Pulsatile Drug Delivery Systems: An Overview

DOI:

https://doi.org/10.37285/ijpsn.2009.2.3.3

Authors

  • Ramesh D. Parmar
  • Rajesh K. Parikh
  • G. Vidyasagar
  • Dhaval V. Patel
  • Chirag J. Patel
  • Biraju D. Patel

Abstract

Pulsatile  Drug  Delivery  Systems  are  gaining  a  lot  of  interest  as  they  deliver  the  drug  at  the  right  place  at  the  right  time  and  in  the  right  amount,  thus  providing  spatial  and  temporal  delivery  and  increasing  patient  compliance.  These  systems  are  designed  according  to  the  circadian  rhythm  of  the  body.  The  principle  rationale  for  the  use  of  pulsatile  release  of  the  drugs is where  a  constant  drug  release  is  not  desired.  A  pulse  has  to  be  designed  in  such  a  way  that  a  complete  and  rapid  drug  release  is  achieved  after  the  lag  time.  Various  systems  like  capsular  systems,  osmotic  systems,  single-  and  multiple-unit  systems  based  on  the  use  of  soluble  or  erodible  polymer  coating  and  use  of  rupturable  membranes  have  been  dealt  with  in  the  article.  It  summarizes  the  latest  technological  developments,  formulation  parameters,  and  release  profiles  of  these  systems.  These  systems  are  beneficial  for  the  drugs  having  chronopharmacological  behavior  where  night  time  dosing  is  required,  such  as  anti-arhythmic  and  anti-asthmatic.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Pulsatile, Rupturable, Erodible, Osmotic

Downloads

Published

2009-11-30

How to Cite

1.
Parmar RD, Parikh RK, G. Vidyasagar, Patel DV, Patel CJ, Patel BD. Pulsatile Drug Delivery Systems: An Overview. Scopus Indexed [Internet]. 2009 Nov. 30 [cited 2024 Nov. 22];2(3):605-14. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/518

Issue

Section

Review Articles

References

A.V. Gothoskar, A.M. Joshi, N.H. Joshi, Pulsatile drug delivery systems: a review, Drug Delivery Technology, Vol. 4 No. 5 June 2004.

Amidon GL, Leesman GD. Pulsatile Drug Delivery System. US Patent No. 5,229,131; 1993.

Balaban SM, Pike JB, Smith JP, Baile CA. Osmotically Driven Delivery Devices with Pulsatile Effect. US Patent No. 5209746; 1993.

Beckert TE, Pogarell K, Hack I, Petereit H-U. Pulsed drug release with film coatings of Eudragit & Mac226; RS 30D. Precede Int’l Symp Control Rel Bioact Mater. 1999; 26:533-534.

Binns J, Stevens HNE, McEwen J, Pritchard G, Brewer FM, Clarke A, Johnson ES, McMillan I. The tolerability of multiple oral doses of Pulsincap & Mac226 capsules in healthy volunteers. J Control Rel. 1996;38:151-158.

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(1):52-56.

Bussemer T, Bodmeier R. Pulsatile drug release from coated capsules. AAPS Pharm Sci. 1999;1(4 suppl):434 (1999).

Bussemer T, Otto I, Bodmeier R. Pulsatile drug delivery systems. Crit Rev Ther Drug Carrier Syst. 2001;18(5):433-58. Review.

Bussemer, T.; Otto, I.; Bodmeier, R. Pulsatile drug-delivery systems. Crit. Rev. Ther. Drug Carr. Syst. 2001, 18 (5), 433–458.

Chang R-K, Guo X, Burside BA, Couch RA, Rudnic EM. Formulation approaches for oral pulsatile drug delivery. Amer Pharma Rev. 1999;2(1):51-57.

Chen C-M. Multiparticulate Pulsatile Drug Delivery System. US Patent No. 5,260,069; 1993.

Chen C-M. Multiparticulate Pulsatile Drug Delivery System. US Patent No. 5,508,040; 1996.

Chen C-M. Pulsatile Particles Drug Delivery System. US Patent No. 5,260,068; 1993.

Conte U, Colombo P, La Manna A, Gazzaniga A. A new ibuprofen pulsed release oral dosage form. Drug Dev Ind Pharm. 1989;15(14-16):2583-2596.

Conte U, Giunchedi P, Maggi L, Sangalli ME, Gazzaniga A, Colombo P, La Manna A. Ibuprofen delayed release dosage forms: a proposal for the preparation of an in vitro/in vivo pulsatile system. Eur J Pharm. 1992;38(6):209-212.

Conte U, La Manna A, Colombo P. Tablet for Pharmaceutical Use Able to Release Active Substances At Successive Times. US Patent No. 4,865,849; 1989.

Crison JR, Siersma PR, Amidon GL. A novel programmable oral release technology for delivering drugs: human feasibility testing using gamma scintigraphy. Proceed Intern Symp Control Rel Bioact Mater. 1996;23:51-52.

