Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets

References

• Fu Y, Yang S, Jeong SH, et al. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst 2004;21:433--476
   PubMed Web of Science ®Google Scholar
• El Maghraby GM, Elsergany RN. Fast disintegrating tablets of nisoldipine for intra-oral administration. Pharm Dev Technol 2014;19:641–650
   PubMed Web of Science ®Google Scholar
• Ramtoola Z, Pabari R, Kelly J. A method of producing fast dissolving tablets. WO Patent 2,008,120,181; 2008
   Google Scholar
• Mostafa HF, Ibrahim MA, Sakr A. Development and optimization of dextromethorphan hydrobromide oral disintegrating tablets: effect of formulation and process variables. Pharm Dev Technol 2013;18:454–463
   PubMed Web of Science ®Google Scholar
• Soh JLP, Grachet M, Whitlock M, Lukas T. Characterization, optimisation and process robustness of a co-processed mannitol for the development of orally disintegrating tablets. Pharm Dev Technol 2013;18:172–185
   PubMed Web of Science ®Google Scholar
• Corveleyn S, Remon JP. Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug. Int J Pharm 1997;152:215–225
   Web of Science ®Google Scholar
• Ahmed IS, Shamma RN, Shoukri RA. Development and optimization of lyophilized orally disintegrating tablets using factorial design. Pharm Dev Technol 2013;18:935–943
   PubMed Web of Science ®Google Scholar
• Roser BJ, Blair J. Rapidly soluble oral solid dosage forms, methods of making same, and compositions thereof. Google Patents; 1998
   Google Scholar
• Gohel M, Patel M, Amin A, et al. Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique. AAPS PharmSciTech 2004;5:10–15
   Web of Science ®Google Scholar
• Assaf SM, Qandil AM, Al-Ani EA. Fast and pH-dependent release of domperidone from orally disintegrating tablets. Pharm Dev Technol 2013;18:897–905
   PubMed Web of Science ®Google Scholar
• Kim J-S, Kim M-S, Park HJ, et al. Physicochemical properties and oral bioavailability of amorphous atorvastatin hemi-calcium using spray-drying and SAS process. Int J Pharm 2008;359:211–219
   PubMed Web of Science ®Google Scholar
• Kim M-S, Jin S-J, Kim J-S, et al. Preparation, characterization and in vivo evaluation of amorphous atorvastatin calcium nanoparticles using supercritical antisolvent (SAS) process. Eur J Pharm Biopharm 2008;69:454–465
   PubMed Web of Science ®Google Scholar
• An S-G, Sohn Y-T. Crystal forms of atorvastatin. Arch Pharm Res 2009;32:933–936
   PubMed Web of Science ®Google Scholar
• Byrn SR, Coates DA, Gushurst KS, et al. Crystalline forms of ′r-(r*, r*)!-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-′phenylamino) carbonyl!-1h-pyrrole-1-heptanoic acid calcium salt (2: 1)(atorvastatin). EP Patent 1,423,364; 2004
   Google Scholar
• Byrn SR, Coates DA, Gushurst KS, et al. Crystalline forms of [R-(R*,R*)]-2-(4-fluorophenyl)-β,α-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt (2:1). US 6605729; 2003
   Google Scholar
• Dixit G, Khile A, Pradhan N, Valgeirsson J. Novel polymorph of atorvastatin calcium and use thereof for the preparation of amorphous atorvastatin calcium. WO Patent 2,009,007,856; 2009
   Google Scholar
• Van Der SPA, Blatter F, Szelagiewicz M, Schöning K-U. Crystalline forms of atorvastatin. EP Patent 1,345,896; 2009
   Google Scholar
• Yin Y-M, Cui F-D, Kim JS, et al. Preparation, characterization and in vitro intestinal absorption of a dry emulsion formulation containing atorvastatin calcium. Drug Deliv 2009;16:30–36
   PubMed Web of Science ®Google Scholar
• Daoust R, Lynch M. Mannitol in chewable tablets. Drug Cosmet Ind 1963;93:26–28
   Google Scholar
• Herman J, Remon J. Aluminium-magnesium hydroxide tablets: effect of processing and composition of granulating solution on the granule properties and in vitro antacid performance. Drug Dev Ind Pharm 1988;14:1221–1234
   Web of Science ®Google Scholar
• Fraser Steele D, Tobyn M, Edge S, et al. Physicochemical and mechanical evaluation of a novel high density grade of silicified microcrystalline cellulose. Drug Dev Ind Pharm 2004;30:103–109
   PubMed Web of Science ®Google Scholar
• Pabari R, Ramtoola Z. Effect of a disintegration mechanism on wetting, water absorption, and disintegration time of orodispersible tablets. J Young Pharm 2012;4:157–163
   PubMedGoogle Scholar
• Shangraw R, Wallace J, Bowers F. Morphology and functionality in tablet excipients for direct compression. Pharm Technol 1987;11:136–143
   Google Scholar
• Pabari RM, Sunderland T, Ramtoola Z. Investigation of a novel 3-fluid nozzle spray drying technology for the engineering of multifunctional layered microparticles. Expert Opin Drug Deliv 2012;9:1463–1474
   PubMed Web of Science ®Google Scholar
• British Pharmacopoeia. British Pharmacopoeia Commission, British Pharmacopoeia 2011 Volume 1–4 Stationery Office; 2010
   Google Scholar
• Pabari RM, Ramtoola Z. Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets. Int J Pharm 2012;430:18–25
   PubMed Web of Science ®Google Scholar
• PhEur. Tablets, orodispersible tablets. European Pharmacopoeia 7.0. 2011
   Google Scholar
• Zhang H-X, Wang J-X, Zhang Z-B, et al. Micronization of atorvastatin calcium by antisolvent precipitation process. Int J Pharm 2009;374:106–113
   PubMed Web of Science ®Google Scholar
• Tobyn MJ, McCarthy GP, Staniforth JN, Edge S. Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose. Int J Pharm 1998;169:183–194
   Web of Science ®Google Scholar
• Swarbrick J, Boylan J. Encyclopedia of pharmaceutical technology: volume 4-design of drugs to drying and driers. USA: Informa Healthcare; 1991
   Google Scholar
• FDA. Guidance for industry orally disintegrating tablets. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER); December 2008. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory/Information/Guidances/ucm070578.pdf [last accessed 30 Jul 2013]
   Google Scholar
• Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) – a novel solid oral dosage form for paediatric use. Eur J Pharm Biopharm 2011;78:462–469
   PubMed Web of Science ®Google Scholar
• Park JH, Holman KM, Bish GA, et al. An alternative to the USP disintegration test for orally disintegrating tablets. Pharm Technol 2008;32:54--58
   Google Scholar
• Determination of atorvastatin and its ortho-, para-hydroxy metabolites in serum by XLC-MS using Symbiosis™ Pharma. Spark Holland Application Info; 2005. Available from: http://ichrom.com/wp-content/uploads/2012/08/53060_Atorvastin.pdf [last accessed Jul 2013]
   Google Scholar