Development of olmesartan medoxomil optimized nanosuspension using the Box–Behnken design to improve oral bioavailability

References

• Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413–20.
   PubMed Web of Science ®Google Scholar
• Aungst BJ. Intestinal permeation enhancers. J Pharm Sci 2000;89:429–42.
   PubMed Web of Science ®Google Scholar
• Aungst BJ. Novel formulation strategies for improving oral bioavailability of drugs with poor membrane permeation or presystemic metabolism. J Pharm Sci 1993;82:976–86.
   Web of Science ®Google Scholar
• Schwendener RA, Schott H. Lipophilic 1-beta-d-arabinofuranosyl cytosine derivatives in liposomal formulations for oral and parenteral antileukemic therapy in the murine L1210 leukemia model. J Can Res Clin Oncol 1996;122:723–6.
   PubMed Web of Science ®Google Scholar
• Floyd AG. Top ten considerations in the development of parenteral emulsions. Pharm Sci Technol Today 1999;4:134–43.
   PubMedGoogle Scholar
• Lawrence MJ, Rees GD. Microemulsion-based media as novel drug delivery systems. Adv Drug Deliv Rev 2000;45:89–121.
   PubMed Web of Science ®Google Scholar
• Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 2000;50:47–60.
   PubMed Web of Science ®Google Scholar
• Loftsson T, Brewster ME. Pharmaceutical applications of cyclodextrins. 1. Drug solubilization and stabilization. J Pharm Sci 1996;85:1017–25.
   PubMed Web of Science ®Google Scholar
• Müller RH, Peters K, Becker R, Kruss B. Nanosuspensions for the i.v. administration of poorly soluble drugs – stability during sterilization and long-term storage. 22nd Int. Symp. Control. Release Bioact. Mater.; 1995:574–5.
   Google Scholar
• Müller RH, Jacobs C, Kayser O. Nanosuspensions as particulate drug formulations in therapy. Rationale for development and what we can expect for the future. Adv Drug Deliv Rev 2001;47:3–19.
   PubMed Web of Science ®Google Scholar
• Suman T, Afzal MS, Ramesh B, Kishan V. Development and in vivo evaluation of cefdinir nanosuspension for improved bioavailability. Int J Pharm Sci Nanotechnol 2014;7:2553–60.
   Google Scholar
• Patravale VB, Date AA, Kulkarni RM. Nanosuspensions: a promising drug delivery strategy. J Pharm Pharmacol 2004;56:827–40.
   PubMed Web of Science ®Google Scholar
• Kleijnen JPC, Den Hertog D, Ang N. Response surface methodology steepest ascent and step size revisited. Eur J Oper Res 2006;170:664–6.
   Web of Science ®Google Scholar
• Box GEP, Behnken DW. Some new three level designs for the study of quantitative variables. Technometrics 1960;2:455–75.
   Google Scholar
• Warne GT, Jarvis B. Olmesartan medoxomil. Drugs 2002;62:1345–53.
   PubMed Web of Science ®Google Scholar
• Lee BS, Kang MJ, Choi WS, et al. Solubilized formulation of olmesartan medoxomil for enhancing oral bioavailability. Arch Pharm Res 2009;32:1629–35.
   PubMed Web of Science ®Google Scholar
• Thakkar HP, Patel BV, Thakkar SP. Development and characterization of nanosuspensions of olmesartan medoxomil for bioavailability enhancement. J Pharm Bioallied Sci 2011;3:426–34.
   PubMedGoogle Scholar
• Li W, Yang Y, Tian Y, et al. Preparation and in vitro/in vivo evaluation of revaprazan hydrochloride nanosuspension. Int J Pharm 2011;408:157–62.
   PubMed Web of Science ®Google Scholar
• Ibrahim HM, Ismail HR, Ahmed EA. Formulation and optimization of ocular poly-d, l-lactic acid nanodrug delivery system of amphotericin B using Box–Behnken design. Int J Pharm 2012;4:342–9.
