Generic placeholder image

Current Drug Delivery

Editor-in-Chief

ISSN (Print): 1567-2018
ISSN (Online): 1875-5704

Research Article

Development of Polyvinyl Alcohol/Polyethylene Glycol Copolymer-based Orodispersible Films Loaded with Entecavir: Formulation and In vitro Characterization

Author(s): Teng Wei, Bing-yu Zhou, Xin-Hong Wu, Xue-Ai Liu, Ming-Wei Huo, Xiang-Xiang Huang, Ling-Zhi Shi, Li-Li Shi* and Qin-Ri Cao*

Volume 21, Issue 10, 2024

Published on: 27 October, 2023

Page: [1362 - 1374] Pages: 13

DOI: 10.2174/0115672018261294231024093926

Price: $65

Open Access Journals Promotions 2
Abstract

Purpose: The aim of the study is to prepare entecavir (ETV)-loaded orodispersible films (ODFs) using polyvinyl alcohol (PVA)/polyethylene glycol (PEG) graft copolymer (Kollicoat® IR) as a film-forming agent, and further to evaluate the dissolution rate, mechanical and physicochemical properties of films.

Methods: ETV-ODFs were prepared by a solvent casting method. The amount of film-forming agent, plasticizer, and disintegrating agent was optimized in terms of the appearance, thickness, disintegration time and mechanical properties of ODFs. The compatibility between the drug and each excipient was conducted under high temperature (60 °C), high humidity (RH 92.5%), and strong light (4500 Lx) for 10 days. The dissolution study of optimal ODFs compared with the original commercial tablet (Baraclude®) was performed using a paddle method in pH 1.0, pH 4.5, pH 6.8, and pH 7.4 media at 37 °C. The morphology of ODFs was observed via scanning electron microscopy (SEM). The mechanical properties such as tensile strength (TS), elastic modulus (EM), and percentage elongation (E%) of ODFs were evaluated using the universal testing machine. The physicochemical properties of ODFs were investigated using X-ray diffraction (XRD), differential scanning calorimetry (DSC), and Fourier transform infrared spectroscopy (FT-IR).

Results: The related substances were less than 0.5% under high temperature, high humidity, and strong light for 10 days when ETV was mixed with excipients. The optimal formulation of ODFs was set as the quality ratio of Kollicoat® IR, glycerol, sodium alginate (ALG-Na): TiO2: MCC+CMC-Na: ETV was 60:9:12:1:1:1. The drug-loaded ODFs were white and translucent with excellent stripping property. The thickness, disintegration time, EM, TS, and E% were 103.33±7.02 μm, 25.31±1.95 s, 25.34±8.69 Mpa, 2.14±0.26 Mpa, and 65.45±19.41 %, respectively. The cumulative drug release from ODFs was more than 90% in four different media at 10 min. The SEM showed that the drug was highly dispersible in ODFs, and the XRD, DSC, and FT-IR results showed that there occurred some interactions between the drug and excipients.

Conclusion: In conclusion, the developed ETV-loaded ODFs showed relatively short disintegration time, rapid drug dissolution, and excellent mechanical properties. This might be an alternative to conventional ETV Tablets for the treatment of chronic hepatitis B.

Keywords: Entecavir, orodispersible film, Kollicoat® IR, sodium alginate, formulation, characterization.

