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All Journal Jurnal Radioisotop dan Radiofarmaka Jurnal Sains Materi Indonesia Jurnal Ilmu Kefarmasian Indonesia
Cecep Taufik Rustendi
Pusat Radioisotop Dan Radiofarmaka-BATAN, Serpong
Biochemistry, Genetics & Molecular Biology Health Professions Materials Science & Nanotechnology Medicine & Pharmacology Public Health

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PREPARASI DAN UJI BIODlSTRlBUSI RENIUM-186-ETlLEN DISISTEIN (186Re-EC) SEBAGAI PREPARAT ENDOVASCULAR BRACHYTHERAPY Widjaksana, Widyastuti; Rustendi, Cecep Taufik; Sovilawati, Evi
Jurnal Radioisotop dan Radiofarmaka Vol 7, No 1 (2004): Jurnal PRR 2004
Publisher : Jurnal Radioisotop dan Radiofarmaka

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ABSTRAK PREPARASI DAN UJI BIODlSTRlBUSI RENIUM-186-ETlLEN DISISTEIN (186Re-EC) SEBAGAI  PREPARAT  ENDOVASCULAR  BRACHYTHERAPY Kasus restenosis atau penyempitan kembali pembuluh arteri jantung paska proses angioplaslybanyak terjadi dan dapat mengakibatkan masalah yang serius. Salah satu cara penanggulangan-nya ialah dengan metoda endovascular brachyfherapy yaitu pembalonan bagian sempit arteri jantung dikombinasi dengan radiasi interna menggunakan scnyawa 186Re-EC dimana radiasi β- yang dipancarkan akan menghancurkan sel sel hyperplasia yang terbentuk didalam pembuluh arteri yang mengakibatkan penyumbatan pembuluh tersebut. Telah dilakukan serangkaian per-cobaan  untuk  mencari kondisi optimum penandaan 186 Re-EC, penambahan asam askorbat sebagai anti oksidan, dan pengaturan pH menjadi pH netral setelah pembentukan 186Re-EC untuk  menyesuaikan dengan pH tubuh sehingga  dapat diperoleh senyawa kompleks yang stabil dengan kemumian radiokimia yang tinggi. Uji biodistribusi pada hewan percobaan telah pula dilakukan untuk melihat sifat farmakokinetika sediaan bertanda inij Hasil percobaan menunjuk- kan bahwa waktu inkubasi 15 menit pada suhu ruangan sudah cukup untuk memreroleh kompleks 186Re_ skorbat dalam jumlah setara dengan reduktor yang digunakan dapat meningkatkan kestabilan kompleks 186Re_EC. Perubahan pH dari pH reaksi kompleksasi (pH 2) hingga pH netral tidak memf.engaruhi kestabilan kompleks 186Re_EC, sehingga untuk keamanan pasien pada saat pemakaian sediaan 186Re-EC dapat diatur pada pH 6 - 7. Pengujian pada mencit sehat menunjuk-kan akumulasi radioaktif yang tinggi pada ginjal dan kandung kemih, hal ini menun-jukkan sifat farmakokinetik sesuai dengan yang diharapkan. Hasil formula terbaik186Re-EC adalah terdiri dari 4 mg etilen disistein (EC) dalam dapar natrium bikarbont 0.5 M, 2 mg timah klorida dihidrat, 2 mg asam askorbat dan 100 µg perenat, dan stabil selama lebih dari sa~ minggu pada pH 6-7. Kata kunci : Radiofarmaka, etilen disistein, I Renium-186 ('86Re), endovascular brachytherapy, penandaan, 186Re_EC. ABSTRACT. PREPARATION AND BIODITRIBUTION OF RHENIUM-186-ETHYLENE DICYSTEINE 186Re-EC) FOR ENDOVASCULA R BRACHYTHERAPY. Restenosis or renarrowing of coronary artery following angioplasty procedur is common- ly occurred and causes serious problem.Endovascular brachytherapy, - a balloonisation procedure into the narrowing cononary artery combined with internal radiation - using 186Re-EC is an alternativ method to solve this problem from which β radiation will destroy hyperplasia cells built up in the vessel walls t at cause blockage. Experiments to obtain optimal condition of labeling I86Re-EC, such as variation of incubation time, addition of ascorbic acid as an antioxidant and pH adjustment to neutral of the final olution have been carried out in order to get a radio labeled compound with high radiochemical purity a d stability. Biodistribution in experimental animal has also been carried out to see its pharmacokinetic behav our. The results showed that incubation time of 15 minutes at room temperature is sufficient to form 186Re- C complex with high radiochemical purity (more than 85%). The addition of an equivalent amount of ascor ic acid to the reducing agent used can increase the stability of the 186Re-EC complex. The pH adjustment rom acidic to neutral did not affect the stability, therefore to avoid irritation at the time of administration the pH of the solution could be adjusted to 6-7. Administration to normal mice showed high accum lation in kidney and bladder, revealed good pharmacokinetic behaviour of this labeled compound. T e results showed that 186Re-ECpreparation can be formulated using 4 mg of etiylene dicysteine (EC) dissol ed in sodium bicarbonate buffer 0.5 M, 2 mg of stannous chloride dihydrate, 2 mg of ascorbic acid and 10 Ilg of perrhenate, stable more than a week at pH 6-7. Keywords: Radiopharmaceuticals, ethylene dicysteine, Rhenium-186 (186Re), endovascular brachytherapy, labeling, I86Re-EC.  
