Formulation and evaluation of solid self-microemulsifying drug delivery system for azilsartan medoxomil

References

• Jones, J. D.; Jackson, S. H.; Agboton, C.; Martin, T. S. Azilsartan Medoxomil (Edarbi): The Eighth Angiotensin II Receptor Blocker. P T 2011, 36, 634.
   PubMedGoogle Scholar
• Pande, V. V.; Sanklecha, V. M.; Arote, S. R. Formulation and Development of Extended Release Matrix Pellets of Water Insoluble Azilsartan Medoxomil with Solid Dispersion. Indian Drugs 2019, 56, 21.
   Google Scholar
• Webb, N. J.; Wells, T.; Tsai, M.; Zhao, Z.; Juhasz, A.; Dudkowski, C. Single-Dose Pharmacokinetics and Safety of Azilsartan Medoxomil in Children and Adolescents with Hypertension as Compared to Healthy Adults. Eur. J. Clin. Pharmacol. 2016, 72, 447–457. DOI: 10.1007/s00228-015-1987-8.
   PubMed Web of Science ®Google Scholar
• Lu, T.; Sun, Y.; Ding, D.; Zhang, Q.; Fan, R.; He, Z.; Wang, J. Study on Enhanced Dissolution of Azilsartan-Loaded Solid Dispersion, Prepared by Combining Wet Milling and Spray-Drying Technologies. AAPS PharmSciTech. 2017, 18, 473–480. DOI: 10.1208/s12249-016-0531-1.
   PubMed Web of Science ®Google Scholar
• Ma, J.; Yang, Y.; Sun, Y.; Sun, J. Optimization, Characterization and in Vitro/Vivo Evaluation of Azilsartan Nanocrystals. Asian J. Pharm. Sci. 2017, 12, 344–352. DOI: 10.1016/j.ajps.2016.09.008.
   PubMed Web of Science ®Google Scholar
• Nassar, T.; Rom, A.; Nyska, A.; Benita, S. A Novel Nanocapsule Delivery System to Overcome Intestinal Degradation and Drug Transport Limited Absorption of P-Glycoprotein Substrate Drugs. Pharm. Res. 2008, 25, 2019–2029. DOI: 10.1007/s11095-008-9585-4.
   PubMed Web of Science ®Google Scholar
• Sinswat, P.; Overhoff, K. A.; McConville, J. T.; Johnston, K. P.; Williams, R. O. III, Nebulization of Nanoparticulate Amorphous or Crystalline Tacrolimus-Single-Dose Pharmacokinetics Study in Mice. European J. Pharm. Biopharm. 2008, 69, 1057–1066. DOI: 10.1016/j.ejpb.2008.01.037.
   PubMed Web of Science ®Google Scholar
• Lee, M. J.; Straubinger, R. M.; Jusko, W. J. Physicochemical, Pharmacokinetic and Pharmacodynamic Evaluation of Liposomal Tacrolimus (FK 506) in Rats. Pharm. Res. 1995, 12, 1055–1059. DOI: 10.1023/A:1016222817860.
   PubMed Web of Science ®Google Scholar
• Park, Y. J.; Ryu, D. S.; Li, D. X.; Quan, Q. Z.; Oh, D. H.; Kim, J. O.; Seo, Y. G.; Lee, Y. I.; Yong, C. S.; Woo, J. S.; Choi, H. G. Physicochemical Characterization of Tacrolimus-Loaded Solid Dispersion with Sodium Carboxylmethyl Cellulose and Sodium Lauryl Sulfate. Arch. Pharm. Res. 2009, 32, 893–898. DOI: 10.1007/s12272-009-1611-5.
   PubMed Web of Science ®Google Scholar
• Yamashita, K.; Nakate, T.; Okimoto, K.; Ohike, A.; Tokunaga, Y.; Ibuki, R.; Higaki, K.; Kimura, T. Establishment of New Preparation Method for Solid Dispersion Formulation of Tacrolimus. Int. J. Pharm. 2003, 267, 79–91. DOI: 10.1016/j.ijpharm.2003.07.010.
