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All Journal HAYATI Journal of Biosciences Jurnal Veteriner Microbiology Indonesia Pharmaciana: Jurnal Kefarmasian Medical Journal of Indonesia Jurnal Matematika & Sains Journal of Mathematical and Fundamental Sciences Jurnal Sains dan Teknologi Farmasi Jurnal Media Gizi Indonesia (MGI) INDONESIAN JOURNAL OF PHARMACY Jurnal Komputer Terapan ANNALES BOGORIENSES Jurnal Sisfokom (Sistem Informasi dan Komputer) FITOFARMAKA: Jurnal Ilmiah Farmasi Jurnal Respirasi (JR) Darmabakti Cendekia: Journal of Community Service and Engagements Jurnal Layanan Masyarakat (Journal of Public Service) Narra J Jurnal Puruhita MEDICINUS Journal of Community Engagement in Health Annales Bogorienses
HENI RACHMAWATI
School of Pharmacy, Institute of Technology Bandung. Jl. Ganesha, 10, Bandung 40132
Agriculture, Biological Sciences & Forestry Humanities Astronomy Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Computer Science & IT Control & Systems Engineering Decision Sciences, Operations Research & Management Dentistry Earth & Planetary Sciences Economics, Econometrics & Finance Education Engineering Environmental Science Health Professions Immunology & microbiology Mathematics Medicine & Pharmacology Neuroscience Nursing Physics Public Health Social Sciences Veterinary Other

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Journal : Medical Journal of Indonesia

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Dissolution test of various low-dose acetylsalicylic acid preparations marketed in Indonesia Sumirtapura, Yeyet C.; Setiawati, Arini; Pamudji, Jessie S.; Rachmawati, Heni
Medical Journal of Indonesia Vol 18, No 3 (2009): July-September
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (389.626 KB) | DOI: 10.13181/mji.v18i3.355