   Google Scholar
• Jana P, Daniela MS, Nina S, et al. Nanosuspensions as advanced printing ink for accurate dosing of poorly soluble drugs in personalized medicines. Int J Pharm 2011;420:93–100.
   PubMed Web of Science ®Google Scholar
• Patel J, Kevin G, Patel A, et al. Development of the UV spectrophotometric method of Olmesartan medoxomil in bulk drug and pharmaceutical formulation and stress degradation studies. Pharm Met 2011;2:36–41.
   PubMedGoogle Scholar
• Hao J, Gao Y, Zhao J, et al. Preparation and optimization of resveratrol nanosuspensions by antisolvent precipitation using Box–Behnken design. AAPS PharmSciTech 2015;16:118–28.
   PubMed Web of Science ®Google Scholar
• Bujňáková Z, Dutková E, Baláž M, et al. Stability studies of As4S4 nanosuspension prepared by wet milling in Poloxamer 407. Int J Pharm 2015;478:187–92.
   PubMed Web of Science ®Google Scholar
• Beirowski J, Inghelbrecht S, Arien A, Gieseler H. Freeze-drying of nanosuspensions. Part 3: investigation of factors compromising storage stability of highly concentrated drug nanosuspensions. J Pharm Sci 2012;101:354–62.
   PubMed Web of Science ®Google Scholar
• Rupali LS, Shashikant ND, Nilesh K, Santhosh LS. Formulation and evaluation of nanosuspension delivery of simvastatin. Int J Pharm Sci Nanotechnol 2014;7:2459–76.
   Google Scholar
• Shah SK, Asnani AJ, Kawade DP, et al. Simultaneous quantitative analysis of olmesartan medoxomil and amlodipine besylate in plasma by high performance liquid chromatography technique. J Young Pharm 2012;4:88–94.
   PubMedGoogle Scholar
• Sudhir V, Yan L, Rajeev G, Diane JB. Quality by design approach to understand the process of nanosuspension preparation. Int J Pharm 2009;377:185–98.
   PubMed Web of Science ®Google Scholar
• Singh B, Kumar R, Ahuja N. Optimizing drug delivery systems using systematic “design of experiments.” Part-I: fundamental aspects. Crit Rev Ther Drug Carrier Syst 2005;22:27–105.
   PubMed Web of Science ®Google Scholar
• Liversidge GG, Cundy KC. Particle size reduction for improvement of oral bioavailability of hydrophobic drugs: absolute oral bioavailability of nanocrystalline danazol in beagle dogs. Int J Pharm 1995;125:91–7.
   Web of Science ®Google Scholar
• Yang JZ, Young AL, Chiang PC, et al. Fluticasone and budesonide nanosuspensions for pulmonary delivery: preparation, characterization, and pharmacokinetic studies. J Pharm Sci 2008;97:4869–78.
   PubMed Web of Science ®Google Scholar
• Bhanu PS, Malay KD. Nanosuspension for enhancement of oral bioavailability of felodipine. Appl Nanosci 2014;4:189–97.
   Web of Science ®Google Scholar
• Otsuka M, Kaneniwa N. Effect of seed crystals on solid state transformation of polymorphs of chloramphenicol palmitate during grinding. J Pharm 1986;75:506–11.
   PubMed Web of Science ®Google Scholar
• Siva Kumar BV, Girish B, Patel NSCP, Shekhar BB. Polymorphic form of olmesartan and process for its preparation. US 20060281800 A1; 2006.
   Google Scholar
• Shamsunder SD, Sandip SC, Krutika KS, Aruna GK. Solid lipid nanoparticles and nanosuspension formulation of saquinavir: preparation, characterization, pharmacokinetics and biodistribution studies. J Microencaps 2011;28:515–27.
   PubMed Web of Science ®Google Scholar
• Mittapalli PK, Yamsani MR, Shashank A. Improved bioavailability of albendazole following oral administration of nanosuspension in rats. Curr Nanosci 2007;3:191–4.
   Web of Science ®Google Scholar