   PubMed Web of Science ®Google Scholar
• Rahman, M. A.; Iqbal, Z.; Hussain, A. Formulation Optimization and in Vitro Characterization of Sertraline Loaded Self-Nanoemulsifying Drug Delivery System (SNEDDS) for Oral Administration. J. Pharm. Investig. 2012, 42, 191–202. DOI: 10.1007/s40005-012-0029-0.
   Google Scholar
• Dangre, P.; Gilhotra, R.; Dhole, S. Formulation and Statistical Optimization of Self-Microemulsifying Drug Delivery System of Eprosartan Mesylate for Improvement of Oral Bioavailability. Drug Deliv. And Transl. Res. 2016, 6, 610–621. DOI: 10.1007/s13346-016-0318-7.
   PubMed Web of Science ®Google Scholar
• Li, P.; Hynes, S. R.; Haefele, T. F.; Pudipeddi, M.; Royce, A. E.; Serajuddin, A. T. Development of Clinical Dosage Forms for a Poorly Water-Soluble Drug II: Formulation and Characterization of a Novel Solid Microemulsion Preconcentrate System for Oral Delivery of a Poorly Water-Soluble Drug. J. Pharm. Sci. 2009, 98, 1750–1764. DOI: 10.1002/jps.21547.
   PubMed Web of Science ®Google Scholar
• Charman, W. N. Lipids, Lipophilic Drugs, and Oral Drug Delivery-Some Emerging Concepts. J. Pharm. Sci. 2000, 89, 967–978. DOI: 10.1002/1520-6017(200008)89:8<967::AID-JPS1>3.0.CO;2-R.
   PubMed Web of Science ®Google Scholar
• Gursoy, R. N.; Benita, S. Self-Emulsifying Drug Delivery Systems (SEDDS) for Improved Oral Delivery of Lipophilic Drugs. Biomed. Pharmacother. 2004, 58, 173–182. DOI: 10.1016/j.biopha.2004.02.001.
   PubMed Web of Science ®Google Scholar
• Rahman, M. A.; Harwansh, R.; Mirza, M. A.; Hussain, S.; Hussain, A. Oral Lipid Based Drug Delivery System (LBDDS): Formulation, Characterization and Application: A Review. CDD. 2011, 8, 330–345. DOI: 10.2174/156720111795767906.
   PubMed Web of Science ®Google Scholar
• Kohli, K.; Chopra, S.; Dhar, D.; Arora, S.; Khar, R. K. Self-Emulsifying Drug Delivery Systems: An Approach to Enhance Oral Bioavailability. Drug Discov. Today. 2010, 15, 958–965. DOI: 10.1016/j.drudis.2010.08.007.
   PubMed Web of Science ®Google Scholar
• Lawrence, M. J.; Rees, G. D. Microemulsion-Based Media as Novel Drug Delivery Systems. Adv. Drug Deliv. Rev. 2000, 45, 89–121. DOI: 10.1016/S0169-409X(00)00103-4.
   PubMed Web of Science ®Google Scholar
• Ito, Y.; Kusawake, T.; Ishida, M.; Tawa, R.; Shibata, N.; Takada, K. Oral Solid Gentamicin Preparation Using Emulsifier and Adsorbent. J. Control. Release. 2005, 105, 23–31. DOI: 10.1016/j.jconrel.2005.03.017.
   PubMed Web of Science ®Google Scholar
• Madan, J. R.; Pawar, K. T.; Dua, K. Solubility Enhancement Studies on Lurasidone Hydrochloride Using Mixed Hydrotropy. Int. J. Pharma. Investig. 2015, 5, 114–120. DOI: 10.4103/2230-973X.153390.
   PubMed Web of Science ®Google Scholar
• Dixit, R. P.; Nagarsenker, M. S. Self-nanoemulsifying Granules of Ezetimibe: Design, Optimization and Evaluation. Eur. J. Pharm. Sci. 2008, 35, 183–183. DOI: 10.1016/j.ejps.2008.06.013.
   PubMed Web of Science ®Google Scholar
• Ebeid, W. M.; Elkady, E. F.; El-Zaher, A. A.; El-Bagary, R. I.; Patonay, G. Spectrophotometric and Spectrofluorimetric Studies on Azilsartan Medoxomil and Chlorthalidone to Be Utilized in Their Determination in Pharmaceuticals. Anal. Chem. Insights. 2014, 9, 33–40.
