RECENT ADVANCE IN PULSATILE DRUG DELIVERY SYSTEM

About Authors:
Dhirendra C. Patel1*, Ritesh B. Patel1, Gargi B. Patel2
1Department of Pharmaceutics and Pharmaceutical Technology;
S.K. Patel College of Pharmaceutical Education and Research;
Ganpat University, Kherva, Mehsana, Gujarat, India.
2Pharma Management & Regulatory Affairs,
K.B. Institute of Pharmaceutical Education & Research, Gandhinagar, Gujarat, India.
*dhiren.pharmacy@gmail.com

Abstract:
Oral controlled drug delivery systems represent the most popular form of controlled drug delivery systems for the obvious advantages of oral route of drug administration. However, there are certain conditions for which such a release pattern is not suitable like cardiovascular diseases, Diabetes mellitus, Asthma, Arthritis, Peptic ulcer etc. In such cases pulsatile drug delivery system is used in which release drug on programmed pattern i.e. at appropriate time & at appropriate site of action. Pulsatile Drug Delivery systems are basically time controlled drug delivery systems in which the system controls the lag time independent of environmental factors like pH, enzymes, gastro-intestinal motility, etc. The principle rationale for the use of pulsatile release is for the drugs where a constant drug release, i.e., a zero-order release is not desired. In chronopharmacotherapy drug administration is synchronized with biological rhythms to produce maximal therapeutic effect & minimum harm for the patient. Technically, pulsatile drug delivery systems administered via the oral route could be divided into two distinct types, the time controlled delivery systems and the site-specific delivery systems, thus providing special and temporal delivery. In recent pharmaceutical applications involving pulsatile delivery; multiparticulate dosage forms (e.g. pellets) are gaining much favor over single-unit dosage forms. Various pulsatile technologies have been developed on the basis of methodologies, these includes ACCU-BREAK™, AQUALON,  CODAS®, PRODAS®, SODAS®, MINITABS®, DIFFUCAPS®, OROS® etc. Designing of proper pulsatile drug delivery will enhance the patient compliance, optimum drug delivery to the target side & minimizing the undesired effects.

Reference Id: PHARMATUTOR-ART-1507

INTRODUCTION
Oral controlled drug delivery systems represent the most popular form of controlled drug delivery systems for the obvious advantages of oral route of drug administration. Such systems release the drug with constant or variable release rates. These dosage forms offer many advantages, such as nearly constant drug level at the site of action, prevention of peak-valley fluctuations, reduction in dose of drug, reduced dosage frequency, avoidance of side effects, and improved patient compliance However, there are certain conditions for which such a release pattern is not suitable. These conditions demand release of drug after a lag time. In other words, it is required that the drug should not be released at all during the initial phase of dosage form administration. Such a release pattern is known as pulsatile release.In recent years there is a continuous interest in the development of controlled drug release systems, to achieve the optimal therapeutic effect of drugs. This is based on the increasing awareness of the importance of circadian rhythms with respect to physiology, disease state and drug action which has given rise to the related fields of chronotherapeutics and chronopharmacology. The principle rationale for the use of pulsatile release is for the drugs where a constant drug release, i.e., a zero-order release is not desired. The release of the drug as a pulse after a lag time (an interval of no drug release) has to be designed in such a way that a complete and rapid drug release follows the lag time.

Fig.1: Drug release profile of pulsatile drug delivery system

ADVANTAGES OF PULSATILE DRUG DELIVERY SYSTEM:
·         Extended daytime or night time activity.
·         Reduced side effects
·         Dosage frequency.
·         Reduction in dose size.
·         Improved patient compliance.
·         Lower daily cost to patient due to fever dosage units are required by the patient in therapy.
·         Drug adapts to suit circadian rhythms of body functions or diseases.
·         Drug targeting to specific sites like colon.
·         Protection of mucosa from irritating drugs.
·         Drug loss is prevented by extensive first pass metabolism.

DRAWBACKS OF PULSATILE DRUG DELIVERY SYSTEM:
·         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.

Table 1. Diseases Requiring Pulsatile Delivery

Disease

Chronological behavior

Drug used

Cardiovascular diseases

BP is at its lowest during night or at early morning awakening period

Nitroglycerin, Calcium channel blocker, ACE Inhibitors etc.

Diabetes mellitus

Increase in the blood sugar level after meal

Sulfonyl urea, Insulin,

Biguanide

Asthma

Precipitation of attacks during night or at early morning hour.

Β2 agonist, Antihistaminics

Arthritis

Pain in the morning and more pain at night

NSAIDS, Glucocorticoids

Peptic ulcer

Acid secretion

H2 blockers

Hypercholesterolemia

Cholesterol synthesis is generally higher during night than during day time

HMG CoA reductase

Inhibitors

Arthritis

Pain in the morning and more pain at night

NSAIDS, Glucocorticoids

CLASSIFICATION OF PULSATILE SYSTEMS


Fig.2: Currently reported classification of pulsatile drug delivery

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