Preparation and in vivo pharmacokinetic evaluation of stable microemulsion system of cholecalciferol

References

• Trivedi, D. P. ; Doll, R. ; Khaw, K. T . Effect of Four Monthly Oral Vitamin D3 (Cholecalciferol) Supplementation on Fractures and Mortality in Men and Women Living in the Community: Randomised Double Blind Controlled Trial. BMJ 2003, 326 , 469–469. DOI: 10.1136/bmj.326.7387.469.
   PubMed Web of Science ®Google Scholar
• Grant, W. B . Epidemiology of Disease Risks in Relation to Vitamin D Insufficiency. Prog. Biophys. Mol. Biol. 2006, 92 , 65–79. DOI: 10.1016/j.pbiomolbio.2006.02.013.
   PubMed Web of Science ®Google Scholar
• Ross, A. C. ; Taylor, C. L. ; Yaktine, A. L. ; Valle, H. B. D . Dietary Reference Intakes for Calcium and Vitamin D ; National Academies Press (US): Washington, D.C., 2011. DOI: 10.17226/13050.
   Google Scholar
• Jones, G . Pharmacokinetics of Vitamin D Toxicity. Am. J. Clin. Nutr. 2008, 88 , 582S–586S. DOI: 10.1093/ajcn/88.2.582S.
   PubMed Web of Science ®Google Scholar
• Nutrition and Bone Health: With Particular Reference to Calcium and Vitamin D. Report of the Subgroup on Bone Health , Working Group on the Nutritional Status of the Population of the Committee on Medical Aspects of the Food Nutrition Policy. Rep. Health Soc. Subj. (Lond). 1998, 49 , 1–24.
   Google Scholar
• Jetter, A. ; Egli, A. ; Dawson-Hughes, B. ; Staehelin, H. B. ; Stoecklin, E. ; Goessl, R. ; Henschkowski, J. ; Bischoff-Ferrari, H. A . Pharmacokinetics of Oral Vitamin D(3) and Calcifediol. Bone 2014, 59 , 14–19. DOI: 10.1016/j.bone.2013.10.014.
   PubMed Web of Science ®Google Scholar
• Fahan Rashid, H. M. ; Syed, U. ; Ahmad, Z. ; Chauhdary, K. K. ; Musharraf, U. ; Kumar, S . Comparison of Different Formulations of Vitamin D. J. Ayub Med. Coll. Abbottabad 2017, 29 , 650–653.
   PubMedGoogle Scholar
• The PPDB (Pesticide Properties Database): Cholecalciferol. https://sitem.herts.ac.uk/aeru/iupac/Reports/160.htm (accessed Feb 23, 2019).
   Google Scholar
• Temova, Ž. ; Roškar, R . Stability-Indicating HPLC–UV Method for Vitamin D 3 Determination in Solutions, Nutritional Supplements and Pharmaceuticals. J. Chromatogr. Sci. 2016, 54 , 1180–1186. DOI: 10.1093/chromsci/bmw048.
   PubMed Web of Science ®Google Scholar
• Patel, M. R. ; Hirani, S. N. ; Patel, R. B . Microemulsion for Nasal Delivery of Asenapine Maleate in Treatment of Schizophrenia: Formulation Considerations. J. Pharm. Investig. 2018, 48 , 301–312. DOI: 10.1007/s40005-017-0318-8.
   Google Scholar
• Feas, D. A. ; Igartúa, D. E. ; Calienni, M. N. ; Martinez, C. S. ; Pifano, M. ; Chiaramoni, N. S. ; del Valle Alonso, S. ; Prieto, M. J . Nutraceutical Emulsion Containing Valproic Acid (NE-VPA): a Drug Delivery System for Reversion of Seizures in Zebrafish Larvae Epilepsy Model. J. Pharm. Investig. 2017, 47 , 429–437. DOI: 10.1007/s40005-017-0316-x.
