PULSATILE DRUG DELIVERY SYSTEM: A FORMULATION APPROACH FOR TREATMENT OF DISEASES
location at a particular time. Some of the conditions under which pulsatile drug delivery system is positive include duodenal ulcer, cardiovascular disease, arthritis, asthma, diabetes, neurological disorder, cancer, hypertension, and hypercholesterolemia. Pulsatile drug delivery systems are essentially time-controlled drug delivery systems in which the lag time is regulated independently of environmental factors such as pH, enzymes, gastrointestinal motility, etc. The theory justification for the use of pulsatile release is for drugs where a continuous release of drugs is not needed, i.e. a zero-order release. Drug administration in chronopharmacotherapy is coordinated with biological rhythms to achieve full therapeutic effect and minimize harm to the patient. This drug delivery system is designed to distribute drugs in accordance with body clock. The pulse must be designed in such a way as to achieve a total and rapid release after the lag time.
Pulsatile drug delivery is therefore one device that provides strong promises of benefit to patients suffering from chronic conditions such as arthritis, asthma, hypertension by delivering medication at the right time, right place and in appropriate quantities. In recent pharmaceutical applications involving pulsatile delivery; multi-particulate dosage forms (e. g. pellets) over single-unit dosage forms are gaining more popularity. On the basis of methodologies, various pulsatile technologies have been developed, including ACCU-BREAKTM, AQUALON, CODAS ®, PRODAS ®, SODAS ®, MINITABS ®, DIFFUCAPS ®, OROS ® etc.
2. Mirelabodea, Ioantomuta, Sorin L. Identification of critical formulation variables for obtaining metoprolol tartrate mini-tablets. Farmacia 2010;58:719-27.
3. Katakam VK, Reddy S, Panakanti PK, Yamsani MR. Design and evaluation of a novel gas formation-based multiple-unit gastro-retentive floating drug delivery system for quetiapine fumarate. Trop J Pharma Res 2014;13:489-49.
4. Patwekar SL, Baramade MK. Controlled release approach to novel multi-particulate drug delivery system. Int J Pharm Pharma Sci 2012;4:756-63.
5. Leemer B. Chronopharmacokinetic: implication for drug treatment. J Pharm Pharmacol 1999;51:887-90.
6. Rubinstein A, Tirosh B, Baluom M, Nassar T, David A. The rationale for peptide drug delivery to the colon and the potential of polymeric carriers as effective tools. J Controlled Release 1995;46:59-73.
7. Sayeed A, Hamed M, Rafiq M, Ali N. Pulsatile drug delivery: recent technology. Int J Pharm Sci Res 2013;4:960-9.
8. Rompicharla B, Suria P. A comprehensive review of pulsatile drug delivery system. Int J Pharm Res 2012;3:106-8.
9. Prasanth V, Mitesh P, Modi, Sam T. Pulsatile: a tool for circardian rhythm-a review. J Drug Delivery Ther 2012;2:58-65.
10. Rajput M, Sharma R, Kumar S, Jamil F, Sissodia N. Pulsatile drug delivery system: a review. Int J Res Pharma Biomed Sci 2012;3:118-22.
11. Tolic IM, Mooskeilde E, Sturis J. Modeling the insulin-glucose feedback system: the significance of pulsatile insulin secretion. J Theor Biol 2000;207:361-75.
12. Cohen S, Bernstein H. Eds. Microparticulate systems for the delivery of proteins and vaccines. New York: Marcel Dekker, Inc; 1995.
13. Pandit V, Kumar A, Ashawat MS, Chander P, Verma CP, Kumar P. Recent advancement and technological aspects of pulsatile drug delivery system. Curr Drug Targets 2017;18:1191-203.
14. Krogel I, Bodmeier R. Floating or pulsatile drug delivery systems based on coated effervescent cores. Int J Pharm 1999;187:175–84.
15. Yui N, Okano T, Sakurai Y. Inflammation responsive degradation of crosslinked hyaluronic acid gels. J Controlled Release 1992;22:105–16.
