Development and optimization of press coated tablets of release engineered valsartan for pulsatile delivery

References

• Mandal AS, Biswas N, Karim KM, et al. Drug delivery system based on chronobiology – a review. J Control Release 2010;147:314–25
   PubMed Web of Science ®Google Scholar
• Smolensky MH, Peppas NA. Chronobiology, drug-delivery, and chronotherapeutics. Adv Drug Deliv Rev 2007;59:823–4
   Web of Science ®Google Scholar
• Lemmer B. Chronobiology, drug-delivery, and chronotherapeutics. Adv Drug Deliv Rev 2007;59:825–7
   PubMed Web of Science ®Google Scholar
• National, state, and local area vaccination coverage among children aged 19–35 months – United States, 2011. 2012; Contract No.: 35
   Google Scholar
• Songa AS, Meka VS, Nali SR, Kolapalli VRM. An in vitro and in vivo investigation into the suitability of compression coated tablets of indomethacin for the treatment of rheumatoid arthritis which follow circadian rhythms. Drug Dev Ind Pharm 2013;39:447–56
   PubMed Web of Science ®Google Scholar
• Tinny T, Chacko AJ, Jose S. Formulation development and statistical optimization of chronotherapeutic tablets of indometacin. Drug Dev Ind Pharm 2013;39:1357–63
   PubMed Web of Science ®Google Scholar
• Yan Y, Ho J, Kook K, et al. Novel valsartan-loaded solid dispersion with enhanced bioavailability and no crystalline changes. Int J Pharm 2011;422:202–10
   PubMed Web of Science ®Google Scholar
• Maroni A, Zema L, Dorly M, et al. Oral pulsatile delivery: rationale and chronopharmaceutical formulations. Int J Pharm 2008;398:1–8
   Web of Science ®Google Scholar
• Zhu Y, Zheng L. Development and mathematical simulation of theophylline pulsatile release tablets. Drug Dev Ind Pharm 2005;31:1009–17
   PubMed Web of Science ®Google Scholar
• Maroni A, Zema L, Loreti G, et al. Film coatings for oral pulsatile release. Int J Pharm 2013;457:362–71
   PubMed Web of Science ®Google Scholar
• Efentakis M, Iliopoyloy A, Siamidi A. Effect of core size and excipients on the lag time and drug release from a pulsatile drug delivery system. Drug Dev Ind Pharm 2011;37:113–20
   PubMed Web of Science ®Google Scholar
• Hermida RC, Ayala DE, Calvo C, et al. Chronotherapy of hypertension: administration-time-dependent effects of treatment on the circadian pattern of blood pressure. Adv Drug Deliver Rev 2007;59:923–39
   PubMed Web of Science ®Google Scholar
• Nixon RM, Muller E, Lowy A, Falvey H. Valsartan vs. other angiotensin II receptor blockers in the treatment of hypertension: a meta-analytical approach. Int J Clin Pract 2009;63:766–75
   PubMed Web of Science ®Google Scholar
• Hermida RC, Calvo C, Ayala DE, et al. Administration time-dependent effects of valsartan on ambulatory blood pressure in hypertensive subjects. Hypertension 2003;42:283–90
   PubMed Web of Science ®Google Scholar
• Nayak UY, Venktesh G, Nayak Y, et al. Chronotherapeutic drug delivery for early morning surge in blood pressure: a programmable delivery system. J Control Release 2009;136:125–31
   PubMed Web of Science ®Google Scholar
• Gurrapu A, Jukanti R, Reddy S, et al. Improved oral delivery of valsartan from maltodextrin based proniosome powders. Adv Powder Technol 2011;23:583–90
   Web of Science ®Google Scholar
• Ma Q, Sun H, Che E, et al. Uniform nano-sized valsartan for dissolution and bioavailability enhancement: influence of particle size and crystalline state. Int J Pharm 2013;441:75–81
   PubMed Web of Science ®Google Scholar
• Zhang Y, Che E, Zhang M, et al. Increasing the dissolution rate and oral bioavailability of the poorly water-soluble drug valsartan using novel hierarchical porous carbon monoliths. Int J Pharm 2014;473:375–83
   PubMed Web of Science ®Google Scholar
• Chella N, Tadikonda R. Melt dispersion granules: formulation and evaluation to improve oral delivery of poorly soluble drugs – a case study with valsartan. Drug Dev Ind Pharm 1–10. [Epub ahead of print]. DOI: 10.3109/03639045.2014.911308
   Web of Science ®Google Scholar
• Dixit AR, Rajput SJ, Patel SG. Preparation and bioavailability assessment of SMEDDS containing valsartan. AAPS PharmSciTech 2010;11:314–21
   PubMed Web of Science ®Google Scholar
• Cao Q, Liu Y, Xu W, et al. Enhanced oral bioavailability of novel mucoadhesive pellets containing valsartan prepared by a dry powder-coating technique. Int J Pharm 2009;434:325–33
   Web of Science ®Google Scholar