   Google Scholar
• Rastogi, V. ; Yadav, P. ; Verma, N. ; Verma, A . Preparation and Characterization of Transdermal Mediated Microemulsion Delivery of T4 Bacteriophages against E.Coli Bacteria: A Novel anti-Microbial Approach. J. Pharm. Investig. 2018, 48 , 393–407. DOI: 10.1007/s40005-017-0335-7.
   Google Scholar
• Parakh, D. R. ; Patil, M. P. ; Sonawane, S. S. ; Kshirsagar, S. J . Application of Factorial Design Approach in Development and Evaluation of Self Microemulsifying Drug Delivery System (SMEDDS) of Mebendazole. J. Pharm. Investig. 2017, 47 , 507–519. DOI: 10.1007/s40005-016-0279-3.
   Google Scholar
• Hajjar, B. ; Zier, K.-I. ; Khalid, N. ; Azarmi, S. ; Löbenberg, R . Evaluation of a Microemulsion-Based Gel Formulation for Topical Drug Delivery of Diclofenac Sodium. J. Pharm. Investig. 2018, 48 , 351–362. DOI: 10.1007/s40005-017-0327-7.
   Google Scholar
• Špiclin, P. ; Gašperlin, M. ; Kmetec, V . Stability of Ascorbyl Palmitate in Topical Microemulsions. Int. J. Pharm. 2001, 222 , 271–279. DOI: 10.1016/S0378-5173(01)00715-3.
   PubMed Web of Science ®Google Scholar
• Mei, Z. ; Chen, H. ; Weng, T. ; Yang, Y. ; Yang, X . Solid Lipid Nanoparticle and Microemulsion for Topical Delivery of Triptolide. Eur. J. Pharm. Biopharm. 2003, 56 , 189–196. DOI: 10.1016/S0939-6411(03)00067-5.
   PubMed Web of Science ®Google Scholar
• Chen, H. ; Chang, X. ; Weng, T. ; Zhao, X. ; Gao, Z. ; Yang, Y. ; Xu, H. ; Yang, X . A Study of Microemulsion Systems for Transdermal Delivery of Triptolide. J. Control. Release 2004, 98 , 427–436. DOI: 10.1016/j.jconrel.2004.06.001.
   PubMed Web of Science ®Google Scholar
• Benigni, M. ; Pescina, S. ; Grimaudo, M. A. ; Padula, C. ; Santi, P. ; Nicoli, S . Development of Microemulsions of Suitable Viscosity for Cyclosporine Skin Delivery. Int. J. Pharm. 2018, 545 , 197–205. DOI: 10.1016/j.ijpharm.2018.04.049.
   PubMed Web of Science ®Google Scholar
• Wu, J.-Y. ; Li, Y.-J. ; Han, M. ; Hu, X.-B. ; Yang, L. ; Wang, J.-M. ; Xiang, D.-X . A Microemulsion of Puerarin–Phospholipid Complex for Improving Bioavailability: Preparation, in Vitro and in Vivo Evaluations. Drug Dev. Ind. Pharm. 2018, 44 , 1336–1341. DOI: 10.1080/03639045.2018.1449856.
   PubMed Web of Science ®Google Scholar
• Goddeeris, C. ; Cuppo, F. ; Reynaers, H. ; Bouwman, W. G. ; Van den Mooter, G . Light Scattering Measurements on Microemulsions: Estimation of Droplet Sizes. Int. J. Pharm. 2006, 312 , 187–195. DOI: 10.1016/j.ijpharm.2006.01.037.
   PubMed Web of Science ®Google Scholar
• Ho, M. J. ; Lee, D. R. ; Im, S. H. ; Yoon, J. A. ; Shin, C. Y. ; Kim, H. J. ; Jang, S. W. ; Choi, Y. W. ; Han, Y. T. ; Kang, M. J . Design and in Vivo Evaluation of Entecavir-3-Palmitate Microcrystals for Subcutaneous Sustained Delivery. Eur. J. Pharm. Biopharm. 2018, 130 , 143–151. DOI: 10.1016/j.ejpb.2018.06.024.
