1. PULSATILE DRUG DELIVERY SYSTEM
BY
C.V. SAIKRISHNA REDDY
M.PHARM I YEAR
JJ COLLEGE OF PHARMACY

2. CONTENTS
 INTRODUCTION
 METHODOLOGIES
 ADVANTAGES
 LIMITATIONS
 COMMERCIAL PRODUCTS
 CONCLUSION
 REFERENCES

3. INTRODUCTION
 Pulsatile drug delivery systems (PDDS) are gaining
importance as they deliver a drug at time and site
specific manner resulting in improved therapeutic
efficacy as well as compliance.
 Chronopharmacotherapy designed according to the
circadian rhythm of the body
 Ecofriendly
 Intelligent drug delivery systemcapable of adjusting
drug release rates in response to a physiological need.

4. NECESSITY OF PULSATILE DRUG
DELIVERY SYSTEMS
 Follow circadian rhythm,
 Protection from gastric environment,
 To achieve localized action,
 First-pass metabolism can be overcome.

7. DISEASES THAT REQUIRE PULSATILE DRUG DELIVERY
Disease Chronological behavior Drugs used
Peptic ulcer Acid secretion is high in the H2blockers
afternoon and at night.
Attention deficit syndrome Increase in DOPA level in Methylphenidate
afternoon
Cardiovascular diseases BP is at its lowest during the Nitroglycerin, calcium
sleep cycle and rises steeply channel,
during the early morning blocker, ACE inhibitors
Asthma Precipitation of attacks Β2 agonist, Antihistamines
during night or at early
morning.
Arthritis Level of pain increases at NSAIDs, Glucocorticoids
night
Diabetes mellitus Increase in the blood sugar Sulfonylurea, Insulin
level after meal
Hypercholesterolemia Cholesterol synthesis is HMG CoA reductase,
generally higher during Inhibitors
night than day time.

9. METHODOLOGIES
 I. Time controlled pulsatile release
 II. Internal Stimuli induced
A. Thermo-Responsive Pulsatile release
B. Chemical stimuli induced pulsatile systems
 III. External stimuli induced
 IV. Multiparticulate pulsatile drug delivery system
 V.Pulsatile release systems for vaccine and hormone
products

10. I) TIME CONTROLLED PULSATILE
RELEASE
 Delivery system provided with erodible coating layers
 Delivery system provided with ruputable coating layer
 Capsule shaped system provided with release controlling plug
These can be formulated as Tablets, Capsules, Pellets, Spheres, Beads,
Films, Hydrogels

12. II) INTERNAL STIMULI INDUCED PULSATILE
RELEASE SYSTEM
 Temperature–induced pulsatile release
 Inflammation-induced Pulsatile Release
 pH Sensitive Drug Delivery System
 Glucose-responsive Insulin Release Devices
III) EXTERNALLY REGULATED PULSATILE
RELEASE
 Magnetic induces release
 Ultrasound induces release
 Electric field induces release
 Light induces release

13. IV) MULTIPARTICULATE PULSATILE DRUG
DELIVERY SYSTEM
 Reservoir systems with rupturable polymeric Coatings
 Reservoir systems with soluble or eroding polymer
coatings
 Floating multiparticulate pulsatile systems
V) PDDS FOR VACCINE AND HORMONE
PRODUCTS
 PDDS offer the possibility of single-shot vaccines if
initial booster release of the antigen can be achieved
from one system in which timing of booster release is
controlled.

14. ADVANTAGES
 Extended daytime or nighttime activity
 Reduced dose size, dosage frequency
 Drug targeting to specific site.
 Drug loss is prevented by extensive first pass metabolism .
 Predictable, reproducible and short gastric residence time
 Less inter- and intra-subject variability
 Improved bioavailability, stability, patient comfort and compliance
 Reduced adverse effects and improved tolerability
 Limited risk of local irritation
 No risk of dose dumping
 Flexibility in design
 Achieve a unique release pattern
 Extend patent protection, globalize product, and overcome competition

15. LIMITATIONS
 Lack of manufacturing reproducibility and efficacy
 Large number of process variables
 Multiple formulation steps
 Higher cost of production
 Need of advanced technology
 Trained/skilled personal needed for manufacturing

16. COMMERCIAL PRODUCTS
 Pulsys® - amoxicillin - Advancis Pharm Corp
 Uniphyl – theophylline - Purdue Pharm Pdts L
 Ritalinβ – methylphenidate – Novartis
 CODAS® - Verapamil HCl
 TIMERx® - Oxymorphone
 PulsincapTM - Dofetilide

17. CONCLUSION
There is a constant need for new delivery systems that can
provide increased therapeutic benefits to the patients. Pulsatile
drug delivery is one such system that, by delivering drug at
the right time, right place, and in right amounts, holds good
promises of benefit to the patients suffering from chronic
problems like arthritis, asthma, hypertension, etc. PDDS can
effectively release drug according to body's circadian clock
giving release of drug after a specified time lag. With increase
in technological advancement and better design parameters
hurdles can be overcome in the near future and more number
of patients will be greatly benefited by these systems.

18. REFERENCES
1. Janugade BU, Patil SS, Patil SV, Lade PD: Pulsatile drug delivery system for
chronopharmacological disorders: an overview. Journal of Pharmacy Research ,
2009; 2 (1):133-143.
2. http://www.uspharmacist.com/oldformat.asp?url=newlook/files/
Feat/ACF2F15.cfm&pub_id, accesed on 15/9/10.
3.Björm Hemmer. Circadian rhythms and drug delivery. J. Control. Release,
1991, 16: 63-74.
4.B. Lemmer, Chronopharmacokinetics: implications for drug treatment, J.
Pharm. Pharmacol., 1999, 51: 887-890.
5.P. Roy, A. Shahiwala. Multiparticulate formulation approach to pulsatile drug
delivery: current perspectives. J. Control. Release, 2009, 134:74-80.
6. R. Gurny, H. E. Junginger, N. Peppas, Eds., In; Pulsatile Drug Delivery:
Current Application and Future Trends,Wissenschefliche Verlagsgesellschaft,
Stuttgart, Germany, 1993, 36.
7.M. M. Massin, K. Maeyns, N. Withofs, et al. Circadian rhythm of heart rate
and heart rate variability. Arch. Dis. Child., 2000, 83: 179-182.
8. J. Qureshi, Mohd. Amir, Alka Ahuja et al. Chronomodulated Drug Delivery
System of Salbutamol Sulphate for the Treatment of Nocturnal Asthma. Indian J.
Pharm. Sci. 2008, 351-356.