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Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: development, optimization and in vitro-in vivo evaluation in healthy human volunteers.
Eur J Pharm Biopharm. 2010 Feb; 74(2):332-9.EJ

Abstract

Ciprofloxacin hydrochloride has a short elimination half-life, a narrow absorption window and is mainly absorbed in proximal areas of GIT. The purpose of this study was to develop a gastroretentive controlled-release drug delivery system with swelling, floating, and adhesive properties. Ten tablet formulations were designed using hydroxypropylmethylcellulose (HPMC K15M) and/or sodium alginate (Na alginate) as release-retarding polymer(s) and sodium bicarbonate (NaHCO(3)) or calcium carbonate (CaCO(3)) as a gas former. Swelling ability, floating behaviour, adhesion period and drug release studies were conducted in 0.1 N HCl (pH 1.2) at 37+/-0.5 degrees C. The tablets showed acceptable physicochemical properties. Drug release profiles of all formulae followed non-Fickian diffusion. Statistical analyses of data revealed that tablets containing HPMC K15M (21.42%, w/w), Na alginate (7.14%, w/w) and NaHCO(3) (20%, w/w) (formula F7) or CaCO(3) (20%, w/w) (formula F10) were promising systems exhibiting excellent floating properties, extended adhesion periods and sustained drug release characteristics. Both formulae were stored at 40 degrees C/75% RH for 3months according to ICH guidelines. Formula F10 showed better physical stability. Abdominal X-ray imaging of formula F10, loaded with barium sulfate, in six healthy volunteers revealed a mean gastric retention period of 5.50+/-0.77h.

Authors+Show Affiliations

Department of Pharmaceutics and Industrial Pharmacy, Cairo University, Egypt. mina_ebrahim@yahoo.com

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

19932750

Citation

Tadros, Mina Ibrahim. "Controlled-release Effervescent Floating Matrix Tablets of Ciprofloxacin Hydrochloride: Development, Optimization and in Vitro-in Vivo Evaluation in Healthy Human Volunteers." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 74, no. 2, 2010, pp. 332-9.
Tadros MI. Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: development, optimization and in vitro-in vivo evaluation in healthy human volunteers. Eur J Pharm Biopharm. 2010;74(2):332-9.
Tadros, M. I. (2010). Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: development, optimization and in vitro-in vivo evaluation in healthy human volunteers. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 74(2), 332-9. https://doi.org/10.1016/j.ejpb.2009.11.010
Tadros MI. Controlled-release Effervescent Floating Matrix Tablets of Ciprofloxacin Hydrochloride: Development, Optimization and in Vitro-in Vivo Evaluation in Healthy Human Volunteers. Eur J Pharm Biopharm. 2010;74(2):332-9. PubMed PMID: 19932750.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Controlled-release effervescent floating matrix tablets of ciprofloxacin hydrochloride: development, optimization and in vitro-in vivo evaluation in healthy human volunteers. A1 - Tadros,Mina Ibrahim, Y1 - 2009/11/22/ PY - 2009/09/29/received PY - 2009/11/13/revised PY - 2009/11/18/accepted PY - 2009/11/26/entrez PY - 2009/11/26/pubmed PY - 2010/5/25/medline SP - 332 EP - 9 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 74 IS - 2 N2 - Ciprofloxacin hydrochloride has a short elimination half-life, a narrow absorption window and is mainly absorbed in proximal areas of GIT. The purpose of this study was to develop a gastroretentive controlled-release drug delivery system with swelling, floating, and adhesive properties. Ten tablet formulations were designed using hydroxypropylmethylcellulose (HPMC K15M) and/or sodium alginate (Na alginate) as release-retarding polymer(s) and sodium bicarbonate (NaHCO(3)) or calcium carbonate (CaCO(3)) as a gas former. Swelling ability, floating behaviour, adhesion period and drug release studies were conducted in 0.1 N HCl (pH 1.2) at 37+/-0.5 degrees C. The tablets showed acceptable physicochemical properties. Drug release profiles of all formulae followed non-Fickian diffusion. Statistical analyses of data revealed that tablets containing HPMC K15M (21.42%, w/w), Na alginate (7.14%, w/w) and NaHCO(3) (20%, w/w) (formula F7) or CaCO(3) (20%, w/w) (formula F10) were promising systems exhibiting excellent floating properties, extended adhesion periods and sustained drug release characteristics. Both formulae were stored at 40 degrees C/75% RH for 3months according to ICH guidelines. Formula F10 showed better physical stability. Abdominal X-ray imaging of formula F10, loaded with barium sulfate, in six healthy volunteers revealed a mean gastric retention period of 5.50+/-0.77h. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/19932750/Controlled_release_effervescent_floating_matrix_tablets_of_ciprofloxacin_hydrochloride:_development_optimization_and_in_vitro_in_vivo_evaluation_in_healthy_human_volunteers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(09)00337-3 DB - PRIME DP - Unbound Medicine ER -