Graphical Abstract
[1]
Lang, J.; Neumann-Haefelin, C.; Thimme, R. Immunological cure of HBV infection. Hepatol. Int., 2019, 13(2), 113-124.
[http://dx.doi.org/10.1007/s12072-018-9912-8] [PMID: 30600480]
[2]
Ginzberg, D.; Wong, R.J.; Gish, R. Global HBV burden: Guesstimates and facts. Hepatol. Int., 2018, 12(4), 315-329.
[http://dx.doi.org/10.1007/s12072-018-9884-8] [PMID: 30054801]
[3]
Wang, M.; Xi, D.; Ning, Q. Virus-induced hepatocellular carcinoma with special emphasis on HBV. Hepatol. Int., 2017, 11(2), 171-180.
[http://dx.doi.org/10.1007/s12072-016-9779-5] [PMID: 28097530]
[4]
Seto, W.K.; Lo, Y.R.; Pawlotsky, J.M.; Yuen, M.F. Chronic hepatitis B virus infection. Lancet, 2018, 392(10161), 2313-2324.
[http://dx.doi.org/10.1016/S0140-6736(18)31865-8] [PMID: 30496122]
[5]
Tsai, K.N.; Kuo, C.F.; Ou, J.H.J. Mechanisms of hepatitis B virus persistence. Trends Microbiol., 2018, 26(1), 33-42.
[http://dx.doi.org/10.1016/j.tim.2017.07.006] [PMID: 28823759]
[6]
Li, T.Y.; Yang, Y.; Zhou, G.; Tu, Z.K. Immune suppression in chronic hepatitis B infection associated liver disease: A review. World J. Gastroenterol., 2019, 25(27), 3527-3537.
[http://dx.doi.org/10.3748/wjg.v25.i27.3527] [PMID: 31367154]
[7]
Zhao, R.H.; Shi, Y.; Zhao, H.; Wu, W.; Sheng, J.F. Acute-on-chronic liver failure in chronic hepatitis B: An update. Expert Rev. Gastroenterol. Hepatol., 2018, 12(4), 341-350.
[http://dx.doi.org/10.1080/17474124.2018.1426459] [PMID: 29334786]
[8]
Sheena, B.S.; Hiebert, L.; Han, H.; Ippolito, H.; Abbasi-Kangevari, M.; Abbasi-Kangevari, Z.; Abbastabar, H.; Abdoli, A.; Abubaker Ali, H.; Adane, M.M.; Adegboye, O.A.; Adnani, Q.E.S.; Advani, S.M.; Afzal, M.S.; Afzal, S.; Aghaie Meybodi, M.; Ahadinezhad, B.; Ahinkorah, B.O.; Ahmad, S.; Ahmad, T.; Ahmadi, S.; Ahmed, H.; Ahmed, M.B.; Ahmed Rashid, T.; Akalu, G.T.; Aklilu, A.; Akram, T.; Al Hamad, H.; Alahdab, F.; Alem, A.Z.; Alem, D.T.; Alhalaiqa, F.A.N.; Alhassan, R.K.; Ali, L.; Ali, M.A.; Alimohamadi, Y.; Alipour, V.; Alkhayyat, M.; Almustanyir, S.; Al-Raddadi, R.M.; Altawalah, H.; Amini, S.; Amu, H.; Ancuceanu, R.; Andrei, C.L.; Andrei, T.; Anoushiravani, A.; Ansar, A.; Anyasodor, A.E.; Arabloo, J.; Arab-Zozani, M.; Argaw, A.M.; Argaw, Z.G.; Arshad, M.; Artamonov, A.A.; Ashraf, T.; Atlaw, D.; Ausloos, F.; Ausloos, M.; Azadnajafabad, S.; Azangou-Khyavy, M.; Azari Jafari, A.; Azarian, G.; Bagheri, S.; Bahadory, S.; Baig, A.A.; Banach, M.; Barati, N.; Barrow, A.; Batiha, A-M.M.; Bejarano Ramirez, D.F.; Belgaumi, U.I.; Berhie, A.Y.; Bhagat, D.S.; Bhardwaj, N.; Bhardwaj, P.; Bhattacharyya, K.; Bhojaraja, V.S.; Bijani, A.; Biondi, A.; Bodicha, B.B.A.; Bojia, H.A.; Boloor, A.; Bosetti, C.; Braithwaite, D.; Briko, N.I.; Butt, Z.A.; Cámera, L.A.; Chakinala, R.C.; Chakraborty, P.A.; Charan, J.; Chen, S.; Choi, J-Y.J.; Choudhari, S.G.; Chowdhury, F.R.; Chu, D-T.; Chung, S-C.; Cortesi, P.A.; Cowie, B.C.; Culbreth, G.T.; Dadras, O.; Dai, X.; Dandona, L.; Dandona, R.; De la Hoz, F.P.; Debela, S.A.; Dedefo, M.G.; Demeke, F.M.; Demie, T.G.G.; Demissie, G.D.; Derbew Molla, M.; Desta, A.A.; Dhamnetiya, D.; Dhimal, M.L.; Dhimal, M.; Didehdar, M.; Doan, L.P.; Dorostkar, F.; Drake, T.M.; Eghbalian, F.; Ekholuenetale, M.; El Sayed, I.; El Sayed