A review on: Formulation Development and Evaluation of Metronidazole Tablet Drug Delivery System

*Corresponding author: Sakshi Prabhakar Modhave Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution License 4.0. A review on: Formulation Development and Evaluation of Metronidazole Tablet Drug Delivery System Sakshi Prabhakar Modhave 1, *, Reema Chandrakant Londhe 2, Prachi Nandkumar Padwal 2, Jayashree Ravindra Matade 1, Akanksha Dattatray Khore 1 and Rutuja Satish Modhave 1 1 Students Samarth Institute of Pharmacy, Belhe, Pune, Maharashtra, India. 2 Department of Quality Assurance, Samarth Institute of Pharmacy, Belhe, Pune, Maharashtra, India. World Journal of Biology Pharmacy and Health Sciences, 2025, 24(02), 001-004 Publication history: Received on 23 September 2025; revised on 28 October 2025; accepted on 31 October 2025 Article DOI: https://doi.org/10.30574/wjbphs.2025.24.2.0966 Abstract Metronidazole is a synthetic nitroimidazole antimicrobial agent Widely used for the treatment of various anaerobic bacterial and protozoal infections.Available in oral tablet form, Metronidazole exhibits high efficacy against Bacteroides fragilis, Clostridium difficile, Trichomonas vaginalis, Giardia lamblia, and Entamoeba histolytica. The drug functions primarily by disrupting DNA synthesis in susceptible organisms, leading to cell death. Metronidazole tablets are rapidly absorbed after oral administration, achieving peak plasma concentrations within 1– 2 hours. The standard dosage and duration of therapy vary depending on the type and severity of infection. Common side effects include nausea, metallic taste, and gastrointestinal discomfort, with rare but serious adverse effects such as neurotoxicity reported with prolonged use. Due to its effectiveness, favorable pharmacokinetics, and broad antimicrobial spectrum, Metronidazole remains a cornerstone in the management of anaerobic and protozoal infections. Keywords: Metronidazole; Carbopol Xanthine gum; Organisms 1. Introduction Metronidazole is a widely used antimicrobial drug belonging to the nitroimidazole class. It is effective against a variety of anaerobic bacteria and protozoa. Metronidazole tablets are commonly prescribed for the treatment of infections caused by organisms such as Entamoeba histolytica, Giardia lamblia. The drug works Primarily by disrupting the DNA synthesis of microorganisms, leading to cell death. Metronidazole tablets are used in the treatment of conditions such as: Amoebiasis, Giardiasis, Trichomoniasis, Bacterial vaginosis. The tablets are usually available in strengths like 200 mg, 250 mg, or 400mg, Depending on therapeutic requirements. They are administered orally and are Rapidly absorbed from the gastrointestinal tract, showing good tissue penetration. Metronidazole is included in the W olds Health Organization (W HO) Model List of Essential Medicines due to its broad spectrum of action, safety, and effectiveness. 2. Material and Method 2.1. Materials Metronidazole of pharmaceutical grade was obtained from a certified supplier.Distilled water or buffer solutions were prepared freshly as required. Culture media, including Mueller– Hinton agar (or any specific media required for the microorganism tested), were procured from a recognized manufacturer. Standard bacterial strains such as Escherichia World Journal of Biology Pharmacy and Health Sciences, 2025, 24(02), 001-004 2 coli, Staphylococcus aureus, Bacteroides fragilis or other anaerobic organisms were sourced from a microbial culture collection. Sterile Petri dishes, inoculating loops, micropipettes, and antibiotic assay disks were used throughout the experiment. 2.2. Preparation of metronidazole tablets Three batches of the metronidazole tablets were formulated using three Binders,namely acacia, sodium CMC, and A. vera gum. W et granulation Method was used in the formulation of the tablets. Metronidazole Powder was triturated together with other ingredients (microcrystalline Cellulose and lactose) in geometric order using mortar and pestle. W weighed quantity of each binder was mixed with 8 ml of water to form Mucilage and then, used to form a damp mass with the powder mix. The Damp mass was passed through 1.7 mm sieve and dried in a hot oven. The resultant dried granules were passed through 1.0 mm sieve and Then through 0.25mm sieve to separate the fine from coarse granules. Magnesium stearate was mixed with the fines and coarse granules then Added and all mixed together. The granules mixture was compressed Into tablets using a single punch machine. Table 1 Formula table Sr.no Ingredients F1 F2 F3 F4 F5 1 Metronidazole 200 200 200 200 200 2 Microcrystalline cellulose 90 65 40 90 65 3 Hydroxypropyl methylcellulose 100 125 150 - - 4 Carbopol - - - 100 125 5 Xanthum gum - - - - - 6 Sodium bicarbonate 20 20 20 20 20 7 Starch 80 80 80 - 8 Talc 5 5 5 5 5 9 Magnesium stearate 5 5 5 5 5 10 Total net(mg) 500 500 500 500 500 Table 2 Equipment used Sr.no Equipment 1 Fourier transform infrared spectophotometer (IR.thermoscientific Nicoletis 10) 2 UV/VIS Spectrophotometer (uv jasco 2016)No:Qc.cp-057 3 PH meter H12216 pH/ORP/ISE Meter 4 Ultra-Sonic 5 Electronic Balance Sartoius No:Oc-Cp.059 6 Hardness Tester Rimek-india.No:cp.010. 