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Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin

Yıl 2021, Cilt: 51 Sayı: 1, 26 - 34, 30.04.2021

Sinem Şahin Burcu Mesut M. Ezgi Durgun Esher Özçelik Yıldız Özsoy

Öz

Background and Aims: The study aimed to design a Fixed-dose tablet formulation of Metformine and Repaglinide. Methods: Wet granulation method was used to prepare tablet formulations. Characterization studies and dissolution studies were performed. Results: A stable formulation was developed according to the requirements of the pharmacopoeia criteria. This new formulsation dissolution results showed that Repaglinide and Metformin HCl dissolved more than 85% from film tablets at 15 minutes. Conclusion: Thus, an alternative product to the market product was developed.

Anahtar Kelimeler

Fixed-Dose Tablet Metformin Repaglinide

Kaynakça

  • • Abbink, E. J., van der Wal, P. S., Sweep, C. G. J. (Fred), Smits, P., & Tack, C. J. (2004). Compared to glibenclamide, repaglinide treatment results in a more rapid fall in glucose level and beta-cell secretion after glucose stimulation. Diabetes/Metabolism Research and Reviews, 20(6), 466–471. https://doi.org/10.1002/dmrr.474
  • • American Diabetes Association. (2000). Type 2 Diabetes in children and adolescents. Pediatrics, 105(3), 671–680. https://doi. org/10.1542/peds.105.3.671 • American Diabetes Association. (2015). Classification and diagnosis of diabetes. Diabetes Care, 38(Supplement_1), S8–S16. https:// doi.org/10.2337/dc15-S005
  • • Cicero, A. F. G., Tartagni, E., & Ertek, S. (2012). Mini-Special issue paper management of diabetic patients with hypoglycemic agents metformin and its clinical use: new insights for an old drug in clinical practice. Archives of Medical Science, 5, 907–917. https:// doi.org/10.5114/aoms.2012.31622
  • • Czyzyk, A., Tawecki, J., Sadowski, J., Ponikowska, I., & Szczepanik, Z. (1968). Effect of biguanides on intestinal absorption of glucose. Diabetes, 17(8), 492–498. https://doi.org/10.2337/diab.17.8.492
  • • EMA. (2010). Guideline on the investigation of bioequivalence. Retrieved from https://www.ema.europa.eu/en/documents/ scientific-guideline/guideline-investigation-bioequivalencerev1_ en.pdf • European Pharmacopeia 6. <2.9.5.> Uniformity of mass of singledose preparations. Retrieved from %2020907e.pdf • FDA. 2009. Dissolution methods. Retrieved from https://www. accessdata.fda.gov/scripts/cder/dissolution/dsp_getalldata.cfm
  • • Gautam, C. S., & Saha, L. (2008). Fixed dose drug combinations (FDCs): rational or irrational: a view point. British Journal of Clinical Pharmacology, 65(5), 795–796. https://doi.org/10.1111/j.1365- 2125.2007.03089.x
  • • Godman, B., McCabe, H., & D Leong, T. (2020). Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries. Expert Review of Pharmacoeconomics & Outcomes Research, 20(1), 1–26. https://doi.org/10.1080/14737167.2020.1734456
  • • Hasslacher, C. (2003). Safety and efficacy of repaglinide in type 2 diabetic patients with and without impaired renal function. Diabetes Care, 26(3), 886–891. https://doi.org/10.2337/diacare.26.3.886
  • • Hostalek, U., Gwilt, M., & Hildemann, S. (2015). Therapeutic use of metformin in prediabetes and diabetes prevention. Drugs, 75(10), 1071–1094. https://doi.org/10.1007/s40265-015-0416-8