Zaki, M.; Elhadi, M.; Elmonem, M.A.; Elsharkawy, A.; Enany, S.; Enyew, D.B.; Erkhembayar, R.; Eskandarieh, S.; Esmaeilzadeh, F.; Ezzikouri, S.; Farrokhpour, H.; Fetensa, G.; Fischer, F.; Foroutan, M.; Gad, M.M.; Gaidhane, A.M.; Gaidhane, S.; Galles, N.C.; Gallus, S.; Gebremeskel, T.G.; Gebreyohannes, E.A.; Ghadiri, K.; Ghaffari, K.; Ghafourifard, M.; Ghamari, S-H.; Ghashghaee, A.; Gholami, A.; Gholizadeh, A.; Gilani, A.; Goel, A.; Golechha, M.; Goleij, P.; Golinelli, D.; Gorini, G.; Goshu, Y.A.; Griswold, M.G.; Gubari, M.I.M.; Gupta, B.; Gupta, S.; Gupta, V.B.; Gupta, V.K.; Haddadi, R.; Halwani, R.; Hamid, S.S.; Hamidi, S.; Hanif, A.; Haque, S.; Harapan, H.; Hargono, A.; Hariri, S.; Hasaballah, A.I.; Hasan, S.M.M.; Hassanipour, S.; Hassankhani, H.; Hay, S.I.; Hayat, K.; Heidari, G.; Herteliu, C.; Heyi, D.Z.; Hezam, K.; Holla, R.; Hosseini, M-S.; Hosseini, M.; Hosseinzadeh, M.; Hostiuc, M.; Househ, M.; Huang, J.; Hussein, N.R.; Iavicoli, I.; Ibitoye, S.E.; Ilesanmi, O.S.; Ilic, I.M.; Ilic, M.D.; Irham, L.M.; Islam, J.Y.; Ismail, N.E.; Jacobsen, K.H.; Jadidi-Niaragh, F.; Javadi Mamaghani, A.; Jayaram, S.; Jayawardena, R.; Jebai, R.; Jha, R.P.; Joseph, N.; Joukar, F.; Kaambwa, B.; Kabir, A.; Kabir, Z.; Kalhor, R.; Kandel, H.; Kanko, T.K.T.; Kantar, R.S.; Karaye, I.M.; Kassa, B.G.; Kemp Bohan, P.M.; Keykhaei, M.; Khader, Y.S.; Khajuria, H.; Khan, G.; Khan, I.A.; Khan, J.; Khan, M.A.B.; Khanali, J.; Khater, A.M.; Khatib, M.N.; Khodadost, M.; Khoja, A.T.; Khosravizadeh, O.; Khubchandani, J.; Kim, G.R.; Kim, H.; Kim, M.S.; Kim, Y.J.; Kocarnik, J.M.; Kolahi, A-A.; Koteeswaran, R.; Kumar, G.A.; La Vecchia, C.; Lal, D.K.; Landires, I.; Lasrado, S.; Lazarus, J.V.; Ledda, C.; Lee, D.W.; Lee, S.; Lee, Y.Y.; Levi, M.; Li, J.; Lim, S.S.; Lobo, S.W.; Lopukhov, P.D.; Loureiro, J.A.; MacLachlan, J.H.; Magdy Abd El Razek, H.; Magdy Abd El Razek, M.; Majeed, A.; Makki, A.; Malekpour, M-R.; Malekzadeh, R.; Malik, A.A.; Mansour-Ghanaei, F.; Mansournia, M.A.; Martins-Melo, F.R.; Matthews, P.C.; Mendoza, W.; Menezes, R.G.; Meretoja, T.J.; Mersha, A.G.; Mestrovic, T.; Miller, T.R.; Minh, L.H.N.; Mirica, A.; Mirmoeeni, S.; Mirrakhimov, E.M.; Misra, S.; Mithra, P.; Moazen, B.; Mohamadkhani, A.; Mohammadi, M.; Mohammed, S.; Moka, N.; Mokdad, A.H.; Moludi, J.; Momtazmanesh, S.; Monasta, L.; Moradi, G.; Moradzadeh, M.; Moradzadeh, R.; Moraga, P.; Mostafavi, E.; Mubarik, S.; Muniyandi, M.; Murray, C.J.L.; Naghavi, M.; Naimzada, M.D.; Narasimha Swamy, S.; Natto, Z.S.; Nayak, B.P.; Nazari, J.; Negoi, I.; Negru, S.M.; Nejadghaderi, S.A.; Neupane Kandel, S.; Nguyen, H.L.T.; Ngwa, C.H.; Niazi, R.K.; Nnaji, C.A.; Noubiap, J.J.; Nowroozi, A.; Nuñez-Samudio, V.; Oancea, B.; Ochir, C.; Odukoya, O.O.; Oh, I-H.; Olagunju, A.T.; Olakunde, B.O.; Omar Bali, A.; Omer, E.; Otstavnov, S.S.; Oumer, B.; Padubidri, J.R.; Pana, A.; Pandey, A.; Park, E-C.; Pashazadeh Kan, F.; Patel, U.K.; Paudel, U.; Petcu, I-R.; Piracha, Z.Z.; Pollok, R.C.G.; Postma, M.J.; Pourshams, A.; Poustchi, H.; Rabiee, M.; Rabiee, N.; Rafiei, A.; Rafiei, S.; Raghuram, P.M.; Rahman, M.; Rahmani, A.M.; Rahmawaty, S.; Rajesh, A.; Ranasinghe, P.; Rao, C.R.; Rao, S.J.; Rashidi, M.; Rashidi, M-M.; Rawaf, D.L.; Rawaf, S.; Rawassizadeh, R.; Rezaei, N.; Rezapour, A.; Rezazadeh-Khadem, S.; Rodriguez, J.A.B.; Rwegerera, G.M.; Sabour, S.; Saddik, B.; Saeb, M.R.; Saeed, U.; Sahebkar, A.; Saif-Ur-Rahman, K.M.; Salahi, S.; Salimzadeh, H.; Sampath, C.; Samy, A.M.; Sanabria, J.; Sanmarchi, F.; Santric-Milicevic, M.M.; Sarveazad, A.; Sathian, B.; Sawhney, M.; Seidu, A-A.; Sepanlou, S.G.; Seylani, A.; Shahabi, S.; Shaikh, M.A.; Shaker, E.; Shakhmardanov, M.Z.; Shannawaz, M.; Shenoy, S.M.; Shetty, J.K.; Shetty, P.H.; Shibuya, K.; Shin, J.I.; Shobeiri, P.; Sibhat, M.M.; Singh, A.D.; Singh, J.A.; Singh, S.; Skryabin, V.Y.; Skryabina, A.A.; Sohrabpour, A.A.; Song, S.; Tabaeian, S.P.; Tadesse, E.G.; Taheri, M.; Tampa, M.; Tan, K-K.; Tavakoli, A.; Tbakhi, A.; Tefera, B.N.; Tehrani-Banihashemi, A.; Tesfaw, H.M.; Thapar, R.; Thavamani, A.; Tohidast, S.A.; Tollosa, D.N.; Tosti, M.E.; Tovani-Palone, M.R.; Traini, E.; Tran, M.T.N.; Trihandini, I.; Tusa, B.S.; Ullah, I.; Vacante, M.; Valadan