PREPARASI DAN UJI STABlLlTAS I77Lu-DOTA-NIMOTUZUMAB SEBAGAI RADIOFARMAKA TERAPI. Human, Titis Sekar; Ramli, Martalena; Rustendi, Cecep Taufik; Subur, Muhammad
Jurnal Radioisotop dan Radiofarmaka Vol 13, No 1 (2010): Jurnal PRR 2010
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ABSTRAK PREPARASI DAN UJI STABlLlTAS I77Lu-DOTA-NIMOTUZUMAB SEBAGAI RADIOFARMAKA TERAPI. Nimotuzumab adalah humanized monoclonal antibody  (mAb) yang spesifik terhadap epidermal growthfoctor receptor (EGFR), sasaran kunci dalam pengembangan obat terapi kanker. Dalam penelitian ini telah dilakukan preparasi dan uji stabilitas I77Lu-DOTA -Nimotuzumab sebagai  radiofarmaka  terapi yang diharapkan  lebih paten dibandingkan dengan penggunaan nitozumab atau radiasi secara sendiri- sendiri. Preparasi I77Lu-DOTA-Nimotuzumab, diawali dengan penyiapan immunokonjugat DOTA -  Nimotuzumab yang kemudian dilanjutkan dengan  proses  penandaan 77Lu dan proses pemurnian dengan kolom Sephadex G-25M, berhasil  memberikan I77Lu-DOTA-Nimotuzumab dengan kemurnian rad iokim ia > 99%. Untuk memonitor kualitas dan stabilitas hasil penandaan system kromatografi lapis tipis (KLT), dengan fase diam dan fase gerak masing-masing adalah ITLC-SG dan salin telah berhasil dikembangkan. Hasil uji stabilitas I77Lu-DOT A-Nimotuzumab memperlihatkan bahwa  radiommunokonjugat ini masih tetap utuh. Kemurnian radiokimia radioimmunokonjugat ini setelah penyimpanan selama 96 turut jam pada suhu kamar, pada suhu 4°C dan dalam serum pad a suhu 37°C berturut adalah 97,42 ± 0,59, 96,27 ± 0,08 dan 99,46 ± 0,07%. Kata kunci : I77Lu-DOTA-Nimbtuzumab, epidermal growth factor receptor (EGFR), radiofarmaka terapi ABSTRACT PREPARATION  AND  STABILITY TEST OF  I77Lu-DOTA-NIMOTUZUMAB  AS RADIOPHARMACEUTICAL  FOR  THERAPY. Nimotuzumab is a humanized monoclonal antibody (mAb) that targets the epidermal growth factor receptor (EGFR), a key target in the development of cancer therapeutics. In this research project a preparation and stability test of a potential therapeutic radiopharmaceutical, 177Lu-DOT A-Nimotuzumab, which was expected to be more potent than the use of Nimotuzumab or radiotherapy alone, had been carried out. Preparation of I77Lu-DOT A-Nimotuzumab, which was initiated by preparing of immunoconjugate DOTA-Nimotuzumab then followed by radiolabelling with  I77Lu and purification process using Sephadex G-25M column, resulted in a I77Lu-DOTA-Nimotuzumab with radiochemical purity I77Lu-DOTA77Lu -Nimotuzumab > 99%. A Thin-Layer Chromatography (TLC) system , where ITLC-SG used as static phase and saline as mobile phase, for monitoring   of quality and  stability of 177Lu-DOT A-Nimotuzumab, had also been developed Successfully. The Stability test  177Lu-DOT A-Nimotuzumab  showed that this radioimmunoconjugate was still intact for 96 hours. The radiochemical purity of  I77Lu-DOT A-Nimotuzumab ehich kept at room temperature, at 4 oC   in serum at 37°C  for  96  hours  was  found to be 97,42 ± 0,59, 96,27 ± 0,08 dan 99,46 ± 0,07%. Kaywords :  l77Lu-DOT A-Nimotuzumab, epidermal growth factor receptor (EGFR), therapeutic  radiopharmaceutical.  
