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International Journal for Research Trends and Innovation
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ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Volume 11 | Issue 6
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Impact Factor : 8.14
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| Paper Title: | Immplementation in Pharmaceutical Development: A Comprehensive Framework for Robust Solid Dosage Formulation of Metformin Hydrochloride |
| Authors Name: | Kartik Bhawani Shingne , Krushna R. Somani , Rohit R. Kharat , Rushikesh Sapkal , Piyush Jain |
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IJRTI_212360
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| Published Paper Id: | IJRTI2605020 |
| Published In: | Volume 11 Issue 5, May-2026 |
| DOI: | |
| Abstract: | Fast dissolving tablets (FDTs) of Metformin hydrochloride were developed using the direct compression technique. The formulations incorporated superdisintegrants such as croscarmellose sodium (4%) and sodium starch glycolate (8%). The hardness of formulations F1–F6 ranged from 4.5±0.08 to 3.7±0.10 kg/cm², while disintegration time varied between 61.5±0.54 and 24.5±1.04 seconds. All batches complied with pharmacopeial limits for friability and weight variation. An increase in superdisintegrant concentration resulted in reduced hardness and faster disintegration. Among all formulations, F6 demonstrated superior performance with the shortest disintegration time (24.5±1.04 seconds), attributed to the effect and mechanism of the superdisintegrants used. In vitro drug release studies showed a release range of 97.40±2.46% to 99.54±1.12%. Evaluation results indicated that formulations containing natural superdisintegrants exhibited improved hardness, disintegration time, wetting time, and drug release compared to those with synthetic agents. Formulation F6 showed optimal characteristics, including hardness of 3.7±0.10 kg/cm², friability of 0.44±0.01%, wetting time of 17.1±0.76 seconds, dispersion time of 16.3±0.8 seconds, and drug content of 100±1.2%. It achieved maximum drug release (99.54±1.12%) and met all criteria for an effective fast dissolving tablet. Overall, F6 was identified as the best formulation due to its rapid disintegration and wetting, along with adequate mechanical strength. |
| Keywords: | Fast Dissolving Tablets, Super Disintegrates, Disintegration Time, Hardness, Wetting Time, Friability, Weight Variation, Drug Release |
| Cite Article: | "Immplementation in Pharmaceutical Development: A Comprehensive Framework for Robust Solid Dosage Formulation of Metformin Hydrochloride", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2456-3315, Vol.11, Issue 5, page no.a138-a160, May-2026, Available :http://www.ijrti.org/papers/IJRTI2605020.pdf |
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2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID: IJRTI2605020
Registration ID:212360
Published In: Volume 11 Issue 5, May-2026
DOI (Digital Object Identifier):
Page No: a138-a160 Country: Buldhana, Maharashtra, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2605020 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2605020 |
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
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