriostatic preservative is present in kits. 

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