Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market
Yıl: 2022 Cilt: 10 Sayı: 6 Sayfa Aralığı: 703 - 708 Metin Dili: İngilizce DOI: 10.14235/bas.galenos.2022.08370 İndeks Tarihi: 05-05-2023
Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market
Öz: Objective: In the study, it was aimed to compare the physicochemical and in vitro dissolution parameters of metformin hydrochloride (MET) tablet brands from Northern Cyprus to evaluate the pharmaceutical equivalence. Methods: Seven brands of MET tablets which were bought from community pharmacies were compared and evaluated with the innovative product Glucophage®. The impurity of MET contained in the sample tablets was determined using Fourier transform infrared spectroscopy. Pharmacopoeia tests were used to evaluate the physicochemical equivalence of the tablets. In vitro dissolution test was performed and dissolution data were analyzed including dissolution difference (f1) and similarity factors (f2) were evaluated. In addition, the release kinetics of selected MET tablets were examined with a release kinetics software (KinetDS3). Results: All the tablet brands complied with the official specifications for uniformity of weight hardness and disintegration. Brand MF failed the friability test (>1%); while brands MC, MF and MG failed the content uniformity (assay) test (<95%). Difference (f1) and similarity factors (f2) of all brands were calculated in pH 6.8 buffer medium and evaluated with reference to the innovative brand. The facts that MB’s f1 value (15.45) was greater than 15 and that the f2 values of MB and MF (48.57, 47.13, respectively) were less than 50 indicated that the dissolution profiles of MB and MF formulations were different from the dissolution profile of the innovative brand. Conclusion: Five of the eight tablet brands passed all the official tests and could be regarded as pharmaceutically equivalent but f2 analysis showed only five brands were similar to the reference brand. The study has shown that all the MET tablet brands sampled in Northern Cyprus are not pharmaceutically equivalent.
Anahtar Kelime: Kuzey Kıbrıs İlaç Pazarında Mevcut Sekiz Farklı Markaya Ait Metformin Tabletlerin Fizikokimyasal Özelliklerinin ve Salım Profillerinin Karşılaştırılması
Öz: Amaç: Çalışmada, Kuzey Kıbrıs’ta bulunan metformin hidroklorür (MET) içeren farklı markalardaki tabletlerin, fizikokimyasal ve in vitro çözünme parametrelerinin karşılaştırılması ve farmasötik eşdeğerliğinin değerlendirilmesi amaçlanmıştır. Yöntemler: Eczaneden satın alınan farklı firmalara ait yedi MET, yenilikçi ürün Glucophage® ile karşılaştırılmış ve değerlendirilmiştir. Örnek tabletlerde bulunan MET'nin safsızlığı, Fourier transform kızılötesi spektroskopisi kullanılarak belirlenmiştir. Tabletlerin fizikokimyasal eşdeğerliğini değerlendirmek için farmakope testleri kullanılmıştır. In vitro çözünme testi yapılmış ve çözünme farkı (f1) ve benzerlik faktörü (f2) dahil olmak üzere analiz edilen çözünme verileri değerlendirilmiştir. Ek olarak, seçilen MET tabletlerinin salım kinetikleri, KinetDS3 yazılımı ile incelenmiştir. Bulgular: Tüm tablet markalarının ağırlık sapması, sertlik ve dağılma özelliklerinin resmi spesifikasyonlara uyduğu saptanmıştır. MF markası friabilite testinde (>%1) başarısızken; MC, MF ve MG markalarının içerik tekdüzeliği (etkin madde miktar tayini) testinde (<%95) başarısız olduğu tespit edilmiştir. pH 6,8 tampon ortamında tüm markaların fark (f1) ve benzerlik faktörü (f2) hesaplanmış ve yenilikçi marka referans alınarak değerlendirilmiştir. Buna göre MB’nin f1 değeri (15,45) 15’ten büyük; MB ve MF’nin f2 değerlerinin (sırasıyla 48,57, 47,13) 50’den küçük olması MB ve MF formülasyonlarının çözünme profillerinin yenilikçi markanın çözünme profilinden farklı olduğunu belirlemiştir. Sonuç: Sekiz tablet markasından beşinin tüm farmakope testlerini geçtiği ve farmasötik açıdan eşdeğer olarak kabul edilebilir olduğu saptanmıştır. Ancak f2 analizi, yalnızca beş markanın referansa benzer olduğunu göstermiştir. Çalışma, KKTC’de örneklenen tüm MET tablet markalarının farmasötik açıdan eşdeğer olmadığını ortaya koymuştur.
Anahtar Kelime: Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
- 1. Rohani B. Oral manifestations in patients with diabetes mellitus. World J Diabetes 2019;10:485-9.
- 2. Votsi C, Toufexis C, Michailidou K, Antoniades A, Skordis N, Karaolis M, et al. Type 2 Diabetes Susceptibility in the Greek-Cypriot Population: Replication of Associations with TCF7L2, FTO, HHEX, SLC30A8 and IGF2BP2 Polymorphisms. Genes (Basel) 2017;8:16.
- 3. Garba, MA, Dauda NJ, Mohammed M, Bello SS. Comparative quality control studies on three brands of metformin hydrochloride tablets marketed in Kaduna, Nigeria. Journal of Pharmaceutical and Allied Sciences 2019;16:3086-93.
- 4. Migdadi EM, Courtenay AJ, Tekko IA, McCrudden MTC, Kearney MC, McAlister E, et al. RF Hydrogel-forming microneedles enhance transdermal delivery of metformin hydrochloride. J Control Release 2018;285:142-51.
- 5. Simionato LD, Petrone L, Baldut M, Bonafede SL, Segall AI. Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina. Saudi Pharm J 2018;26:578-84.