16. Miyata N, Asami T, Uragami. A reversibly antigen responsive hydrogel. Nature 1999;399:766-9.
17. Saslawski O, Weigarten C, Benoit JP. Magnetically responsive microspheres for pulsed delivery of insulin. Life Sci 1988;42:1521-8.
18. Barzegar Jalali M, Siyahi Shadbad M. Design and evaluation of delayed release osmotic capsule of acetaminophen. Iran J Pharma Sci 2006;2:65–72.
19. Linkwitz A, Magruder JA, Merrill S. Osmotically driven delivery device with expandable orifice for pulsatile delivery effect. US Patent 5,318,558; 1994.
20. Balaban SM, Pike JB, Smith JP, Baile CA. Osmotically driven delivery devices with pulsatile effect. US Patent 5,209,746; 1993.
21. Niwa K, Takaya T, Morimoto T, Takada K. Preparation and evaluation of time controlled release capsule made of ethyl cellulose for colon delivery of drugs. J Drug Target 1995;3:83–9.
22. Arora S, Ali J, Ahuja A, Baboota S, Qureshi J. Pulsatile drug delivery systems: an approach for controlled drug delivery. Indian J Pharm Sci 2006;68:295–300.
23. Bussemer T, Dashevsky A, Bodmeier R. A pulsatile drug delivery system based on rupturable coated hard gelatin capsules. J Controlled Release 2003;93:331–9.
24. Krogel I, Bodmeier R. Pulsatile drug release from an insoluble capsule bodycontrolled by an erodible plug. Pharm Res 1998;15:474–81.
25. Krogel I, R Bodmeier R. Evaluation of an enzyme-containing capsular shaped pulsatile drug delivery system. Pharm Res 1999;16:1424–9.
26. Mohamad A, Dashevsky A. pH-independent pulsatile drug delivery system based on hard gelatin capsules and coated with aqueous dispersion Aquacoat® ECD. Eur J Pharm Biopharm 2006;64:173–9.
27. Pozzi F, Furlani P, Gazzaniga A, Davis SS. The TIME CLOCK system: a new oral dosage form for fast and complete release of drug after predetermined lag time. J Controlled Release 1994;31:99–108.
28. Wilding IR, Davis SS, Pozzi F, Furlani P, Gazzaniga A. Enteric coated timed release systems for colonic targeting. Int J Pharm 1994;111:99–102.
29. Gazzaniga A, Iamartino P, Maffione G, Sangalli ME. Oral delayed-release system for colonic specific delivery. Int J Pharm 1994;2:77–83.
30. Maroni A, Zema L, Cerea M, Sangalli ME. Oral pulsatile drug delivery systems. Expert Opin Drug Delivery 2005;2:855–71.
31. Sangalli ME, Maroni A, Zema L, Busetti C, Giordano F, Gazzaniga A. In vitro and in vivo evaluation of an oral system for time and/or site-specific drug delivery. J Controlled Release 2001;73:103–10.
32. Conte U, La Manna A, Colombo P. Tablet for pharmaceutical use able to release active substances at successive times. US Patent 4,865,849; 1989.
33. Conte U, Giunchedi P, Maggi L, Sangalli ME, Gazzaniga A, Colombo P, et al. Ibuprofen delayed release dosage forms: a proposal for the preparation of an in vitro/in vivo pulsatile system. Eur J Pharm 1992;38:209–12.
34. Roy P, Shahiwala A. Multiparticulate formulation approach to pulsatile drug delivery: current perspectives. J Controlled Release 2009;134:74–80.
35. Bussemer T, Bodmeier R. Multiparticulate pulsatile drug delivery systems. In: S Benita. Ed. Microencapsulation Methods and Industrial Applications Second Edition, CRC Press: Tyalor and Francis Group, 6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742; 2006.
36. Krogel I, Bodmeier R. Floating or pulsatile drug delivery systems based on coated effervescent cores. Int J Pharm 1999;187:175–84.