  • • ICH. (2003). Stability testıng of new drug substances and products Q1A(R2). Retrieved from https://database.ich.org/sites/default/ files/Q1A%28R2%29 Guideline.pdf
  • • Johansen, O. E., & Birkeland, K. I. (2007). Defining the role of repaglinide in the management of type 2 diabetes mellitus. American Journal of Cardiovascular Drugs, 7(5), 319–335. https://doi. org/10.2165/00129784-200707050-00002
  • • Kawamori, R., Kaku, K., Hanafusa, T., Oikawa, T., Kageyama, S., & Hotta, N. (2014). Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus. Journal of Diabetes Investigation, 5(1), 72–79. https://doi.org/10.1111/jdi.12121
  • • Lefèbvre, P. J., & Scheen, A. J. (1992). Management of non-insulindependent diabetes mellitus. Drugs, 44(Supplement 3), 29–38. https://doi.org/10.2165/00003495-199200443-00005
  • • Longo, M., Bellastella, G., Maiorino, M. I., Meier, J. J., Esposito, K., & Giugliano, D. (2019). Diabetes and aging: From treatment goals to pharmacologic therapy. Frontiers in Endocrinology, 10. https://doi. org/10.3389/fendo.2019.00045
  • • Maffi, P., & Secchi, A. (2017). The Burden of Diabetes: Emerging Data. https://doi.org/10.1159/000459641
  • • Malone, J. I. (2016). Diabetic central neuropathy: CNS damage related to hyperglycemia. Diabetes, 65(2), 355–357. https://doi. org/10.2337/dbi15-0034
  • • Marbury, T. (2000). Pharmacokinetics of repaglinide in subjects with renal impairment. Clinical Pharmacology & Therapeutics, 67(1), 7–15. https://doi.org/10.1067/mcp.2000.103973
  • • Massi-Benedetti, M., & Orsini-Federici, M. (2008). Treatment of type 2 diabetes with combined therapy: What are the pros and cons? Diabetes Care, 31(Supplement 2), S131–S135. https://doi. org/10.2337/dc08-s233
  • • Nasri, H., & Rafieian-Kopaei, M. (2014). Metformin: Current knowledge. J Res Med Sci, 19(7), 658–664.
  • • Natali, A., & Ferrannini, E. (2006). Effects of metformin and thiazolidinediones on suppression of hepatic glucose production and stimulation of glucose uptake in type 2 diabetes: a systematic review. Diabetologia, 49(3), 434–441. https://doi.org/10.1007/ s00125-006-0141-7
  • • Pernicova, I., & Korbonits, M. (2014). Metformin—mode of action and clinical implications for diabetes and cancer. Nature Reviews Endocrinology, 10(3), 143–156. https://doi.org/10.1038/ nrendo.2013.256
  • • Rachdaoui, N. (2020). Insulin: The friend and the foe in the development of type 2 diabetes mellitus. International Journal of Molecular Sciences, 21(5), 1770. https://doi.org/10.3390/ijms21051770
  • • Riddle, M. C., & Herman, W. H. (2018). The cost of diabetes care— An elephant in the room. Diabetes Care, 41(5), 929–932. https:// doi.org/10.2337/dci18-0012
  • • Sanchez-Rangel, E., & Inzucchi, S. E. (2017). Metformin: clinical use in type 2 diabetes. Diabetologia, 60(9), 1586–1593. https://doi. org/10.1007/s00125-017-4336-x
  • • Schumacher, S., Abbasi, I., Weise, D., Hatorp, V., Sattler, K., Sieber, J., & Hasslacher, C. (2001). Single- and multiple-dose pharmacokinetics of repaglinide in patients with type 2 diabetes and renal impairment. European Journal of Clinical Pharmacology, 57(2), 147–152. https://doi.org/10.1007/s002280100280
  • • Scott, L. J. (2012). Repaglinide. Drugs, 72(2), 249–272. https://doi. org/10.2165/11207600-000000000-00000

