Kajian Sediaan Orally Dissolving Film (ODF)
DOI:
https://doi.org/10.29313/jrf.v2i2.1270Keywords:
Film lapis tipis, Strip oral, Film larut cepatAbstract
Abstract. Oral route administration is the most common route and most widely known. However, this route is not always given beneficial. Some of the problems commonly encountered in this route are difficulty swallowing such hard tablets and capsules for patients who are at risk of choking on their use so the therapeutic effect is not optimal. Orally dissolving film (ODF) is a new invention that allows drugs to be used more comfortably than other oral solid preparations without the need for drinking water. In the oral cavity, there is vascularity that allows drugs to enter the systemic circulation without undergoing first-pass metabolism in the liver. ODF formulations consist of active pharmaceutical substances and excipients (film-forming polymers, plasticizers, saliva stimulants, sweeteners, flavoring agents). The ideal ODF preparation should be smooth, strong, and elastic but has a fast dissolving time. To ensure that ODF preparation is ideal, it is necessary to carry out evaluation tests including organoleptic, weight variety, film thickness, dissolution time, surface pH, folding endurance, tensile strength, percent elongation, drug content, transparency, and dissolution test.
Abstrak. Rute pemberian oral merupakan rute paling umum dan paling banyak diketahui oleh masyarakat. Namun rute oral tidak selamanya memberikan keuntungan. Beberapa permasalahan yang umum ditemui pada rute ini yaitu kesulitan menelan seperti pada tablet dan kapsul keras bagi pasien yang berisiko tersedak pada penggunaanya sehingga efek terapi tidak optimal. Sediaan orally dissolving film (ODF) merupakan sebuah penemuan baru yang memungkinkan obat dapat digunakan secara nyaman dibandingkan sediaan solida oral lainnya tanpa memerlukan bantuan air minum. Dalam rongga mulut terdapat vaskularisasi yang membuat sebagian besar obat akan memasuki sirkulasi sistemik tanpa mengalami metabolisme lintas pertama di hati. Formulasi sediaan ODF terdiri atas zat aktif farmasi dan eksipien (polimer pembentuk film, plastisizer, penstimulasi saliva, pemanis, flavouring agent). Sediaan ODF yang ideal harus bersifat halus, kuat, elastis, namun memiliki waktu melarut cepat. Untuk memastikan sediaan ODF yang dihasilkan ideal perlu dilakukan uji evaluasi meliputi organoleptis, keragaman bobot, ketebalan film, waktu larut, pH sediaan, ketahanan lipat, kekuatan tarik, persen pemanjangan, penetapan kadar, transparansi, dan uji disolusi.
References
H. . Ansel, Pengantar Bentuk Sediaan Farmasi. Edisi Keempat. Jakarta: Penerbit UI Press, 2005.
R. Asija, S. Manmohan, G. Avinash, and B. Shailendra, “Orodispersible Film: A Novel Approach for Patient Compliance,” Int. J. Med. Pharm. Res., vol. 1, no. 4, pp. 386–390, 2013.
T. R. Fajria and R. F. Nuwarda, “Teknologi Sediaan Oral Lapis Tipis Terlarut Cepat (Fast Dissolving Film),” Maj. Farmasetika, vol. 3, no. 3, p. 58, May 2018, doi: 10.24198/farmasetika.v3i3.23341.
D. P. Sari and F. Ferdiansyah, “Variasi Frekuensi Alel Terkait Polimorfisme CYP4F2 dan CYP2C9 (* 2 ,* 3 ) pada Berbagai Etnis di Dunia : Review,” Indones. J. Appl. Sci., vol. 7, pp. 73–76, 2017, doi: https://doi.org/10.24198/.v7i3.8599.g8140.
T. Zhang, K. Yu, and X. Li, “Cytochrome P450 family 4 subfamily F member 2 (CYP4F2) rs1558139, rs2108622 polymorphisms and susceptibility to several cardiovascular and cerebrovascular diseases,” BMC Cardiovasc. Disord., vol. 18, no. 1, pp. 1–10, 2018, doi: 10.1186/s12872-018-0763-y.
M. D. Caldwell et al., “CYP4F2 genetic variant alters required warfarin dose,” Blood First Ed. Pap. J., vol. 111, no. 8, pp. 4106–4113, 2008, doi: 10.1182/blood-2007-11-122010.The.
M. G. McDonald, M. J. Rieder, M. Nakano, C. K. Hsia, and A. E. Rettie, “CYP4F2 is a vitamin K1 oxidase: An explanation for altered warfarin dose in carriers of the V433M variant,” Mol. Pharmacol., vol. 75, no. 6, pp. 1337–1346, 2009, doi: 10.1124/mol.109.054833.
M. L. Alvarellos, K. Sangkuhl, R. Daneshjou, M. Whirl-carrillo, R. B. Altman, and T. E. Klein, “PharmGKB summary : very important pharmacogene information for CYP4F2,” Liipincott Williams & Wilkins, vol. 25, pp. 41–47, 2015, doi: 10.1097/FPC.0000000000000100.
L. N. Al-eitan, A. Y. Almasri, A. H. Alnaamneh, H. A. Aman, and N. N. Alrabadi, “Influence of CYP4F2, ApoE, and CYP2A6 gene polymorphisms on the variability of Warfarin dosage requirements and susceptibility to cardiovascular disease in Jordan,” Int. J. Med. Sci., vol. 18, pp. 826–834, 2021, doi: 10.7150/ijms.51546.
J. M. Joshua, R. Hari, F. K. Jyothish, and S. . Surendran, Fast Dissolving Oral Thin Films: An Effective Dosage Form For Quick Releases. International Journal of Pharmaceutical Sciences Review and Research. 2016.
N. N. and V. Nurilawati, Farmakologi. Pusat Pendidikan Sumber Daya Manusia Kesehatan Kemenkes RI. 2017.
B. Bhyan, S. Jangra, M. Kaur, and H. Singh, “Orally Fast Dissolving Films: Innovations in Formulation and Technology,” Int. J. Pharm. Sci. Rev. Res., 2011.
M. Irfan, S. Rabel, Q. Bukhtar, M. I. Qadir, F. Jabeen, and A. Khan, “Orally disintegrating films: A modern expansion in drug delivery system,” Saudi Pharm. J., vol. 24, no. 5, pp. 537–546, 2015, doi: 10.1016/j.jsps.2015.02.024.
U. M. Musazzi, G. M. Khalid, F. Selmin, P. Minghetti, and F. Cilurzo, “Trends In The Production Methods Of Orodispersible Films,” Int. J. Pharm., 2019.
K. Wasilewska and K. Winnicka, “How to assess orodispersible film quality? A review of applied methods and their modifications,” Acta Pharm., 2019.
S. Kalyan and M. Bansal, “Recent Trends In The Development Oral Dissolving Film,” Int. J. PharmTech, 2012.
U. M. Musazzi, G. M. Khalid, F. Selmin, P. Minghetti, and F. Cilurzo, “Trends in the production methods of orodispersible films,” Elsevier B.V., 2019, doi: 10.1016/j.ijpharm.2019.118963.