37. Percel P, Vishnupad KS, Venkatesh GM. Timed pulsatile drug delivery systems. US Patent. 6,627,223B2; 2003.
38. Narisawa S, Nagata M, Hirakawa Y, Kobayashi M, Yoshino H. An organic acid induced sigmoidal release system for oral controlled-release preparations. Part II: permeability enhancement of Eudragit RS coating led by the physicochemical interactions with organic acid. J Pharm Sci 1996;85:184–8.
39. Narisawa S, Nagata M, Danyoshi C, Yoshino H, Murata K, Hirakawa Y, et al. An organic acid-induced sigmoidal release system for oral controlled-release preparations. Pharm Res 1994;11:111–6.
40. Bodmeier R, Guo X, Sarabia RE, Skultety P. The influence of buffer species and strength on diltiazem HCl release from beads coated with aqueous cationic polymer dispersions, Eudragit RS, RL 30D. Pharm Res 1996;13:52–6.
41. Kumar GA, Bhat A, Lakshmi AP, Reddy K. An overview of stimuli-induced pulsatile drug delivery systems. Int J Phys The R 2010;2:2364-78.
42. Sarfaraz Md, Joshi VG. Development and evaluation of enteric coated drug delivery system for treatment of asthma. IOSR J Pharm 2014;4:34-6.
43. Jain D, Raturi R, Jain V, Bansal P, Singh R. Recent technologies in pulsatile drug delivery systems. Biomatter 2011;1:1-9.
44. MacNeil ME, Rashid A, Stevens HN. Dispensing device. World Patent; 1990. p. 9009168.
45. Fukui E, Miyamura N, Uemura K, Kobayashi M. Preparation of enteric coated timed release press-coatedtablets and evaluation of their function by in vitro and in vivo tests for colon targeting. Int J Pharm 2000;204:7-15.
46. Jose S, Dhanya K, Cinu TA, Litty J, Chacko AJ. Colon targeted drug delivery: different approaches. J Young Pharmacist 2009;1:13-9.
47. Patel GC, Patel MM. Developing a modified pulsincap system. Pharm Tech Europe 2009;21.
48. Steve E. Bio-enhancement technologies improve absorption of insoluble drugs in oral dosage forms. Drug Deliv Syst 2007;2:4.
49. Percel P, Vishnupad KS, Venkatesh GM. Timed sustained release systems for Propranolol. US Patent. 2002;6500454.
50. Roy P, Shahiwala A. Multiparticulate formulation approach to pulsatile drug delivery: Current perspectives. J Control Release 2009;134:74-80.
51. Verma RK, Garg S. Current Status of Drug Delivery Technologies and Future Directions. Pharma Technol On-Line 2001;25:1-14.
52. Deng GY, Li-Min Z, Christopher J, Branford W, Xiang LY. Three-dimensional printing in pharmaceutics: Promises and problems. J Pharm Sci 2008;97:3666-90.
53. Rowe CW, Katstra WE, Palazzolo RD, Giritlioglu B, Teung P, Cima MJ. Multimechanism oral dosage forms fabricated by three dimensional printing. J ContRele 2000;66:11-7.
54. Katstra WE. Fabrication of complex oral drug delivery forms by Three Dimensional Printing, Massachusetts Institute of Technology 2001;237-41.
55. Panoz DE. Geoghegan A, Edward J. Controlled absorption pharmaceutical composition. US Patent. 1989. 4863742.
56. Troy MH. Timing drug availability with therapeutic need. Speciality Pharma 2006;2:1.
57. Rappar D. Oral extended release: Snapshots and benefits. Drug Delivery Technol 2007;7:42.
58. Devesh AB, Pethe AM. Lipid technology—a promising drug delivery system for poorly water soluble drugs. Int J Pharm Res Devel 2010;2:1-11.
59. Shram M, Romach M, Sellers E, Thipphawong J. Assessing the abuse potential of an oral osmotic controlled extended release (OROS) hydromorphone compared to immediate release hydromorphone. J Pain 2009;10:45-54.