Yıl 2021, Cilt: 51 Sayı: 1, 26 - 34, 30.04.2021

Sinem Şahin Burcu Mesut M. Ezgi Durgun Esher Özçelik Yıldız Özsoy

Öz

Kaynakça

  • • Abbink, E. J., van der Wal, P. S., Sweep, C. G. J. (Fred), Smits, P., & Tack, C. J. (2004). Compared to glibenclamide, repaglinide treatment results in a more rapid fall in glucose level and beta-cell secretion after glucose stimulation. Diabetes/Metabolism Research and Reviews, 20(6), 466–471. https://doi.org/10.1002/dmrr.474
  • • American Diabetes Association. (2000). Type 2 Diabetes in children and adolescents. Pediatrics, 105(3), 671–680. https://doi. org/10.1542/peds.105.3.671 • American Diabetes Association. (2015). Classification and diagnosis of diabetes. Diabetes Care, 38(Supplement_1), S8–S16. https:// doi.org/10.2337/dc15-S005
  • • Cicero, A. F. G., Tartagni, E., & Ertek, S. (2012). Mini-Special issue paper management of diabetic patients with hypoglycemic agents metformin and its clinical use: new insights for an old drug in clinical practice. Archives of Medical Science, 5, 907–917. https:// doi.org/10.5114/aoms.2012.31622
  • • Czyzyk, A., Tawecki, J., Sadowski, J., Ponikowska, I., & Szczepanik, Z. (1968). Effect of biguanides on intestinal absorption of glucose. Diabetes, 17(8), 492–498. https://doi.org/10.2337/diab.17.8.492
  • • EMA. (2010). Guideline on the investigation of bioequivalence. Retrieved from https://www.ema.europa.eu/en/documents/ scientific-guideline/guideline-investigation-bioequivalencerev1_ en.pdf • European Pharmacopeia 6. <2.9.5.> Uniformity of mass of singledose preparations. Retrieved from %2020907e.pdf • FDA. 2009. Dissolution methods. Retrieved from https://www. accessdata.fda.gov/scripts/cder/dissolution/dsp_getalldata.cfm
  • • Gautam, C. S., & Saha, L. (2008). Fixed dose drug combinations (FDCs): rational or irrational: a view point. British Journal of Clinical Pharmacology, 65(5), 795–796. https://doi.org/10.1111/j.1365- 2125.2007.03089.x
  • • Godman, B., McCabe, H., & D Leong, T. (2020). Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries. Expert Review of Pharmacoeconomics & Outcomes Research, 20(1), 1–26. https://doi.org/10.1080/14737167.2020.1734456
  • • Hasslacher, C. (2003). Safety and efficacy of repaglinide in type 2 diabetic patients with and without impaired renal function. Diabetes Care, 26(3), 886–891. https://doi.org/10.2337/diacare.26.3.886
  • • Hostalek, U., Gwilt, M., & Hildemann, S. (2015). Therapeutic use of metformin in prediabetes and diabetes prevention. Drugs, 75(10), 1071–1094. https://doi.org/10.1007/s40265-015-0416-8
  • • ICH. (2003). Stability testıng of new drug substances and products Q1A(R2). Retrieved from https://database.ich.org/sites/default/ files/Q1A%28R2%29 Guideline.pdf
  • • Johansen, O. E., & Birkeland, K. I. (2007). Defining the role of repaglinide in the management of type 2 diabetes mellitus. American Journal of Cardiovascular Drugs, 7(5), 319–335. https://doi. org/10.2165/00129784-200707050-00002
  • • Kawamori, R., Kaku, K., Hanafusa, T., Oikawa, T., Kageyama, S., & Hotta, N. (2014). Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus. Journal of Diabetes Investigation, 5(1), 72–79. https://doi.org/10.1111/jdi.12121
  • • Lefèbvre, P. J., & Scheen, A. J. (1992). Management of non-insulindependent diabetes mellitus. Drugs, 44(Supplement 3), 29–38. https://doi.org/10.2165/00003495-199200443-00005
  • • Longo, M., Bellastella, G., Maiorino, M. I., Meier, J. J., Esposito, K., & Giugliano, D. (2019). Diabetes and aging: From treatment goals to pharmacologic therapy. Frontiers in Endocrinology, 10. https://doi. org/10.3389/fendo.2019.00045
  • • Maffi, P., & Secchi, A. (2017). The Burden of Diabetes: Emerging Data. https://doi.org/10.1159/000459641
  • • Malone, J. I. (2016). Diabetic central neuropathy: CNS damage related to hyperglycemia. Diabetes, 65(2), 355–357. https://doi. org/10.2337/dbi15-0034
  • • Marbury, T. (2000). Pharmacokinetics of repaglinide in subjects with renal impairment. Clinical Pharmacology & Therapeutics, 67(1), 7–15. https://doi.org/10.1067/mcp.2000.103973
  • • Massi-Benedetti, M., & Orsini-Federici, M. (2008). Treatment of type 2 diabetes with combined therapy: What are the pros and cons? Diabetes Care, 31(Supplement 2), S131–S135. https://doi. org/10.2337/dc08-s233
  • • Nasri, H., & Rafieian-Kopaei, M. (2014). Metformin: Current knowledge. J Res Med Sci, 19(7), 658–664.
  • • Natali, A., & Ferrannini, E. (2006). Effects of metformin and thiazolidinediones on suppression of hepatic glucose production and stimulation of glucose uptake in type 2 diabetes: a systematic review. Diabetologia, 49(3), 434–441. https://doi.org/10.1007/ s00125-006-0141-7
  • • Pernicova, I., & Korbonits, M. (2014). Metformin—mode of action and clinical implications for diabetes and cancer. Nature Reviews Endocrinology, 10(3), 143–156. https://doi.org/10.1038/ nrendo.2013.256
  • • Rachdaoui, N. (2020). Insulin: The friend and the foe in the development of type 2 diabetes mellitus. International Journal of Molecular Sciences, 21(5), 1770. https://doi.org/10.3390/ijms21051770
  • • Riddle, M. C., & Herman, W. H. (2018). The cost of diabetes care— An elephant in the room. Diabetes Care, 41(5), 929–932. https:// doi.org/10.2337/dci18-0012
  • • Sanchez-Rangel, E., & Inzucchi, S. E. (2017). Metformin: clinical use in type 2 diabetes. Diabetologia, 60(9), 1586–1593. https://doi. org/10.1007/s00125-017-4336-x
  • • Schumacher, S., Abbasi, I., Weise, D., Hatorp, V., Sattler, K., Sieber, J., & Hasslacher, C. (2001). Single- and multiple-dose pharmacokinetics of repaglinide in patients with type 2 diabetes and renal impairment. European Journal of Clinical Pharmacology, 57(2), 147–152. https://doi.org/10.1007/s002280100280
  • • Scott, L. J. (2012). Repaglinide. Drugs, 72(2), 249–272. https://doi. org/10.2165/11207600-000000000-00000
Toplam 26 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılık ve İlaç Bilimleri, Sağlık Kurumları Yönetimi
Bölüm Original Article
Yazarlar