Tahbaz, S.; Valdez, P.R.; Varthya, S.B.; Vo, B.; Waheed, Y.; Weldesenbet, A.B.; Woldemariam, M.; Xu, S.; Yahyazadeh Jabbari, S.H.; Yaseri, M.; Yeshaw, Y. Yiğit, V.; Yirdaw, B.W.; Yonemoto, N.; Yu, C.; Yunusa, I.; Zahir, M.; Zaki, L.; Zamani, M.; Zamanian, M.; Zastrozhin, M.S.; Vos, T.; Ward, J.W.; Dirac, M.A. Global, regional, and national burden of hepatitis B, 1990–2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet Gastroenterol. Hepatol., 2022, 7(9), 796-829.
[http://dx.doi.org/10.1016/S2468-1253(22)00124-8] [PMID: 35738290]
[9]
Block, T.M.; Chang, K.M.; Guo, J.T. Prospects for the global elimination of hepatitis B. Annu. Rev. Virol., 2021, 8(1), 437-458.
[http://dx.doi.org/10.1146/annurev-virology-091919-062728] [PMID: 34586871]
[10]
Razavi-Shearer, D.; Gamkrelidze, I.; Nguyen, M.H.; Chen, D-S.; Van Damme, P.; Abbas, Z.; Abdulla, M.; Abou Rached, A.; Adda, D.; Aho, I.; Akarca, U.; Hasan, F.; Al Lawati, F.; Al Naamani, K.; Al-Ashgar, H.I.; Alavian, S.M.; Alawadhi, S.; Albillos, A.; Al-Busafi, S.A.; Aleman, S.; Alfaleh, F.Z.; Aljumah, A.A.; Anand, A.C.; Anh, N.T.; Arends, J.E.; Arkkila, P.; Athanasakis, K.; Bane, A.; Ben-Ari, Z.; Berg, T.; Bizri, A.R.; Blach, S.; Brandão Mello, C.E.; Brandon, S.M.; Bright, B.; Bruggmann, P.; Brunetto, M.; Buti, M.; Chan, H.L.Y.; Chaudhry, A.; Chien, R-N.; Choi, M.S.; Christensen, P.B.; Chuang, W-L.; Chulanov, V.; Clausen, M.R.; Colombo, M.; Cornberg, M.; Cowie, B.; Craxi, A.; Croes, E.A.; Cuellar, D.A.; Cunningham, C.; Desalegn, H.; Drazilova, S.; Duberg, A-S.; Egeonu, S.S.; El-Sayed, M.H.; Estes, C.; Falconer, K.; Ferraz, M.L.G.; Ferreira, P.R.; Flisiak, R.; Frankova, S.; Gaeta, G.B.; García-Samaniego, J.; Genov, J.; Gerstoft, J.; Goldis, A.; Gountas, I.; Gray, R.; Guimarães Pessôa, M.; Hajarizadeh, B.; Hatzakis, A.; Hézode, C.; Himatt, S.M.; Hoepelman, A.; Hrstic, I.; Hui, Y-T.T.; Husa, P.; Jahis, R.; Janjua, N.Z. Jarčuška, P.; Jaroszewicz, J.; Kaymakoglu, S.; Kershenobich, D.; Kondili, L.A.; Konysbekova, A.; Krajden, M.; Kristian, P.; Laleman, W.; Lao, W.C.; Layden, J.; Lazarus, J.V.; Lee, M-H.; Liakina, V.; Lim, Y-S.S.; Loo, C.K.; Lukšić B.; Malekzadeh, R.; Malu, A.O.; Mamatkulov, A.; Manns, M.; Marinho, R.T.; Maticic, M.; Mauss, S.; Memon, M.S.; Mendes Correa, M.C.; Mendez-Sanchez, N.; Merat, S.; Metwally, A.M.; Mohamed, R.; Mokhbat, J.E.; Moreno, C.; Mossong, J.; Mourad, F.H.; Müllhaupt, B.; Murphy, K.; Musabaev, E.; Nawaz, A.; Nde, H.M.; Negro, F.; Nersesov, A.; Nguyen, V.T.T.; Njouom, R.; Ntagirabiri, R.; Nurmatov, Z.; Obekpa, S.; Ocama, P.; Oguche, S.; Omede, O.; Omuemu, C.; Opare-Sem, O.; Opio, C.K.; Örmeci, N.; Papatheodoridis, G.; Pasini, K.; Pimenov, N.; Poustchi, H.; Quang, T.D.; Qureshi, H.; Ramji, A.; Razavi-Shearer, K.; Redae, B.; Reesink, H.W.; Rios, C.Y.; Rjaskova, G.; Robbins, S.; Roberts, L.R.; Roberts, S.K.; Ryder, S.D.; Safadi, R.; Sagalova, O.; Salupere, R.; Sanai, F.M.; Sanchez-Avila, J.F.; Saraswat, V.; Sarrazin, C.; Schmelzer, J.D.; Schréter, I.; Scott, J.; Seguin-Devaux, C.; Shah, S.R.; Sharara, A.I.; Sharma, M.; Shiha, G.E.; Shin, T.; Sievert, W.; Sperl, J.; Stärkel, P.; Stedman, C.; Sypsa, V.; Tacke, F.; Tan, S.S.; Tanaka, J.; Tomasiewicz, K.; Urbanek, P.; van der Meer, A.J.; Van Vlierberghe, H.; Vella, S.; Vince, A.; Waheed, Y.; Waked, I.; Walsh, N.; Weis, N.; Wong, V.W.; Woodring, J.; Yaghi, C.; Yang, H-I.; Yang, C-L.; Yesmembetov, K.; Yosry, A.; Yuen, M-F.; Yusuf, M.A.M.; Zeuzem, S.; Razavi, H. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: A modelling study. Lancet Gastroenterol. Hepatol., 2018, 3(6), 383-403.
