Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung

A development and comparison study of the Nuclear Malaysia’s Tc99m-sestamibi heart imaging agents (NM kits) and the commercial products is reported. Three batches of kits labelled as B1, B2 and B3 were produced by freeze drying technique. The commercial products such as sestamibi Cardiolite, Polatom...

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Main Authors: Wan Hamirul Bahrin W.K.,, Mohd Cairul Iqbal M.A,, Rosnani H.,, Zulkifli M.H,, Yahaya T.,, Karuppaiya A.,, Rasyieda A.,
Format: Article
Language:English
Published: Universiti Kebangsaan Malaysia 2009
Online Access:http://journalarticle.ukm.my/37/1/
http://journalarticle.ukm.my/37/
http://www.ukm.my/jsm
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spelling my-ukm.journal.372016-12-14T06:26:13Z http://journalarticle.ukm.my/37/ Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung Wan Hamirul Bahrin W.K., Mohd Cairul Iqbal M.A, Rosnani H., Zulkifli M.H, Yahaya T., Karuppaiya A., Rasyieda A., A development and comparison study of the Nuclear Malaysia’s Tc99m-sestamibi heart imaging agents (NM kits) and the commercial products is reported. Three batches of kits labelled as B1, B2 and B3 were produced by freeze drying technique. The commercial products such as sestamibi Cardiolite, Polatom, ChiMIBI and tetrofosmin Myoview were used in this study. The quality control testing which included microbiology testing, radiochemical and animal biodistribution study were conducted accordingly. The NM sestamibi kits passed the sterility and pirogen test. The Radiochemical Purity testing (RCP) was assessed by the Instant Thin Layer Chromatography (ITLC) and High-Performance Liquid Chromatography (HPLC) methods after the reconstitution of the Tc99m-sestamibi. The RCP results were above 90% and the kits were stable for 52 weeks. The animal biodistribution studies were carried out on Sprague-Dawley rats at 5, 30, 60, 120 and 1440 minutes post injection time intervals. The percentage injected dose per gram organ in heart for Tc99m-B1 were 4.722±0.343%, 3.752±0.438%, 4.564±0.664%, 4.180±1.293% and 1.090±0.230% at 5, 30, 60, 120 and 1440 minutes respectively. This is followed by the Tc99m-B2; 3.852±0.406%, 3.268±0.425%, 3.366±0.316%, 4.324±1.044% and 1.038±0.144%, Tc99m-B3; 5.404±0.351%, 4.818±0.579%, 6.015±0.774%, 5.028±1.353% and 1.623±0.692% at the same time intervals. Independent T Test showed that heart uptake was significant as compared to the control (p<0.05). The biodistribution study also showed that the radiopharmaceuticals localized selectively in the myocardium of rats. The NM sestamibi kits were comparable to the commercial products. Blood, lung, kidney and intestines washout were found to be fast and efficient. The biodistribution and analysis of heart-to-lung and heart-to-liver uptake ratios showed that NM sestamibi kits has a potential and could be used as heart imaging agents. Universiti Kebangsaan Malaysia 2009-08 Article PeerReviewed application/pdf en http://journalarticle.ukm.my/37/1/ Wan Hamirul Bahrin W.K., and Mohd Cairul Iqbal M.A, and Rosnani H., and Zulkifli M.H, and Yahaya T., and Karuppaiya A., and Rasyieda A., (2009) Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung. Sains Malaysiana, 38 (4). pp. 601-607. ISSN 0126-6039 http://www.ukm.my/jsm
institution Universiti Kebangsaan Malaysia
building Perpustakaan Tun Sri Lanang Library
collection Institutional Repository
continent Asia
country Malaysia
content_provider Universiti Kebangsaan Malaysia
content_source UKM Journal Article Repository
url_provider http://journalarticle.ukm.my/
language English
description A development and comparison study of the Nuclear Malaysia’s Tc99m-sestamibi heart imaging agents (NM kits) and the commercial products is reported. Three batches of kits labelled as B1, B2 and B3 were produced by freeze drying technique. The commercial products such as sestamibi Cardiolite, Polatom, ChiMIBI and tetrofosmin Myoview were used in this study. The quality control testing which included microbiology testing, radiochemical and animal biodistribution study were conducted accordingly. The NM sestamibi kits passed the sterility and pirogen test. The Radiochemical Purity testing (RCP) was assessed by the Instant Thin Layer Chromatography (ITLC) and High-Performance Liquid Chromatography (HPLC) methods after the reconstitution of the Tc99m-sestamibi. The RCP results were above 90% and the kits were stable for 52 weeks. The animal biodistribution studies were carried out on Sprague-Dawley rats at 5, 30, 60, 120 and 1440 minutes post injection time intervals. The percentage injected dose per gram organ in heart for Tc99m-B1 were 4.722±0.343%, 3.752±0.438%, 4.564±0.664%, 4.180±1.293% and 1.090±0.230% at 5, 30, 60, 120 and 1440 minutes respectively. This is followed by the Tc99m-B2; 3.852±0.406%, 3.268±0.425%, 3.366±0.316%, 4.324±1.044% and 1.038±0.144%, Tc99m-B3; 5.404±0.351%, 4.818±0.579%, 6.015±0.774%, 5.028±1.353% and 1.623±0.692% at the same time intervals. Independent T Test showed that heart uptake was significant as compared to the control (p<0.05). The biodistribution study also showed that the radiopharmaceuticals localized selectively in the myocardium of rats. The NM sestamibi kits were comparable to the commercial products. Blood, lung, kidney and intestines washout were found to be fast and efficient. The biodistribution and analysis of heart-to-lung and heart-to-liver uptake ratios showed that NM sestamibi kits has a potential and could be used as heart imaging agents.
format Article
author Wan Hamirul Bahrin W.K.,
Mohd Cairul Iqbal M.A,
Rosnani H.,
Zulkifli M.H,
Yahaya T.,
Karuppaiya A.,
Rasyieda A.,
spellingShingle Wan Hamirul Bahrin W.K.,
Mohd Cairul Iqbal M.A,
Rosnani H.,
Zulkifli M.H,
Yahaya T.,
Karuppaiya A.,
Rasyieda A.,
Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
author_facet Wan Hamirul Bahrin W.K.,
Mohd Cairul Iqbal M.A,
Rosnani H.,
Zulkifli M.H,
Yahaya T.,
Karuppaiya A.,
Rasyieda A.,
author_sort Wan Hamirul Bahrin W.K.,
title Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
title_short Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
title_full Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
title_fullStr Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
title_full_unstemmed Tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
title_sort tc99m-sestamibi: pembangunan kit radiofarmaseutikal untuk pemetaan jantung
publisher Universiti Kebangsaan Malaysia
publishDate 2009
url http://journalarticle.ukm.my/37/1/
http://journalarticle.ukm.my/37/
http://www.ukm.my/jsm
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score 13.211869