Sinem Şahin Bu kişi benim 0000-0002-0377-2757

Burcu Mesut Bu kişi benim 0000-0003-2838-1688

M. Ezgi Durgun Bu kişi benim 0000-0001-5724-9809

Esher Özçelik Bu kişi benim 0000-0002-5611-1143

Yıldız Özsoy Bu kişi benim 0000-0002-9110-3704

Yayımlanma Tarihi 30 Nisan 2021
Gönderilme Tarihi 13 Temmuz 2020
Yayımlandığı Sayı Yıl 2021 Cilt: 51 Sayı: 1

Kaynak Göster

APA Şahin, S., Mesut, B., Durgun, M. E., Özçelik, E., vd. (2021). Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin. İstanbul Journal of Pharmacy, 51(1), 26-34.
AMA Şahin S, Mesut B, Durgun ME, Özçelik E, Özsoy Y. Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin. iujp. Nisan 2021;51(1):26-34.
Chicago Şahin, Sinem, Burcu Mesut, M. Ezgi Durgun, Esher Özçelik, ve Yıldız Özsoy. “Preparation and in Vitro Studies of Fixed-Dose Tablet Combination of Repaglinide and Metformin”. İstanbul Journal of Pharmacy 51, sy. 1 (Nisan 2021): 26-34.
EndNote Şahin S, Mesut B, Durgun ME, Özçelik E, Özsoy Y (01 Nisan 2021) Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin. İstanbul Journal of Pharmacy 51 1 26–34.
IEEE S. Şahin, B. Mesut, M. E. Durgun, E. Özçelik, ve Y. Özsoy, “Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin”, iujp, c. 51, sy. 1, ss. 26–34, 2021.
ISNAD Şahin, Sinem vd. “Preparation and in Vitro Studies of Fixed-Dose Tablet Combination of Repaglinide and Metformin”. İstanbul Journal of Pharmacy 51/1 (Nisan 2021), 26-34.
JAMA Şahin S, Mesut B, Durgun ME, Özçelik E, Özsoy Y. Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin. iujp. 2021;51:26–34.
MLA Şahin, Sinem vd. “Preparation and in Vitro Studies of Fixed-Dose Tablet Combination of Repaglinide and Metformin”. İstanbul Journal of Pharmacy, c. 51, sy. 1, 2021, ss. 26-34.
Vancouver Şahin S, Mesut B, Durgun ME, Özçelik E, Özsoy Y. Preparation and in vitro studies of fixed-dose tablet combination of repaglinide and metformin. iujp. 2021;51(1):26-34.
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