432
Views
5
CrossRef citations to date
0
Altmetric
Research Article

Development of a new esomeprazole delayed release gastro-resistant pellet formulation with improved storage stability

&
Pages 942-952 | Received 12 Sep 2017, Accepted 24 Dec 2017, Published online: 08 Jan 2018

References

  • Jones R, Patrikios T. The effectiveness of esomeprazole 40 mg in patients with persistent symptoms of gastro-esophageal reflux disease following treatment with a full dose proton pump inhibitor. Int J Clin Pract. 2008;62:1844–1850.
  • Scarpignato C, Hunt RH. Nonsteroidal antiinflammatory drug-related injury to the gastrointestinal tract: clinical picture, pathogenesis, and prevention. Gastroenterol Clin North Am. 2010;39:433–464.
  • Yang HB, Sheu BS, Wang ST, et al. H. pylori eradication prevents the progression of gastric intestinal metaplasia in reflux esophagitis patients using long-term esomeprazole. Am J Gastroenterol. 2009;104:1642–1649.
  • European Marketing Authorization, Nexium (Esomeprazole): Summary of product characteristics in electronic medicines compendium (eMC) [Internet]. UK; [cited 2017 Jul 25]. Available from: https://www.medicines.org.uk/emc/medicine/24696
  • Hassan-Ali M, Andersson T, Niazi M, et al. A pharmacokinetic study comparing single and repeated oral doses of 20 mg and 40 mg omeprazole and its two optical isomers, S-omeprazole (esomeprazole) and R-omeprazole, in healthy subjects. Eur J Clin Pharmacol. 2005;60:779–784.
  • Andersson T, Hassan-Alin M, Hasselgren G, et al. Pharmacokinetic studies with esomeprazole, the (S)-isomer of omeprazole. Clin Pharmacokinet. 2001;40:411–426.
  • Nexium Rx List NDA 21-153/S-027 and NDA 21-689/S-008 [Internet]. San Clemente, California; [cited 2017 Aug 1]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf
  • Lindberg PL, Von Sverker U. Inventors; Astra Aktiebolag, assignee. Optically pure salts of pyridinylmethyl sulfinyl-1H-benzimidazole compounds. World Patent WO 9,427,988. 1994 Dec 8.
  • Horn JR, Howden C. Review article: similarities and differences among delayed-release proton-pump inhibitor formulations. Aliment Pharmacol Ther. 2005;22:20–24.
  • Alsulays BB, Kulkarni V, Alshehri SM, et al. Preparation and evaluation of enteric coated tablets of hot-melt extruded lansoprazole. Drug Dev Ind Pharm. 2017;43:789–796.
  • Shibata H, Yoshida H, Izutsu K, et al. Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets. J Pharm Pharmacol. 2016;68:467–474.
  • Missaghi S, Young C, Fegely K, et al. Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies. Drug Dev Ind Pharm. 2010;36:180–189.
  • Van Nguyen H, Baek N, Lee BJ. Enhanced gastric stability of esomeprazole by molecular interaction and modulation of microenvironmental pH with alkalizers in solid dispersion. Int J Pharm. 2017;523:189–202.
  • Hoover A, Sun D, Wen H, et al. In vitro evaluation of nasogastric tube delivery performance of esomeprazole magnesium delayed-release capsules. J Pharm Sci. 2017;106:1859–1864.
  • Liu Z, Wang W, Chen H, et al. Novel application method of talcum powder to prevent sticking tendency and modify release of esomeprazole magnesium enteric-coated pellets. Pharm Dev Technol. 2016;21:405–414.
  • Marvola M, Nykänen P, Rautio S, et al. Enteric polymers as binders and coating materials in multiple-unit site-specific drug delivery systems. Eur J Pharm Sci. 1999;7:259–267.
  • Smith AM, Ingham A, Grover LM, et al. Polymer film formulations for the preparation of enteric pharmaceutical capsules. J Pharm Pharmacol. 2010;62:167–172.
  • Lu J, Kan S, Zhao Y, et al. Novel naproxen/esomeprazole magnesium compound pellets based on acid-independent mechanism: in vitro and in vivo evaluation. Drug Dev Ind Pharm. 2016;42:1495–1503.
  • Benetti C, Flammini L, Vivo V, et al. Esomeprazole immediate release tablets: gastric mucosa ex vivo permeation, absorption and antisecretory activity in conscious rats. J Control Release. 2016;239:203–210.
  • Stroyer A, McGinity JW, Leopold CS. Solid state interactions between the proton pump inhibitor omeprazole and various enteric coating polymers. J Pharm Sci. 2006;95:1342–1353.
  • Nair AB, Gupta R, Kumria R, et al. Formulation and evaluation of enteric coated tablets of proton pump inhibitor. J Basic Clin Pharm. 2010;1:215–221.
  • He W, Yang M, Fan JH, et al. Influences of sodium carbonate on physicochemical properties of lansoprazole in designed multiple coating pellets. AAPS PharmSciTech. 2010;11:1287–1293.
  • Fang Y, Wang G, Zhang R, et al. Eudragit L/HPMCAS blend enteric-coated lansoprazole pellets: enhanced drug stability and oral bioavailability. AAPS PharmSciTech. 2014;15:513–521.
  • Riedel A, Leopold CS. Degradation of omeprazole induced by enteric polymer solutions and aqueous dispersions: HPLC investigations. Drug Dev Ind Pharm. 2005;31:151–160.
  • Erickson M, Josefsson L. Inventors; Astra Zeneca, assignee. Pharmaceutical formulation of omeprazole. European patent EP-B-0984773. 2000 Mar 15.
  • Bergstrand P, Wan P. Inventors; Astra Zeneca, assignee. Pharmaceutical formulation comprising omeprazole. European patent EP-B-1124539. 2003 Jul 2.
  • Agatonovic-Kustrin S, Beresford R. Basic concepts of artificial neural network (ANN) modeling and its application in pharmaceutical research. J Pharm Biomed Anal. 2000;22:717–727.
  • Missaghi S, Fegely KA, Kumar A, et al. Formulation and process considerations for delayed release multiparticulates of esomeprazole magnesium. Poster session presented at: AAPS Annual Meeting and Exposition; 2008 Nov 16–20; Atlanta, GA.
  • U.S. Pharmacopoeia-National Formulary [USP 40-NF 35]. Supplement: No 1. Rockville, Md: United States Pharmacopeial Convention, Inc.; 2017. Esomerpazole Magnesium Delayed-Release Capsules; p. 8279–8282.
  • Kennard R, Stone L. Computer aided design of experiments. Technometrics. 1969;11:137–148.
  • Brouwer RK. A feed-forward network for input that is both categorical and quantitative. Neural Netw. 2002;15:881–890.
  • Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13:123–133.
  • Matsaridou I, Barmpalexis P, Salis A, et al. The influence of surfactant HLB and oil/surfactant ratio on the formation and properties of self-emulsifying pellets and microemulsion reconstitution. AAPS PharmSciTech. 2012;13:1319–1330.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.