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Yıl 2022, Cilt: 2 Sayı: 4, 114 - 124, 14.10.2022

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Kaynakça

  • [1] Hannan PA, Khan JA, Khan A, Safiullah S. Oral dispersible system: A new approach in drug delivery system. Indian J Pharm Sci. 2016;78:2–7. https://doi.org/10.4103/0250-474x.180244.
  • [2] Ghourichay MP, Kiaie SH, Nokhodchi A, Javadzadeh Y. Formulation and quality control of orally disintegrating tablets (ODTs): Recent advances and perspectives. BioMed Research International. 2021;e6618934. https://doi.org/10.1155/2021/6618934.
  • [3] Abay F, Ugurlu T. Orally disintegrating tablets: A short review. Journal of Pharmaceutics & Drug Development. 2015;3:303.
  • [4] FDA. Guidance for Industry, Orally Disintegrating Tablets. 2008. Accessed 29 August 2022. Available: https://www.fda.gov/media/70877/download.
  • [5] Koner JS, Rajabi-Siahboomi AR, Missaghi S, Kirby D, Perrie Y, Ahmed J, et al. Conceptualisation, development, fabrication and in vivo validation of a novel disintegration tester for orally disintegrating tablets. Sci Rep. 2019;9:12467. https://doi.org/10.1038/s41598-019-48859-x.
  • [6] Japanese Pharmacopoeia Eighteenth Edition. Accessed 30 August 2022. Available: https://jpdb.nihs.go.jp/kyokuhou/files/000904418.pdf.
  • [7] Deepika B, Raju K, Kabeer A, Begum S, Rao K. A review on orally disintegrating tablets. World Journal of Pharmacy and Pharmaceutical Sciences. 2017;6(3):460-475.
  • [8] Comoglu T, Ozyilmaz ED. Orally disintegrating tablets and orally disintegrating mini tablets–novel dosage forms for pediatric use. Pharm Dev Technol. 2019;24(7):902–914. https://doi.org/10.1080/10837450.2019.1615090.
  • [9] Rahman M, Islam F, Rahman A, Ahmed T, Uddin MB, Shaheen SM, et al. Present and future prospect of combination drugs therapy. World Journal of Pharmaceutical Research. 2020;9:1625–1638.
  • [10] Sun W, Sanderson PE, Zheng W. Drug combination therapy increases successful drug repositioning. Drug Discov Today. 2016;21:1189–1195. https://doi.org/10.1016/j.drudis.2016.05.015.
  • [11] Ma L, Kohli M, Smith A. Nanoparticles for combination drug therapy. ACS Nano. 2013;7:9518–9525. https://doi.org/10.1021/nn405674m.
  • [12] Güvenç Paltun B, Kaski S, Mamitsuka H. Machine learning approaches for drug combination therapies. Briefings in Bioinformatics. 2021;22(6):bbab293. https://doi.org/10.1093/bib/bbab293.
  • [13] Janczura M, Sip S, Cielecka-Piontek J. The development of innovative dosage forms of the fixed-dose combination of active pharmaceutical ingredients. Pharmaceutics. 2022;14(4):834. https://doi.org/10.3390/pharmaceutics14040834.
  • [14] FDA. Hypertension: Developing fixed-combination drug products for treatment, Guidence for Industry. 2018. Accessed 29 August 2022. Available: https://www.fda.gov/media/117975/download.
  • [15] Godman B, McCabe H, Leong TD, Mueller D, Martin AP, Hoxha I, et al. Fixed dose drug combinations–are they pharmacoeconomically sound? Findings and implications especially for lower-and middle-income countries. Expert Review of Pharmacoeconomics & Outcomes Research. 2020;20:1–26. https://doi.org/10.1080/14737167.2020.1734456.
  • [16] Gupta YK, Ramachandran SS. Fixed dose drug combinations: Issues and challenges in India. Indian J Pharmacol. 2016;48:347–349. https://doi.org/10.4103/0253-7613.186200.
  • [17] Patel S, Shah S, Desai C. An analysis of banned fixed-dose combinations in India. Asian Journal of Pharmaceutical and Clinical Research. 2021;14(2):158–161. https://doi.org/10.22159/ajpcr.2021.v14i2.40368.
  • [18] Kalra S, Das AK, Priya G, Ghosh S, Mehrotra RN, Das S, et al. Fixed-dose combination in management of type 2 diabetes mellitus: Expert opinion from an international panel, J Family Med Prim Care. 2020;9:5450–5457. https://doi.org/10.4103/jfmpc.jfmpc_843_20.
  • [19] FDA. Orange Book: Approved drug products with therapeutic equivalence evaluations. Accessed 31 August 2022. Available: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
  • [20] Chandrasekaran G, Rajalakshmi AN. Fixed dose combination products as oro-dispersible tablets: A review. Journal of Drug Delivery and Therapeutics. 2019;9:563–573. https://doi.org/10.22270/jddt.v9i2.2515.