[http://dx.doi.org/10.1016/S2468-1253(18)30056-6] [PMID: 29599078]
[11]
Schweitzer, A.; Horn, J.; Mikolajczyk, R.T.; Krause, G.; Ott, J.J. Estimations of worldwide prevalence of chronic hepatitis B virus infection: A systematic review of data published between 1965 and 2013. Lancet, 2015, 386(10003), 1546-1555.
[http://dx.doi.org/10.1016/S0140-6736(15)61412-X] [PMID: 26231459]
[12]
Lok, A.S.F.; McMahon, B.J.; Brown, R.S., Jr; Wong, J.B.; Ahmed, A.T.; Farah, W.; Almasri, J.; Alahdab, F.; Benkhadra, K.; Mouchli, M.A.; Singh, S.; Mohamed, E.A.; Abu Dabrh, A.M.; Prokop, L.J.; Wang, Z.; Murad, M.H.; Mohammed, K. Antiviral therapy for chronic hepatitis B viral infection in adults: A systematic review and meta‐analysis. Hepatology, 2016, 63(1), 284-306.
[http://dx.doi.org/10.1002/hep.28280] [PMID: 26566246]
[13]
Niu, C.; Li, L.; Daffis, S.; Lucifora, J.; Bonnin, M.; Maadadi, S.; Salas, E.; Chu, R.; Ramos, H.; Livingston, C.M.; Beran, R.K.; Garg, A.V.; Balsitis, S.; Durantel, D.; Zoulim, F.; Delaney, W.E., IV; Fletcher, S.P. Toll-like receptor 7 agonist GS-9620 induces prolonged inhibition of HBV via a type I interferon-dependent mechanism. J. Hepatol., 2018, 68(5), 922-931.
[http://dx.doi.org/10.1016/j.jhep.2017.12.007] [PMID: 29247725]
[14]
Xia, Y.; Stadler, D.; Lucifora, J.; Reisinger, F.; Webb, D.; Hösel, M.; Michler, T.; Wisskirchen, K.; Cheng, X.; Zhang, K.; Chou, W.M.; Wettengel, J.M.; Malo, A.; Bohne, F.; Hoffmann, D.; Eyer, F.; Thimme, R.; Falk, C.S.; Thasler, W.E.; Heikenwalder, M.; Protzer, U. Interferon-γ and tumor necrosis factor-α produced by T cells reduce the HBV persistence form, cccDNA, without cytolysis. Gastroenterology, 2016, 150(1), 194-205.
[http://dx.doi.org/10.1053/j.gastro.2015.09.026] [PMID: 26416327]
[15]
Bi, J.; Zhang, Z.; Qin, E.; Hou, J.; Liu, S.; Liu, Z.; Li, S.; Wei, Z.; Zhong, Y. Nucleoside analogs treatment delay the onset of hepatocellular carcinoma in patients with HBV-related cirrhosis. Oncotarget, 2017, 8(57), 96725-96731.
[http://dx.doi.org/10.18632/oncotarget.18075] [PMID: 29228565]
[16]
Geng, C.A.; Yang, T.H.; Huang, X.Y.; Yang, J.; Ma, Y.B.; Li, T.Z.; Zhang, X.M.; Chen, J.J. Anti-hepatitis B virus effects of the traditional Chinese herb Artemisia capillaris and its active enynes. J. Ethnopharmacol., 2018, 224, 283-289.
[http://dx.doi.org/10.1016/j.jep.2018.06.005] [PMID: 29890315]
[17]
Jia, H.H.; Li, K.W.; Chen, Q.Y.; Wang, X.Y.; Harrison, T.J.; Liang, S.J.; Yang, Q.L.; Wang, C.; Hu, L.P.; Ren, C.C.; Fang, Z.L. High prevalence of HBV lamivudine-resistant mutations in HBV/HIV co-infected patients on antiretroviral therapy in the area with the highest prevalence of HIV/HBV co-infection in China. Intervirology, 2018, 61(3), 123-132.
[http://dx.doi.org/10.1159/000493797] [PMID: 30368502]
[18]
Sun, J.; Li, Y.; Wang, Y.; Liu, Y.; Liu, Y.; Wang, X. Comparison of anti-HBV regimen with or without adefovir on hepatocellular carcinoma development of Chronic hepatitis B patients with compensated cirrhosis: A retrospective cohort study. Infect. Agent. Cancer, 2018, 13(1), 17.
[http://dx.doi.org/10.1186/s13027-018-0189-2] [PMID: 29796061]
[19]
Yu, S.; Luo, H.; Pan, M.; Luis, A.P.; Xiong, Z.; Shuai, P.; Zhang, Z. Comparison of entecavir and lamivudine in preventing HBV reactivation in lymphoma patients undergoing chemotherapy: A meta-analysis. Int. J. Clin. Pharm., 2016, 38(5), 1035-1043.