Crison JR, Siersma PR, Taylor MD, Amidon GL. Programmable oral release technology, Port Systems & Mac226: a novel dosage form for time and site specific oral drug delivery. Proceed Intern Symp Control Rel Bioact Mater. 1995;22:278-279.

Crison JR, Vieira ML, Kim J-S, Siersma C, Amidon GL. Pulse delivery of methylphenidate in dogs using an osmotic drug delivery system. Proceed Intern Symp Control Rel Bioact Mater. 2001;28:6101.

Daumesnil R. Marketing Considerations for multiparticulate drug delivery systems. In: Ghebre-Sellassie I, ed. Multiparticulate Oral Drug Delivery. New York, NY: Marcel Dekker, Inc.; 1994:457-474.

Dethlefsen U, Repges R. Ein neues therapieprinzip bei nächtlichem asthma. Med Klinik. 1985;80:44-47.

Gazzaniga A, Busetti C, Moro L, Crimella T, Sangalli ME, Giordano F. Evaluation of low viscosity HPMC as retarding coating material in the preparation of a time-based oral colon specific delivery system. Proceed Intern Symp Control Rel Bioact Mater. 1995;22:242-243.

Gazzaniga A, Iamartino P, Maffione G, Sangalli ME. Oral delayed-release system for colonic specific delivery. Int J Pharm. 1994;2(108):77-83.

Gazzaniga A, Sangalli ME, Giordano F. Oral chronotopic & Mac226: drug delivery systems: achievement of time and/or site specifity. Eur J Biopharm. 1994;40(4):246-250.

Gazzaniga, A.; Iamartino, P.; Maffione, G.; Sangalli, M.E. Oral delayed-release system for colonic specific delivery. Int. J. Pharm. 1994, 108, 77–83.

Gazzaniga, P. Iamartino, G. Maffione, M.E. Sangalli, Oral delayed-release system for colonic specific delivery. Int. J. Pharm. 1994;108:77–83.

Gennaro AR, ed. Remington: The Science and Practice of Pharmacy. 20th ed. USA: Lippincott, Williams & Wilkins; 2000;20:903-905.

Goo RH, Moore JG, Greenberg E, Alazraki NP. Circadian variation in gastric emptying of meals in humans. Gastroenterol. 1987;93(3):515-518.

Guo X. Physicochemical and Mechanical Properties Influencing the Drug Release From Coated Dosage Forms. Doctoral Thesis. The University of Texas at Austin;1996.

Gurny R, Junginger HE, Peppas N. Pulsatile Drug Delivery: Current Applications and Future Trends. Stuttgart, Germany: Wissenschaftliche Verlagsgesellschaft;1993.

Hariharan, M.; Gupta, V.K. Encore: a novel compression-coated tablet dosage form. In Proceed. Int. Symp. Control. Rel. Bioact. Mater., San Diego, CA, 2001; Controlled Release Society: Minneapolis, MN, 2001; 6102.

Hata T, Shimazaki Y, Kagayama A, Tamura S, Ueda S. Development of a novel drug delivery system (TES): Part V: animal pharmacodynamic study and human bioavailability study. Int J Pharm. 1994;110:1-7.

Higgins, R.; Baumgarner, C.; Gilday, S.; Ketsela, S.; Sanghvi, P.; Smith, E.; Woodcock, P.; Baker, H. Chronotherapeutic drug delivery system using compression coating of a polysaccharide hydrogel matrix system. In Controlled Release Society 29th Annual Meeting Proc., 2002; Controlled Release Society: Minneapolis, MN, 2002; 237.

Krögel I, Bodmeier R. Evaluation of an enzyme-containing capsular shaped pulsatile drug delivery system. Pharm Res. 1999;16(9):1424-1429.

Krögel I, Bodmeier R. Floating or pulsatile drug delivery systems based on coated effervescent cores. Int J Pharm. 1999;187:175-184.

Krögel I, Bodmeier R. Pulsatile drug release from an insoluble capsule body controlled by an erodible plug. Pharm Res. 1998;15(3):474-481.

Lachman L, Lieberman HA, Kanig JL, The Theory and Practice of Industrial Pharmacy. Vol. 3. India: Verghese Publishing House; 1991.

Lemmer B. Chronopharmacokinetics: implications for drug treatment. J Pharm Pharmacol. 1999;51:887-890.

Lemmer, B. Chronopharmacokinetics: implicationsfor drug treatment. J. Pharm. Pharmacol. 1999, 51, 887–890.

Lerner, I.E. Flashner, M. Penhasi, A. Delayed Total Release Gastrointestinal Drug Delivery System. WO Patent 99/18938, 1999.

Linkwitz A, Magruder JA, Merrill S. Osmotically Driven Delivery Device with Expandable Orifice for Pulsatile Delivery Effect. US Patent No. 5,221,278; 1993.

