Recent trends in pulsatile drug delivery systems - A review
Keywords:
Pulsatile drug delivery systems, Circadian rhythm, Single unit, Multiple units, Pulsatile release pulsincapAbstract
The purpose of writing this review on pulsatile drug delivery systems (PDDS) is to compile the recent literatures with special focus on the different types and approaches involved in the development of the formulation. PDDS are gaining importance in the field of pharmaceutical technology as these systems deliver the right dose at specific time at a specific site. Some of the disease conditions wherein PDDS are promising include duodenal ulcer, cardiovascular diseases, arthritis, asthma, diabetes, neurological disorder, cancer, hypertension and hypercholesterolemia. PDDS can be classified into time controlled systems wherein the drug release is controlled primarily by the delivery system, stimuli induced PDDS in which release is controlled by the stimuli, such as the pH or enzymes present in the intestinal tract or enzymes present in the drug delivery system and externally regulated system where release is programmed by external stimuli like magnetism, ultrasound, electrical effect and irradiation. This review also summarizes some current PDDS already available in the market. These systems are useful to several problems encountered during the development of a pharmaceutical dosage form.
References
Gennaro AR, ed. Remington. The Science and
Practice of Pharmacy 20th ed. USA: Lippincott,
Williams & Wilkins 2000;20:903-905.
Bussemer T, Otto I, Bodmeier R. Pulsatile drug
delivery systems Crit Rev. Ther Drug Carrier
Syst 2001;18(5):433-58.
Alessandra Maroni, Lucia Zema, Matteo Cerea,
Maria Edvige Sangalli. Oral pulsatile drug
delivery systems. Exp Opin Drug Del 2005; 2 (5):
-871.
Lemmer B. Chronopharmacokinetics:
implications for drug treatment. J Pharm
Pharmacology 1999; 51: 887-890.
Ritschel, Forusz WA. Chronopharmacology: a
review of drugs studies, Methods Find. Exp Clin
Pharmacol 1994; 16 (1): 57-75.
Veena S Belgamwar, Madhuri V Gaikwad,
Ganesh B Patil, Sanjay Surana. Pulsatile drug
delivery system. Asian J of Pharmaceutics 2008;
(3):141-145.
Das NG, Das SK. Controlled release of oral
dosage forms, formulation, finish, and fill. 2003;
-16.journal name
Khamidov N, Zaslavskaia RM, Arustamian GS.
The daily dynamics of blood lipids in elderly
subjects with hypertension. Lab Del 1990; 47–50.
Hulcher FH, Reynolds J, Rose JC. Circadian
rhythm of HMG-CoA reductase and insulin in
African green monkeys. Biochem Int 1985; 10:
– 185.
Mayer D. The circadian rhythm of synthesis and
catabolism of cholesterol. Arch Toxicol 1976; 36:
–276.
Goff WL, Guerin M, Chapman J, Bruckert E.
Circadian and interindividual variations of
cholesterol synthesis. Sang Thromb Vaiss 2001;
: 461– 467.
Stein EA, Davidson MH, Dobs AS, Schrott H,
Dujovne CA, Bays H, Weiss SR, Melino MR,
Mitchel ME, Mitchel YB. Efficacy and safety of
simvastatin 80 mg/day in hypercholesterolemic
patients. Am J Cardiol 1998; 82: 311- 316.
Richard MD, Havel J. Simvastatin: a one-a-day
treatment for hypercholesterolemia An
Introduction. Am J Med 1989; 87 (Suppl 4): 1S–
S.
Martin RJ, Banks-Schlegel S. Chronobiology of
asthma, Am J Respir Crit Care Med. 1998; 158:
– 1007.
Arkinstall WW. Review of the North American
experience with evening administration of
Uniphyl tablets, a once-daily theophylline. 1994;
–524.
Preparation, in the treatment of nocturnal asthma,
Am. J. Med 1988;85:60-63
Hrushesky W, Langer R, Theeuwes F. Temporal
Control of Drug Delivery. New York Academy of
Sciences, New York1991.
Buchi KN, Moore JG, Hrushesky WJ, Sothern
RB, Rubin NH. Circadian rhythm of cellular
proliferation in the human rectal mucosa,
Gastroenterology 1991; 101: 410– 415.
Hori K, Zhang QH, Li HC, Saito S, Sato Y.
Timing of cancer chemotherapy based on
circadian variations in tumor tissue blood flow.
