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Clarithromycin and Pantoprazole Gastro-Retentive Floating Bilayer Tablet for the Treatment of Helicobacter Pylori: Formulation and Characterization

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Clarithromycin and Pantoprazole Gastro-Retentive Floating Bilayer Tablet for the Treatment of Helicobacter Pylori Formulation and Characterization.pdf (2.59 MB)

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2023-01-04

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MDPI

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Abstract

Bilayer/multilayer tablets have been introduced to formulate incompatible components for compound preparations, but they are now more commonly used to tailor drug release. This research aimed to formulate a novel gastro-retentive tablet to deliver a combination of a fixed dose of two drugs to eliminate Helicobacter pylori (H. pylori) in the gastrointestinal tract. The bilayer tablets were prepared by means of the direct compression technique. The controlled-release bilayer tablets were prepared using various hydrophilic swellable polymers (sodium alginate, chitosan, and HPMC-K15M) alone and in combination to investigate the percent of swelling behavior and average drug release. The weight of the controlled-release floating layer was 500 mg, whereas the weight of the floating tablets of pantoprazole was 100 mg. To develop the most-effective formulation, the effects of the experimental components on the floating lag time, the total floating time, T 50%, and the amount of drug release were investigated. The drugs’ and excipients’ compatibilities were evaluated using ATR-FTIR and DSC. Pre-compression and post-compression testing were carried out for the prepared tablets, and they were subjected to in vitro characterization studies. The pantoprazole layer of the prepared tablet demonstrated drug release (95%) in 2 h, whereas clarithromycin demonstrated sustained drug release (83%) for up to 24 h (F7). The present study concluded that the combination of sodium alginate, chitosan, and HPMC polymers (1:1:1) resulted in a gastro-retentive and controlled release drug delivery system of the drug combination. Thus, the formulation of the floating bilayer tablets successfully resulted in a biphasic drug release. Moreover, the formulation (F7) offered the combination of two drugs in a single-tablet formulation containing various polymers (sodium alginate, chitosan, and HPMC polymers) as the best treatment option for local infections such as gastric ulcers.

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Volume 9 Issue 1

Keywords

pantoprazole; clarithromycin; immediate-release layer; controlled-release floating layer; floating drug delivery

Citation

Ullah, G., Nawaz, A., Latif, M. S., Shah, K. U., Ahmad, S., Javed, F., Alfatama, M., et al. (2023). Clarithromycin and Pantoprazole Gastro-Retentive Floating Bilayer Tablet for the Treatment of Helicobacter Pylori: Formulation and Characterization. Gels, 9(1), 43. MDPI AG. Retrieved from http://dx.doi.org/10.3390/gels9010043

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https://www.mdpi.com/2310-2861/9/1/43
 https://www.scopus.com/record/display.uri?eid=2-s2.0-85146770830&origin=resultslist&sort=plf-f&src=s&sid=fe0aae13e8998803167d13a7fa59c866&sot=b&sdt=b&s=TITLE-ABS-KEY%28Clarithromycin+and+Pantoprazole+Gastro-Retentive+Floating+Bilayer+Tablet+for+the+Treatment+of+Helicobacter+Pylori%3A+Formulation+and+Characterization%29&sl=162&sessionSearchId=fe0aae13e8998803167d13a7fa59c866
 https://oarep.usim.edu.my/handle/123456789/10753

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