  • [21] Nausieda PA, Pfeiffer RF, Tagliati M, Kastenholz KV, DeRoche C, Slevin JT. A multicenter, open-label, sequential study comparing preferences for carbidopa-levodopa orally disintegrating tablets and conventional tablets in subjects with Parkinson’s disease. Clin Ther. 2005;27:58–63. https://doi.org/10.1016/j.clinthera.2005.01.004.
  • [22] Sotoyama M, Uchida S, Kamiya C, Tanaka S, Kashiwagura Y, Hakamata A, et al. Ease of taking and palatability of fixed-dose orally disintegrating mitiglinide/voglibose tablets. Chem Pharm Bull (Tokyo). 2019;67:540–545. https://doi.org/10.1248/cpb.c18-00902.
  • [23] Belayneh A, Molla F, Kahsay G. Formulation and optimization of monolithic fixed-dose combination of metformin HCl and glibenclamide orodispersible tablets. Advances in Pharmacological and Pharmaceutical Sciences. 2020;3546597.
  • [24] Gulsun T, Akdag Y, Izat N, Cetin M, Oner L, Sahin S. Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets. Pharm Dev Technol. 2020; 25:999–1009. https://doi.org/10.1080/10837450.2020.1772290.
  • [25] Dennison TJ, Smith JC, Badhan RK, Mohammed AR. Fixed-dose combination orally disintegrating tablets to treat cardiovascular disease: formulation, in vitro characterization and physiologically based pharmacokinetic modeling to assess bioavailability. Drug Des Devel Ther. 2017;11:811–826. https://doi.org/10.2147/DDDT.S126035.
  • [26] Flora GD, Nayak MK. A brief review of cardiovascular diseases, associated risk factors and current treatment regimes. Curr Pharm Des. 2019;25:4063–4084. https://doi.org/10.2174/1381612825666190925163827.
  • [27] Kandilli B, Ugur Kaplan AB, Cetin M, Taspınar N, Genc S, Yeni Y, et al. Orally disintegrating tablet containing carbamazepine and levetiracetam: formulation and in vitro and in vivo characterization. Drug Dev Ind Pharm. 2021;47:1153–1165. https://doi.org/10.1080/03639045.2021.1988094.
  • [28] Dennison TJ, J.C. Smith JC, Badhan RKS, Mohammed AR. Formulation and bioequivalence testing of fixed-dose combination orally disintegrating tablets for the treatment of tuberculosis in the paediatric population. J Pharm Sci. 2020;109:3105–3113. https://doi.org/10.1016/j.xphs.2020.07.016.
  • [29] WHO. Cardiovascular diseases (CVDs). Accessed 30 August 2022. Available: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
  • [30] Teaima MH, Abdel-Haleem KM , Osama R, El-Nabarawi MA, Elnahas OS. A promising single oral disintegrating tablet for co-delivery of pitavastatin calcium and lornoxicam using co-processed excipients: Formulation, characterization and pharmacokinetic study. Drug Des Devel Ther. 2021;15:4229–4242. https://doi.org/10.2147/DDDT.S332729.
  • [31] Sidgel U, Sheeba FR, Kumar S. Formulation and evaluation of fast dissolving tablets containing a combination of valsartan and amlodipine for the treatment of hypertension. World Journal of Pharmaceutical Sciences. 2016;4:147–152.
  • [32] Reed J, S. Bain S, Kanamarlapudi V. A review of current trends with type 2 diabetes epidemiology, aetiology, pathogenesis, treatments and future perspectives. Diabetes Metab Syndr Obes. 2021;14:3567–3602. https://doi.org/10.2147/DMSO.S319895.
  • [33] Park YJ, Woo M. Pancreatic β cells: Gatekeepers of type 2 diabetes. Journal of Cell Biology. 2019;218:1094–1095. https://doi.org/10.1083/jcb.201810097.
  • [34] WHO. Diabetes. Accessed 5 September 2022. Available: https://www.who.int/news-room/fact-sheets/detail/diabetes.
  • [35] Olokoba AB, Obateru OA, Olokoba LB. Type 2 diabetes mellitus: A review of current trends. Oman Med J. 2012;27:269–273. https://doi.org/10.5001/omj.2012.68.
  • [36] Ganesan K, Rana MBM, Sultan S. Oral Hypoglycemic Medications, in: StatPearls, StatPearls Publishing, Treasure Island (FL), 2022. Accessed 5 September 2022. Available: http://www.ncbi.nlm.nih.gov/books/NBK482386.
  • [37] Hu L, Gu D, Zhang H, Yang X. A novel approach to formulate and optimize orally disintegrating tablets of bambuterol hydrochloride. Pharmaceut Anal Acta. 2013;4:216. https://doi.org/10.4172/2153-2435.1000216.
  • [38] Ono Y, Kameda H, Cho KY. Mitiglinide/voglibose fixed-dose combination improves postprandial glycemic excursions in Japanese patients with type 2 diabetes mellitus. Expert Opin Pharmacother. 2013;14:361–370. https://doi.org/10.1517/14656566.2013.770839.

