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Design and In-vitro Evaluation of Sustained Release Floating Tablets of Metformin HCl Based on Effervescence and Swelling.

作者信息

Senjoti Faria Gias, Mahmood Syed, Jaffri Juliana Md, Mandal Uttam Kumar

机构信息

Department of Pharmaceutical Technology, Kulliyyah of Pharmacy, International Islamic University Malaysia (IIUM), Kuantan, Malaysia.

出版信息

Iran J Pharm Res. 2016 Winter;15(1):53-70.


DOI:
PMID:27610147
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4986121/
Abstract

An oral sustained-release floating tablet formulation of metformin HCl was designed and developed. Effervescence and swelling properties were attributed on the developed tablets by sodium bicarbonate and HPMC-PEO polymer combination, respectively. Tablet composition was optimized by response surface methodology (RSM). Seventeen (17) trial formulations were analyzed according to Box-Behnken design of experiment where polymer content of HPMC and PEO at 1: 4 ratio (A), amount of sodium bi-carbonate (B), and amount of SSG (C) were adopted as independent variables. Floating lag time in sec (Y1), cumulative percent drug released at 1 h (Y2) and 12 h (Y3) were chosen as response variables. Tablets from the optimized formulation were also stored at accelerated stability condition (40°C and 75% RH) for 3 months to assess their stability profile. RSM could efficiently optimize the tablet composition with excellent prediction ability. In-vitro drug release until 12 h, floating lag time, and duration of floating were dependent on the amount of three selected independent variables. Optimized tablets remained floating for more than 24 h with a floating lag time of less than 4 min. Based on best fitting method, optimized formulation was found to follow Korsmeyer-Peppas release kinetic. Accelerated stability study revealed that optimized formulation was stable for three months without any major changes in assay, dissolution profile, floating lag time and other physical properties.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/89b372211e6a/ijpr-15-053-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/f90ba9163135/ijpr-15-053-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/d47df50323b0/ijpr-15-053-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/9dde52bb809b/ijpr-15-053-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/66cad2b329f7/ijpr-15-053-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/5878aab8c343/ijpr-15-053-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/4978100efeba/ijpr-15-053-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/bcf581f0e278/ijpr-15-053-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/89b372211e6a/ijpr-15-053-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/f90ba9163135/ijpr-15-053-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/d47df50323b0/ijpr-15-053-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/9dde52bb809b/ijpr-15-053-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/66cad2b329f7/ijpr-15-053-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/5878aab8c343/ijpr-15-053-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/4978100efeba/ijpr-15-053-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/bcf581f0e278/ijpr-15-053-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1283/4986121/89b372211e6a/ijpr-15-053-g008.jpg

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Design and In-vitro Evaluation of Sustained Release Floating Tablets of Metformin HCl Based on Effervescence and Swelling.

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[2]
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[3]
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[4]
DoE-Based Design of a Simple but Efficient Preparation Method for a Non-Effervescent Gastro-Retentive Floating Tablet Containing Metformin HCl.

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[5]
Development of Floating Tablets of Metformin HCl by Thermoplastic Granulation. Part II: Evaluation of the Combined Effect of Acacia Gum/HPMC on Biopharmaceutical Performances.

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本文引用的文献

[1]
Bifunctional capsular dosage form: novel fanicular cylindrical gastroretentive system of clarithromycin and immediate release granules of ranitidine HCl for simultaneous delivery.

Int J Pharm. 2014-1-30

[2]
Assessing the viability of microsponges as gastro retentive drug delivery system of curcumin: optimization and pharmacokinetics.

Int J Pharm. 2013-11-1

[3]
Applications of poly(ethylene oxide) in controlled release tablet systems: a review.

Drug Dev Ind Pharm. 2014-7

[4]
Pharmacokinetics, efficacy, and tolerability of a once-daily gastroretentive dosage form of gabapentin for the treatment of postherpetic neuralgia.

J Pharm Sci. 2013-2-4

[5]
Formulation, in vitro evaluation and study of variables on tri-layered gastro-retentive delivery system of diltiazem HCl.

Drug Dev Ind Pharm. 2013-2-1

[6]
Preparation of highly porous gastroretentive metformin tablets using a sublimation method.

Eur J Pharm Biopharm. 2012-12-12

[7]
Bioavailability enhancement of baclofen by gastroretentive floating formulation: statistical optimization, in vitro and in vivo pharmacokinetic studies.

Drug Dev Ind Pharm. 2012-8-20

[8]
Industrial perspective of gastroretentive drug delivery systems: physicochemical, biopharmaceutical, technological and regulatory consideration.

Expert Opin Drug Deliv. 2012-5

[9]
Development of gastroretentive drug delivery system for cefuroxime axetil: in vitro and in vivo evaluation in human volunteers.

Pharm Dev Technol. 2012-2-21

[10]
Gastroretentive microballoons of metformin: Formulation development and characterization.

J Adv Pharm Technol Res. 2011-1

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