Author(s): Shital Trivedi, Shreeraj Shah

Email(s): shreeraj.shah@ljinstitutes.edu.in

DOI: 10.52711/0974-360X.2024.00294   

Address: Shital Trivedi, Shreeraj Shah*
Department of Pharmaceutical Technology, L. J. Institute of Pharmacy,
L.J. University, Ahmedabad 382210, Gujarat, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 4,     Year - 2024


ABSTRACT:
Dried Ferrous Sulphate is commonly used as iron salt for the treatment of iron deficiency by oral route, but conventional products face the problems of poor bioavailability due to its carrier-mediated absorption in an upper gastrointestinal region with a lower residence time at the absorption site and gastrointestinal side effects due to immediate release of the entire dose of an irritant drug which requires higher dosage frequency and prolonged duration of treatment to replenish deficient iron. Gastroretentive floating pellets of Dried Ferrous Sulphate would overcome these problems and to develop them using extrusion-spheronization, various grades of HPMC, ETHOCELTM 100cp along with Gelucire® 43/01 were tried in preliminary batches. Further optimization was done using Central Composite Design by selecting the different ratios of Gelucire® 43/01 and ETHOCELTM 100cp to a drug as formulation variables and spheronization time and speed as process variables, each at 3 levels. PVP K-30 as a binder and Isopropyl alcohol as a solvent were used. Pellets were characterized for average pellet size by sieving, roundness by microscopy, drug content, % drug release in vitro, and floating behaviour. Std run 3 with Gelucire® 43/01 (1.8:1) and ETHOCELTM 100cp (1.6:1), spheronized at 2000 RPM for 5 minutes was considered an optimized formulation which yielded an average pellet size of 868 µm ± 30, pellet roundness of 0.93± 0.02, immediate floating and sustained release for 12 hours in 0.1 N HCl dissolution medium and formulation with these characteristics could result into increased utilization of iron from the administered dose with reduced side effects.


Cite this article:
Shital Trivedi, Shreeraj Shah. Formulation Development of Non-effervescent Floating Pellets of Dried Ferrous Sulphate by Extrusion- Spheronization Technique. Research Journal of Pharmacy and Technology.2024; 17(4):1851-7. doi: 10.52711/0974-360X.2024.00294

Cite(Electronic):
Shital Trivedi, Shreeraj Shah. Formulation Development of Non-effervescent Floating Pellets of Dried Ferrous Sulphate by Extrusion- Spheronization Technique. Research Journal of Pharmacy and Technology.2024; 17(4):1851-7. doi: 10.52711/0974-360X.2024.00294   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-4-68