Linkwitz A, Magruder JA, Merrill S. Osmotically Driven Delivery Device with Expandable Orifice for Pulsatile Delivery Effect. US Patent No. 5,318,558; 1994.

Magruder PR, Barclay B, Wong PSL, Theeuwes F. Composition Comprising a Therapeutic Agent and a Modulating Agent. US Patent No. 4851229; 1989.

Magruder PR, Barclay B, Wong PSL, Theeuwes F. Composition Comprising Salbutamol. US Patent No. 4751071; 1988.

Magruder PR, Barclay B, Wong PSL, Theeuwes F. Constant Release System with Pulsed Release. US Patent No. 4777049; 1988.

Maroni A, Sangalli ME, Cerea M, Busetti C, Giordano F, Gazzaniga A. Low viscosity HPMC coating of soft and hard gelatin capsules for delayed and colonic release: preliminary investigations on process parameters and in vitro release performances. Proceed Int Control Rel Bioact Mater. 1999; 26:887-888.

Martindale --- The Complete Drug Reference, The Pharmaceutical Press, London, 2006.

McNeil ME, Rashid A, Stevens HNE. Dispensing Device. WO Patent No. 90/09168 (1990).

Narisawa S, Nagata M, Danyoshi C, Yoshino H, Murata K, Hirakawa Y, Noda K. An organic acid-induced sigmoidal release system for oral controlled-release preparations. Pharm Res. 1994; 11(1):111-116.

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(2):184-188.

Narisawa S, Nagata M, Ito T, Yoshino H, Hirakawa Y, Noda K. Drug release behavior in gastrointestinal tract of beagle dogs from multiple unit type rate-controlled or time-controlled release preparations coated with insoluble polymer-based film. J Control Rel. 1995 33:253-260.

Niwa K, Takaya T, Morimoto T, Takada I. Preparation and evaluation of a time controlled release capsule made of ethyl cellulose for colon delivery of drugs. J Drug Target. 1995;3:83-89.

Petereit HU. Pulsed release drug delivery. www.iptonline.com. 2003:101-104.

Poli S, Busetti C, Moro L. Oral Pharmaceutical Composition for Specific Colon Delivery. EP Patent No. 0,572,942; 1993.

Pollock-Dove C, Dong L, Wong P. A new system to deliver a delayed bolus of liquid drug formulation. Proceed Intern Symp Control Rel Bioact Mater. 2001;28:6033.

Pozzi F, Furlani P. Orale Feste Pharmazeutische Darreichungsform Mit Programmierter Freisetzung. DE Patent No. 4122039; 1992.

Ritschel, W.A.; Forusz, H. Chronopharmacology: areview of drugs studies. Methods Find. Exp. Clin. Pharmacol. 1994, 16 (1), 57–75.

Saeger H, Virley P. Pulsincap& Mac226: Pulsed-Release Dosage Form. Product information from Scherer DDS, Ltd; 2004.

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 Contr Rel. 2001;73:103-110.

Schultz P, Kleinebudde P. A new multiparticulate delayed release system. Part I: dissolution properties and release mechanism. J Contr Rel. 1997;47:181-189.

Schultz P, Tho I, Kleinebudde P. A new multiparticulate delayed release system. Part II: coating formulation and properties of free films. J Contr Rel. 1997; 47:191-199.

T.Y. Fan, S.L. Wei, W.W. Yan, D.B. Chen, J. Li, An investigation of pulsatile release tablets with ethyl cellulose and Eudragitt L as film coating materials and cross-linked polyvinylpyrrolidone in the core tablets., Journal of Controlled Release 2001;77:245-251.

Ueda S, Ibuki R, Kimura S, Murata S, Takahashi T, Tokunaga Y, Hata 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(2):364-367.

Ueda S, Yamaguchi H, Kotani M, Kimura S, Tokunaga Y, Kagayama A, Hata T. Development of a novel drug release system, time-controlled explosion system (TES). Part II: design of multiparticulate TES and in vitro drug release properties. Chem Pharm Bull. 1994; 42(2):359-363.

Ueda Y, Hata T, Yamaguchi H, Kotani M, Ueda S. Development of a novel drug release system, time-controlled explosion system (TES). Part 1: concept and design. J Drug Targeting. 1994;2:35-44.

Ueda Y, Hata T, Yamaguchi H, Ueda S, Kotani M. Time Controlled Explosion System and Process for Preparation for the Same. US Patent No. 4,871,549;1989.

Urwitz, H., Karim, A. and Burns, H.S., J. of ClinicalPharmocol., 1987, 27, 855.

Wilding IR, Davis SS, Bakhshaee M, Stevens HNE, Sparrow RA, Brennan J. Gastrointestinal transit and systemic absorption of captopril from a pulsed-release formulation. Pharm Res. 1992; 9:654-657.

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.