[http://dx.doi.org/10.1007/s11096-016-0358-6] [PMID: 27450506]
[20]
Nicolò, A.D.; Boglione, L.; Cusato, J.; Fatiguso, G.; Favata, F.; Allegra, S.; Cariti, G.; Perri, G.D.; D’Avolio, A. Correlation between entecavir penetration in peripheral blood mononuclear cells and HBV DNA decay during treatment of HBeAg-negative chronic hepatitis B. Antivir. Ther., 2018, 23(4), 373-377.
[http://dx.doi.org/10.3851/IMP3207] [PMID: 29168696]
[21]
Zeng, J.; Zheng, C.; Li, H. Effectiveness of tenofovir or telbivudine in preventing HBV vertical transmission for pregnancy. Medicine, 2019, 98(14), e15092.
[http://dx.doi.org/10.1097/MD.0000000000015092] [PMID: 30946367]
[22]
Pol, S.; Lampertico, P. First‐line treatment of chronic hepatitis B with entecavir or tenofovir in ‘real‐life’ settings: from clinical trials to clinical practice. J. Viral Hepat., 2012, 19(6), 377-386.
[http://dx.doi.org/10.1111/j.1365-2893.2012.01602.x] [PMID: 22571899]
[23]
Han, S.H.; Tran, T.T. Management of chronic hepatitis B: An overview of practice guidelines for primary care providers. J. Am. Board Fam. Med., 2015, 28(6), 822-837.
[http://dx.doi.org/10.3122/jabfm.2015.06.140331] [PMID: 26546661]
[24]
Han, Y.; Zeng, A.; Liao, H.; Liu, Y.; Chen, Y.; Ding, H. The efficacy and safety comparison between tenofovir and entecavir in treatment of chronic hepatitis B and HBV related cirrhosis: A systematic review and Meta-analysis. Int. Immunopharmacol., 2017, 42, 168.
[http://dx.doi.org/10.1016/j.intimp.2016.11.022] [PMID: 27915131]
[25]
Wong, G.L.H.; Seto, W.K.; Wong, V.W.S.; Yuen, M.F.; Chan, H.L.Y. Review article: Long‐term safety of oral anti‐viral treatment for chronic hepatitis B. Aliment. Pharmacol. Ther., 2018, 47(6), 730-737.
[http://dx.doi.org/10.1111/apt.14497] [PMID: 29359487]
[26]
Clark, D.N.; Hu, J. Hepatitis B virus reverse transcriptase – Target of current antiviral therapy and future drug development. Antiviral Res., 2015, 123, 132-137.
[http://dx.doi.org/10.1016/j.antiviral.2015.09.011] [PMID: 26408354]
[27]
Zhao, L.; Li, X.; Cheng, Y.; Chen, R.; Shao, J.; Zhou, Y.; Li, Q.; Liao, H.; Zhao, Y.; Liu, L.; Su, H.; Liu, Y.; Liu, Y.; Xu, D. Hepatitis B virus rtA181T/sW172non-stop mutation may increase resistance fold to adefovir- and entecavir-resistant mutants compared to rtA181T/sW172* mutation. Antiviral Res., 2018, 154, 26-34.
[http://dx.doi.org/10.1016/j.antiviral.2018.04.003] [PMID: 29630974]
[28]
Choi, J.; Kim, H.J.; Lee, J.; Cho, S.; Ko, M.J.; Lim, Y.S. Risk of hepatocellular carcinoma in patients treated with entecavir vs tenofovir for chronic hepatitis B. JAMA Oncol., 2019, 5(1), 30-36.
[http://dx.doi.org/10.1001/jamaoncol.2018.4070] [PMID: 30267080]
[29]
Sarin, S.K.; Kumar, M.; Lau, G.K.; Abbas, Z.; Chan, H.L.Y.; Chen, C.J.; Chen, D.S.; Chen, H.L.; Chen, P.J.; Chien, R.N.; Dokmeci, A.K.; Gane, E.; Hou, J.L.; Jafri, W.; Jia, J.; Kim, J.H.; Lai, C.L.; Lee, H.C.; Lim, S.G.; Liu, C.J.; Locarnini, S.; Al Mahtab, M.; Mohamed, R.; Omata, M.; Park, J.; Piratvisuth, T.; Sharma, B.C.; Sollano, J.; Wang, F.S.; Wei, L.; Yuen, M.F.; Zheng, S.S.; Kao, J.H. Asian-Pacific clinical practice guidelines on the management of hepatitis B: A 2015 update. Hepatol. Int., 2016, 10(1), 1-98.
[http://dx.doi.org/10.1007/s12072-015-9675-4] [PMID: 26563120]
[30]
Henry, S.J.; Barrett, S.E.; Forster, S.P.; Teller, R.S.; Yang, Z.; Li, L.; Mackey, M.A.; Doto, G.J.; Ruth, M.P.; Tsuchiya, T.; Klein, L.J.; Gindy, M.E. Exploration of long-acting implant formulations of hepatitis B drug entecavir. Eur. J. Pharm. Sci., 2019, 136, 104958.
[http://dx.doi.org/10.1016/j.ejps.2019.104958] [PMID: 31212018]