PREPARASI 99mTc_MAb ANTI CEA DAN UJI BIODISTRIBUSI PADA MENCIT Widyastuti,, Widyastuti,; Rustendi, Cecep Taufik; Rosseliana, Anna; Karyadi, Karyadi
Jurnal Radioisotop dan Radiofarmaka Vol 13, No 2 (2010): Jurnal PRR 2010
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ABSTRAKPREPARASI 99mTc_MAb ANTI CEA DAN UJI BIODISTRIBUSI PADA MENCITRadiofarmaka 99mTc_MAb antiCEA sudah digunakan secara luas di pasaran dengan nama dagang Zevalin yang digunakan untuk mendeteksi kanker kolorektal. Sampai saat ini MAb yang digunakan berasal dari tikus, meskipun sebenarnya yang lebih disukai adalah yang berasal dari manusia. Antibodi ini berikatan secara spesifik dengan antigen karsinoembrionik (CEA) yang terekspresi melimpah pada permukaan sel kanker kolorektal. MAb AntiCEA direduksi terlebih dahulu dengan 2-merkaptoetanol (1 :2000) sebelum ditandai dengan teknesium-99m, dan MOP digunakan sebagai transkelator pad a penandaan dengan 99mTc.Efisiensi penandaan ditcntukan menggunakan kromatografi lapis tipis dengan ITLC-SG yang dijenuhkan dengan albumin serum manusia sebagai fasa diamnya dan campuran amonia-etanol-air (I :2:5) sebagai fasageraknya untuk menentukan pengotor polar, sedangkan untuk menentukan pengotor koloid digunakan ITLCSG sebagai fasa diam dan larutan NaCI 0,9% sebagai fasa geraknya. Studi kestabilan dilakukan terhadap antiCEA bertanda yang disimpan pada suhu kamar selama beberapa jam dan terhadap antiCEA tereduksi yang belum ditandai setclah disimpan pada suhu -40°C selama beberapa minggu. Biodistribusi 99mTc_MAbantiCEA pada mencit normal diamati pada I jam dan 4 jam paska injeksi. Penandaan dengan 99mTcmenunjukkan efisiensi penandaan 98,53% ± 0.21 % dan menurun hingga dibawah 90% setelah 9 minggu.MAb anti CEA bertanda yang disimpan pada suhu kamar stabil hingga 5 jam paska injeksi, sedangkan yangbelum ditandai stabil hingga 9 minggu. Biodistribusi 99mTc_MAb anti CEA pada mencit normal I jam dan 4jam paska injeksi menunjukkan penangkapan yang tinggi pada berbagai organ. Katakunci: teknesium-99m, monoklonal antibodi anti CEA, penandaan, biodistribusi, kanker kolorektal. ABSTRACT PREPARATION OF 99mTc_ANTI CEA MAb AND BIODISTRIBUTION TEST IN MICE. 99mTc-antiCEA MAb radiopharmaceutical has been commercially used under the brand name of Zevalinwhich is used to detect colorectal cancer. Although human MAb is preferred but commercial product is stillusing murine originated MAb. This antibody binds specifically to carcinoembrionic antigen (CEA) which isoverexpressed in colorectal cancer cells. AntiCEA Mab was reduced with diluted 2-mercaptoethanol(I :2000) prior to labelling with 99mTc, and MOP was used as transchelating agent. Labeling efficiency wasanalysed with chromatography using HSA impregnated ITLC-SG as stationary phase and mixture ofammona-ethanol-water (1 :2:5) as eluants to determine polar 99mTc impurities, and ITLC-SG eluted with salinto determine 99mTc-colloid. Stability study was carried out on radio labeled antiCEA Mab stored at roomtemperature within several hours and on reduced antiCEA Mab stored at -40°C for several weeks.Biodistribution of 99mTc-antiCEA Mab in normal mice was observed I hour and 4 hours post injection.Labeling efficiency of antiCEA Mab was 98,53% ± 0.21 % and decreasing to less than 90% after 9 weeks.Radiolabeled anti CEA Mab kept at room temperature was stable within 5 hours post injection, and thefrozen kits were stable up to 9 weeks. Biodistribution of 99mTc-antiCEA Mab in normal mice at I hour and 4hours post injection showed high uptake in various organs.Keywords: technetium-99m, anti CEA Mab, labelling, biodistribution, colorectal cancer.    
