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1 / : ,.. 1,.. 1,.. 1,.. 1,.. 1,.. 1,.. 2,.. 2,.. 2, , 2,,, : ,, 24;. +7(499) lantsova1979@mail.ru , B-, AICAR ( ),, ,., %- 10 %- Kollidon 17 PF, : -., , + 5 º , :,,, A.V. Lantsova 1, E.V. Sanarova 1, N.A. Oborotova 1, A.P. Poloskova 1, O.L. Orlova 1, E.V. Ignateva 1, I.V. Yartseva 1, A.S. Mironov 2, R.S. Shakulov 2, S.V. Yarotskiy 2, K.V. Lobanov 2 DEVELOPMENT OF TECHNOLOGY FOR INJECTABLE DOSAGE FORM BASED ON THE NATIONAL SUBSTANCE OF PURINE NUCLEOSIDE AKV-12 1 FSBSI «N.N. Blokhin Russian Cancer Research Center» FASO, Moscow 2 State Research Institute for Genetics and Selection of Industrial Microorganisms Abstract Overseas, a candidate for drugs for the treatment of B-cell chronic lymphocytic leukemia in on the second phase of clinical trials, a new drug AICAR (5-aminoimidazole-4-carboxamide ribonucleoside), an agonist of adenosine receptors selectively suppresses reproduction of tumor B-lymphocytes. In the Russian Federation Scientific Center Research Institute of Genetics and Selection of Industrial Microorganisms («Genetika») synthesized substance AKV-12 of purine nucleoside, which is also an agonist of adenosine receptors. This substance difficulty soluble in water, in this connection is the actual development of rational based injectable dosage form for cancer patients. In this regard, the aim of this study was to develop injectable substance for domestic dosage form AKV-12. In the study developed a parenteral dosage form based on the AKV-12 in the form of a lyophilisate for solution for injection. As co-solvents for the substance AKV-12 selected 5% mannitol solution and 10% solution of Kollidon 17 PF, solubilizing AKV times. Proposed adjuvants inhibiting reaction decay AKV-12: sodium metabisulfite, and ascorbic acid. It is shown that the stability of the AKV-12 in solution are strongly influenced by temperature. It is noted that the solution temperature is lowered to +5 º C, the degradation of the AKB 12 slows down 3 times. Developed the technology for production of dosage form AKV-12 as a lyophilisate for solution for injection, which allows you to increase the shelf life of the drug. Defined quality criteria of dosage form in accordance with the requirements of the current Russian Federation standard documentation for quality control of drugs. Key words: formulation, co-solvents, antioxidants, lyophilisation. - -, - -., RBG_3_2014.indd :27:28
2 34.,, , -,. -., , %.,,, (50 % ), - [1 3; 5; 6; 11; 14]. -, :,,, -, -,. -, - [1; 4; 7; 10; 13 16]. - B-, AICAR ( ), -, - [18; 19; 24; 25] [8; 9; 17]. -12, -, [12]. -12,, - 90 % [28], - - [27] P13K-Akt, [26],, - ERK Akt/mTOR/P70S6K [18] , [22; 25], [23], [24]. ES [19 23], - -12, -,, -, , - 12, ,. 258,2 /. ( ),., -,,. 1%- 7 7,5. -. Sartorius 2405 (Sartorius AG, ); - Sartorius LA1200S (Sartorius AG, - ); «Edwards Minifast DO.2» (Ero Electronic S.p.A., ); - Cary-100; - Sartorius PP-15 (Sartorius AG, ); - (Millipore, ); «Oxford», «Pipettor», 0,5 10 ;, ; - RZR 2021 Heidolph - PR 30 Heidolph (Heidolph, ) , , Stericup GP Millipore Express Plus, 0,22. - Minifast DO.2 (Edwards, ). -. -,, -. -,,, -, -,. -, RBG_3_2014.indd :27:28
3 35-12, 6 30, , ( ), ( 40 45). 3, ( ) Cary 100 (Varian, In., ) 267., ( 0,5 0,48 ) ±2 10, ( ) : D1 a0 V X D V 0 0 1, D 1 D 0-12 V 0-12 (20 000) V 1-12 (100) ,5 ( ) ph- HANNA 211 (Hanna Instruments, ) ,, /. -, -,., -, -,., ( ), Kollidon 17 PF, , (, ), Lutrol (BASF), (ISP, - ),,. (20±2), ,, (5 %- ) Kollidon 17 PF (10 %- ), (5 %- ) Kollidon 17 PF (10 %- ), (5 %- ). -12 Kollidon 17 PF 1 : 1; 1 : 2; 1 : 3; 1 : (9 %) 1 : 1, Kollidon 17 PF 1 : 2. - Kollidon 17 PF , - -12,, -.. 2, -12 -, -,. - -, -. -, - 7,5 (5 %- ),.., , ( + 25 ) ,, , ,, -12, - +5., : -12, Kollidon 17 PF,,, -, , -, -, , -,, RBG_3_2014.indd :27:29