   PubMed Web of Science ®Google Scholar
• Yi, R. ; Chung, E. ; Gray, D. ; Pinnawala, A. ; Ostonal, S. ; Peng, X. ; Gugten, G. ; van der.; Nutley, B . LC-MS/MS Method for the Determination of Vitamin D3 in Human Plasma. Pharm. Technol. Eur. 2009, 21 , 24–33.
   Google Scholar
• Jeon, J. Y. ; Lee, S. Y. ; Im, Y. J. ; Kim, E. Y. ; Kim, Y. ; Park, T. S. ; Chae, S. W. ; Lee, J. W. ; Jun, H. ; Lee, T. W. ; Kim, M. G . Comparison of the Pharmacokinetics, Safety, and Tolerability of Vitamin D3 in DP-R206 (150-Mg Ibandronate/24,000-IU Vitamin D3 Tablet) and as Monotherapy (24,000 IU) in Healthy Male Korean Adults. Clin. Ther. 2014, 36 , 48–57. DOI: 10.1016/j.clinthera.2013.12.001.
   PubMed Web of Science ®Google Scholar
• Szejtli, J. ; Bolla-Pusztai, E. ; Szabó, P. ; Ferenczy, T . Enhancement of Stability and Biological Effect on Cholecalciferol by Beta-Cyclodextrin Complexation. Pharmazie 1980, 35 , 779–787.
   PubMed Web of Science ®Google Scholar
• Khalid, N. ; Kobayashi, I. ; Wang, Z. ; Neves, M. A. ; Uemura, K. ; Nakajima, M. ; Nabetani, H . Formulation of Monodisperse Oil-in-Water Emulsions Loaded with Ergocalciferol and Cholecalciferol by Microchannel Emulsification: Insights of Production Characteristics and Stability. Int. J. Food Sci. Technol. 2015, 50 , 1807–1814. DOI: 10.1111/ijfs.12832.
   Web of Science ®Google Scholar
• Anilkumar, S. G. ; Pratibha, S. P. ; Maharukh, T. R . Stabilized Vitamin D Formulations. U.S. Patent 9,801,821 B2, March 27, 2014.
   Google Scholar
• BASF. We Create Chemistry https://products.basf.com/documents (accessed Feb 23, 2019).
   Google Scholar
• Loewen, A. J . Optimizing the Loading of Vitamin a and Vitamin D into Re-Assembled Casein Micelles and Investigating the Effect of Micellar Complexation on Vitamin D Stability. MA Thesis, University of British Columbia, Vancouver, 2014, DOI: 10.14288/1.0135605.
   Google Scholar
• Kristensen, S. ; Lao, Y. E. ; Brustugun, J. ; Braenden, J. U . Influence of Formulation Properties on Chemical Stability of Captopril in Aqueous Preparations. Pharmazie 2008, 63 , 872–877.
   PubMed Web of Science ®Google Scholar
• Kubík, Ľ. ; Zeman, S . Determination of Oxygen Permeability of Polyethylene and Polypropylene Nonwoven Fabric Foils. Res. Agr. Eng. 2013, 59 , 105–113. DOI: 10.17221/31/2012-RAE.
   Google Scholar
• Bagwe, R. P. ; Kanicky, J. R. ; Palla, B. J. ; Patanjali, P. K. ; Shah, D. O . Improved Drug Delivery Using Microemulsions: Rationale, Recent Progress, and New Horizons. Crit. Rev. Ther. Drug Carrier Syst. 2001, 18 , 77–140.
   PubMed Web of Science ®Google Scholar
• Sasaki, H. ; Takakura, Y. ; Hashida, M. ; Kimura, T. ; Sezaki, H . Antitumor Activity of Lipophilic Prodrugs of Mitomycin C Entrapped in Liposome or O/W Emulsion. J. Pharmacobio-Dyn. 1984, 7 , 120–130. DOI: 10.1248/bpb1978.7.120.
   PubMedGoogle Scholar