Güncel Bakış Açısı ile Yüzen Dozaj Formlarına Öncelik Vererek Gastroretentif İlaç Salım Sistemlerinin Derlemesi
Yıl 2021,
Cilt: 4 Sayı: 2, 43 - 64, 21.06.2021
Nur Sena Başarır
Burcu Mesut
,
Yıldız Özsoy
Öz
Mevcut farmasötik yaklaşımlarda, diğer tüm yollarından farklı olarak halen oral dozaj formları tercih edilmeye devam etmektedir. Bunun nedeni uygulama kolaylığı ve hasta uyuncunun yüksek olmasıdır. İlaç salım sistemlerinin ortak amacı, ilacın tek bir dozaj formu olarak alınabilmesini sağlamaktır. Yine de, ilaç salım mekanizmaları genellikle uygun bir biyoyararlanım ve uzatılmış yarı ömür gibi özelliklerden yoksundur. Yüzebilen ilaç salım sistemleri (FDDS), mide içeriği üzerinde kalabilme özelliğine sahip, düşük yoğunluklu olan sistemlerdir ve gastroretentif ilaç salım sistemlerinin (GRDDS) bir parçası olarak değerlendirilirler. Yüzebilen dozaj formları ağızdan alınır ve etken maddenin gastrointestinal sistemden geçiş süresini uzatarak lokal/sistemik etki elde etmek için geliştirilirler. Söz konusu ilaç mide boşalma hızını etkilemeden uzun süre midede yüzer halde kalır. FDDS ilaç biyoyararlanımını iyileştirir, ilaç israfını azaltır ve kontrollü ilaç salım sistemi etkisini sağlamak için etkili bir yöntem olarak değerlendirilir. Bu derleme, genellikle bir gastoretentif ilaç sistemlerinden birisi olan yüzebilen dozaj formlarına odaklanmıştır ve özetle gastrik sistemde kalabilen alternatif sistemlerden ve bu sistemleri geliştirmek için kullanılan eksipiyanlardan bahsedecektir.
Destekleyen Kurum
İstanbul Üniversitesi
Kaynakça
- 1.Homayun B, Lin X, Choi HJ. Challenges and recent progress in oral drug delivery systems for biopharmaceuticals. Pharmaceutics 2019;11(3):129.
- 2.Tripathi J, Thapa P, Maharjan R, Jeong S H. Current state and future perspectives on gastroretentive drug delivery systems. Pharmaceutics 2019;11(4):193.
- 3.O’Morain NR, Dore MP, O’Connor AJP, Gisbert JP, O’Morain CA. Treatment of Helicobacter pylori infection in 2018. Helicobacter 2018;23(Sup1):e12519.
- 4.Klausner EA, Lavy E, Friedman M, Hoffman A. Expandable gastroretentive dosage forms. J Control Release 2003;90:143-62.
- 5.Pawar VK, Kansal S, Garg G, Awasthi R, Singodia D, Kulkarni G T. Gastroretentive dosage forms: a review with special emphasis on floating drug delivery systems. Drug Deliv. 2011;18(2):97-110.
- 6.Garg R, Gupta GD. Progress in controlled gastroretentive delivery systems. Trop J Pharm Res 2008;7(3):1055-66.
- 7.Gupta R, Tripathi P, Bhardwaj P, Mahor A. Recent advances in gastro retentive drug delivery systems and its application on treatment of H.Pylori infections. J Anal Pharm Res 2018;7(4):404-10.
- 8.Patil H, Tiwari RV, Repka MA. Recent advancements in mucoadhesive floating drug delivery systems: a mini-review. J Drug Deliv Sci Technol 2016;31:65-71.
- 9.Bansal S, Beg S, Garg B, Asthana A, Asthana GS, Singh B. QbD-Oriented development and characterization of effervescent floating-bioadhesive tablets of cefuroxime axetil. AAPS PharmSciTech 2016;17:1086-99.
- 10.Doodipala N, Palem CR, Reddy S, Rao YM. Pharmaceutical development and clinical pharmacokinetic evaluation of gastroretentive floating matrix tablets of levofloxacin. Int J Pharm Sci Nanotech 2011;4(3):1463-69.