- 6. Adegbolagun OA, Olalade OA, Osumah SE. Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially available brands of ciprofloxacin hydrochloride tablets. Tropical Journal of Pharmaceutical Research 2007;6:737-45.
- 7. Uddin M. Blockchain Medledger: Hyperledger fabric enabled drug traceability system for counterfeit drugs in pharmaceutical industry. International Journal of Pharmaceutics 2021;597:120235.
- 8. Blackstone EA, Fuhr JP Jr, Pociask S. The health and economic effects of counterfeit drugs. Am Health Drug Benefits 2014;7:216-24.
- 9. Çomoğlu T, Gönül, N. Quality control studies on conventional Carbamazepine tablets available on the Turkish drug market. Turkish Journal of Med Sci 2005;35:217-21.
- 10. Sougi A, Ofori-Kwakye K, Kuntworbe N, Kipo SL, El Boakye- Gyasi M. Evaluation of the physicochemical and in vitro dissolution properties of metformin hydrochloride tablet brands marketed in five cities in Ghana. Br J Pharm Res 2016; 9:1-14.
- 11. Munde MK, Kulkarni NS, Khiste RH, Sen DB. Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy. Research Journal of Pharmacy and Technology 2020;13:1236-42.
- 12. Sahle SB, Ayane AT, Wabe NT. Comparative quality evaluation of paracetamol tablet marketed in Somali region of Ethiopia. International Journal of Pharmaceutical Sciences and Research 2012;3:545.
- 13. Gündoğan M, Çomoğlu T, Gönül N. Comparison of the quality and in vitro dissolution profiles of commercial losartan potassium film tablets. Turk J Pharm Sci 2008;5:75-88.
- 14. XXXII, U. (2009). USP 32: United States Pharmacopeia. In Rocville: United States Pharmacopeial Convention (pp. 2905-2906).
- 15. British Pharmacopoeia. Her Majesty‘s Stationery Office, London. 2013;2.
- 16. Chavan H, Chhabra G, Gujarathi N, Jadhav A. Comparative study of In-process and finished products quality control test for tablet and capsules according to pharmacopoeias. Asian Journal of Pharmaceutical Research and Development 2018;6:60-8.
- 17. Liu Y, Wang A, Wen L, Yang Z, Yang X, Zhang X, Yan D. A Chinese medicine formula (Jinqi Jiangtang Tablet): a review on its chemical constituents, quality control, pharmacokinetics studies, pharmacological properties and clinical applications. Journal of Ethnopharmacology 2019;236:1-8.
- 18. JI O, Onyemelukwe J I. Comparative assessment of ginger and cassava starch as a binder on ibuprofen tablet formulation. Int J Life Sci Scienti Res 2018;2455:1716.
- 19. Zhang Y, Yang F, Zhang J, Sun G, Wang C, Guo Y, et al. Quantitative fingerprint and quality control analysis of Compound Liquorice Tablet combined with antioxidant activities and chemometrics methods. Phytomedicine 2019;59:152790.
- 20. Davit BM, Stier E, Jiang X, Anand, O. Expectations of the US-FDA regarding dissolution data in generic drug regulatory submissions. Biopharma Asia 2013;2:14-21.
| APA | Özyılmaz E, Comoglu T (2022). Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. , 703 - 708. 10.14235/bas.galenos.2022.08370 |
| Chicago | Özyılmaz Emine Dilek,Comoglu Tansel Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. (2022): 703 - 708. 10.14235/bas.galenos.2022.08370 |
| MLA | Özyılmaz Emine Dilek,Comoglu Tansel Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. , 2022, ss.703 - 708. 10.14235/bas.galenos.2022.08370 |
| AMA | Özyılmaz E,Comoglu T Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. . 2022; 703 - 708. 10.14235/bas.galenos.2022.08370 |
| Vancouver | Özyılmaz E,Comoglu T Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. . 2022; 703 - 708. 10.14235/bas.galenos.2022.08370 |
| IEEE | Özyılmaz E,Comoglu T "Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market." , ss.703 - 708, 2022. 10.14235/bas.galenos.2022.08370 |
| ISNAD | Özyılmaz, Emine Dilek - Comoglu, Tansel. "Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market". (2022), 703-708. https://doi.org/10.14235/bas.galenos.2022.08370 |
| APA | Özyılmaz E, Comoglu T (2022). Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. Bezmiâlem Science, 10(6), 703 - 708. 10.14235/bas.galenos.2022.08370 |
| Chicago | Özyılmaz Emine Dilek,Comoglu Tansel Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. Bezmiâlem Science 10, no.6 (2022): 703 - 708. 10.14235/bas.galenos.2022.08370 |
| MLA | Özyılmaz Emine Dilek,Comoglu Tansel Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. Bezmiâlem Science, vol.10, no.6, 2022, ss.703 - 708. 10.14235/bas.galenos.2022.08370 |
| AMA | Özyılmaz E,Comoglu T Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. Bezmiâlem Science. 2022; 10(6): 703 - 708. 10.14235/bas.galenos.2022.08370 |
| Vancouver | Özyılmaz E,Comoglu T Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market. Bezmiâlem Science. 2022; 10(6): 703 - 708. 10.14235/bas.galenos.2022.08370 |
| IEEE | Özyılmaz E,Comoglu T "Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market." Bezmiâlem Science, 10, ss.703 - 708, 2022. 10.14235/bas.galenos.2022.08370 |
| ISNAD | Özyılmaz, Emine Dilek - Comoglu, Tansel. "Comparison of the Physicochemical Properties and Release Profiles of Metformin Tablets of Eight Different Brands Available in the Northern Cyprus Pharmaceutical Market". Bezmiâlem Science 10/6 (2022), 703-708. https://doi.org/10.14235/bas.galenos.2022.08370 |