   PubMedGoogle Scholar
• Date, A. A.; Nagarsenker, M. S. Design and Evaluation of Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) for Cefpodoxime Proxetil. Int. J. Pharm. 2007, 329, 166–172. DOI: 10.1016/j.ijpharm.2006.08.038.
   PubMed Web of Science ®Google Scholar
• Patel, A. R.; Vavia, P. R. Preparation and in Vivo Evaluation of SMEDDS (Self-Microemulsifying Drug Delivery System) Containing Fenofibrate. AAPS J. 2007, 9, E344–352. DOI: 10.1208/aapsj0903041.
   PubMed Web of Science ®Google Scholar
• Nasr, A.; Gardouh, A.; Ghorab, M. Novel Solid Self- Nanoemulsifying Drug Delivery System (S-SNEDDS0 for Oral Delivery of Olmesartan Medoxomil: Design, Formulation, Pharmacokinetic and Bioavailability Evaluation. Pharmaceutics. 2016, 8, 20. DOI: 10.3390/pharmaceutics8030020.
   PubMed Web of Science ®Google Scholar
• Atef, E.; Belmonte, A. A. Formulation, in-Vitro and in-Vivo Characterization of Phenytoin Self-Emulsifying Drug Delivery System. Eur J Pharm Sci. 2008, 35, 257–263. DOI: 10.1016/j.ejps.2008.07.004.
   PubMed Web of Science ®Google Scholar
• Kang, M. J.; Kim, H. S.; Jeon, H. S.; Park, J. H.; Lee, B. S.; Ahn, B. K.; Moon, K. Y.; Choi, Y. W. In Situ Intestinal Permeability and in Vivo Absorption Characteristics of Olmesartan Medoxomil in Self-Microemulsifying Drug Delivery System. Drug Dev. Ind. Pharm. 2012, 38, 587–596. DOI: 10.3109/03639045.2011.619194.
   PubMed Web of Science ®Google Scholar
• Wu, H.; Long, X.; Yuan, F.; Chen, L.; Pan, S.; Liu, Y.; Stowell, Y.; Li, X. Combined Use of Phospholipid Complexes and Self-Emulsifying Microemulsion for Improving the Oral Absorption of a BCS Class IV Compound, Baicalin. Acta Pharmaceutica Sinica B. 2014, 4, 217–226. DOI: 10.1016/j.apsb.2014.03.002.
   PubMed Web of Science ®Google Scholar
• Guoqing, L.; Huafeng, Z.; Jing, Z.; Zemin, Y.; Mingxing, D.; Yingfang, L.; Qiang, X. Preparation and Characterisation of a Soy Lecithin-Based Self-Microemulsifying Drug Delivery System of Resveratrol. Micro-Nano Letters. 2014, 9, 561–565. DOI: 10.1049/mnl.2014.0015.
   Web of Science ®Google Scholar
• Yue, P. F.; Yuan, H. L.; Li, X. Y.; Yang, M.; Zhu, W. F. Process Optimization, Characterization and Evaluation in Vivo of Oxymatrine-Phospholipid Complex. Int. J. Pharm. 2010, 387, 139–1346. DOI: 10.1016/j.ijpharm.2009.12.008.
   PubMed Web of Science ®Google Scholar
• Miller, J. M.; Dahan, A.; Gupta, D.; Varghese, S.; Amidon, G. L. Enabling the Intestinal Absorption of Highly Polar Antiviral Agents: In-Pair Facilitated Membrane Permeation of Zanamivir Heptyl Ester and Guanidino Oseltamivir. Mol. Pharmaceutics 2010, 7, 1223–1234. DOI: 10.1021/mp100050d.
   PubMed Web of Science ®Google Scholar
• Engelmann, F. M.; Rocha, S. V.; Toma, H. E.; Araki, K.; Baptista, M. S. Determination of n-Octanol/Water Partition and Membrane Binding of Cationic Porphyrins. Int. J. Pharm. 2007, 329, 12–18. DOI: 10.1016/j.ijpharm.2006.08.008.
   PubMed Web of Science ®Google Scholar
• Taha, E. I.; Al-Saidan, S.; Samy, A. M.; Khan, M. A. Preparation and in Vitro Characterization of Self-Nanoemulsified Drug Delivery System (SNEDDS) of All-Trans-Retinol Acetate. Int. J. Pharm. 2004, 285, 109–119. DOI: 10.1016/j.ijpharm.2004.03.034.