FIXED-DOSE COMBINATION-ORALLY DISINTEGRATING TABLET (FDC-ODT) STUDIES FOR THE TREATMENT OF TYPE 2 DIABETES OR CARDIOVASCULAR DISEASES-A MINI REVIEW

Yıl 2022, Cilt: 2 Sayı: 4, 114 - 124, 14.10.2022

Öz

The orally disintegrating tablet (ODT) is a dosage form that stands out for its organoleptic elegancy, better patient compliance, rapid disintegration, and rapid onset of action in geriatric, psychiatric, pediatric, paralyzed, and bedridden patients. Drug combination therapy refers to the concomitant use of two or more drugs used separately or the use of two or more active pharmaceutical ingredients (APIs) in fixed-dose combinations (FDCs) in a single dosage form. FDC drug products have been developed to target a single disease or multiple diseases/conditions. There have been studies showing that taking FDC drug products may be more effective than using dosage forms containing individual APIs. However, the safety, efficacy, and rationality of many FDCs still remain questionable. Furthermore, FDC-ODTs combine the advantages such as better compliance and efficacy of both FDC and ODTs, especially in dysphagic patients and the patients on multiple drug therapy. FDC-ODTs have been prepared for the treatment of different diseases such as Type 2 diabetes, epilepsy, cardiovascular disease, Parkinson’s disease. In this mini-review, I aimed to provide an overview with some studies on FDC-ODTs prepared for cardiovascular diseases and Type 2 diabetes treatments in the literature.

