Buccoadhesive films for once-a-day administration of rivastigmine: systematic formulation development and pharmacokinetic evaluation

References

• Mutlu NB, Degim Z, Yilmaz S, Essiz D, Nacar A. (2011). New perspective for the treatment of Alzheimer diseases: liposomal rivastigmine formulations. Drug Dev Ind Pharm, 37:775–789.
   PubMed Web of Science ®Google Scholar
• Drach LM. Drug treatment of dementia with Lewy bodies and Parkinson’s disease dementia--common features and differences. Med Monatsschr Pjarm. 2011;34:47–52.
   PubMedGoogle Scholar
• Kapil R, Beg S, Singh B.. (2012). Alzheimer’s disease: pathology and treatment strategies. Trendz in Med World, 6:31–41.
   Google Scholar
• Inglis F. (2002). The tolerability and safety of cholinesterase inhibitors in the treatment of dementia. Int J Clin Pract Suppl: 45–63.
   PubMedGoogle Scholar
• Jhee SS, Shiovitz T, Hartman RD, Messina J, Anand R, Sramek J et al. (2002). Centrally acting antiemetics mitigate nausea and vomiting in patients with Alzheimer’s disease who receive rivastigmine. Clin Neuropharmacol, 25:122–123.
   PubMed Web of Science ®Google Scholar
• Darvesh S, Walsh R, Kumar R, Caines A, Roberts S, Magee D et al. (2003). Inhibition of human cholinesterases by drugs used to treat Alzheimer disease. Alzheimer Dis Assoc Disord, 17:117–126.
   PubMed Web of Science ®Google Scholar
• Grossberg GT. Cholinesterase inhibitors for the treatment of Alzheimer’s disease: getting on and staying on. Curr Ther Res. 2003;64:216–235.
   PubMed Web of Science ®Google Scholar
• Jann MW, Shirley KL, Small GW. (2002). Clinical pharmacokinetics and pharmacodynamics of cholinesterase inhibitors. Clin Pharmacokinet, 41:719–739.
   PubMed Web of Science ®Google Scholar
• Wentrup A, Oertel WH, Dodel R. (2009). Once-daily transdermal rivastigmine in the treatment of Alzheimer’s disease. Drug Des Devel Ther, 2:245–254.
   PubMedGoogle Scholar
• Llabot JM, Palma SD, Manzo RH, Allemandi DA. (2007). Design of novel antifungal mucoadhesive films. Part II. Formulation and in vitro biopharmaceutical evaluation. Int J Pharm, 336: 263–268.
   PubMed Web of Science ®Google Scholar
• Peh KK, Wong CF. Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties. J Pharm Pharm Sci, 1999;2:53–61.
   PubMed Web of Science ®Google Scholar
• Singh S, Soni R, Rawat MK, Jain A, Deshpande SB, Deshpande SB et al. (2010). In vitro and in vivo evaluation of buccal bioadhesive films containing salbutamol sulphate. Chem Pharm Bull, 58:307–311.
   PubMed Web of Science ®Google Scholar
• Kapil R, Dhawan S, Singh B. (2009). Development and validation of a spectrofluorimetric method for the estimation of rivastigmine in formulations. Indian J Pharm Sci, 71:585–589.
   PubMed Web of Science ®Google Scholar
• Liltorp K, Larsen TG, Willumsen B, Holm R. (2011). Solid state compatibility studies with tablet excipients using non thermal methods. J Pharm Biomed Anal, 55:424–428.
   PubMed Web of Science ®Google Scholar
• Monajjemzadeh F, Hassanzadeh D, Valizadeh H, Siahi-Shadbad MR, Mojarrad JS, Robertson TA et al. (2009). Compatibility studies of acyclovir and lactose in physical mixtures and commercial tablets. Eur J Pharm Biopharm, 73:404–413.
   PubMed Web of Science ®Google Scholar
• Singh B, Kumar R, Ahuja N. (2005). Optimizing drug delivery systems using systematic “design of experiments.” Part I: fundamental aspects. Crit Rev Ther Drug Carrier Syst, 22:27–105.
   PubMed Web of Science ®Google Scholar
• Dhawan S, Kapil R, Singh B. (2011). Formulation development and systematic optimization of solid lipid nanoparticles of quercetin for improved brain delivery. J Pharm Pharmacol, 63:342–351.
   PubMed Web of Science ®Google Scholar
• Singh B, Singh S. A compreshensive computer program for study of drug release kinetics from compressed matrices. Indian J Pharm Sci. 1998;60:313–316.
   Google Scholar
• Singh B, Kaur T, Singh S. Correction of raw dissolution data for loss of drug during sampling. Indian J Pharm Sci. 1997;59:196–199.
   Google Scholar
• Singh B, Ahuja N. (2002). Development of controlled-release buccoadhesive hydrophilic matrices of diltiazem hydrochloride: optimization of bioadhesion, dissolution, and diffusion parameters. Drug Dev Ind Pharm, 28:431–442.
   PubMed Web of Science ®Google Scholar
• Zhang H, Robinson JR. In Vitro Methods for Measuring Permeability of the Oral Mucosa. In: Rathbone MJ editor Oral Mucosal Drug Delivery; Drugs and The Pharmaceutical Sciences. New York: Marcel Dekker; 1996. p. 85–100.
   Google Scholar
• Rajput G, Majmudar F, Patel J. (2011). Formulation and evaluation of mucoadhesive glipizide films. Acta Pharm, 61:203–216.