   PubMed Web of Science ®Google Scholar
• Patel, P. V.; Patel, H. K.; Panchal, S. S.; Mehta, T. A. Self Micro-Emulsifying Drug Delivery System of Tacrolimus: Formulation, in Vitro Evaluation and Stability Studies. Int. J. Pharma. Investig. 2013, 3, 95. DOI: 10.4103/2230-973X.114899.
   PubMedGoogle Scholar
• Nekkanti, V.; Karatgi, P.; Prabhu, R.; Pillai, R. Solid Self-Microemulsifying Formulation for Candesartan Cilexetil. AAPS PharmSciTech. 2010, 11, 9–17. DOI: 10.1208/s12249-009-9347-6.
   PubMed Web of Science ®Google Scholar
• Khoo, S. M.; Humberstone, A. J.; Porter, C. J.; Edwards, G. A.; Charman, W. N. Formulation Design and Bioavailability Assessment of Lipidic Self-Emulsifying Formulations of Halofantrine. Int. J. Pharm. 1998, 167, 155–164. DOI: 10.1016/S0378-5173(98)00054-4.
   Web of Science ®Google Scholar
• Onoue, S.; Uchida, A.; Kuriyama, K.; Nakamura, T.; Seto, Y.; Kato, M.; Hatanaka, J.; Tanaka, T.; Miyoshi, H.; Yamada, S. Novel Solid Self-Emulsifying Drug Delivery System of Coenzyme Q10 with Improved Photochemical and Pharmacokinetic Behaviors. European J. Pharm. Sci. 2012, 46, 492–499. DOI: 10.1016/j.ejps.2012.03.015.
   PubMed Web of Science ®Google Scholar
• Ghosh, P. K.; Majithiya, R. J.; Umrethia, M. L.; Murthy, R. S. R. Design and Development of Microemulsion Drug Delivery System of Acyclovir for Improvement of Oral Bioavailability. AAPS PharmSciTech. 2006, 7, 172–177. DOI: 10.1208/pt070377.
   Web of Science ®Google Scholar
• Chudasama, A. S.; Patel, V. V.; Nivsarkar, M.; Vasu, K. K.; Shishoo, C. J. In Vivo Evaluation of Self Emulsifying Drug Delivery System for Oral Delivery of Nevirapine. Indian J Pharm Sci. 2014, 76, 218–224.
   PubMed Web of Science ®Google Scholar
• Balakrishnan, P.; Lee, B. J.; Oh, D. H.; Kim, J. O.; Hong, M. J.; Jee, J. P.; Kim, J. A.; Yoo, B. K.; Woo, J. S.; Yong, C. S.; Choi, H. G. Enhanced Oral Bioavailability of Dexibuprofen by a Novel Solid Self-Emulsifying Drug Delivery System (SEDDS). European J. Pharm. Biopharm. 2009, 72, 539–545. DOI: 10.1016/j.ejpb.2009.03.001.
   PubMed Web of Science ®Google Scholar
• Odeberg, J. M.; Kaufmann, P.; Kroon, K. G.; Hoglund, P. Lipid Drug Delivery and Rational Formulation Design for Lipophilic Drugs with Low Oral Bioavailability, Applied to Cyclosporine. European J. Pharm. Sci. 2003, 20, 375–382. DOI: 10.1016/j.ejps.2003.08.005.
   PubMed Web of Science ®Google Scholar
• Avachat, A. M.; Patel, V. G. Self Nanoemulsifying Drug Delivery System of Stabilized Ellagic Acid–Phospholipid Complex with Improved Dissolution and Permeability. Saudi Pharm. J. 2015, 23, 276–289. DOI: 10.1016/j.jsps.2014.11.001.
   PubMed Web of Science ®Google Scholar
• Agrawal, A. G.; Kumar, A.; Gide, P. S. Self Emulsifying Drug Delivery System for Enhanced Solubility and Dissolution of Glipizide. Colloids Surf. B Biointerfaces. 2015, 126, 553–560. DOI: 10.1016/j.colsurfb.2014.11.022.