Kaynakça

  • [1] Hannan PA, Khan JA, Khan A, Safiullah S. Oral dispersible system: A new approach in drug delivery system. Indian J Pharm Sci. 2016;78:2–7. https://doi.org/10.4103/0250-474x.180244.
  • [2] Ghourichay MP, Kiaie SH, Nokhodchi A, Javadzadeh Y. Formulation and quality control of orally disintegrating tablets (ODTs): Recent advances and perspectives. BioMed Research International. 2021;e6618934. https://doi.org/10.1155/2021/6618934.
  • [3] Abay F, Ugurlu T. Orally disintegrating tablets: A short review. Journal of Pharmaceutics & Drug Development. 2015;3:303.
  • [4] FDA. Guidance for Industry, Orally Disintegrating Tablets. 2008. Accessed 29 August 2022. Available: https://www.fda.gov/media/70877/download.
  • [5] Koner JS, Rajabi-Siahboomi AR, Missaghi S, Kirby D, Perrie Y, Ahmed J, et al. Conceptualisation, development, fabrication and in vivo validation of a novel disintegration tester for orally disintegrating tablets. Sci Rep. 2019;9:12467. https://doi.org/10.1038/s41598-019-48859-x.
  • [6] Japanese Pharmacopoeia Eighteenth Edition. Accessed 30 August 2022. Available: https://jpdb.nihs.go.jp/kyokuhou/files/000904418.pdf.
  • [7] Deepika B, Raju K, Kabeer A, Begum S, Rao K. A review on orally disintegrating tablets. World Journal of Pharmacy and Pharmaceutical Sciences. 2017;6(3):460-475.
  • [8] Comoglu T, Ozyilmaz ED. Orally disintegrating tablets and orally disintegrating mini tablets–novel dosage forms for pediatric use. Pharm Dev Technol. 2019;24(7):902–914. https://doi.org/10.1080/10837450.2019.1615090.
  • [9] Rahman M, Islam F, Rahman A, Ahmed T, Uddin MB, Shaheen SM, et al. Present and future prospect of combination drugs therapy. World Journal of Pharmaceutical Research. 2020;9:1625–1638.
  • [10] Sun W, Sanderson PE, Zheng W. Drug combination therapy increases successful drug repositioning. Drug Discov Today. 2016;21:1189–1195. https://doi.org/10.1016/j.drudis.2016.05.015.
  • [11] Ma L, Kohli M, Smith A. Nanoparticles for combination drug therapy. ACS Nano. 2013;7:9518–9525. https://doi.org/10.1021/nn405674m.
  • [12] Güvenç Paltun B, Kaski S, Mamitsuka H. Machine learning approaches for drug combination therapies. Briefings in Bioinformatics. 2021;22(6):bbab293. https://doi.org/10.1093/bib/bbab293.
  • [13] Janczura M, Sip S, Cielecka-Piontek J. The development of innovative dosage forms of the fixed-dose combination of active pharmaceutical ingredients. Pharmaceutics. 2022;14(4):834. https://doi.org/10.3390/pharmaceutics14040834.
  • [14] FDA. Hypertension: Developing fixed-combination drug products for treatment, Guidence for Industry. 2018. Accessed 29 August 2022. Available: https://www.fda.gov/media/117975/download.
  • [15] Godman B, McCabe H, Leong TD, Mueller D, Martin AP, Hoxha I, et al. Fixed dose drug combinations–are they pharmacoeconomically sound? Findings and implications especially for lower-and middle-income countries. Expert Review of Pharmacoeconomics & Outcomes Research. 2020;20:1–26. https://doi.org/10.1080/14737167.2020.1734456.
  • [16] Gupta YK, Ramachandran SS. Fixed dose drug combinations: Issues and challenges in India. Indian J Pharmacol. 2016;48:347–349. https://doi.org/10.4103/0253-7613.186200.
  • [17] Patel S, Shah S, Desai C. An analysis of banned fixed-dose combinations in India. Asian Journal of Pharmaceutical and Clinical Research. 2021;14(2):158–161. https://doi.org/10.22159/ajpcr.2021.v14i2.40368.
  • [18] Kalra S, Das AK, Priya G, Ghosh S, Mehrotra RN, Das S, et al. Fixed-dose combination in management of type 2 diabetes mellitus: Expert opinion from an international panel, J Family Med Prim Care. 2020;9:5450–5457. https://doi.org/10.4103/jfmpc.jfmpc_843_20.
  • [19] FDA. Orange Book: Approved drug products with therapeutic equivalence evaluations. Accessed 31 August 2022. Available: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
  • [20] Chandrasekaran G, Rajalakshmi AN. Fixed dose combination products as oro-dispersible tablets: A review. Journal of Drug Delivery and Therapeutics. 2019;9:563–573. https://doi.org/10.22270/jddt.v9i2.2515.
  • [21] Nausieda PA, Pfeiffer RF, Tagliati M, Kastenholz KV, DeRoche C, Slevin JT. A multicenter, open-label, sequential study comparing preferences for carbidopa-levodopa orally disintegrating tablets and conventional tablets in subjects with Parkinson’s disease. Clin Ther. 2005;27:58–63. https://doi.org/10.1016/j.clinthera.2005.01.004.