PEMBUATAN 186Re_Sn KOLOID UNTUK TERAPI RADIOSINOVEKTOMI Rustendi, Cecep T. Rustendi Taufik; Ramli, Martalena Ramli; Subur, Muhammad
Jurnal Radioisotop dan Radiofarmaka Vol 13, No 2 (2010): Jurnal PRR 2010
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ABSTRAK PEMBUATAN 186Re_Sn KOLOID UNTUK TERAPI RADIOSINOVEKTOMI. Radiosinovektomi adalah suatu alternatif terapi selain pembedahan dimana radiofarmaka pemancar beta disuntikkan ke dalam lapisan dalam bungkus sendi untuk mengobati reumatoid artritis. Salah satu sediaan radiofarmaka yang dapat digunakan dalam radiosinovektomi adalah 186Re_Sn koloid. Pembuatan 186Re_Sn koloid dilakukan dengan mencari kondisi reaksi terbaik untuk memperoleh efisiensi peJabelan yang tinggi (>95%), ukuran partikel yang sesuai dan kestabilan yang baik saat disimpan pad a suhu kamaI'. Pembuatan 186Re_Sn koloid telah berhasil dilakukan dengan menggunakan rasio mol SnCh.2H20 terhadap Re senilai 1000: I (~ 50 mg SnCh.2H20) dan waktu pemanasan 90 menit dengan presentase efisiensi penandaan > 95%. 186Re_Sn koloid cukup stabil saat disimpan selama 24 jam pada suhu kamar dan mempunyai ukuran partikel yang sesuai untuk digunakan sebagai radiofarmaka untuk terapi radiosinovektomi. Kata kunci: 186Re_Sn koloid, radiosinovektomi, reumatoid arthritis ABSTRACT PREPARATION OF RHENIUM-186 TIN COLLOID AS RADIOSYNOVECTOMY AGENT. Radiosynovectomy is an alternative therapy besides surgery whereby a beta-emitting radiopharmaceutical is delivered into the affected synovial compartment in order to threat rheumatoid arthritis. One of radiopharmaceuticals that could be applied as radiosynovectomy agent is 186Re_Sn colloid. Preparation of 186Re_Sn colIoid has been carried out by searching the best condition of the reaction to obtain a high labeling efficiency (>95%), appropriate particle size and stable at room temperature. Preparation of 186Re_Sn colloid has been done successfulIy using a mol ratio ofSn to Re with value 1000:1 (~50 mg SnCh.2H20) by heating for 90 minutes and resulting >95% labeling efficiency. Stability of 186Re_Sn colloid was found to be good enough when it was stored at room temperature for 24 hours. The 186Re_Sn colIoid was also found to have an appropriate particle size for radiopharmaceutical agent for radiosynovectomy. Keywords: 186Re_Sn colIoid, radiosynovectomy, rheumatoid arthritis    
VALIDASI METODE PENENTUAN KADAR GADOLINIUM (III) DAN LIGAN DIETHYL TETRAAMINE PENTAACETIC ACID (DTPA) DALAM CONTRAST AGENT Gd-DTPA Ritawidya, Rien; Ramli, Martalena; Rustendi, Cecep Taufik
Jurnal Radioisotop dan Radiofarmaka Vol 17, No 1 (2014): Jurnal PTRR 2014
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Gd-DTPA merupakan salah satu contrast agent yang penting dalam Magnetic Resonance Imaging (MRI). Kadar ion Gd (III) dan ligan DTPA bebas dalam contrast agent yang terlalu besar akan bersifat toksik pada tubuh manusia. Oleh karena itu diperlukan suatu metode untuk penentuaan kadar ion Gd (III) dan ligan DTPA bebas sehingga contras agent dapat digunakan untuk tujuan klinis. Metode analisis yang dipilih pada penelitian ini adalah titrasi kompleksometri yang harus divalidasi sehingga diperoleh data-data perolehan kembali (recovery), koefisien variansi (CV) dan linearitas. Serangkaian percobaan yang telah dilakukan pada penentuan Gd (III) dengan DTPA menunjukkan hasil parameter akurasi % recovery antara 30,33 %-183,59 %, presisi dari % CV antara 2,34 %-35,25 %, dan linieritas dengan nilai R=0.9760. Sementara pada penentuan DTPA dengan Gd (III) menunjukkan hasil % recovery antara 105,15 %-139,12 %, nilai % CV antara 6,78 %-10,96 %, dan nilai R=0.9994. Hasil validasi menunjukkan bahwa metode penentuan ini tidak dapat digunakan sebagai salah satu metode alternatif penentuan ion Gd(III) bebas dan ligan DTPA bebas dalam contrast agent. Gd-DTPA is one of the contrast agent which is important in Magnetic Resonance Imaging (MRI) application. The presence of free Gd (III) ion and free DTP A ligand isextremely toxic in human body. Therefore, it needs a method in order to detennine free ion Gd (III) and freeDTP A ligand concentration which then MRI would be applicable for clinical purpose. The analyticalmethod  that selected for the research was complexometric titration. The research was carried out in order tomake validation methodJof free ion Gd (III) and free DTPA ligand detennination, then validation criteriasuch  as % recovery, % coefisien of variance and linierity could be obtained. Some experiments that had been done on detennination of free Gd (III) with DTPA resulted in % recovery between 30,33% - 183,59%, theprecision from %CY between 2,34% - 35,25% and linearity showed with value ofR = 0,9525. Meanwhile on detennination ofDTPA with Gd (III) resulted in % recovery between 105.15% - 139,12%, %CY between 6,78% - 10,96% and R = 0,9525. Yalidation result indicates that detennination method can not be used as a method to detennine free ion Gd(III) and free DTPA ligand in contrast agent. Keywords: Gd-DTPA, contrast agent, ion Gd (III), complexometric, validation 
SISTEM KOMPUTASI TABEL PELURUHAN RADIOAKTIVITAS MENGGUNAKANTURBO PASCAL WINDOWS Maskur, Maskur; Rustendi, Cecep T.
Jurnal Radioisotop dan Radiofarmaka Vol 9 (2006): jurnal PRR 2006
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SISTEM KOMPUTASI TABEL PELURUHAN RADIOAKTIVITAS MENGGUNAKAN TURBO PASCAL WINDOWS. Dalam usahanya untuk mencapai keadaan stabil, radioisotop melakukan transformasi inti melalui peluruhan dengan cara memancarkan partikel α,β atau sinar γ, x atau sekaligus memancarkan gabungan diantaranya. Program tabel peluruhan radioaktivitas dalam bahasa Turbo Pascal Windows yang telah dibuat merupakan sebuah program yang dapat menghitung peluruhan dan faktor peluruhan radioaktivitas dalam bentuk tabel untuk segala jenis radionuklida dalam periode waktu tertentu, jenis radionuklida dan periode waktunya tergantung data masukan yang diberikan. Dari hasil uji internal, diketahui bahwa penulisan (pengkodean) listing program telah ditulis dengan benar dalam bahasa Turbo Pascal Windows, terbukti sistem program dapat dieksekusi run. Dari hasil uji eksternal diketahui bahwa sistem program secara logika dan matematika telah berjalan sesuai perancangan. Sistem pilihan menu, hasil perhitungan peluruhan dan faktor peluruhan berjalan dengan benar. Program ini dapat menghitung dengan cepat dan akurat, sehingga dapat meningkatkan efisiensi kerja. Kata kunci: Tabel Peluruhan Radioaktivitas, Tabel Faktor Peluruhan Radioaktivitas, Turbo Pascal Windows THE COMPUTATION SYSTEM OF RADIOACTIVITY DECAY TABLE USING TURBO PASCAL WINDOWS. In order to obtain a stabil state, radioisotope transform to do the decay and emit α,β particle or γ, x ray or both of them as a unity. Radioactivity decay table program in Turbo Pascal Windows that has been made is a program which could count the decay and decay factor of radioactivity with table form used for every radionuclide in period of time given, the radionuclide and its time period depending on the data entry given. From the internal test result, we know that writing (codying) program listing has been written correctly in Turbo Pascal Windows language proved by the system which could be executed (run). From the external test result we know that the system could work logically and mathematically proper with the design. Menu choice system, decay and decay factor counting has given the result and running well. This program could count fast and accurate, therefore the efficiency of work could be raised. Key words : Radioactivity decay table, Radioactivity decay factor table, Turbo Pascal Windows
PEMBUATAN 186Re_Sn KOLOID UNTUK TERAPI RADIOSINOVEKTOMI Rustendi, Cecep T. Rustendi Taufik; Ramli, Martalena Ramli; Subur, Muhammad
Jurnal Radioisotop dan Radiofarmaka Vol 13, No 2 (2010): Jurnal PRR 2010