60. Zentner GM, Rork GS, Himmelstein KJ. The controlled porosity osmotic pump. J Control Release 1985;1:269-82.
61. Elan Corporation. Intestinal protective drug absorption system. US Patent. 1997. 75111480.
62. Shaji J, Chadawar V, Talwalkar P. Multiparticulate Drug Delivery System. The Indian Pharmacist 2007;6:21-8.
63. Steven AG. Bio-therapeutics—from drug discovery to drug delivery. Control release society Newsletter 2004;21:3.
64. Conte U, Colombo P, Maggi L, La MA. Compressed barrier layers for constant drug release in swellable matrix tablets. STP Pharma Sci 1994;4:107-13.
65. Conte U, Maggi L. Modulation of the dissolution profiles from Geomatrix® multi-layer matrix tablets, containing drugs of different solubility. Biomaterials 1996;17:889-96.
66. Conte U, La Manna A, Colombo P. Tablets with controlled-rate release of active substances. US Patent Application; 1992.
67. Ozeki Y, Danjo K. Development of one-step drycoated tablet system (OSDRC-System) and the comparison of its compression characteristics with those of conventional dry-coated tablets. J Pharm Sci Technol 2004;5:59-66.
68. Yuichi O, Masaki A, Yukinao W, Kazumi D. Evaluation of novel one-step dry-coated tablets as a platform for delayed-release tablets. J Controlled Release 2004;95:51-60.
69. Yuichi O, Yukinao W, Hirokazu O, Kazumi D. Development of dividable one-step dry-coated tablets (Dividable-OSDRC) and their evaluation as a new platform for controlled drug release. Pharm Res 2004;21:1177-83.
70. Bussemer T, Otto I, Bodmeier R. Pulsatile drug delivery systems. Crit Rev Ther Drug Carrier Syst 2001;18:433-58.
71. Shaji J, Chadawar V, Talwalkar P. Multiparticulate drug delivery system. Indian Pharm 2007;6:21-8.
72. Dey NS, Majumdar S, Rao MEB. Multiparticulate drug delivery systems for controlled release. Trop J Pharm Res 2008;7:1067-75.
73. Shidhaye S, Dhone A, Budhkar T, Surve C. Technologies in pulsatile drug delivery system. Int J Adv Pharm Biol Chem 2012;1:438-42.
74. Jones JW, Francis J. Softgels: consumer perceptions and market impact relative to other oral dosage forms. Adv Ther 2000;17:15-20.
75. Roy P, Shahiwala A. Multiparticulate formulation approach to pulsatile drug delivery: current perspectives. J Controlled Release 2009;134:74–80.
76. Prisant LM, Devane JG, Butler J. A steady-state evaluation of the bioavailability of chrono therapeutic oral drug absorption system verapamil PM after night time dosing versus immediate acting verapamil dosed every 8 h. Am J Ther 2000;7:345-51.
77. Smith DH, Neutel JM, Weber MA. A new chrono therapeutic oral drug absorption system for verapamil optimizes blood pressure control in the morning. Am J Hypertens 2001;4:14–9.
78. Bussemer T, Otto I, Bodmeier R. Pulsatile drug delivery systems. Crit Rev Ther Drug Carrier Syst 2001;18:433-58.
79. Ueda S, Ibuki R, Kimura S, Murata S, Takahashi T. Development of a novel drug release system, time controlled explosion system (TES). Part III: relation between lag time and membrane thickness. Chem Pharm Bull 1994;42:364-7.
80. Verma RK, Sanjay G. Current status of drug delivery technologies and future directions. Pharma Technol On-Line 2001;25:1-14.
81. Venkatesh G. Diffucaps technology for controlled release drug delivery. In: Youan BC. ed. Chronotherapeutics: science and technology for biological rhythm guided therapy and prevention of diseases. New York: John Wiley and Sons; 2009. p. 122-42.
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