- 11.Davis SS. Formulation strategies for absorption windows. Drug Discov Today 2005;10(4):249-57.
- 12.Sharma AR, Khan A. Gastroretentive drug delivery systems: an approach to enhance gastric retention for prolonged drug release. Int J Pharm Sci Res 2014;2:1095-106.
- 13. Liu Z, Lu W, Qian L, Zhang X, Zeng P, Pan J. In vitro and in vivo studies on mucoadhesive microspheres of amoxicillin. J Control Release 2005;102:135-44.
- 14.Pande SD, Vaidya KP, Gulhane KP. Floating drug delivery system (FDDS): a new way for oral drug delivery system. Int J Pharm Sci Res 2013;3(1):1-13.
- 15.Patial K, Dua JS, Menra M, Prasad DN. A review: floating drug delivery system (FDDS) World J Pharm Res. 2015;4(3):9-23.
- 16.Rouge N, Leroux JC, Cole ET, Doelker E, Buri P. Prevention of the sticking tendency of floating minitablets filled into hard gelatin capsules. Eur J Pharm Biopharm 1997; 43:165-71.
- 17.KCM, Roy P, Nandy B C. An overview of gastro retentive dosage forms (GRDFS). J Drug Deliv Ther 2017;5(2):01-16.
- 18.Dey S, Saha P. Floating drug delivery system. Int J Pharm Eng 2013;1(1):1-5.
- 19.El-Zahaby SA, Kassem AA, El-Kamel AH. Design and evaluation of gastroretentive levofloxacin floating mini-tablets-in-capsule system for eradication of Helicobacter pylori. Saudi Pharm J 2014; 22:570-9.
- 20.Jaimini R, Gupta MK, Sharma V. A review on formulation and evaluation of gastroretentive floating tablet of Nifedipin. J Drug Deliv Ther 2019;9(4):651-6.
- 21.Chowdary KPR, Chaitanya CKL. Recent research on floating drug delivery systems- a review. J Glob Trends Pharm Sci 2014;5(1):1361-73.
- 22.Gong L, Yu M, Sun Y, Gao Y, An T, Zou M, Cheng G. Design and optimization of gastric floating sustained-release mini-tablets of alfuzosin hydrochloride based on a factorial design: in vitro/in vivo evaluation. Drug Dev Ind Pharm 2018;12(44):1990-99.
- 23.Awasthi R, Kulkarni GT. Development and characterization of amoxicillin loaded floating microballoons for the treatment of Helicobacter pylori induced gastric ulcer. Asian J Pharm Sci 2013;8:174-80.
- 24.Arvapally S, Harika NS, Mounika B, Spandana S. Formulation and in vitro evaluation of gastroretentive dosage forms of balofloxacin. World J Pharm Pharm Sci 2016;5(4):2163-77.
- 25.Shaik S, Maddela S, Nalluri BN. Development of Capecitabine floating tablet dosage forms for treating stomach cancer. J Drug Deliv Ther 2020;10(3-s):199-205.
- 26.Chai X, Chai H, Wang X, Yang J, Li J, Zhao Y, Cai W, Tao T, Xiang X. Fused deposition modeling (FDM) 3D printed tablets for intragastric floating delivery of domperidone Sci Rep. 2017;7:2829.
- 27.Dutta P, Sruti J, Patra N, Rao MEB. Floating microspheres: recent trends in the development of gastroretentive floating drug delivery system. Int J Pharm Sci Nanotech 2011;4(1):1296-306.
- 28.Dolas RT, Sharma S, Sharma M. Formulation and evaluation of gastroretentive floating tablets of lafutidine. J Drug Deliv Ther 2018;8(5):393-9.
- 29.Mehta R, Patel K. Formulation development and evaluation of gastroretentive floating films of lafutidine. J Innov Pharm Biol Sci 2019;7(2):16-56.
- 30.Gadad AP, Naik SS, Dandagi PM, Bolmal UB. Formulation and evaluation of gastroretentive floating microspheres of lafutidine. Indian J Pharm Educ Res 2016;50(2):76-81.
- 31.Qi X, Chen H, Rui Y, Yang F, Ma N, Zhenghong W. Floating tablets for controlled release of ofloxacin via compression coating of hydroxypropyl cellulose combined with effervescent agent. Int J Pharm 2015;489: 210-7.
- 32.Iftequar S, Saifee M, Swaroop L, Zaheer Z, Meraj S, Khan F, Khan S, Yasar Q, Abdulla S. Formulation and evaluation of floating drug delivery system of ramipril. J Innov Pharm Biol Sci 2016;3(1):85-95.
- 33.Saini D, Asija R. Formulation development and evaluation of floating drug delivery of gelucire beads of ramipril. Int J Pharm Erud 2019;9(3):21-31.
- 34.Alexander S, Kumar M, Kumudhavalli MV, Umamaheswari D, Jaykar B. Formulation and evaluation of buoyant type of gastro retentive dosage forms of ranolazine tablets. J Pharm Sci Res 2017;9(2):145-9.
- 35.Prasanthi NL, Prasad AR, Durga K, Rao MD N. mulation and evaluation of gastroretentive floating tablets of venlafaxine HCl. Indo Am J Pharm 2016;6(7):6171-618.
- 36.Doodipala N, Palem CR, Reddy S, Rao YM. Pharmaceutical development and clinical pharmacokinetic evaluation of gastroretentive floating matrix tablets of Levofloxacin. Int J Pharm Sci Nanotech 2011;4(3):1463-69.
- 37.Jha P, Prajapati V, Solanki H, Jani G, Kotak U. Pharmaceutical aspects of various floating drug delivery system. World J Pharm Pharm Sci 2015;4(4):569-89.
- 38.Ozsoy Y, Ozcelik E. Pharmaceutical approach to the floating/gastroretentive systems in stomach. J Lit Pharm Sci 2018;7(2):146-59.
- 39.Javaid MU, Zaman M, Shahid S. A comprehensive discussion about gastro retentive drug delivery system. Int J Pharm Pharm Res 2016;8(1):35-52.
- 40.Gupta ME, Amulya C, Babu IS. A review on floating drug delivery systems. World J Pharm Res 2019;8(6):1294-302.
- 41.Bardonnet PL, Faivre V, Pugh WJ, Piffaretti JC, Falson F. Gastroretentive dosage forms: overview and special case of Helicobacter pylori. J Control Release 2006;111(1-2):1-18.
- 42.Gholap SB, Banarjee SK, Gaikwad DD, Jadhav SL, Thorat RM. Hollow microsphere: a review. Int J Pharm Sci Rev Res 2010;1(1):74-9.
- 43.Gupta P, Gnanarajan, Kothiyal P. Floating drug delivery system: a review. Int J Pharm Res Rev 2015;4(8):37-44.
- 44.Pattan SR, Wani NP, Shelar MU, Nirmal SA, Chaudhari PD, Gude RS. Scope and Significance of floating drug delivery system. Indian Drugs 2012;49(10):5-12.
- 45.Ishak RAH. Buoyancy-generating agents for stomach-specific drug delivery: an overview with special emphasis on floating behavior. J Pharm Pharm Sci 2015;18(1):77-100.
- 46.Kaushik AY, Tiwari AK, Gaur A. Role of excipients and polymeric advancements in preparation of floating drug delivery systems. Int J Pharm Investig 2015;5(1):1-12.
- 47.Gopalakrishnan S, Chenthilnathan A. Floating drug delivery systems: a review. J Pharm Sci Technol 2011;3(2):548-54.
- 48.Nabarawi MAE, Teaima MH, El-Monem RA A, Nabarawy NAE, Gaber DA. Formulation, release characteristics, and bioavailability study of gastroretentive floating matrix tablet and floating raft system of Mebeverine HCI. Drug Des Devel Ther 2017;11:1081-93.
- 49.Senyigit ZA, Vetter A, Guneri T, Bernkop-Schnurch A. Gastroretentive particles formulated with thiomers: development and in vitro evaluation. J Drug Target 2010;18(5):362-72.
- 50.Kucukoflaz M, Saracoglu Kaya B, Caglayan M O. Determination of mechanical properties of polymeric microspheres used in controlled drug delivery systems by nanoindentation. Polym Plast Technol Mat 2019;58(7):765-75.
A Review On Current Perspective Of Gastroretentive Drug Delivery Systems Prioritising Floating Dosage Forms
Yıl 2021,
Cilt: 4 Sayı: 2, 43 - 64, 21.06.2021
Nur Sena Başarır
Burcu Mesut
,
Yıldız Özsoy
Öz
Current pharmaceutical approaches continue to favour oral dosage delivery systems above all other routes. This is due to ease of administration and increase in patient complaisance. A common objective of a drug delivery systems is to achieve a drug that could be taken in a single dosage form. Yet, drug delivery mechanisms generally lack certain characteristics such as an adequate oral bioavailability and a prolonged half-life. Floating drug delivery systems (FDDS) are systems that are a part of gastroretentive drug delivery systems (GRDDS) with low density that has floating ability over the gastric contents of the stomach. Floating dosage forms are taken orally and developed to increase the transit time of the active substance through the gastrointestinal tract and to achieve a systemic effect. The taken drug will remain at floating state in the stomach for an extended period without affecting the gastric emptying rate. FDDS provides an efficient method for improving the drug’s bioavailability, reducing drug waste and providing controlled drug delivery systems. This review will generally focus on FDDS as a GRDDS and classify alternative systems, such as non-floating systems, and briefly mention excipients used in order to obtain an effective gastroretentive system.
Kaynakça
- 1.Homayun B, Lin X, Choi HJ. Challenges and recent progress in oral drug delivery systems for biopharmaceuticals. Pharmaceutics 2019;11(3):129.
- 2.Tripathi J, Thapa P, Maharjan R, Jeong S H. Current state and future perspectives on gastroretentive drug delivery systems. Pharmaceutics 2019;11(4):193.
- 3.O’Morain NR, Dore MP, O’Connor AJP, Gisbert JP, O’Morain CA. Treatment of Helicobacter pylori infection in 2018. Helicobacter 2018;23(Sup1):e12519.
- 4.Klausner EA, Lavy E, Friedman M, Hoffman A. Expandable gastroretentive dosage forms. J Control Release 2003;90:143-62.
- 5.Pawar VK, Kansal S, Garg G, Awasthi R, Singodia D, Kulkarni G T. Gastroretentive dosage forms: a review with special emphasis on floating drug delivery systems. Drug Deliv. 2011;18(2):97-110.
- 6.Garg R, Gupta GD. Progress in controlled gastroretentive delivery systems. Trop J Pharm Res 2008;7(3):1055-66.
- 7.Gupta R, Tripathi P, Bhardwaj P, Mahor A. Recent advances in gastro retentive drug delivery systems and its application on treatment of H.Pylori infections. J Anal Pharm Res 2018;7(4):404-10.
- 8.Patil H, Tiwari RV, Repka MA. Recent advancements in mucoadhesive floating drug delivery systems: a mini-review. J Drug Deliv Sci Technol 2016;31:65-71.
- 9.Bansal S, Beg S, Garg B, Asthana A, Asthana GS, Singh B. QbD-Oriented development and characterization of effervescent floating-bioadhesive tablets of cefuroxime axetil. AAPS PharmSciTech 2016;17:1086-99.
- 10.Doodipala N, Palem CR, Reddy S, Rao YM. Pharmaceutical development and clinical pharmacokinetic evaluation of gastroretentive floating matrix tablets of levofloxacin. Int J Pharm Sci Nanotech 2011;4(3):1463-69.
- 11.Davis SS. Formulation strategies for absorption windows. Drug Discov Today 2005;10(4):249-57.
- 12.Sharma AR, Khan A. Gastroretentive drug delivery systems: an approach to enhance gastric retention for prolonged drug release. Int J Pharm Sci Res 2014;2:1095-106.