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ABSTRAK PEMBUATAN 186Re_Sn KOLOID UNTUK TERAPI RADIOSINOVEKTOMI. Radiosinovektomi adalah suatu alternatif terapi selain pembedahan dimana radiofarmaka pemancar beta disuntikkan ke dalam lapisan dalam bungkus sendi untuk mengobati reumatoid artritis. Salah satu sediaan radiofarmaka yang dapat digunakan dalam radiosinovektomi adalah 186Re_Sn koloid. Pembuatan 186Re_Sn koloid dilakukan dengan mencari kondisi reaksi terbaik untuk memperoleh efisiensi peJabelan yang tinggi (>95%), ukuran partikel yang sesuai dan kestabilan yang baik saat disimpan pad a suhu kamaI'. Pembuatan 186Re_Sn koloid telah berhasil dilakukan dengan menggunakan rasio mol SnCh.2H20 terhadap Re senilai 1000: I (~ 50 mg SnCh.2H20) dan waktu pemanasan 90 menit dengan presentase efisiensi penandaan > 95%. 186Re_Sn koloid cukup stabil saat disimpan selama 24 jam pada suhu kamar dan mempunyai ukuran partikel yang sesuai untuk digunakan sebagai radiofarmaka untuk terapi radiosinovektomi. Kata kunci: 186Re_Sn koloid, radiosinovektomi, reumatoid arthritis ABSTRACT PREPARATION OF RHENIUM-186 TIN COLLOID AS RADIOSYNOVECTOMY AGENT. Radiosynovectomy is an alternative therapy besides surgery whereby a beta-emitting radiopharmaceutical is delivered into the affected synovial compartment in order to threat rheumatoid arthritis. One of radiopharmaceuticals that could be applied as radiosynovectomy agent is 186Re_Sn colloid. Preparation of 186Re_Sn colIoid has been carried out by searching the best condition of the reaction to obtain a high labeling efficiency (>95%), appropriate particle size and stable at room temperature. Preparation of 186Re_Sn colloid has been done successfulIy using a mol ratio ofSn to Re with value 1000:1 (~50 mg SnCh.2H20) by heating for 90 minutes and resulting >95% labeling efficiency. Stability of 186Re_Sn colloid was found to be good enough when it was stored at room temperature for 24 hours. The 186Re_Sn colIoid was also found to have an appropriate particle size for radiopharmaceutical agent for radiosynovectomy. Keywords: 186Re_Sn colIoid, radiosynovectomy, rheumatoid arthritis    
PREPARASI KIT CAIR TETROFOSMIN UNTUK DETEKSI KANKER DAN PERFUSI JANTUNG Widyastuti, Widyastuti; Setyowati, Sri; Rustendi, Cecep Taufik; Yunilda, Yunilda
Jurnal Radioisotop dan Radiofarmaka Vol 15, No 2 (2012): JURNAL PRR 2012
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Abstract

ABSTRAKPREPARASI KIT CAIR TETROFOSMIN UNTUK DETEKSI KANKER DAN PERFUSI JANTUNG.Kit tetrofosmin yang ditandai dengan teknesium-99m telah digunakan secara luas di bidang kedokteran nuklir untuk deteksi perfusi jantung dan deteksi kanker, yang dikenal dengan nama Myoview. Telah dilakukan pembuatan kit cair tetrofosmin untuk ditandai dengan teknesium-99m sebagaistudi awal dalam pengembangan radiofarmaka 99mTc-tetrofosmin untuk mempelajari teknik pembuatan,pengujian dan kestabilannya dalam penyimpanan. Metode uji kemumian radiokimia menggunakankromatografi lapis tipis (KLT), kromatografi kertas (KK) dan pemisahan dengan kolom SepPak CI8 telah divalidasi menggunakan larutan perteknetat 99mTcdan 99mTc-tetrofosmin dari kit impor (Myoview) sebagaistandar. Karakterisasi tetrofosmin, 99mTcdan 99mTc-tetrofosmin menggunakan kromatografi cair kinerjatinggi (HPLC) telah dilakukan dan menunjukkan perbedaan waktu retensi yang cukup signifikan antara99mTc dan 99mTc-tetrofosminyaitu 6 dan 8 menit. Pengujian kemumian radiokimia terhadap 3 batch kit tetrofosmin yangdilakukan menggunakan KLT dengan fase diam ITLC-SG dan eluen campuran aseton dan diklorometan (35 : 65), KK denganfase diam kertas Whatman-3 dan eluen etil asetat serta kolom Sep Pak CI8 dengan eluen larutan NaCI fisiologis (salin) menunjukkan kemumian radiokimia rata-rata 85,89%(SD=I,44%) dan stabil pOOapenyimpananan di suhu -80°C hingga 2 bulan. Hasil penelitian menunjukkan bahwa kit