• Matharu AS, Taillardat A, inventors. Pulsatile release of valsartan. United States, 2011; US Patent Application No. US20110189286 A1
   Google Scholar
• Sokar MS, Hanafy AS, El-Kamel AH, El-Gamal SS. Pulsatile core-in-cup valsartan tablet formulations: in vitro evaluation. Asian J Pharm Sci 2013;8:234–43
   Google Scholar
• Nalawade P, Aware B, Dand N, et al. Solid state characterization of the inclusion complex of valsartan with methyl β-cyclodextrin. J Incl Phenom Macro Chem 2009;65:377–83
   Web of Science ®Google Scholar
• Cappello B, Maio CD, Iervolino MA. Improvement of solubility and stability of valsartan by hydroxypropyl-β-cyclodextrin. J Incl Phenom Macro Chem 2006;54:289–94
   Web of Science ®Google Scholar
• Parmar K, Patel K, Shah S, Sheth N. Inclusion complexes of lamotrigine and hydroxy propyl β-cyclodextrin: solid state characterization and dissolution studies. J Incl Phenom Macro Chem 2009;65:263–8
   Web of Science ®Google Scholar
• Iacovino R, Valentina Caso J, Rapuano F, et al. Physicochemical characterization and cytotoxic activity evaluation of hydroxymethylferrocene: β-cyclodextrin inclusion complex. Molecules 2012;17:6056–70
   PubMed Web of Science ®Google Scholar
• Renny JS, Tomasevich LL, Tallmadge EH, Collum DB. Method of continuous variations: applications of job plots to the study of molecular associations in organometallic chemistry. Angewandte Chemie (International ed in English) 2013;52:11998–2013
   PubMed Web of Science ®Google Scholar
• Doile MM, Fortunato KA, Schmücker ICS, et al. Physicochemical properties and dissolution studies of dexamethasone acetate-β-cyclodextrin inclusion complexes produced by different methods. AAPS PharmSciTech 2008;9:314–21
   PubMed Web of Science ®Google Scholar
• USFDA. Available from: http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults_Dissolutions.cfm?PrintAll=1 [last accessed 12 Feb 2014]
   Google Scholar
• Mahapatra A, Murthy PN, Biswal S, et al. Dissolution enhancement and physicochemical characterization of valsartan in solid dispersions with β-CD, HP β-CD, and PVP K-30. Dissolut Technol 2011;18:39–45
   Web of Science ®Google Scholar
• Kale VV, Kasliwal RH, Avari JG. Attempt to design continuous dissolution–absorption system using everted intestine segment for in vitro absorption studies of slow drug release formulations. Dissolut Technol 2007;14:31–6
   Web of Science ®Google Scholar
• Nayak UY, Shavi GV, Nayak Y, et al. Chronotherapeutic drug delivery for early morning surge in blood pressure: a programmable delivery system. J Control Release 2009;136:125–31
   PubMed Web of Science ®Google Scholar
• Dabhi C, Randale S, Belgamwar V, et al. Predictable pulsatile release of tramadol hydrochloride for chronotherapeutics of arthritis. Drug Deliv 2010;17:273–81
   PubMed Web of Science ®Google Scholar
• Shah SR, Parikh RH, Chavda JR, Sheth NR. Application of Plackett–Burman screening design for preparing glibenclamide nanoparticles for dissolution enhancement. Powder Technol 2013;235:405–11
   Web of Science ®Google Scholar
• Shah S, Parikh R, Chavda J, Sheth N. Glibenclamide nanocrystals for bioavailability enhancement: formulation design, process optimization, and pharmacodynamic evaluation. J Pharm Innov 2014;9:227–37
   Web of Science ®Google Scholar
• Jensen C, Santos R, Denadai A, et al. Pharmaceutical composition of valsartan: β-cyclodextrin: physico–chemical characterization and anti-hypertensive evaluation. Molecules 2010;15:4067–84
   PubMed Web of Science ®Google Scholar
• Hirlekar R, Kadam V. Preformulation study of the inclusion complex irbesartan-β-cyclodextrin. AAPS PharmSciTech 2009;10:276–81
   PubMed Web of Science ®Google Scholar
• Gafourian T, Safari A, Adibkia K, et al. A drug release study from hydroxypropylmethylcellulose (HPMC) matrices using QSPR modeling. J Pharm Sci 2007;96:3334–51
   PubMed Web of Science ®Google Scholar
• Caviglioli G, Baldassari S, Cirrincione P, et al. An innovative matrix controlling drug delivery produced by thermal treatment of DC tablets containing polycarbophil and ethylcellulose. Int J Pharm 2013;458:74–82
   PubMed Web of Science ®Google Scholar
• Shah SR, Parikh RH, Chavda JR, Sheth NR. Self-nanoemulsifying drug delivery system of glimepiride: design, development, and optimization. PDA J Pharm Sci Technol 2013;67:201–13
   PubMedGoogle Scholar