Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets
Generic medications are bioequivalent to brand-name medications, but the quality and purity of generic medications are still debatable. The aim of this study was to compare the generic product of metformin (MET) to its branded counterpart using pure MET powder as a reference. Quality control tablet...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-04-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/16/4/539 |
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| author | Mosab Arafat Molham Sakkal Priya Yuvaraju Anna Esmaeil Vijo Poulose Salahdein Aburuz |
| author_facet | Mosab Arafat Molham Sakkal Priya Yuvaraju Anna Esmaeil Vijo Poulose Salahdein Aburuz |
| author_sort | Mosab Arafat |
| collection | DOAJ |
| description | Generic medications are bioequivalent to brand-name medications, but the quality and purity of generic medications are still debatable. The aim of this study was to compare the generic product of metformin (MET) to its branded counterpart using pure MET powder as a reference. Quality control tablet assessment and in vitro evaluation of drug release were carried out in various pH media. Additionally, several analytical methods and thermal techniques were used, namely differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray diffraction (XRD), scanning electron microscopy (SEM), Fourier-transform infrared (FTIR), and confocal Raman microscopy. The results showed a significant difference between the two products. In terms of friability assessment, mean resistance force, and tablet disintegration, the generic MET product showed significant weight loss, higher mean resistance force, longer disintegration time, and a slower rate of drug release. In addition, DSC and TGA showed that the generic product had the lowest melting point and the least weight loss compared to the branded product and pure powder. XRD and SEM demonstrated some changes in the crystallinity structure of the molecule particles for the generic product. Additionally, FTIR and confocal Raman revealed the same peaks and band shifts in all samples, but with differences in the intensity for the generic tablet only. The observed differences could be due to the use of different excipients in the generic product. The possibility of forming a eutectic mixture between the polymeric excipient and metformin in the generic tablet was presumed, which might be attributed to alterations in the physicochemical properties of the drug molecule in the generic product. In conclusion, using different excipients might have a significant effect on the physicochemical properties of drugs in generic formulations, leading to significant changes in drug release behavior. |
| first_indexed | 2024-03-11T04:39:32Z |
| format | Article |
| id | doaj.art-9e80d424e78a41b38bc8cec2f6998eaa |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-11T04:39:32Z |
| publishDate | 2023-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-9e80d424e78a41b38bc8cec2f6998eaa2023-11-17T20:50:22ZengMDPI AGPharmaceuticals1424-82472023-04-0116453910.3390/ph16040539Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl TabletsMosab Arafat0Molham Sakkal1Priya Yuvaraju2Anna Esmaeil3Vijo Poulose4Salahdein Aburuz5College of Pharmacy, Al Ain University, Al Ain P.O. Box 64141, United Arab EmiratesCollege of Pharmacy, Al Ain University, Al Ain P.O. Box 64141, United Arab EmiratesDepartment of Pharmacology and Therapeutics, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain P.O. Box 17666, United Arab EmiratesPharmalink and Medicina Group of Pharmacies, Abu Dhabi P.O. Box 41412, United Arab EmiratesDepartment of Chemistry, United Arab Emirates University, Al Ain P.O. Box 17666, United Arab EmiratesDepartment of Pharmacology and Therapeutics, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain P.O. Box 17666, United Arab EmiratesGeneric medications are bioequivalent to brand-name medications, but the quality and purity of generic medications are still debatable. The aim of this study was to compare the generic product of metformin (MET) to its branded counterpart using pure MET powder as a reference. Quality control tablet assessment and in vitro evaluation of drug release were carried out in various pH media. Additionally, several analytical methods and thermal techniques were used, namely differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray diffraction (XRD), scanning electron microscopy (SEM), Fourier-transform infrared (FTIR), and confocal Raman microscopy. The results showed a significant difference between the two products. In terms of friability assessment, mean resistance force, and tablet disintegration, the generic MET product showed significant weight loss, higher mean resistance force, longer disintegration time, and a slower rate of drug release. In addition, DSC and TGA showed that the generic product had the lowest melting point and the least weight loss compared to the branded product and pure powder. XRD and SEM demonstrated some changes in the crystallinity structure of the molecule particles for the generic product. Additionally, FTIR and confocal Raman revealed the same peaks and band shifts in all samples, but with differences in the intensity for the generic tablet only. The observed differences could be due to the use of different excipients in the generic product. The possibility of forming a eutectic mixture between the polymeric excipient and metformin in the generic tablet was presumed, which might be attributed to alterations in the physicochemical properties of the drug molecule in the generic product. In conclusion, using different excipients might have a significant effect on the physicochemical properties of drugs in generic formulations, leading to significant changes in drug release behavior.https://www.mdpi.com/1424-8247/16/4/539metforminin vitro evaluationthermal analysisgeneric drugbrand-name drugquality control test |
| spellingShingle | Mosab Arafat Molham Sakkal Priya Yuvaraju Anna Esmaeil Vijo Poulose Salahdein Aburuz Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets Pharmaceuticals metformin in vitro evaluation thermal analysis generic drug brand-name drug quality control test |
| title | Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets |
| title_full | Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets |
| title_fullStr | Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets |
| title_full_unstemmed | Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets |
| title_short | Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets |
| title_sort | effect of excipients on the quality of drug formulation and immediate release of generic metformin hcl tablets |
| topic | metformin in vitro evaluation thermal analysis generic drug brand-name drug quality control test |
| url | https://www.mdpi.com/1424-8247/16/4/539 |
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