[31]
Talwar, P.M.N. Pharmaceutical composition of entecavir and process of manufacturing. U.S. Patent Application No. 15/944,452,
[32]
Scarpa, M.; Stegemann, S.; Hsiao, W.K.; Pichler, H.; Gaisford, S.; Bresciani, M.; Paudel, A.; Orlu, M. Orodispersible films: Towards drug delivery in special populations. Int. J. Pharm., 2017, 523(1), 327-335.
[http://dx.doi.org/10.1016/j.ijpharm.2017.03.018] [PMID: 28302515]
[33]
Musazzi, U.M.; Khalid, G.M.; Selmin, F.; Minghetti, P.; Cilurzo, F. Trends in the production methods of orodispersible films. Int. J. Pharm., 2020, 576, 118963.
[http://dx.doi.org/10.1016/j.ijpharm.2019.118963] [PMID: 31857185]
[34]
Shi, L.L.; Xu, W.J.; Cao, Q.R.; Yang, M.; Cui, J.H. Preparation, characterization and in vitro evaluation of a polyvinyl alcohol/sodium alginate based orodispersible film containing sildenafil citrate. Pharmazie, 2014, 69(5), 327-334.
[PMID: 24855822]
[35]
Xu, L.L.; Shi, L.L.; Cao, Q.R.; Xu, W.J.; Cao, Y.; Zhu, X.Y.; Cui, J.H. Formulation and in vitro characterization of novel sildenafil citrate-loaded polyvinyl alcohol-polyethylene glycol graft copolymer-based orally dissolving films. Int. J. Pharm., 2014, 473(1-2), 398-406.
[http://dx.doi.org/10.1016/j.ijpharm.2014.07.037] [PMID: 25079431]
[36]
Zhao, Z.L.; Peng, D.; Liu, X.; Li, X-C.; Lan, L-J.; Wu, X-H.; Liu, X-A.; Cui, J-H.; Lee, B-J.; Shi, L-L.; Cao, Q-R. Formulation and characterization of tadalafil-loaded orodispersible films with enhanced dissolution rate and membrane permeability. J. Drug Deliv. Sci. Technol., 2023, 84, 104535.
[http://dx.doi.org/10.1016/j.jddst.2023.104535]
[37]
Shah, H.G.; Rathod, V.; Basim, P.; Gajera, B.; Dave, R.H. Understanding the impact of multi-factorial composition on efficient loading of the stable ketoprofen nanoparticles on orodispersible films using box-behnken design. J. Pharm. Sci., 2022, 111(5), 1451-1462.
[http://dx.doi.org/10.1016/j.xphs.2021.10.016] [PMID: 34678275]
[38]
Steiner, D.; Finke, J.H.; Kwade, A. Efficient production of nanoparticle-loaded orodispersible films by process integration in a stirred media mill. Int. J. Pharm., 2016, 511(2), 804-813.
[http://dx.doi.org/10.1016/j.ijpharm.2016.07.058] [PMID: 27477101]
[39]
Pechová, V.; Gajdziok, J.; Muselík, J.; Vetchý, D. Development of orodispersible films containing benzydamine hydrochloride using a modified solvent casting method. AAPS PharmSciTech, 2018, 19(6), 2509-2518.
[http://dx.doi.org/10.1208/s12249-018-1088-y] [PMID: 29948980]
[40]
Serrano, D.R.; Fernandez-Garcia, R.; Mele, M.; Healy, A.M.; Lalatsa, A. Designing fast-dissolving orodispersible films of amphotericin b for oropharyngeal candidiasis. Pharmaceutics, 2019, 11(8), 369.
[http://dx.doi.org/10.3390/pharmaceutics11080369] [PMID: 31374879]
[41]
Nair, A.B.; Kumria, R.; Harsha, S.; Attimarad, M.; Al-Dhubiab, B.E.; Alhaider, I.A. In vitro techniques to evaluate buccal films. J. Control. Release, 2013, 166(1), 10-21.
[http://dx.doi.org/10.1016/j.jconrel.2012.11.019] [PMID: 23219961]
[42]
Vuddanda, P.R.; Montenegro-Nicolini, M.; Morales, J.O.; Velaga, S. Effect of plasticizers on the physico-mechanical properties of pullulan based pharmaceutical oral films. Eur. J. Pharm. Sci., 2017, 96, 290-298.
[http://dx.doi.org/10.1016/j.ejps.2016.09.011] [PMID: 27629498]
[43]
Alizadeh-Sani, M.; Mohammadian, E.; McClements, D.J. Eco-friendly active packaging consisting of nanostructured biopolymer matrix reinforced with TiO2 and essential oil: Application for preservation of refrigerated meat. Food Chem., 2020, 322, 126782.
[http://dx.doi.org/10.1016/j.foodchem.2020.126782] [PMID: 32305879]