   PubMed Web of Science ®Google Scholar
• Beg, S.; Katare, O. P.; Saini, S.; Garg, B.; Khurana, R. K.; Singh, B. Solid Self-Nanoemulsifying Systems of Olmesartan Medoxomil: Formulation Development, Micromeritic Characterization, in Vitro and in Vivo Evaluation. Powder Technol. 2016, 294, 93–104. DOI: 10.1016/j.powtec.2016.02.023.
   Web of Science ®Google Scholar
• Abbaspour, M.; Jalayer, N.; Makhmalzadeh, B. S. Development and Evaluation of a Solid Self-Nanoemulsifying Drug Delivery System for Loratadin by Extrusion-Spheronization. Adv Pharm Bull. 2014, 4, 113–119.
   PubMedGoogle Scholar
• Reddy, M. N.; Rehana, T.; Ramakrishna, S.; Chowdary, K. P.; Diwan, P. V. β-Cyclodextrin Complexes of Celecoxib: Molecular-Modeling, Characterization, and Dissolution Studies. AAPS J. 2004, 6, 68–76. DOI: 10.1208/ps060107.
   Google Scholar
• Tang, J. L.; Sun, J.; He, Z. G. Self-Emulsifying Drug Delivery Systems: Strategy for Improving Oral Delivery of Poorly Soluble Drugs. CDTH. 2007, 2, 85–93. DOI: 10.2174/157488507779422400.
   Google Scholar
• Kassem, A. A.; Marzouk, M. A.; Ammar, A. A.; Elosaily, G. H. Preparation and in Vitro Evaluation of Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) Containing Clotrimazole. Drug Discov. Ther. 2010, 4, 373–379.
   PubMedGoogle Scholar
• Beg, S.; Swain, S.; Singh, H. P.; Patra, C. N.; Rao, M. B. Development, Optimization, and Characterization of Solid Self-Nanoemulsifying Drug Delivery Systems of Valsartan Using Porous Carriers. AAPS PharmSciTech. 2012, 13, 1416–1427. DOI: 10.1208/s12249-012-9865-5.
   PubMed Web of Science ®Google Scholar
• Madan, J. R.; Sudarshan, B.; Kadam, V. S.; Dua, K. Formulation and Development of Self-Microemulsifying Drug Delivery System of Pioglitazone Hydrochloride. Asian J. Pharm. 2014, 8, 27–34. DOI: 10.4103/0973-8398.134097.
   Google Scholar
• Patil, S.; Patil, V.; Shete, A.; Doijad, R. Design, Development and in-Vitro Characterization of Self Emulsifying Drug Delivery System for Irbesartan. Iranian J. Pharm. Sci. 2013, 9, 67–80.
   Google Scholar
• Li, J.; Yang, L.; Shen, R.; Gong, L.; Tian, Z.; Qiu, H.; Shi, Z.; Gao, L.; Sun, H.; Zhang, G. Self-Nanoemulsifying System Improves Oral Absorption and Enhances anti-Acute Myeloid Leukemia Activity of Berberine. J. Nanobiotechnol. 2018, 16, 76. DOI: 10.1186/s12951-018-0402-x.
   PubMed Web of Science ®Google Scholar
• Kim, D. S.; Cho, J. H.; Park, J. H.; Kim, J. S.; Song, E. S.; Kwon, J.; Giri, B. R.; Jin, S. G.; Kim, K. S.; Choi, H. G.; Kim, D. W. Self-Microemulsifying Drug Delivery System (SMEDDS) for Improved Oral Delivery and Photostability of Methotrexate. IJN. 2019, Volume 14, 4949. DOI: 10.2147/IJN.S211014.
   Google Scholar
• Murdande, S. B.; Pikal, M. J.; Shanker, R. M.; Bogner, R. H. Aqueous Solubility of Crystalline and Amorphous Drugs: Challenges in Measurement. Pharm. Dev. Technol. 2011, 16, 187–200. DOI: 10.3109/10837451003774377.
   PubMed Web of Science ®Google Scholar
• Radl, S.; Cerny, J.; Stach, J.; Holec, J.; Písa, O.; Gablikova, Z. Synthesis of Azilsartan and Its Selected Potential Impurities. J. Heterocyclic Chem. 2013, 50, 929–936. DOI: 10.1002/jhet.1783.
   Web of Science ®Google Scholar