tetrofosmin dalam bentuk cair telah berhasil dibuat dan dapat ditandai dengan 99mTc-dengan kemumian radiokimia yang cukup tinggi meskipun belum sesuai dengan persyaratan kit pada umumnya.Kata kunci : 99mTc-Tetrofosmin,kemumian radiokimia, diagnosis, perfusi jantung.ABSTRACTPREPARATION OF TETROFOSMIN FROZEN KIT FOR CANCER DETECTION ANDMYOCARDIAL PERFUSION.Tetrofosmin labeled with technetium-99m has been widely used in nuclear medicine as myocardial perfusion imaging agent and for use in cancer detection, with brand name of Myoview. Preparation of tetrofosmin liquid kits labeled with 99mTchas been carried out as a preliminary study in development of tetrofosmin radiopharmaceuticals which focuses in the techniques of preparation, quality control and stability study upon storage. Analytical methods using thin layer chromatography (TLC), paper chromatography (PC) and SepPak Cl8 have been validated using pertechnetate 99mTcand 99mTctetrofosmin from commercial product (Myoview) as standards. Characterisation of tetrofosmin, 99mTcclan99mTc-tetrofosminusing HPLC has also been carried out which showed significant difference in retention time between 99mTcand 99mTc-tetrofosmini.e 6 and 8 minute. Radiochemical purity testing in 3 batches of tetrofosmin kits uses TLC with ITLC-SG and mixture of acetone and dichloromethane (35:65), PC with Whatman-3 and ethyl acetate as eluants and SepPak Cl8 cartridge eluted with saline showed radiochemicalpurity of 85,89% (SD=I,44%) which was stabile up to 2 months upon storage in -80°C. Results showed thatwet preparation of tetrofosmin kits can be labeled with 99mTcwith high labeling efficiency although notsufficiently high as stated in the common requirements of radiopharmaceuticals.Key-words: 99mTc-tetrofosmin,radiochemical purity, diagnosis, myocardial perfusion
PREPARATION OF 99mTc-TRICINE-EDDA-HYNIC-FOLATE, A POTENTIAL RADIOPHARMACEUTICAL FOR RADIODIAGNOSIS OF FOLATE RECEPTORS OVER EXPRESSED CANCER Martalena Ramli; Rien Ritawidya; Cecep Taufik Rustendi; Titis Sekar Humani; Widyastuti Widjaksana
Jurnal Sains Materi Indonesia Vol 15, No 1: OKTOBER 2013
Publisher : Center for Science & Technology of Advanced Materials - National Nuclear Energy Agency

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (381.26 KB) | DOI: 10.17146/jsmi.2013.15.1.4379

Abstract

PREPARATION OF 99mTc-TRICINE-EDDA-HYNIC-FOLATE, A POTENTIAL RADIOPHARMACEUTICAL FOR RADIODIAGNOSIS OF FOLATE RECEPTORS OVER EXPRESSED CANCER. Folate receptors (FRs) have been reported to be over expressed on various types of cancers. Therefore, it would be possible for its ligand in this case folic acid, also known as vitamin B9, to be used as delivery agent for diagnosis and therapy of FRs over expressed cancers. The aim of this projectwas to prepare 99mTc radiolabeled folic acid via 6-hydrazinonicotinamido-hydrazido (HYNIC) in the form of 99mTc-tricine-ethylenediamine diacetate-HYNIC-folate (99mTc-tricine-EDDA-HYNIC-folate), which was expected to be potential for radiodiagnosis of the FRs over expressed cancers. Preparation of 99mTc-tricine-EDDA-HYNIC-folate was initiated by preparation of HYNIC-folate by reacting of folate-γ- hydrazide with 6-chloronicotinic acid NHS ester which was then followed by addition of hydrazine-hydrate. The HYNIC-folate was recovered in its HCl salt-form which was then formulated to form a freeze dried kit which consisted of HYNIC-folate, tricine and EDDA (co-ligands) and Sn(II) as reducing agent. The formation of 99mTc-tricine-EDDA-HYNIC-folate was carried out by addition of 99mTc into tricine-EDDA-HYNIC-folate freeze dried kit which resulted in 99mTc-tricine-EDDA-HYNIC-folate with radiochemical purity of 97.0 ± 1.8% met with the requirement of a good radiopharmaceutical (≥ 90%). The stability test showed that the 99mTc-tricine-EDDA-HYNIC-folate was still intact (radiochemical purity ~ 95%) when stored at 37 °C for four hours.
