Stability enhancement of proton pump inhibitor in stomach

Formulation and in vitro evaluation of stabilized proton pump inhibitor

P. M. Aravind, Mahalaxmi Rathnanand, C. Madhu Kumar

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objective: The aim of the present study was to prepare a pantoprazole rosin complex tablet which would stabilize the drug in the mild acidic condition (pH 5) of the stomach during the fed state. Methods: The method of slow solvent evaporation and antisolvent was used for the preparation of pantoprazole rosin complex. Results: The prepared pantoprazole rosin complex exhibited decreased solubility than that of pure drug. Fourier transform infrared spectroscopy and differential scanning calorimetry studies confirmed the formation of a complex between the pantoprazole sodium and rosin through weak ionic bonds. The in vitro release studies of the pantoprazole rosin complex showed more than 80% release at the end of 90 minutes. Tablets were formulated using direct compression method and the prepared tablets were evaluated in vitro. The tablets were found to be within official limits with respect to hardness, weight variation, drug content, friability, etc. Conclusion: The tablet formulated with croscarmellose sodium as superdisintegrant showed 97% drug release within 60 minutes. The optimized tablets were found to be stable in accelerated study conditions for 1 month with respect to physical characteristics and drug content. If this process can be scaled up to manufacturing level, this technique has the potential to develop into an invaluable technology in future.

Original languageEnglish
Pages (from-to)88-92
Number of pages5
JournalAsian Journal of Pharmaceutical and Clinical Research
Volume10
Issue number5
DOIs
Publication statusPublished - 2017

Fingerprint

Proton Pump Inhibitors
Tablets
Stomach
Pharmaceutical Preparations
Carboxymethylcellulose Sodium
Differential Scanning Calorimetry
Hardness
Fourier Transform Infrared Spectroscopy
Solubility
In Vitro Techniques
rosin
pantoprazole
Technology
Weights and Measures

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmaceutical Science
  • Pharmacology (medical)

Cite this

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abstract = "Objective: The aim of the present study was to prepare a pantoprazole rosin complex tablet which would stabilize the drug in the mild acidic condition (pH 5) of the stomach during the fed state. Methods: The method of slow solvent evaporation and antisolvent was used for the preparation of pantoprazole rosin complex. Results: The prepared pantoprazole rosin complex exhibited decreased solubility than that of pure drug. Fourier transform infrared spectroscopy and differential scanning calorimetry studies confirmed the formation of a complex between the pantoprazole sodium and rosin through weak ionic bonds. The in vitro release studies of the pantoprazole rosin complex showed more than 80{\%} release at the end of 90 minutes. Tablets were formulated using direct compression method and the prepared tablets were evaluated in vitro. The tablets were found to be within official limits with respect to hardness, weight variation, drug content, friability, etc. Conclusion: The tablet formulated with croscarmellose sodium as superdisintegrant showed 97{\%} drug release within 60 minutes. The optimized tablets were found to be stable in accelerated study conditions for 1 month with respect to physical characteristics and drug content. If this process can be scaled up to manufacturing level, this technique has the potential to develop into an invaluable technology in future.",
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