4 , % 2,0 ( ) 5,0-5, ,0 - (2-10%) 8,0 - (2-10%) 8,0 9,0 - (5-20%) - (5-20%) 8,0-5% 8,0 - (5%) (10-20%) 8,0 9,0 - (5%) (10%) 8,0 9, (168 ), -12, % º + 5 º ,0 11,0 8, ,0 5,0 11,0 8, ,0 9, ,0 5,0 0, ,0 0,035 0, ,0 0,035 0,017 0,0007 5, ,0 0,035 0,017 0,0007 5, ,0 0,036 5, ,0 5,0 0, ,0 10,0 8,9 6,8 6,8 7,0 11,5 2,8 2,5 2,0 5,1 4,0 7, ( ),, ( ) -12, ( ), 11 ; ; Na 2 SO 4 0,48 1,98 0, ; ;. 0,48 1,98 0, ;. - ; NaHCO 3 0,48 1,98 0, ; ;. - ; NaHCO 3 ; 0,3 1,20 0,304 ;. - ; NaHCO 3 ; 0,3 0,90 0, ;. - 0,3 0,90 0, ; ; Na 2 SO 4 0,3 1,20 0, ,3 0,6 0,293 RBG_3_2014.indd :27:29
5 37-12, ( 5 : 7) º -, (-21:-23) º - -12, , : I -12 (5 %- ); 2-12 (5 %- ) (10 %- ) ; ( 5: 7), ( 21: 23). - 5 % ,,. -, ,5 ; 5,0 ; 5,5 ; ( 0,3-12 ) ( 50 40) ,, ,, -.,., -, ( ) -., :, 6, -,,, -. - (-40-45). - 2,5 3,5. -. ( 40 45) / , ,, (. 3). - «-12, 300» : 1 : PF 300,0 300,0 600,0 2,15 1,03 0,043-3 ( 300 ) «-12, 300». -12 «.» , I,. 1. 2, II, I, -, - : ( ); ; ; RBG_3_2014.indd :27:29
6 38 ; ; ; ; , -, , - 1,16 1,21 ; ±5 % ( XII,. 1,. 98), - - Y6 ( XII,. 1,. 93) ,0. ( XII,. 1,. 85) , - 1 XII,.1,. 176, 1,0 % ±2 (. 2) ,0015 %- -12.,,, (. 3). -, - -., -12, - 267± ,005 0,025 / %- Kollidon 17 PF, , - 12, -,, 2. -., º , : 1.. II.., // ,.. // LVI, 3 4. C ,.. // , RBG_3_2014.indd :27:29
7 ,..,... // , ,..,... // , ,..,.. - // , ,.., // , ,.., // , ,..,... - in vivo// , ,.. - // , ,..,... - // , ,..... :..., // , ,.. // , ,..,... // , ,..,... RU Baumann P., Mandl-Weber S., Emmerich B. et al. Activation of adenosine monophosphate activated protein kinase inhibits growth of multiple myeloma cells // Exp Cell Res P Campas C., Lopez J., Santidrian A. et al. Acadesine activates AMPK and induces apoptosis in B-cell chronic lymphocytic leukemia cells but not in T lymphocytes // Blood P Campas C., Santidrian A., Domingo A. et al. Acadesine induces apoptosis in B-cells from mantle cell lymphoma and splenic marginal zone lymphoma // Leukemia P Coll-Mulet L., Iglesias-Serret D., Santidrian A. et al. MDM2 antagonists activate p53 and synergize with genotoxic drugs in B-cell chronic lymphocytic leukemia cells // Blood P Garcia-Gil M., Pesi R., Perna S. et al. 5 -aminoimidazole-4-carboxamide riboside induces apoptosis in human neuroblastoma cells // Neuroscience P Kefas B., Heimberg H., Vaulont S. et al. AICA-riboside induces apoptosis of pancreatic beta cells through stimulation of AMP-activated protein kinase // Diabetologia P Meisse D., Van de Casteele M., Beauloye C. et al. Sustained activation of AMP-activated protein kinase induces c-jun N-terminal kinase activation and apoptosis in liver cells // FEBS Lett P Pesi R., Micheli V., Jacomelli G. et al. Cytosolic 5 -nucleotidase hyperactivity in erythrocytes of Lesch- Nyhan syndrome patients // Neuroreport P Rattan R., Giri S., Singh A., Singh I. et al.5-aminoimidazole-4-carboxamide-1-beta-d-ribofuranoside inhibits cancer cell proliferation in vitro and in vivo via AMP-activated protein kinase // J Biol Chem P Swinnen J., Beckers A., Brusselmans K. et al. Mimicry of a cellular low energy status blocks tumor cell anabolism and suppresses the malignant phenotype // Cancer Res P Xiang X., Saha A., Wen R. et al. AMP-activated protein kinase activators can inhibit the growth of prostate cancer cells by multiple mechanisms // Biochem Biophys Res Commun P / - RBG_3_2014.indd :27:30
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