Abstract

Aim To compare the dissolution profi les of various enteric-coated low-dose acetylsalicylic acid (ASA) tablets marketed in Indonesia.Methods The dissolution study was carried out according to US Pharmacocopoeiae (USP) /European Pharmacopoeiae, method A, using USP apparatus 1 (basket) 100 rpm, with 2 media: 0.1 N HCl, 120 minutes for acid stage, and phosphate buffer pH 6.8, 90 minutes for buffer stage. The sampling points were 120 minutes for the acid stage, and every 10 minutes until 90 minutes for the buffer stage. The acetylsalicylic acid was assayed using spectrophotometry at 280 nm for the acid stage, and at 265 nm for the buffer stage. The free salicylic acid was determined only at the end of the buffer stage with HPLC method. There were 6 test products (Cardio Aspirin® 100 mg, Aptor® 100 mg, Ascardia® 80 mg, Thrombo Aspilet® 80 mg, Astika® 100 mg and Farmasal® 100 mg), 3 batches for each product, and 6 units for each batch.Results The amount of ASA released from each ASA product tested at the end of acid stage (120 minutes) ranged from 1.79% for Cardio Aspirin® to 6.92% for Thrombo Aspilet®, all conformed to the compendial requirement for enteric-coated product (< 10%). The amount of salicylic acid observed at the end of the dissolution test ranged from 3.47% for Cardio Aspirin® to 10.90% for Astika® and 11.90 % for Thrombo Aspilet®. Thrombo Aspilet® showed sustained-release properties, causing high variability in ASA release, such that one of the 3 batches tested did not fulfill the compendial requirement of more than 75% (the release was only 55.11%). High variability in ASA release between batches was also found with Farmasal® at 10, 20, and 30 minutes in buffer medium. The lowest effective dose of ASA as an antiplatelet drug for longterm use is 75 mg of plain ASA, and this is equivalent to 100 mg of enteric-coated ASA.Conclusions All of the low-dose ASA preparations marketed in Indonesia are enteric-coated products, while Thrombo Aspilet® is not only an enteric-coated but also a sustained-release product. Cardio Aspirin®, followed by Aptor®, has the right dose for low-dose enteric-coated preparation (100 mg), produces consistent ASA release between batches,and the most stable towards deacetylation (antiplatelet inactivation). (Med J Indones 2009;18:159-64)Key words: Dissolution profile, enteric coated, deacetylation
Co-Authors Abdillah, Oktaviardi Bityasmawan Agustiyanti, Dian Fitria Agustiyanti, Dian Fitria Alfan Danny Arbianto Ali Iqbal Tawakal Ali Iqbal Tawakal Amalia, Riezki Ambarwati, Rini Amirah Adlia Amirah Adlia Amirah Adlia Anna Smdyah Putri Anna Surgean Veterini Annis Catur Adi Arbianto, Alfan Danny Arbianto, Alfan Danny Arini Setiawati Asrul Muhamad Fuad Asrul Muhamad Fuad, Asrul Muhamad Atsarina Anindya Bambang Wahjuprajitno Citra Ariani Edityaningrum, Citra Damar Rasti Adhika Deandra Ardya Regitasari Deandra Ardya Regitasari Debbie Sofie Retnoningrum DEBBIE SOFIE RETNONINGRUM DEBBIE SOFIE RETNONINGRUM Dewi Esti Restiani Dian Fitria Agustiyanti Dwiyatna, Archie Arman Emyr Reisha Ishaura Estherina Juliana Marbun, Estherina Juliana Farapti Farapti Fathrizqita Aghnia Raudhany Fatona Suraya, Fatona Ferry Iskandar Fibriani, Azzania Hamzah Hamzah Herdiani Sulistyo Putri Hidayat, Erzi I Ketut Adnyana Irda Fidrianny Isaura, Emyr Reisha Iskandar, Fery Jessie S. Pamudji Kusnandar Anggadiredja Leonny Yulita Hartiadi Lili Fitriani Magdalena Yuni Kristanti Maharani, Dita Galuh Mahmud Aditya Rifqi Marlina Indriastuti Meirawan, Rizky Fajar Muhammad mahrus zain Nelly Setiawaty Nuthathai Sutthiwong Pambudi, Sabar Pambudi, Sabar Permatasari, Fitri A. Permatasari, Fitri Aulia Pricillia Sinambela Putri, Dea Mayang Yulia Rachmad Suhanda Rachmadani, Nisa Amanda Rachmat Mauludin Rahmah, Ainur Rahmana E. Kartasasmita Rahmana E. Kartasasmita Rasyidi, Mohammad Fahmi RATIH ASMANA NINGRUM Rehatta, Nancy Margarita Resmi, Juniar Kalpika Restiani, Dewi Esti Restiani, Dewi Esti Rika Hartati Rini Ambarwati S.Pd. M Kes I Ketut Sudiana . Sabar Pambudi Safira Prisya Dewi Sakinah Aljuffrie Salisa, Wizara Santika, Arum Sinda Sari, Ririn Andika Sarmanu, Sarmanu Satuman Satuman Shafiqah Adam Siti Fatimah Zahro Soetomo, Meilisa Keizia Sophi Damayanti Subijanto Marto Soedarmo Subijanto Marto Soedarmo Sukmadjaja Asyarie Sukmadjaja Asyarie Sukmadjaja Asyarie Sulistiawan, Soni Sunarso Syefrida Yulina, Syefrida Taharuddin, Audrey Angelina Putri Tarwadi Tarwadi Tarwadi, Tarwadi Tarwadi, Tarwadi Tjandrawati Mozef Tri Suciati Vidya Anggarini Rahmasari Vidya Anggarini Rahmasari Wenda Novayani Wibowo, Indra Widijiati Widijiati Widjiati Widjiati Widodo Jatim P Widodo Jatim Pudjirahardjo Widodo, Ferri Wijayanti, Ni PAD. Wizara Salisa Wizara Salisa Wizara Salisa Yeyet C. Sumirtapura YEYET CAHYATI Yogie Handoko