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PULSATILE DRUG DELIVERY SYSTEM
BY
C.V. SAIKRISHNA REDDY
M.PHARM I YEAR
JJ COLLEGE OF PHARMACY
CONTENTS
INTRODUCTION METHODOLOGIES ADVANTAGES LIMITATIONS COMMERCIAL PRODUCTS CONCLUSION REFERENCES
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.
NECESSITY OF PULSATILE DRUG DELIVERY SYSTEMS
Follow circadian rhythm,
Protection from gastric environment,
To achieve localized action,
First-pass metabolism can be overcome.
DISEASES THAT REQUIRE PULSATILE DRUG DELIVERY
Disease Chronological behavior Drugs used
Peptic ulcer Acid secretion is high in the afternoon and at night.
H2blockers
Attention deficit syndrome Increase in DOPA level in afternoon
Methylphenidate
Cardiovascular diseases BP is at its lowest during the sleep cycle and rises steeply during the early morning
Nitroglycerin, calcium channel,blocker, ACE inhibitors
Asthma Precipitation of attacks during night or at early morning.
Β2 agonist, Antihistamines
Arthritis Level of pain increases at night
NSAIDs, Glucocorticoids
Diabetes mellitus Increase in the blood sugar level after meal
Sulfonylurea, Insulin
Hypercholesterolemia Cholesterol synthesis is generally higher during night than day time.
HMG CoA reductase, Inhibitors
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
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
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
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.
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
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
COMMERCIAL PRODUCTS
Pulsys® - amoxicillin - Advancis Pharm Corp Uniphyl – theophylline - Purdue Pharm Pdts L Ritalinβ – methylphenidate – Novartis CODAS® - Verapamil HCl TIMERx® - Oxymorphone PulsincapTM - Dofetilide
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.
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.
THANQ