Exploring the potential of tianeptine matrix tablets: Synthesis, physico-chemical characterization and acute toxicity studies

The main objective of the present study was to explore the potential of matrix tablets as extended release dosage form of tianeptine, using HMPC K100 as a polymer. HPMC K100 extended the release of the drug from formulation due to the gel-like structure. Direct compression method was adopted to comp...

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Bibliographic Details
Published in:Pakistan journal of pharmaceutical sciences 2020-01, Vol.33 (1(Supplementary)), p.269
Main Authors: Salam, Nabila Abdus, Naeem, Muhammad Aamir, Malik, Nadia Shamshad, Riaz, Muhammad, Shahiq-Uz-Zaman, -, Masood-Ur-Rehman, -, Aslam, Fahmida
Format: Article
Language:English
Subjects:
Animals
Antidepressive Agents, Tricyclic - chemical synthesis
Antidepressive Agents, Tricyclic - toxicity
Chemistry, Pharmaceutical - methods
Delayed-Action Preparations - chemical synthesis
Delayed-Action Preparations - toxicity
Female
Hypromellose Derivatives - chemical synthesis
Hypromellose Derivatives - toxicity
Methylcellulose - chemical synthesis
Methylcellulose - toxicity
Mice
Tablets
Thiazepines - chemical synthesis
Thiazepines - toxicity
Toxicity Tests, Acute - methods
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Summary:The main objective of the present study was to explore the potential of matrix tablets as extended release dosage form of tianeptine, using HMPC K100 as a polymer. HPMC K100 extended the release of the drug from formulation due to the gel-like structure. Direct compression method was adopted to compress the tablets using different concentrations of polymer. Tablets were evaluated for pre-compression and post-compression parameters. Drug release study showed that tablet extends the release of drug with the increasing concentration of polymer. Drug, polymers and tablets were analyzed and/or characterized for compatibility, degradation, thermal stability, amorphous or crystalline nature via FTIR, DSC, TGA, XRD studies. SEM study predicted that tablets had a uniform structure. HPMC K100 based tablets were similar to that of the reference product. Acute toxicity study conducted on Swiss albino mice showed that matrix tablets were safe and non-toxic, as no changes in physical activity and functions of organs were observed. Biochemical and histopathological study revealed lack of any kind of abnormality in liver and renal function. Moreover, necrotic changes were absent at organ level.
ISSN:1011-601X
DOI:10.36721/PJPS.2020.33.1.SUP.269-279.1