[44]
Siripatrawan, U.; Kaewklin, P. Fabrication and characterization of chitosan-titanium dioxide nanocomposite film as ethylene scavenging and antimicrobial active food packaging. Food Hydrocoll., 2018, 84, 125-134.
[http://dx.doi.org/10.1016/j.foodhyd.2018.04.049]
[45]
Wang, Y.; Wang, J.; Lai, J.; Zhang, X.; Wang, Y.; Zhu, Y. Preparation and characterization of chitosan/whey isolate protein active film containing TiO2 and white pepper essential oil. Front. Nutr., 2022, 9, 1047988.
[http://dx.doi.org/10.3389/fnut.2022.1047988] [PMID: 36479295]
[46]
Zhang, X.; Liu, Y.; Yong, H.; Qin, Y.; Liu, J.; Liu, J. Development of multifunctional food packaging films based on chitosan, TiO2 nanoparticles and anthocyanin-rich black plum peel extract. Food Hydrocoll., 2019, 94, 80-92.
[http://dx.doi.org/10.1016/j.foodhyd.2019.03.009]
[47]
Zhang, X.; Xiao, G.; Wang, Y.; Zhao, Y.; Su, H.; Tan, T. Preparation of chitosan-TiO2 composite film with efficient antimicrobial activities under visible light for food packaging applications. Carbohydr. Polym., 2017, 169, 101-107.
[http://dx.doi.org/10.1016/j.carbpol.2017.03.073] [PMID: 28504125]
[48]
Cataldi, A.; Dorigato, A.; Deflorian, F.; Pegoretti, A. Thermo-mechanical properties of innovative microcrystalline cellulose filled composites for art protection and restoration. J. Mater. Sci., 2014, 49(5), 2035-2044.
[http://dx.doi.org/10.1007/s10853-013-7892-6]
[49]
Izzati Zulkifli, N.; Samat, N.; Anuar, H.; Zainuddin, N. Mechanical properties and failure modes of recycled polypropylene/microcrystalline cellulose composites. Mater. Des., 2015, 69, 114-123.
[http://dx.doi.org/10.1016/j.matdes.2014.12.053]
[50]
Pan, L.; Li, P.; Tao, Y. Preparation and properties of microcrystalline cellulose/fish gelatin composite film. Materials, 2020, 13(19), 4370.
[http://dx.doi.org/10.3390/ma13194370] [PMID: 33008075]
[51]
Kim, D.Y.; Kim, J.H.; Tak, W.Y.; Yeon, J.E.; Lee, J.H.; Yoon, J.H.; Lee, Y.J.; Lee, B.S.; Han, B.H.; Lee, H.C. Baracle®vs Baraclude® for 48 weeks in patients with treatment-naïve chronic hepatitis B: A comparison of efficacy and safety. Drug Des. Devel. Ther., 2017, 11, 3145-3152.
[http://dx.doi.org/10.2147/DDDT.S149199] [PMID: 29184389]
[52]
Wu, Y.; Weller, C.L.; Hamouz, F.; Cuppett, S.L.; Schnepf, M. Development and application of multicomponent edible coatings and films: A review. Adv. Food Nutr. Res., 2002, 44, 347-394.
[http://dx.doi.org/10.1016/S1043-4526(02)44007-7] [PMID: 11885140]
[53]
Reddy, K.A.; Karpagam, S. Cellulose orodispersible films of donepezil: Film characterization and drug release. Pharm. Chem. J., 2017, 51(8), 707-715.
[http://dx.doi.org/10.1007/s11094-017-1679-z]
[54]
Zhang, C.; Wang, A.; Wang, H.; Yan, M.; Liang, R.; He, X.; Fu, F.; Mu, H.; Sun, K. Entecavir-loaded poly (lactic-co-glycolic acid) microspheres for long-term therapy of chronic hepatitis-B: Preparation and in vitro and in vivo evaluation. Int. J. Pharm., 2019, 560, 27-34.
[http://dx.doi.org/10.1016/j.ijpharm.2019.01.052] [PMID: 30711615]
[55]
Yellanki, S.K.; Jagtap, S.; Masareddy, R. Dissofilm: A novel approach for delivery of phenobarbital; design and characterization. J. Young Pharm., 2011, 3(3), 181-188.
[http://dx.doi.org/10.4103/0975-1483.83756] [PMID: 21897656]
[56]
Nagaraju, T.; Gowthami, R.; Rajashekar, M.; Sandeep, S.; Mallesham, M.; Sathish, D.; Shravan, K.Y. Comprehensive review on oral disintegrating films. Curr. Drug Deliv., 2013, 10(1), 96-108.
[http://dx.doi.org/10.2174/1567201811310010016] [PMID: 22920576]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy