Floating Drug Delivery System: As A Novel Approach for Drug Delivery
Abstract
The retention period of the drug and dosage form in the stomach is very challenging for the treatment of gastrointestinal disease. To solve this problem and improve the efficacy and bioavailability of the drug, most researchers develop a novel carrier system that is called a Floating drug delivery system (FDDS). The goal of this review on floating drug delivery systems (FDDS) is to synthesise contemporary material with a particular concentration on the main mechanism of flotation for stomach retention. The physiology of the stomach (including gastric pH and movement) has been shown a major effect on gastrointestinal holding period and drug delivery behaviour in both intra- and inter-subject variability. The most recent advancements in the Floating drug delivery system (FDDS) are thoroughly reviewed, including the physiological and formulation factors that influence stomach retention, design methods for single-unit and multiple-unit floating systems, and their categorization and formulation characteristics. A synopsis of the research that has been done to determine the effectiveness and utility of floating systems, as well as uses for such systems, is also included in this review. This study covers the most recent Floating drug delivery system (FDDS) technology advances, including patented delivery techniques and commercial devices, along with their benefits and potential applications for oral controlled drug administration in the future.
Keywords: Floating drug delivery system, Gastric-emptying time, Inter-digestive myoelectric cycle (IDMC), Polymers, Bioavailability, Membrane permeability.
Keywords:
Floating drug delivery system, Gastric-emptying time, Inter-digestive myoelectric cycle (IDMC), Polymers, Bioavailability, Membrane permeability
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References
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3. Desai S, Bolton S, “A floating controlled-release drug delivery system: in vitro-in vivo evaluation” Pharmaceutical Research, 1993; 10(9):1321-5. DOI: https://doi.org/10.1023/A:1018921830385.
4. Desai SA, “Novel floating controlled release drug delivery system based on a dried gel matrix (Doctoral dissertation, St. John's University)”, 1984.
5. Kamel AH, Sokar MS, Gamal SS, Naggar VF, “Preparation and evaluation of ketoprofen floating oral delivery system” International journal of pharmaceutics, 2001; 220(1-2):13-21. DOI: https://doi.org/10.1016/S0378-5173(01)00574-9.
6. Fell, J, Digenis, CG, “Imaging and behaviour of solid oral dosage forms in vivo” Int. J. Pharm, 1984; 22(1):1-15. DOI: https://doi.org/10.1016/0378-5173(84)90040-1.
7. Van Gansbeke B, Timmermans J, Schoutens A, Moës A, “Intragastric positioning of two concurrently ingested pharmaceutical matrix dosage forms” International journal of radiation applications and instrumentation, Part B. Nuclear medicine and biology, 1991; 18(7):711-8. DOI: https://doi.org/10.1016/0883-2897(91)90009-A.
8. Sanjay S, Vaibhav J, Kumar BP, “Gastro retentive drug delivery systems” In National Institute of Pharmaceutical Education and Research (NIPER), Pharmatech 2003.
9. Gohel MC, Mehta PR, Dave RK, Bariya NH. A more relevant dissolution method for evaluation of floating drug delivery system. 2004; 11(4):22-25. https://doi.org/10.14227/DT110404P22
10. Harries D, Sharma, HL, “GI transit of potential bio adhesives formulations in man: Ascintigraphic study” J. Cont. Rel, 1990; 12(1):45- 53. DOI: https://doi.org/10.1016/0168-3659(90)90182-S.
11. Joseph NJ, Lakshmi S, Jayakrishnan A, “A floating-type oral dosage form for piroxicam based on hollow polycarbonate microspheres: in vitro and in vivo evaluation in rabbits” Journal of controlled release, 2002; 79(1-3):71-9. DOI: https://doi.org/10.1016/S0168-3659(01)00507-7.
12. Hirtz J, “The gastrointestinal absorption of drugs in man: a review of current concepts and methods of investigation” British journal of clinical pharmacology, 1985; 19(S2):77S-83S. DOI: https://doi.org/10.1111/j.1365-2125.1985.tb02746.x.
13. Iannuccelli V, Sala N, Sergi S, Coppi G, “Oral absorption of riboflavin dosed by a floating multiple-unit system in different feeding conditions” Journal of Drug Delivery Science and Technology, 2004; 14(2):127-33. DOI: https://doi.org/10.1016/S1773-2247(04)50024-2.
14. Rubinstein A, Friend DR, “Specific delivery to the gastrointestinal tract” polymeric site-specific Pharmacotherapy, Wiley, Chichester, 1994:282-3.
15. Karande AD, Yeole PG, “Comparative assessment of different dissolution apparatus for floating drug delivery systems” Dissolute Technol, 2006; 13(1):20-23. DOI: http://dx.doi.org/10.14227/DT130106P20.
16. Iannuccelli V, Coppi G, Sansone R, Ferolla G, “Air compartment multiple-unit system for prolonged gastric residence. Part II. In-vivo evaluation” Int. J. Pharm, 1998; 174:55-62. DOI: https://doi.org/10.1016/S0378-5173(98)00230-0.
17. Tardi P, Troy H, European patent no. EP1432402. 2002.
18. Ikura, Hiroshi, Suzuki, Yoshiki, (1988) United States Patent 4777033.
19. Umezawa, Hamao., United States Patent 4101650. 1978.
20. Stops F, Fell JT, Collett JH, Martini LG, “Floating dosage forms to prolong gastro-retention-The characterisation of calcium alginate beads” International journal of pharmaceutics, 2008; 350:301-311. DOI: https://doi.org/10.1016/j.ijpharm.2007.09.009.
21. More S, Gavali K, Doke O, Kasgawade P, Gastroretentive drug delivery system. Journal of drug delivery and Therapeutics, 2018; 8(4):24-35. https://doi.org/10.22270/jddt.v8i4.1788
22. Patil JM, Hirlekar RS, Gide PS, Kadam VJ, “Trends in floating drug delivery systems” Journal of Scientific and Industrial Research, 2006; 65: 11-21.
23. Timmermans J, Moes AJ, “How well do floating dosage forms float” International journal of pharmaceutics, 1990; 62(2-3):207-16. DOI: https://doi.org/10.1016/0378-5173(90)90234-U.
24. Basavaraj BV, “A multiple units floating controlled drug delivery system of Famotidine” J Pharm Res, 2009; 2(5):826-829.
25. Thanoo BC, Sunny MC, Jayakrishnan A, “Oral sustained‐release drug delivery systems using polycarbonate microspheres capable of floating on the gastric fluid” Journal of pharmacy and pharmacology, 1993; 45(1):21-4. DOI: https://doi.org/10.1111/j.2042-7158.1993.tb03672.x.
26. Sato Y, Kawashima Y, Takeuchi H, Yamamoto H, “Physicochemical properties to determine the buoyancy of hollow microspheres (micro balloons) prepared by the emulsion solvent diffusion method” European journal of pharmaceutics and biopharmaceutics, 2003; 55(3):297-304. DOI: https://doi.org/10.1016/S0939-6411(03)00003-1.
27. Jain SK, Agrawal GP, Jain NK, “Evaluation of porous carrier-based floating orlistat microspheres for gastric delivery” AAPS pharmscitech, 2006; 7(4):54-62. https://doi.org/10.1208/pt070490
28. Oth M, Franz M, Timmermans J, Möes A, “The bilayer floating capsule: a stomach-directed drug delivery system for misoprostol” Pharmaceutical Research, 1992; 9(3):298-302. DOI: https://doi.org/10.1023/A:1015870314340.
29. Paterson RS, O Mahony B, Eccleston GM, Stevens HN, Foster J, Murray JG, “An assessment of floating raft formation in man using magnetic resonance imaging” Journal of Pharmacy and Pharmacology, 2000; 52(9):1-8.
30. Garg S, Sharma S, “Gastroretentive Drug Delivery System” Business Briefing: Pharmatech, 2003; 160-166.
31. Vedha H, Chaudhary J, “The recent developments on gastric floating drug delivery system: An overview” Journal of Pharmaceutical Technology and Research, 2010; 2(1):524-34.
32. Timmermans J, Moes AJ, “Factors controlling the buoyancy and gastric retention capabilities of floating matrix capsules: new data for reconsidering the controversy” Journal of pharmaceutical sciences, 1994; 83(1):18-24. DOI: https://doi.org/10.1002/jps.2600830106.
33. Karande AD, Yeole PG, “Comparative assessment of different dissolution apparatus for floating drug delivery systems” Dissolut Technol, 2006; 13(1):20-23. DOI: http://dx.doi.org/10.14227/DT130106P20.
34. Timmermans J, Gansbeke BV, Moes AJ, “Assessing by gamma scintigraphy the in vivo buoyancy of dosage forms having known size and floating force profiles as a function of time” InProc. 5th Int. Conf. Pharm. Technol, APGI, Paris, 1989; 1:42-51.
35. Sawicki W, “Pharmacokinetics of verapamil and norverapamil from controlled release floating pellets in humans” European journal of pharmaceutics and biopharmaceutics, 2002; 53(1):29-35. DOI: https://doi.org/10.1016/S0939-6411(01)00189-8.
36. Vantrappen GR, Peeters TL, Janssens J, “The secretory component of the interdigestive migrating motor complex in man” Scandinavian journal of gastroenterology, 1979; 14(6):663-7. DOI: https://doi.org/10.3109/00365527909181934.
37. Whitehead L, Fell JT, Collett JH, Sharma HL, Smith AM, “Floating dosage forms: an in vivo study demonstrating prolonged gastric retention” Journal of controlled release, 1998; 55(1):3-12. DOI: https://doi.org/10.1016/S0168-3659(97)00266-6.
38. Wilson CG, Washington N, “The stomach: its role in oral drug delivery. Physiological Pharmaceutical: Biological Barriers to Drug Absorption” Chichester, UK: Ellis Horwood, 1989; 47-70.
39. Sonar GS, Rao MR, Mandsaurwale RR, Gogad VK, Vanshiv SD, “Bioadhesive-floating matrix tablet of salbutamol sulphate using response surface methodology: optimization and in vitro evaluation” J Pharm Res, 2009; 2(5):908-914.
40. Chien YW, “Novel drug delivery systems” Drugs and the pharmaceutical sciences, 1992; 50. https://doi.org/10.1201/b14196
41. Patel A, Ray S, Thakur RA, “Invitro evaluation and optimization of controlled release floating drug delivery system of metformin hydrochloride” DARU Journal of Pharmaceutical Sciences, 2006; 14(2):57-64.
42. Fell JT, Digenis GA, “Imaging and behaviour of solid oral dosage forms in vivo” International journal of pharmaceutics, 1984; 22(1): 1-5. DOI: https://doi.org/10.1016/0378-5173(84)90040-1.
43. Nayak AK, Das B, Maji R, “Gastroretentive hydrodynamically balanced systems of ofloxacin: In vitro evaluation” Saudi Pharmaceutical Journal, 2013; 21(1):113-7. DOI: https://doi.org/10.1016/j.jsps.2011.11.002.
44. Mojaverian P, Vlasses PH, Kellner PE, Rocci ML, “Effects of gender, posture, and age on the gastric residence time of an indigestible solid: pharmaceutical considerations” Pharmaceutical Research, 1988; 5(10):639-44. DOI: https://doi.org/10.1023/A:1015922903843.
45. Patel SS, Ray S, Thakur RS, “Formulation and evaluation of floating drug delivery system containing clarithromycin for Helicobacter pylori” Acta Pol Pharm, 2006; 63(1):53-61. PMID: 17515330.
46. Kanekar AS, Patil AB, Kanavaje AM, Khade AB, Battase AP, “A comprehensive review and its possible scope” International journal of pharmacy review and research, 2014; 4(3):183-9.
47. Awasthi R, Pawar V, Kulkarni GT, “Floating microparticulate systems: an approach to increase gastric retention” Indian J Pharm, 2010; 1(1):17-26.
2. Babu VB, Khar RK, “In vitro and in vivo studies of sustained-release floating dosage forms containing salbutamol sulfate” Die Pharmazie, 1990; 45(4):268-70. PMID: 2381979.
3. Desai S, Bolton S, “A floating controlled-release drug delivery system: in vitro-in vivo evaluation” Pharmaceutical Research, 1993; 10(9):1321-5. DOI: https://doi.org/10.1023/A:1018921830385.
4. Desai SA, “Novel floating controlled release drug delivery system based on a dried gel matrix (Doctoral dissertation, St. John's University)”, 1984.
5. Kamel AH, Sokar MS, Gamal SS, Naggar VF, “Preparation and evaluation of ketoprofen floating oral delivery system” International journal of pharmaceutics, 2001; 220(1-2):13-21. DOI: https://doi.org/10.1016/S0378-5173(01)00574-9.
6. Fell, J, Digenis, CG, “Imaging and behaviour of solid oral dosage forms in vivo” Int. J. Pharm, 1984; 22(1):1-15. DOI: https://doi.org/10.1016/0378-5173(84)90040-1.
7. Van Gansbeke B, Timmermans J, Schoutens A, Moës A, “Intragastric positioning of two concurrently ingested pharmaceutical matrix dosage forms” International journal of radiation applications and instrumentation, Part B. Nuclear medicine and biology, 1991; 18(7):711-8. DOI: https://doi.org/10.1016/0883-2897(91)90009-A.
8. Sanjay S, Vaibhav J, Kumar BP, “Gastro retentive drug delivery systems” In National Institute of Pharmaceutical Education and Research (NIPER), Pharmatech 2003.
9. Gohel MC, Mehta PR, Dave RK, Bariya NH. A more relevant dissolution method for evaluation of floating drug delivery system. 2004; 11(4):22-25. https://doi.org/10.14227/DT110404P22
10. Harries D, Sharma, HL, “GI transit of potential bio adhesives formulations in man: Ascintigraphic study” J. Cont. Rel, 1990; 12(1):45- 53. DOI: https://doi.org/10.1016/0168-3659(90)90182-S.
11. Joseph NJ, Lakshmi S, Jayakrishnan A, “A floating-type oral dosage form for piroxicam based on hollow polycarbonate microspheres: in vitro and in vivo evaluation in rabbits” Journal of controlled release, 2002; 79(1-3):71-9. DOI: https://doi.org/10.1016/S0168-3659(01)00507-7.
12. Hirtz J, “The gastrointestinal absorption of drugs in man: a review of current concepts and methods of investigation” British journal of clinical pharmacology, 1985; 19(S2):77S-83S. DOI: https://doi.org/10.1111/j.1365-2125.1985.tb02746.x.
13. Iannuccelli V, Sala N, Sergi S, Coppi G, “Oral absorption of riboflavin dosed by a floating multiple-unit system in different feeding conditions” Journal of Drug Delivery Science and Technology, 2004; 14(2):127-33. DOI: https://doi.org/10.1016/S1773-2247(04)50024-2.
14. Rubinstein A, Friend DR, “Specific delivery to the gastrointestinal tract” polymeric site-specific Pharmacotherapy, Wiley, Chichester, 1994:282-3.
15. Karande AD, Yeole PG, “Comparative assessment of different dissolution apparatus for floating drug delivery systems” Dissolute Technol, 2006; 13(1):20-23. DOI: http://dx.doi.org/10.14227/DT130106P20.
16. Iannuccelli V, Coppi G, Sansone R, Ferolla G, “Air compartment multiple-unit system for prolonged gastric residence. Part II. In-vivo evaluation” Int. J. Pharm, 1998; 174:55-62. DOI: https://doi.org/10.1016/S0378-5173(98)00230-0.
17. Tardi P, Troy H, European patent no. EP1432402. 2002.
18. Ikura, Hiroshi, Suzuki, Yoshiki, (1988) United States Patent 4777033.
19. Umezawa, Hamao., United States Patent 4101650. 1978.
20. Stops F, Fell JT, Collett JH, Martini LG, “Floating dosage forms to prolong gastro-retention-The characterisation of calcium alginate beads” International journal of pharmaceutics, 2008; 350:301-311. DOI: https://doi.org/10.1016/j.ijpharm.2007.09.009.
21. More S, Gavali K, Doke O, Kasgawade P, Gastroretentive drug delivery system. Journal of drug delivery and Therapeutics, 2018; 8(4):24-35. https://doi.org/10.22270/jddt.v8i4.1788
22. Patil JM, Hirlekar RS, Gide PS, Kadam VJ, “Trends in floating drug delivery systems” Journal of Scientific and Industrial Research, 2006; 65: 11-21.
23. Timmermans J, Moes AJ, “How well do floating dosage forms float” International journal of pharmaceutics, 1990; 62(2-3):207-16. DOI: https://doi.org/10.1016/0378-5173(90)90234-U.
24. Basavaraj BV, “A multiple units floating controlled drug delivery system of Famotidine” J Pharm Res, 2009; 2(5):826-829.
25. Thanoo BC, Sunny MC, Jayakrishnan A, “Oral sustained‐release drug delivery systems using polycarbonate microspheres capable of floating on the gastric fluid” Journal of pharmacy and pharmacology, 1993; 45(1):21-4. DOI: https://doi.org/10.1111/j.2042-7158.1993.tb03672.x.
26. Sato Y, Kawashima Y, Takeuchi H, Yamamoto H, “Physicochemical properties to determine the buoyancy of hollow microspheres (micro balloons) prepared by the emulsion solvent diffusion method” European journal of pharmaceutics and biopharmaceutics, 2003; 55(3):297-304. DOI: https://doi.org/10.1016/S0939-6411(03)00003-1.
27. Jain SK, Agrawal GP, Jain NK, “Evaluation of porous carrier-based floating orlistat microspheres for gastric delivery” AAPS pharmscitech, 2006; 7(4):54-62. https://doi.org/10.1208/pt070490
28. Oth M, Franz M, Timmermans J, Möes A, “The bilayer floating capsule: a stomach-directed drug delivery system for misoprostol” Pharmaceutical Research, 1992; 9(3):298-302. DOI: https://doi.org/10.1023/A:1015870314340.
29. Paterson RS, O Mahony B, Eccleston GM, Stevens HN, Foster J, Murray JG, “An assessment of floating raft formation in man using magnetic resonance imaging” Journal of Pharmacy and Pharmacology, 2000; 52(9):1-8.
30. Garg S, Sharma S, “Gastroretentive Drug Delivery System” Business Briefing: Pharmatech, 2003; 160-166.
31. Vedha H, Chaudhary J, “The recent developments on gastric floating drug delivery system: An overview” Journal of Pharmaceutical Technology and Research, 2010; 2(1):524-34.
32. Timmermans J, Moes AJ, “Factors controlling the buoyancy and gastric retention capabilities of floating matrix capsules: new data for reconsidering the controversy” Journal of pharmaceutical sciences, 1994; 83(1):18-24. DOI: https://doi.org/10.1002/jps.2600830106.
33. Karande AD, Yeole PG, “Comparative assessment of different dissolution apparatus for floating drug delivery systems” Dissolut Technol, 2006; 13(1):20-23. DOI: http://dx.doi.org/10.14227/DT130106P20.
34. Timmermans J, Gansbeke BV, Moes AJ, “Assessing by gamma scintigraphy the in vivo buoyancy of dosage forms having known size and floating force profiles as a function of time” InProc. 5th Int. Conf. Pharm. Technol, APGI, Paris, 1989; 1:42-51.
35. Sawicki W, “Pharmacokinetics of verapamil and norverapamil from controlled release floating pellets in humans” European journal of pharmaceutics and biopharmaceutics, 2002; 53(1):29-35. DOI: https://doi.org/10.1016/S0939-6411(01)00189-8.
36. Vantrappen GR, Peeters TL, Janssens J, “The secretory component of the interdigestive migrating motor complex in man” Scandinavian journal of gastroenterology, 1979; 14(6):663-7. DOI: https://doi.org/10.3109/00365527909181934.
37. Whitehead L, Fell JT, Collett JH, Sharma HL, Smith AM, “Floating dosage forms: an in vivo study demonstrating prolonged gastric retention” Journal of controlled release, 1998; 55(1):3-12. DOI: https://doi.org/10.1016/S0168-3659(97)00266-6.
38. Wilson CG, Washington N, “The stomach: its role in oral drug delivery. Physiological Pharmaceutical: Biological Barriers to Drug Absorption” Chichester, UK: Ellis Horwood, 1989; 47-70.
39. Sonar GS, Rao MR, Mandsaurwale RR, Gogad VK, Vanshiv SD, “Bioadhesive-floating matrix tablet of salbutamol sulphate using response surface methodology: optimization and in vitro evaluation” J Pharm Res, 2009; 2(5):908-914.
40. Chien YW, “Novel drug delivery systems” Drugs and the pharmaceutical sciences, 1992; 50. https://doi.org/10.1201/b14196
41. Patel A, Ray S, Thakur RA, “Invitro evaluation and optimization of controlled release floating drug delivery system of metformin hydrochloride” DARU Journal of Pharmaceutical Sciences, 2006; 14(2):57-64.
42. Fell JT, Digenis GA, “Imaging and behaviour of solid oral dosage forms in vivo” International journal of pharmaceutics, 1984; 22(1): 1-5. DOI: https://doi.org/10.1016/0378-5173(84)90040-1.
43. Nayak AK, Das B, Maji R, “Gastroretentive hydrodynamically balanced systems of ofloxacin: In vitro evaluation” Saudi Pharmaceutical Journal, 2013; 21(1):113-7. DOI: https://doi.org/10.1016/j.jsps.2011.11.002.
44. Mojaverian P, Vlasses PH, Kellner PE, Rocci ML, “Effects of gender, posture, and age on the gastric residence time of an indigestible solid: pharmaceutical considerations” Pharmaceutical Research, 1988; 5(10):639-44. DOI: https://doi.org/10.1023/A:1015922903843.
45. Patel SS, Ray S, Thakur RS, “Formulation and evaluation of floating drug delivery system containing clarithromycin for Helicobacter pylori” Acta Pol Pharm, 2006; 63(1):53-61. PMID: 17515330.
46. Kanekar AS, Patil AB, Kanavaje AM, Khade AB, Battase AP, “A comprehensive review and its possible scope” International journal of pharmacy review and research, 2014; 4(3):183-9.
47. Awasthi R, Pawar V, Kulkarni GT, “Floating microparticulate systems: an approach to increase gastric retention” Indian J Pharm, 2010; 1(1):17-26.
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Choudhary M, Tiwari C, Chahar RK, Malik P, JAISWAL P, Chauhan R. Floating Drug Delivery System: As A Novel Approach for Drug Delivery. JDDT [Internet]. 15Nov.2022 [cited 1Dec.2023];12(6):210-8. Available from: https://jddtonline.info/index.php/jddt/article/view/5778
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