REFERENCES:
1.    Muñoz M, et al. Disorders of iron metabolism. Part 1: Molecular basis of iron homoeostasis. Journal of Clinical Pathology. 2011 Dec 20; 64(4): 281–86. doi:10.1136/jcp.2010.079046
2.    World Health Organization. Nutritional Anaemias : Tools for Effective Prevention. World Health Organization. 2017. Available on https://apps.who.int/iris/bitstream/handle/10665/259425/9789241513067-eng.pdf?sequence=1
3.    Wang J, et al. Novel Iron-Whey Protein Microspheres Protect Gut Epithelial Cells from Iron-Related Oxidative Stress and Damage and Improve Iron Absorption in Fasting Adults. Acta Haematologica. 2018 Feb 1; 138(4): 223–32. doi: 10.1159/000480632
4.    Serati M, Torella M. Preventing complications by persistence with iron replacement therapy: a comprehensive literature review. Current Medical Research and Opinion. 2019; 35(6): 1065–72. 10.1080/03007995.2018.1552850.
5.    Moriarty-craige SE, et al. Multivitamin-mineral supplementation is not as efficacious as iron supplementation in improving hemoglobin concentrations in nonpregnant anemic women living in Mexico. American Society for Clinical Nutrition. 2004; 80(3): 1308–11.
6.    Muñoz M, et al. The safety of available treatment options for iron-deficiency anemia. Expert Opinion on Drug Safety. 2018; 17(2): 149–59. doi:10.1080/14740338.2018.1400009. Available from: http://dx.doi.org/10.1080/14740338.2018.1400009
7.    Santiago P. Ferrous versus ferric oral iron formulations for the treatment of iron deficiency: A clinical overview. The Scientific World Journal. 2012. doi:10.1100/2012/846824
8.    Haridwar Lodh, et al. Floating Drug Delivery System: A Brief Review. Asian Journal of Pharmacy and Technology. 2020; 10(4): 255-64. doi: 10.5958/2231-5713.2020.00043.4
9.    Sharma A, et al. Development and Characterization of Gastroretentive High-Density Pellets Lodged With Zero Valent Iron Nanoparticles. Journal of Pharmaceutical Sciences. 2018; 107(10): 1-11. doi:10.1016/j.xphs.2018.06.014
10.    Gunjan L. Zope, et al. Glimpse of Floating Drug Delivery in Pharmaceutical Formulations: A Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2016; 8(2): 147-53. doi: 10.5958/0975-4377.2016.00019.7
11.    Shaik. Mohammad Farooq, et al. Floating Drug Delivery Systems: An updated Review. Asian Journal of Pharmaceutical Research. 2020; 10(1): 39-47. doi: 10.5958/2231-5691.2020.00009.X
12.    Sarika S. Lokhande. Recent Trends in Development of Gastro-Retentive Floating Drug Delivery System: A Review. Asian Journal of Research in Pharmaceutical Sciences. 2019; 9(2): 91-6. doi: 10.5958/2231-5659.2019.00014.6
13.    A.V.S. Hima Bindu, et al. Padmalatha. Floating Drug Delivery System: An Overview. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(4): 295-300. doi: 10.52711/2231-5659.2021.00046
14.    Michie H, et al. The influence of plate design on the properties of pellets produced by extrusion and spheronization. International Journal of Pharmaceutics. 2012; 434(1–2): 175–82. doi: 10.1016/j.ijpharm.2012.05.050
15.    Singh BN, Kim KH. Floating drug delivery systems : an approach to oral controlled drug delivery via gastric retention. Journal of Controlled Release. 2000; 63: 235–59. PII: S0168-3659(99)00204-7
16.    Mali Hanmant S., et al. A Review on Floating and Mucoadhesive Drug Delivery System. Asian Journal of Pharmacy and Technology. 2021; 11(3): 225-30. doi: 10.52711/2231-5713.2021.00037
17.    Vinod Matole, et al. A Brief Review on Gastro-Retentive Drug Delivery Systems. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(1): 62-65. doi : 10.5958/0975-4377.2021.00011.2
18.    Patel DM, et al. Floating Granules of Ranitidine Hydrochloride-Gelucire 43/01: Formulation Optimization Using Factorial Design. AAPS PharmSciTech. 2007; 8(2): E1-7.
19.    Mavani Prakash, et al. Design, Development and Optimization Aceclofenac Effervescence tablets by Central Composite Design. Research Journal of Pharmaceutical Dosage Forms and Technology. 2015; 7(1): 15–20.
20.    Lee D. Experimental investigation of laser ablation characteristics on nickel-coated beryllium copper. Metals (Basel). 2018; 8(4): 8–20. doi:10.3390/met8040211
21.    University of Kentucky. Molecular Absorption Spectroscopy: Determination of iron with 1,10-Phenanthroline. Analytical Chemistry Laboratory. 2005; 5: 30–4. Available from: http://www.chem.uky.edu/Courses/che226/Labs/05-Fe_Absorption-2005Fa
22.    Smita S. Aher, et al. Formulation and Evaluation of Controlled Release Matrix Tablet of Albuterol Sulphate. Asian Journal of Research in Pharmaceutical Sciences. 2016;6(4):223-9. doi: 10.5958/2231-5659.2016.00031.X
23.    B. Ranga Nayakulu, et al. Formulation and evaluation of floating matrix tablet of Losartan for gastro-retentive drug delivery. Asian Journal of Pharmacy and Technology. 2016; 6(2): 85-90. doi: 10.5958/2231-5713.2016.00012.X
24.    ICH Q1A(R2). International Conference on Harmonization (ICH). Guidance for industry: Q1A(R2) Stability Testing of New Drug Substances and Products. ICH Harmonised Tripartite Guideline. 2003; 4(February):24.

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