Metoda Penyiapan Konjugat (DOTA)n-[Dendrimer PAMAM]-(Trastuzumab)m Sebagai Bahan Radiofarmaka Radioimunoterapi (177Lu-DOTA)n-[Dendrimer PAMAM]- (Trastuzumab)m RIEN RITAWIDYA; SRI SETYOWATI; CECEP TAUFIK RUSTENDI; MASKUR MASKUR; MARTALENA RAMLI; BASUKI HIDAYAT; MUHAMMAD SUBUR; ABDUL MUTALIB; JOHAN MASHYUR
JURNAL ILMU KEFARMASIAN INDONESIA Vol 12 No 2 (2014): JIFI
Publisher : Fakultas Farmasi Universitas Pancasila

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Abstract

Radioimmunotherapy is one of modalities means of treatment for cancer that exploits the antibody monoclonal specificity to bind to its receptor and the ability of alfa or beta radiation in destroying cancer cells. Trastuzumab is humanized IgG1 monoclonal antibodies which selectively bind to extracellular domain of Human Epidermal Growth Factor Receptor-2 (HER-2). HER-2 has now became a target receptor for treatment of human breast cancer due to their overexpression in the human breast cancer cell surface. This study was aimed in developing a method for preparation of (DOTA) n-[Dendrimer PAMAM]-(trastuzumabm conjugate, a precursor of (177Lu-DOTA)n-PAMAM-(trastuzumab) m radioimmunoconjugate, which is expected to be potential for breast cancer radioimmunotherapy. The conjugate was prepared through several conjugation steps. Characterization of (DOTA)n-[Dendrimer PAMAM]-(trastuzumab)m which was carried out by using a HPLC equipped size exclusion column (SEC) gave a clean peak with retention time (tR) of 10.53 mins which was slower compared to tR of its precursor unconjugated trastuzumab (10.70 mins). This result indicated that molecular weight of (DOTA)n-[Dendrimer PAMAM]-(trastuzumab)m was bigger than its precursor (unconjugated trastuzumab) and pure. The purity of (DOTA)n-[Dendrimer PAMAM]- (trastuzumab)m was verified by measuring the Rf of 177Lu-radiolabeled-(DOTA)n-[Dendrimer PAMAM]-(trastuzumab)m using instance thin layer chromatography-silica gel (ITLC-SG). The ITLC-SG of (DOTA)n-[Dendrimer PAMAM]-(trastuzumab)m which was radiolabeled with 177Lu- gave a clean peak with Rf of <0.3, while the precursors which were regards as impurities, (free 177Lu in form 177Lu-EDTA, 177Lu-DOTA, and 177Lu- dendrimer PAMAM which was incubated as non specific binding), all of them gave Rf of >0.6. These ITLC results indicated that (DOTA)n-[Dendrimer PAMAM]-(trastuzumab)m radiolabeled with 177Lu was pure.
Co-Authors ABDUL MUTALIB Anna Rosseliana Basuki Hidayat Evi Sovilawati JOHAN MASHYUR Karyadi Karyadi MARTALENA RAMLI Martalena Ramli Martalena Ramli Martalena Ramli Ramli MASKUR MASKUR Maskur Maskur MUHAMMAD SUBUR Muhammad Subur RIEN RITAWIDYA Rien Ritawidya Rien Ritawidya SRI SETYOWATI Sri Setyowati Titis Sekar Human Titis Sekar Humani Widyastuti Widjaksana Widyastuti Widjaksana Widyastuti Widyastuti Widyastuti, Widyastuti, Yunilda Yunilda