   PubMed Web of Science ®Google Scholar
• ICH. The European agency for the evaluation of medical products. Topic Q2B: Note for guidance on validation of analytical procedures: Methodology. GPMP/ICH. 1996281/95.
   Google Scholar
• USP. USP 27, NF 22 The United States Pharmacopeia and The National Formulary, Rockwille, MD: The United States Pharmacopeial Convention; 20852 ISSN: 0195-7996, ISBN: 1-889788-20-0. 2004
   Google Scholar
• Reagan-Shaw S, Nihal M, Ahmad N. (2008). Dose translation from animal to human studies revisited. FASEB J, 22:659–661.
   PubMed Web of Science ®Google Scholar
• Rossi RC, Dias CL, Bajerski L, Bergold AM, Fröehlich PE. (2011). Development and validation of discriminating method of dissolution for fosamprenavir tablets based on in vivo data. J Pharm Biomed Anal, 54:439–444.
   PubMed Web of Science ®Google Scholar
• Singh B, Kapil R, Nandi M, Ahuja N. (2011). Developing oral drug delivery systems using formulation by design: vital precepts, retrospect and prospects. Expert Opin Drug Deliv, 8:1341–1360.
   PubMed Web of Science ®Google Scholar
• Singh B, Chakkal SK, Ahuja N. (2006). Formulation and optimization of controlled release mucoadhesive tablets of atenolol using response surface methodology. AAPS PharmSciTech, 7:E3.
   PubMed Web of Science ®Google Scholar
• Li L, Zhao X, Yang C, Hu H, Qiao M, Chen D. (2011). Preparation and optimization of doxorubicin-loaded albumin nanoparticles using response surface methodology. Drug Dev Ind Pharm, 37:1170–1180.
   PubMed Web of Science ®Google Scholar
• Siddique S, Bose A, Khanam J. (2011). Modulation of drug (metoprolol succinate) release by inclusion of hydrophobic polymer in hydrophilic matrix. Drug Dev Ind Pharm, 37:1016–1025.
   PubMed Web of Science ®Google Scholar
• Shayeda Gannu, R, Palem CR, Rao YM. Development of novel bioadhesive buccal formulation of diltiazem: in vitro and in vivo characterization. PDA J Pharm Sci Technol. 2009;63:401–408.
   PubMedGoogle Scholar
• Hassan N, Khar RK, Ali M, Ali J. (2009). Development and evaluation of buccal bioadhesive tablet of an anti-emetic agent ondansetron. AAPS PharmSciTech, 10:1085–1092.
   PubMed Web of Science ®Google Scholar
• Tamilvanan S, Bangale GS, Ananthi JJ, Sivakumar V, Vinothapooshan G, Palanivelu M et al. (2009). Carvedilol-loaded mucoadhesive buccal tablets: influence of various mucoadhesive polymers on drug release behavior. PDA J Pharm Sci Technol, 63:196–206.
   PubMedGoogle Scholar
• Yehia SA, El-Gazayerly ON, Basalious EB. (2009). Fluconazole mucoadhesive buccal films: in vitro/in vivo performance. Curr Drug Deliv, 6:17–27.
   PubMedGoogle Scholar
• Singh B, Pahuja S, Kapil R, Ahuja N. (2009). Formulation development of oral controlled release tablets of hydralazine: optimization of drug release and bioadhesive characteristics. Acta Pharm, 59:1–13.
   PubMed Web of Science ®Google Scholar
• Singh B, Rani A, Babita Ahuja, N, Kapil R. (2010). Formulation Optimization of Hydrodynamically Balanced Oral Controlled Release Bioadhesive Tablets of Tramadol Hydrochloride. Sci Pharm, 78:303–323.
   PubMedGoogle Scholar
• Mughal MA, Iqbal Z, Neau SH. (2011). Guar gum, xanthan gum, and HPMC can define release mechanisms and sustain release of propranolol hydrochloride. AAPS PharmSciTech, 12:77–87.
   PubMed Web of Science ®Google Scholar
• Aguilar-de-Leyva A, Sharkawi T, Bataille B, Baylac G, Caraballo I. Release behaviour of clozapine matrix pellets based on percolation theory. Int J Pharm. 2011;404:133–141.
   PubMed Web of Science ®Google Scholar
• Pan J, Lu W, Li C, Wang S, He L. (2010). Imperatorin sustained-release tablets: In vitro and pharmacokinetic studies. Arch Pharm Res, 33:1209–1216.
   PubMed Web of Science ®Google Scholar
• Patel VM, Prajapati BG, Patel HV, Patel KM. (2007). Mucoadhesive bilayer tablets of propranolol hydrochloride. AAPS PharmSciTech, 8:E77.
   PubMed Web of Science ®Google Scholar
• Venugopal K, Movva S, Saha RN. New, rapid, and sensitive spectrofluorimetric method for the estimation of gatifloxacin in bulk and formulations. Indian J Pharm Sci. 2006;68:726.
   Google Scholar
• Cummings J, Lefèvre G, Small G, Appel-Dingemanse S. (2007). Pharmacokinetic rationale for the rivastigmine patch. Neurology, 69:S10–S13.
   PubMed Web of Science ®Google Scholar
• Sankalia JM, Sankalia MG, Mashru RC. (2008). Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC. J Control Release, 129:49–58.
   PubMed Web of Science ®Google Scholar