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Preformulation studies and optimization of sodium alginate based floating drug delivery system for eradication of Helicobacter pylori.
Eur J Pharm Biopharm. 2015 Oct; 96:196-206.EJ

Abstract

The aim of this study was to design a local, floating, mucoadhesive drug delivery system containing metronidazole for Helicobacter pylori eradication. Face-centered central composite design (with three factors, in three levels) was used for evaluation and optimization of in vitro floating and dissolution studies. Sodium alginate (X1), low substituted hydroxypropyl cellulose (L-HPC B1, X2) and sodium bicarbonate (X3) concentrations were the independent variables in the development of effervescent floating tablets. All tablets showed acceptable physicochemical properties. Statistical analysis revealed that tablets with 5.00% sodium alginate, 38.63% L-HPC B1 and 8.45% sodium bicarbonate content showed promising in vitro floating and dissolution properties for further examinations. Optimized floating tablets expressed remarkable floating force. Their in vitro dissolution studies were compared with two commercially available non-floating metronidazole products and then microbiologically detected dissolution, ex vivo detachment force, rheological mucoadhesion studies and compatibility studies were carried out. Remarkable similarity (f1, f2) between in vitro spectrophotometrically and microbiologically detected dissolutions was found. Studies revealed significant ex vivo mucoadhesion of optimized tablets, which was considerably increased by L-HPC. In vivo X-ray CT studies of optimized tablets showed 8h gastroretention in rats represented by an animation prepared by special CT technique.

Authors+Show Affiliations

Institute of Pharmaceutical Technology and Biopharmacy, University of Pécs, Rókus Str. 2, H-7624 Pécs, Hungary. Electronic address: peter.dios@aok.pte.hu.Institute of Pharmaceutical Technology and Biopharmacy, University of Pécs, Rókus Str. 2, H-7624 Pécs, Hungary.Institute of Pharmaceutical Technology and Biopharmacy, University of Pécs, Rókus Str. 2, H-7624 Pécs, Hungary.Institute of Pharmaceutical Technology and Biopharmacy, University of Pécs, Rókus Str. 2, H-7624 Pécs, Hungary.Department of Microbiology, University of Pécs, Szigeti Str. 12, H-7624 Pécs, Hungary.CROmed Translational Research Centers, Baross Str. 91-95, H-1047 Budapest, Hungary; Department of Public Health Medicine, University of Pécs, Szigeti Str. 12, H-7624 Pécs, Hungary.CROmed Translational Research Centers, Baross Str. 91-95, H-1047 Budapest, Hungary.CROmed Translational Research Centers, Baross Str. 91-95, H-1047 Budapest, Hungary.Department of Pharmacology and Pharmacotherapy, University of Pécs, Szigeti Str. 12, H-7624 Pécs, Hungary.CROmed Translational Research Centers, Baross Str. 91-95, H-1047 Budapest, Hungary.Institute of Pharmaceutical Technology and Biopharmacy, University of Pécs, Rókus Str. 2, H-7624 Pécs, Hungary.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26247118

Citation

Diós, Péter, et al. "Preformulation Studies and Optimization of Sodium Alginate Based Floating Drug Delivery System for Eradication of Helicobacter Pylori." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 96, 2015, pp. 196-206.
Diós P, Nagy S, Pál S, et al. Preformulation studies and optimization of sodium alginate based floating drug delivery system for eradication of Helicobacter pylori. Eur J Pharm Biopharm. 2015;96:196-206.
Diós, P., Nagy, S., Pál, S., Pernecker, T., Kocsis, B., Budán, F., Horváth, I., Szigeti, K., Bölcskei, K., Máthé, D., & Dévay, A. (2015). Preformulation studies and optimization of sodium alginate based floating drug delivery system for eradication of Helicobacter pylori. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 96, 196-206. https://doi.org/10.1016/j.ejpb.2015.07.020
Diós P, et al. Preformulation Studies and Optimization of Sodium Alginate Based Floating Drug Delivery System for Eradication of Helicobacter Pylori. Eur J Pharm Biopharm. 2015;96:196-206. PubMed PMID: 26247118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preformulation studies and optimization of sodium alginate based floating drug delivery system for eradication of Helicobacter pylori. AU - Diós,Péter, AU - Nagy,Sándor, AU - Pál,Szilárd, AU - Pernecker,Tivadar, AU - Kocsis,Béla, AU - Budán,Ferenc, AU - Horváth,Ildikó, AU - Szigeti,Krisztián, AU - Bölcskei,Kata, AU - Máthé,Domokos, AU - Dévay,Attila, Y1 - 2015/08/03/ PY - 2015/02/28/received PY - 2015/05/21/revised PY - 2015/07/21/accepted PY - 2015/8/7/entrez PY - 2015/8/8/pubmed PY - 2016/9/13/medline KW - Ex vivo mucoadhesion KW - Floating force KW - Gastroretention KW - Low substituted hydroxypropyl cellulose KW - Sodium alginate KW - X-ray CT imaging SP - 196 EP - 206 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 96 N2 - The aim of this study was to design a local, floating, mucoadhesive drug delivery system containing metronidazole for Helicobacter pylori eradication. Face-centered central composite design (with three factors, in three levels) was used for evaluation and optimization of in vitro floating and dissolution studies. Sodium alginate (X1), low substituted hydroxypropyl cellulose (L-HPC B1, X2) and sodium bicarbonate (X3) concentrations were the independent variables in the development of effervescent floating tablets. All tablets showed acceptable physicochemical properties. Statistical analysis revealed that tablets with 5.00% sodium alginate, 38.63% L-HPC B1 and 8.45% sodium bicarbonate content showed promising in vitro floating and dissolution properties for further examinations. Optimized floating tablets expressed remarkable floating force. Their in vitro dissolution studies were compared with two commercially available non-floating metronidazole products and then microbiologically detected dissolution, ex vivo detachment force, rheological mucoadhesion studies and compatibility studies were carried out. Remarkable similarity (f1, f2) between in vitro spectrophotometrically and microbiologically detected dissolutions was found. Studies revealed significant ex vivo mucoadhesion of optimized tablets, which was considerably increased by L-HPC. In vivo X-ray CT studies of optimized tablets showed 8h gastroretention in rats represented by an animation prepared by special CT technique. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/26247118/Preformulation_studies_and_optimization_of_sodium_alginate_based_floating_drug_delivery_system_for_eradication_of_Helicobacter_pylori_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(15)00323-9 DB - PRIME DP - Unbound Medicine ER -