- 13. Liu Z, Lu W, Qian L, Zhang X, Zeng P, Pan J. In vitro and in vivo studies on mucoadhesive microspheres of amoxicillin. J Control Release 2005;102:135-44.
- 14.Pande SD, Vaidya KP, Gulhane KP. Floating drug delivery system (FDDS): a new way for oral drug delivery system. Int J Pharm Sci Res 2013;3(1):1-13.
- 15.Patial K, Dua JS, Menra M, Prasad DN. A review: floating drug delivery system (FDDS) World J Pharm Res. 2015;4(3):9-23.
- 16.Rouge N, Leroux JC, Cole ET, Doelker E, Buri P. Prevention of the sticking tendency of floating minitablets filled into hard gelatin capsules. Eur J Pharm Biopharm 1997; 43:165-71.
- 17.KCM, Roy P, Nandy B C. An overview of gastro retentive dosage forms (GRDFS). J Drug Deliv Ther 2017;5(2):01-16.
- 18.Dey S, Saha P. Floating drug delivery system. Int J Pharm Eng 2013;1(1):1-5.
- 19.El-Zahaby SA, Kassem AA, El-Kamel AH. Design and evaluation of gastroretentive levofloxacin floating mini-tablets-in-capsule system for eradication of Helicobacter pylori. Saudi Pharm J 2014; 22:570-9.
- 20.Jaimini R, Gupta MK, Sharma V. A review on formulation and evaluation of gastroretentive floating tablet of Nifedipin. J Drug Deliv Ther 2019;9(4):651-6.
- 21.Chowdary KPR, Chaitanya CKL. Recent research on floating drug delivery systems- a review. J Glob Trends Pharm Sci 2014;5(1):1361-73.
- 22.Gong L, Yu M, Sun Y, Gao Y, An T, Zou M, Cheng G. Design and optimization of gastric floating sustained-release mini-tablets of alfuzosin hydrochloride based on a factorial design: in vitro/in vivo evaluation. Drug Dev Ind Pharm 2018;12(44):1990-99.
- 23.Awasthi R, Kulkarni GT. Development and characterization of amoxicillin loaded floating microballoons for the treatment of Helicobacter pylori induced gastric ulcer. Asian J Pharm Sci 2013;8:174-80.
- 24.Arvapally S, Harika NS, Mounika B, Spandana S. Formulation and in vitro evaluation of gastroretentive dosage forms of balofloxacin. World J Pharm Pharm Sci 2016;5(4):2163-77.
- 25.Shaik S, Maddela S, Nalluri BN. Development of Capecitabine floating tablet dosage forms for treating stomach cancer. J Drug Deliv Ther 2020;10(3-s):199-205.
- 26.Chai X, Chai H, Wang X, Yang J, Li J, Zhao Y, Cai W, Tao T, Xiang X. Fused deposition modeling (FDM) 3D printed tablets for intragastric floating delivery of domperidone Sci Rep. 2017;7:2829.
- 27.Dutta P, Sruti J, Patra N, Rao MEB. Floating microspheres: recent trends in the development of gastroretentive floating drug delivery system. Int J Pharm Sci Nanotech 2011;4(1):1296-306.
- 28.Dolas RT, Sharma S, Sharma M. Formulation and evaluation of gastroretentive floating tablets of lafutidine. J Drug Deliv Ther 2018;8(5):393-9.
- 29.Mehta R, Patel K. Formulation development and evaluation of gastroretentive floating films of lafutidine. J Innov Pharm Biol Sci 2019;7(2):16-56.
- 30.Gadad AP, Naik SS, Dandagi PM, Bolmal UB. Formulation and evaluation of gastroretentive floating microspheres of lafutidine. Indian J Pharm Educ Res 2016;50(2):76-81.
- 31.Qi X, Chen H, Rui Y, Yang F, Ma N, Zhenghong W. Floating tablets for controlled release of ofloxacin via compression coating of hydroxypropyl cellulose combined with effervescent agent. Int J Pharm 2015;489: 210-7.
- 32.Iftequar S, Saifee M, Swaroop L, Zaheer Z, Meraj S, Khan F, Khan S, Yasar Q, Abdulla S. Formulation and evaluation of floating drug delivery system of ramipril. J Innov Pharm Biol Sci 2016;3(1):85-95.
- 33.Saini D, Asija R. Formulation development and evaluation of floating drug delivery of gelucire beads of ramipril. Int J Pharm Erud 2019;9(3):21-31.
- 34.Alexander S, Kumar M, Kumudhavalli MV, Umamaheswari D, Jaykar B. Formulation and evaluation of buoyant type of gastro retentive dosage forms of ranolazine tablets. J Pharm Sci Res 2017;9(2):145-9.
- 35.Prasanthi NL, Prasad AR, Durga K, Rao MD N. mulation and evaluation of gastroretentive floating tablets of venlafaxine HCl. Indo Am J Pharm 2016;6(7):6171-618.
- 36.Doodipala N, Palem CR, Reddy S, Rao YM. Pharmaceutical development and clinical pharmacokinetic evaluation of gastroretentive floating matrix tablets of Levofloxacin. Int J Pharm Sci Nanotech 2011;4(3):1463-69.
- 37.Jha P, Prajapati V, Solanki H, Jani G, Kotak U. Pharmaceutical aspects of various floating drug delivery system. World J Pharm Pharm Sci 2015;4(4):569-89.
- 38.Ozsoy Y, Ozcelik E. Pharmaceutical approach to the floating/gastroretentive systems in stomach. J Lit Pharm Sci 2018;7(2):146-59.
- 39.Javaid MU, Zaman M, Shahid S. A comprehensive discussion about gastro retentive drug delivery system. Int J Pharm Pharm Res 2016;8(1):35-52.
- 40.Gupta ME, Amulya C, Babu IS. A review on floating drug delivery systems. World J Pharm Res 2019;8(6):1294-302.
- 41.Bardonnet PL, Faivre V, Pugh WJ, Piffaretti JC, Falson F. Gastroretentive dosage forms: overview and special case of Helicobacter pylori. J Control Release 2006;111(1-2):1-18.
- 42.Gholap SB, Banarjee SK, Gaikwad DD, Jadhav SL, Thorat RM. Hollow microsphere: a review. Int J Pharm Sci Rev Res 2010;1(1):74-9.
- 43.Gupta P, Gnanarajan, Kothiyal P. Floating drug delivery system: a review. Int J Pharm Res Rev 2015;4(8):37-44.
- 44.Pattan SR, Wani NP, Shelar MU, Nirmal SA, Chaudhari PD, Gude RS. Scope and Significance of floating drug delivery system. Indian Drugs 2012;49(10):5-12.
- 45.Ishak RAH. Buoyancy-generating agents for stomach-specific drug delivery: an overview with special emphasis on floating behavior. J Pharm Pharm Sci 2015;18(1):77-100.
- 46.Kaushik AY, Tiwari AK, Gaur A. Role of excipients and polymeric advancements in preparation of floating drug delivery systems. Int J Pharm Investig 2015;5(1):1-12.
- 47.Gopalakrishnan S, Chenthilnathan A. Floating drug delivery systems: a review. J Pharm Sci Technol 2011;3(2):548-54.
- 48.Nabarawi MAE, Teaima MH, El-Monem RA A, Nabarawy NAE, Gaber DA. Formulation, release characteristics, and bioavailability study of gastroretentive floating matrix tablet and floating raft system of Mebeverine HCI. Drug Des Devel Ther 2017;11:1081-93.
- 49.Senyigit ZA, Vetter A, Guneri T, Bernkop-Schnurch A. Gastroretentive particles formulated with thiomers: development and in vitro evaluation. J Drug Target 2010;18(5):362-72.
- 50.Kucukoflaz M, Saracoglu Kaya B, Caglayan M O. Determination of mechanical properties of polymeric microspheres used in controlled drug delivery systems by nanoindentation. Polym Plast Technol Mat 2019;58(7):765-75.