Int J Cancer 1996; 65:360–364.
Levi V. Circadian chronotherapy for human
cancers. Lancet Oncol 2001; 2: 307– 315.
Moore JG, Englert Jr E. Circadian rhythm of
gastric acid secretion in man. Nature 1970;
:1261–1262.
Cloud ML, Offen WW, Nizatidine versus placebo
ingastroesophageal reflux
disease.A6week,multicenter,randomized,doublebl
indcomparison.NizatidineGastroesophageal Relux
Disease Study Group. Dig Dis Sci 1992; 37: 865–
Sanders SW, Moore JG. Gastrointestinal
chronopharmacology: physiology, pharmacology
and therapeutic implications. Pharmacol Ther
; 54: .1-15.
Humphries TJ, Root JK, Hufnagel K. Successful
drugspecific chronotherapy with the H2 blocker
famotidine in the symptomatic relief of
gastroesophageal reflux disease. Ann New York
Acad Sci 1991; 517-518.
Auvil-Novak SE. The chronobiology,
chronopharmacology, and chronotherapeutics of
pain. Annu Rev Nurs Res. 1999; 17: 133–153.
Herold M, Gunther R.. Circadian rhythm of Creactive protein in patients with rheumatoid
arthritis. Prog Clin Biol Res 1987; 271– 279.
Arvidson NG, Gudbjornsson B, Elfman L, Ryden
AC, Totterman TH, Hallgren R. Circadian rhythm
of serum interleukin-6 in rheumatoid arthritis.
Ann Rheum Dis1994; 53: 521-524.
Rigas AN, Bittles AH, Hadden DR, Montgomery
DA. Circadian variation of glucose, insulin, and
free fatty acids during long-term use of oral
hypoglycaemic agents in diabetes mellitus. Br
Med J 1968; 3: 25– 28.
Cincotta AH, Meier AH. Circadian rhythms of
lipogenic and hypoglycaemic responses to insulin
in the golden hamster (Mesocricetus auratus). J
Endocrinol 1984; 103: 141-146.
Poirel C,Ennaji M. Chronobiological paradigms
of mental life and clinical neuroscience.
Encephhale 2000; 26: 57-66.
Lemmer B. Cardiovascular chronobiology and
chronopharmacology. Biological Rhythms in
Clinical and Laboratory Medicine 1992; 418–
Tofler GH, Brezinski D, Schafer AI, Czeisler CA,
Rutherford JD, Willich SN, Gleason RE, Williams
GH, Muller JE. Concurrent morning increase in
platelet aggregability and the risk of myocardial
infarction and sudden cardiac death. J Med 1987;
: 1514–1518.
Muller JE, Tofler GH, Stone PH. Circadian
variation and triggers of onset of acute
cardiovascular disease. Circulation 1989; 79:733–
Drayer JI, Weber MA, Nakamura DK. Automated
ambulatory blood pressure monitoring: a study in
age-matched normotensive and hypertensive men.
Am Heart J 1985; 109: 1334–1338.
Libo Yan,James L,Chu,Josph A,Fix.Colonicspecific drug delivery:new approaches and
Invitro/invivo evaluation. Int J Pharma
;235:1-15.
Saeger H, Virley P. Pulsincap& Mac226: PulsedRelease Dosage Form. Product information from
Scherer DDS, Ltd; 2004.
Bodmeier R. Pulsatile drug release from an
insoluble capsule body controlled by an erodible
plug. Pharm Res 1998; 15(3): 474-481.
Krgel I, Bodmeier R. Evaluation of an enzymecontaining capsular shaped pulsatile drug delivery
system. Pharm Res 1999; 16(9): 1424-1429.
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-
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.
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.
Linkwitz A, Magruder JA, Merrill S. Osmotically
Driven Delivery Device with Expandable Orifice
for Pulsatile Delivery Effect. US Patent No.
,318,558; 1994.
Linkwitz A, Magruder JA, Merrill S. Osmotically
Driven Delivery Device with Expandable Orifice
for Pulsatile Delivery Effect. US Patent No.
,221,278; 1993.
Balaban SM, Pike JB, Smith JP, Baile CA.
Osmotically Driven Delivery Devices with
Pulsatile Effect. US Patent No. 5209746; 1993.
Magruder PR, Barclay B, Wong PSL, Theeuwes
F. Composiition comprising salbutamol. US
Patent No.4751071;1988.
