Formulation And Evaluation Of Metformin Hydrochloride Sustained Release Capsule
DOI:
https://doi.org/10.52783/jns.v14.3200Keywords:
Metformin hydrochloride (MH); polyvinylpyrrolidone (PVP K30); Fourier Transform Infrared Spectroscopy (FTIR); Sustained releaseAbstract
Metformin Hydrochloride (MH) is a synthesis of N, N -dimethyl guanidine, a type of medicament which is used to treat type II diabetes. Emil Worner and James Belt in the year 1922 were the first to synthesized dimethyl guanidine. MH has various other advantages such as; weight loss, improper fertility, slowing down the tumour growth and few more. The current work is focused on, to sustain the release of the drug in the body for a larger period of time. To perform this study various factor were taken into consideration such as drug, Excipients (HPMC, PVP K30, Magnesium stearate, MCC, NaCMC and Starch) compatibility study, Preformulation studies of raw material and granules. The granules were prepared using wet granulation method, and all the quality control parameter study for formulated 10 capsules were performed. Out of these 10 formulations, formulation 7 (F7) was subjected to have sustain release. Further, F7 was subjected to comparative study with other marketed available tablet and was found out that our formulation has sustained release up to the 13th hr and were as marketed tablet up to 11th hr. Finally accelerated stability study was performed till 3 months and was found that there were no significant changes.
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Hernández-Velázquez ED, Alba-Betancourt C, Alonso-Castro ÁJ, Ortizalvarado R, López JA, Meza- Carmen V, Solorio-Alvarado CR. Metformin, A Biological And Synthetic Overview. Bioorganic & Medicinal Chemistry Letters. 2023 Mar 16:129241
FU Y. Historical Story On Natural Medicinal Chemistry: 60 Years History Of Metformin, A Classical Antidiabetic Drug Originated From Galega Officinalis. Chinese Traditional And Herbal Drugs. 2017:4591-600.
Owen MR, Doran E, Halestrap AP. Evidence That Metformin Exerts Its Antidiabetic Effects Through Inhibition Of Complex 1 Of The Mitochondrial Respiratory Chain. Biochem J 2000; 348:607-614
Yüksel N, Tinçer T, Baykara T. Interaction Between Nicardipine Hydrochloride And Polymeric Microspheres For A Controlled Release System. International Journal Of Pharmaceutics. 1996 Aug 30;140(2):145-54.
Siavash M, Tabbakhian M, Sabzghabaee AM, Razavi N. Severity Of Gastrointestinal Side Effects Of Metformin Tablet Compared To Metformin Capsule In Type 2 Diabetes Mellitus Patients. Journal Of Research In Pharmacy Practice. 2017 Apr 1;6(2):73-6.
Hu LD, Liu Y, Tang X, Zhang Q. Preparation And In Vitro/In Vivo Evaluation Of Sustained-Release Metformin Hydrochloride Pellets. European Journal Of Pharmaceutics And Biopharmaceutics. 2006 Oct 1;64(2):185-92.
Panda BP, Krishnamoorthy R, Shivashekaregowda NK, Patnaik S. Influence Of Poloxamer 188 On Design And Develop-Ment Of Second Generation PLGA Nanocrystals Of Metformin Hydrochloride. Nano Biomedicine And Engineering. 2018 Dec31;10(4):334-4
ICH Harmonised Tripartite Guideline, Impurities In New Drug Substances, Q3A(R2) (2016);
Tomar A, Wadhwani S, Bhadauria RS. A PREFORMULATION STUDY OF PURE METFORMIN Hcl
Yu C, Sun X, Wang Y, Du S, Shu L, Sun Q, Xue F. Determination And Correlation Of Solubility Of Metformin Hydrochloride In Aqueous Binary Solvents From 283.15 To 323.15 K. ACS Omega. 2022 Mar 1;7(10):8591-600.
Jordan, S., Katz, J.S., Yezer, B. (2021). Excipients: Characterization, Purpose, And Selection. In: Li, J., Krause, M.E., Tu, R. (Eds) Protein Instability At Interfaces During Drug Product Development. AAPS Advances In The Pharmaceutical Sciences Series, Vol 43. Springer, Cham. Https://Doi.Org/10.1007/978-3-030-57177-1-10
Wei Q, Deng NN, Guo J, Deng J. Synthetic Polymers For Biomedical Applications. Int J Biomater. 2018 Apr 24;2018:7158621.Doi: 10.1155/2018/7158621. PMID: 29849645; PMCID: PMC5941756.
Sahoo, Chinmaya & Rao, S.R.M. & Sudhakar, M.. (2015). HPMC A Biomedical Polymer In Pharmaceutical Dosage Forms. Journal Of Chemical And Pharmaceutical Sciences. 8. 875-881.
Moosavi SM, Ghassabian S. Linearity Of Calibration Curves For Analytical Methods: A Review Of Criteria For Assessment Of Method Reliability, Calibration And Validation Of Analytical Methods - A Sampling Of Current Approaches. Intech; 2018. Dx.Doi.Org/10.5772/Intechopen.72932
Choudhary, A., Preparation Of Buffer Solutions (Phosphate, Acetate And Other Buffers. 2023, June 18 12248-011-(12)58774-J.
DAIICHI JITSUGYO VISWILL CO., LTD. Tablet / Capsule Visual Inspection System Healthcare Products. DAIICHI JITSUGYO VISWILL CO., LTD.; 2021.
Aliyu RS, Lawal AM, Chasta P, Sharma GK. CAPSULES: TYPES, MANUFACTURING, FORMULATION, QUALITY CONTROL TESTS AND, PACKAGING AND STORAGE – A COMPREHENSIVE REVIEW. World Journal Of Pharmaceutical And Life Sciences; 2020
Ghadermazi R, Hamdipour S, Sadeghi K, Ghadermazi R, Khosrowshahi Asl A. Effect Of Various Additives On The Properties Of The Films And Coatings Derived From Hydroxypropyl Methylcellulose—A Review. Food Science & Nutrition. 2019 Nov;7(11):3363-77.
Dange, Yuvraj Dilip, Et Al. "Development And Validation Of UV- Spectrophotometric Method For Estimation Of Metformin In Bulk And Tablet Dosage Form." Indian Journal Of Pharmaceutical Education And Research 51.4S (2017): S754- S760.)
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