7 Disintegration Tester (Disintegration tester-bj-3) 8 HPLC 2020 9 Dissolution tester (RC-80C)No:QC-cp-071 10 Tablet machine Rotary tablets press machine Zp-7 11 Friabilty Tester (Cjy-300D Tablets friabilty Tester) 12 Thickness tester Vernier(stainless hardned) 13 Oven Incubator Accelerate stability study champer World Journal of Biology Pharmacy and Health Sciences, 2025, 24(02), 001-004 3 3. Methodology Dry Granulation Procedure: • Weight all the ingredients. • Take the mortar and pestle and add the MCC, Sustained release polymer and Metronidazole. • Add the Starch powder and Sodium bicarbonate powder. • Mix all the ingredients. • Dry screening. • Mixing with other ingredients: A dry lubricant and glidant is added to the granules either by dusting over the spread-out granules or by blending with the granules. • Tableting: Last step in which the tablets is fed into the die cavity and the compressed. 3.1. Evaluation of Metronidazole Evaluation of precompression flow properties of powder blend Organoleptic properties - Organoleptic properties of API like colour, odour and stability. Were observed an recorded. Solubility was observed in methanol and sodium hydroxide. • Bulk Density - Bulk density was measured using bulk density apparatus. • Tapped Density = Bulk weight/Tapped volume. • Weight variationThe weight variation test would be satisfactory method of determining the drug content uniformity. Twenty tablets randomly were taken from each batch and weighted individually, The average weight of one tablet was calculated. • Diameter test - The diameter test one of tests which used for determination of the tablets size, it is done by taking five tablets from each batch randomly. Diameter may obtain by using suitable micrometer. • Thickness test - The thickness test of five tablets were picked from each batch randomly and thickness was measured individually using “Vernier-caliper”. It is expressed in millimeter and average was calculated. • Hardness test - The hardness test or tablet crushing strength. It is expressed in kg/cm. • Friability test – The friability test is performed to assess the effect of friction and Shocks, which may often cause tablet to chip, cap or break. Roche friabilator was Used for the purpose. • Invitro disintegration timeThe invitro disintegration time was determined Using Disintegration test apparatus. A tablet was placed in each of the six tubes of the Apparatus and one disc was added to each tube. 3.2. Conclusion The tablets of various formulation were subjected to various evolution test such as weight variation, Friability, hardness and drug release by dissolution studies according to the procedure specified in the I.P. The results of the test were tabulated and found to be within the pharmacopoeial limits. This studies Indicated that all the prepared formulation were good. The release of drug form sustained release tablets were preparation by 3 polymers like Carbopol 934, HPMC K100, Xanthan gum acts as sustained release polymers. The carbopol 934 formulation shows Best release compared with remaining polymers. Carbopol 934> Hydroxypropyl Methyl Cellulose K100> Cantgum. By using Carbopol. 4. Result and discussions Table 3 Evaluation parameters of Metronidazole Formulation Hardness Weight variation Friabilty Floating time F1 2.5 ±7 15 10 F2 3.2 ±5 18 10 F3 3.8 ±6 23 10 F4 3 ±8 16 10 F5 4.2 ±6 13 10 F6 3.4 ±5 24 10 World Journal of Biology Pharmacy and Health Sciences, 2025, 24(02), 001-004 4 All evaluation parameters of the formulated metronidazole tablets were found to be within the acceptable pharmacopoeial limits. The tablets exhibited uniformity in weight, hardness, and thickness, indicating good formulation characteristics. The drug content and in-vitro dissolution results confirm the effective release and bioavailability of metronidazole from the formulation. 5. Conclusion We sincerely acknowledge the continuous guidance, motivation, and constructive feedback provided by our mentor, Prachi Nandkumar Padwal, Technique patience have been instrumental in shaping this review paper. We also extend our gratitude to Samarth Institute of Pharmacy Belhe for providing the necessary academic environment and resources that supported this work. References [1] Indian Pharmacopoeia Commission. The Indian pharmacopoeia, 6th Ed. Ghaziabad. 2010; 187-98 [2] Formulation and Evaluation of Controlled-Release (Matrix) Metronidazole Tablets “Formulation of sustained release matrix tablets of metronidazole” (IJPSR). [3] Formulation and Evaluation of Floating Tablet of Metronidazole “Formulation and Evaluation of Floating tablet of Metronidazole for eradication of Helicobacter pylori” (Research Journal of Pharmacy & Technology) . [4] Metronidazole Based Floating Bioadhesive Drug Delivery System” Metronidazole Based Floating Bioadhesive Drug Delivery System(MDPI). [5] Formulation and Evaluation of Tablets using Co-processed Excipient for Metronidazole “Formulation and Evaluation of Metronidazole Tablets using Co-processed Caesalpinia Gum and Annealed Maize Starch. [6] Preparation and Evaluation of Metronidazole Tablets Produced with Different Binders (Wet Granulation) “Preparation and Evaluation of Metronidazole Tablets Produced with Different Binders using Wet Granulation Method” . [7] Sustained release drug delivery system: A review. In J Pharm Res Dev. 2011; 2: 147-60. [8] Sustained release matrix type drug delivery system: Kumar: a review. World Journal of Pharmacy and Pharmaceutical Sciences. 2012; : 934-60. [9] Formulation and evaluation of sustained release Tablets of metronidazole. International Journal of Pharmaceutical Sciences and Research, 5(6), 2294–2301. [10] Formulation and evaluation of sustained-release matrix tablet of metronidazole. International Journal of Pharmaceutical Sciences and Research, Shah, R. K., & Patel, G. 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