  • [22] Sotoyama M, Uchida S, Kamiya C, Tanaka S, Kashiwagura Y, Hakamata A, et al. Ease of taking and palatability of fixed-dose orally disintegrating mitiglinide/voglibose tablets. Chem Pharm Bull (Tokyo). 2019;67:540–545. https://doi.org/10.1248/cpb.c18-00902.
  • [23] Belayneh A, Molla F, Kahsay G. Formulation and optimization of monolithic fixed-dose combination of metformin HCl and glibenclamide orodispersible tablets. Advances in Pharmacological and Pharmaceutical Sciences. 2020;3546597.
  • [24] Gulsun T, Akdag Y, Izat N, Cetin M, Oner L, Sahin S. Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets. Pharm Dev Technol. 2020; 25:999–1009. https://doi.org/10.1080/10837450.2020.1772290.
  • [25] Dennison TJ, Smith JC, Badhan RK, Mohammed AR. Fixed-dose combination orally disintegrating tablets to treat cardiovascular disease: formulation, in vitro characterization and physiologically based pharmacokinetic modeling to assess bioavailability. Drug Des Devel Ther. 2017;11:811–826. https://doi.org/10.2147/DDDT.S126035.
  • [26] Flora GD, Nayak MK. A brief review of cardiovascular diseases, associated risk factors and current treatment regimes. Curr Pharm Des. 2019;25:4063–4084. https://doi.org/10.2174/1381612825666190925163827.
  • [27] Kandilli B, Ugur Kaplan AB, Cetin M, Taspınar N, Genc S, Yeni Y, et al. Orally disintegrating tablet containing carbamazepine and levetiracetam: formulation and in vitro and in vivo characterization. Drug Dev Ind Pharm. 2021;47:1153–1165. https://doi.org/10.1080/03639045.2021.1988094.
  • [28] Dennison TJ, J.C. Smith JC, Badhan RKS, Mohammed AR. Formulation and bioequivalence testing of fixed-dose combination orally disintegrating tablets for the treatment of tuberculosis in the paediatric population. J Pharm Sci. 2020;109:3105–3113. https://doi.org/10.1016/j.xphs.2020.07.016.
  • [29] WHO. Cardiovascular diseases (CVDs). Accessed 30 August 2022. Available: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
  • [30] Teaima MH, Abdel-Haleem KM , Osama R, El-Nabarawi MA, Elnahas OS. A promising single oral disintegrating tablet for co-delivery of pitavastatin calcium and lornoxicam using co-processed excipients: Formulation, characterization and pharmacokinetic study. Drug Des Devel Ther. 2021;15:4229–4242. https://doi.org/10.2147/DDDT.S332729.
  • [31] Sidgel U, Sheeba FR, Kumar S. Formulation and evaluation of fast dissolving tablets containing a combination of valsartan and amlodipine for the treatment of hypertension. World Journal of Pharmaceutical Sciences. 2016;4:147–152.
  • [32] Reed J, S. Bain S, Kanamarlapudi V. A review of current trends with type 2 diabetes epidemiology, aetiology, pathogenesis, treatments and future perspectives. Diabetes Metab Syndr Obes. 2021;14:3567–3602. https://doi.org/10.2147/DMSO.S319895.
  • [33] Park YJ, Woo M. Pancreatic β cells: Gatekeepers of type 2 diabetes. Journal of Cell Biology. 2019;218:1094–1095. https://doi.org/10.1083/jcb.201810097.
  • [34] WHO. Diabetes. Accessed 5 September 2022. Available: https://www.who.int/news-room/fact-sheets/detail/diabetes.
  • [35] Olokoba AB, Obateru OA, Olokoba LB. Type 2 diabetes mellitus: A review of current trends. Oman Med J. 2012;27:269–273. https://doi.org/10.5001/omj.2012.68.
  • [36] Ganesan K, Rana MBM, Sultan S. Oral Hypoglycemic Medications, in: StatPearls, StatPearls Publishing, Treasure Island (FL), 2022. Accessed 5 September 2022. Available: http://www.ncbi.nlm.nih.gov/books/NBK482386.
  • [37] Hu L, Gu D, Zhang H, Yang X. A novel approach to formulate and optimize orally disintegrating tablets of bambuterol hydrochloride. Pharmaceut Anal Acta. 2013;4:216. https://doi.org/10.4172/2153-2435.1000216.
  • [38] Ono Y, Kameda H, Cho KY. Mitiglinide/voglibose fixed-dose combination improves postprandial glycemic excursions in Japanese patients with type 2 diabetes mellitus. Expert Opin Pharmacother. 2013;14:361–370. https://doi.org/10.1517/14656566.2013.770839.
Toplam 38 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılık ve İlaç Bilimleri
Bölüm Reviews
Yazarlar

Meltem Çetin 0000-0003-4009-2432

Yayımlanma Tarihi 14 Ekim 2022
Yayımlandığı Sayı Yıl 2022 Cilt: 2 Sayı: 4

Kaynak Göster

EndNote Çetin M (01 Ekim 2022) FIXED-DOSE COMBINATION-ORALLY DISINTEGRATING TABLET (FDC-ODT) STUDIES FOR THE TREATMENT OF TYPE 2 DIABETES OR CARDIOVASCULAR DISEASES-A MINI REVIEW. International Journal of PharmATA 2 4 114–124.