Pozzi F, Furlani P. Orale Feste Pharmazeutische
Darreichungsform Mit Programmierter
Freisetzung. DE Patent No. 4122039; 1992.
Wilding IR, Davis SS, Pozzi F, Furlani P,
Gazzaniga A. Enteric coated timed release
systems for colonic targeting. Int J Pharm 1994;
: 99-102.
Gazzaniga A, Iamartino P, Maffione G, Sangalli
ME. Oral delayed-release system for colonic
specific delivery. Int J Pharm 1994; 2(108): 77-
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.
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.
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-
Amidon GL, Leesman GD. Pulsatile Drug
Delivery System. US Patent No. 5,229,131; 1993.
Chen CM. Multiparticulate Pulsatile Drug
Delivery System. US Patent No. 5,508,040; 1996.
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.
Beckert TE, Pogarell K, Hack I, Petereit HU.
Pulsed drug release with film coatings of Eudragit
& Mac226; RS 30D. Proceed Int'l Symp Control
Rel Bioact
Narisawa S, Nagata M, Danyoshi C, Yoshino H,
Murata K, Hirakawa Y, Noda K. An organic acidinduced sigmoidal release system for oral
controlled-release preparations. Pharm Res 1994;
(1):111-116.
Narisawa S, Nagata M, Hirakawa Y, Kobayashi
M, Yoshino H. An organic acid-induced
sigmoidal release system for oral controlledrelease 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.
Roy, Shahiwala A. Multiparticulate formulation
approach to pulsatile drug delivery: Current
perspectives. J Control Rele 2009; 134:74–80.
Lee DY, Chen CM, Anil K. Triggered Release of
Bioactive Compounds, Recent Patents on
Endocrine. Metabolic & Immune Drug Disc 2007;
: 183-190.
Sershen SR, Westcott SL, Halas NJ, West NJ.
Temperaturesensitive Polymer-nanoshell
composites for photothermally modulated drug
delivery. J Biomed Mater Res 2000; 293-298.
Dinaravand RD, Emanele A. Use of
thermoresponsive hydrogels for on-off release of
molecules. J Control Rel 1995; 221-227.
Gutowska A, Bark JS, Kwon IC, Bae YH, Kim
SW. Squeezing hydrogels for controlled oral drug
delivery. J Control Rel 1997; 48: 141-148.
Yui N, Okano T, Sakurai Y. Inflammation
Responsive Degradation of Cross-Linked
Hyaluronic-Acid Gels. J Control Rel 1992;
:105-116
Miyata T, Asami N, Uragami T. A reversibly
antigen-responsive hydrogel. Nature 1999;
:766-769.
Sachin sanvase, Neeraj kumar. Pulsatile drug
delivery: Current scenario.CRIPS 2007;8:27-33.
Santini JT, Cima MJ, Langer R. A controlledrelease microchip. Nature 1999; 335-338.
Santini JT, Richards AC, Schiedt R, Cima MJ,
Langer R. Microchips as controlled-drug delivery
devices. Angew Chem Int Ed 2000; 2396-2407.
Chen H, Langer R. Magnetically-responsive
polymerizedliposomes as potential oral delivery
vehicles. Pharm Res 1997; 537-540.
Ada G. Strategies for exploiting the immune
system in the design of vaccines. Mol Immunol
; 28: 225–230.
Gupta RK, Relyveld EH, Lindblad EB, Bizzini B,
Ben-Efraim S, Gupta CK. Adjutants a balance
between toxicity and adjuvanticity. Vaccine 1993;
: 293–306.
Dvane, John G, Stark, Paul, Fanning, Niall MM.
Multiparticulate modified release composition.
US Patent No.4863742 2009.
White WB, Mehrotra DV, Black HR, Fakouhi
TD. Effects of controlled onset extended release
Verapamil on nocturnal blood pressure ( dippers
versus nondipprs)-verapamil study group; Am J
Cardiol 1997;80:469-474.
Gopi Venketesh. New tools for timed, pulsatile
drug delivery. Pharma Formu & Qual 2005.
Parcel P, Vishnupad KS, Venkatesh GM. Timed
pulsatile drug delivery systems. US Patent
,627,2231.
Nitin S, Satarkar, Zach Hilt S. Magnetic hydrogel
nanocomposite for remote controlled pulsatile
drug release. J Cont Relea 2008;130:246-251.
