FORMULATION AND EVALUATION OF CHRONOMODULATED PULSATILE THERAPEUTIC SYSTEM FOR EARLY MORNING SURGE IN BLOOD PRESSURE
Keywords:Pulsatile drug delivery, Hypertension, Chronotherapy, Captopril, Lag time
Objective: The objective of this study was to design and developed a rupturable coating type of pulsatile press coated tablet, which releases drug early in the morning hours. This delivery system was helpful to control an early morning surge in Blood Pressure because cardiovascular events occur more frequently in the morning. This delivery system would be useful for the prevention of cardiovascular events in hypertensive patients.
Methods: Initially core tablet was prepared by using Captopril HCl as a model drug, which is having Angiotensin-converting enzyme inhibition activity and different concentration of cross carmellose sodium as a superdisintegrant by the direct compression method. Core tablet was press coated by using HPMC K4M and Ethyl Cellulose in different ratios as a press coating polymers.
Results: Core tablet was evaluated for different evaluation parameters and the formulation which shows least disintegration time has been selected for further study. Dissolution profiles clearly indicate that Captopril released from the press-coated tablet depends on the amount of an HPMC/EC ratio used.
Conclusion: From in-vitro dissolution study it was concluded that the lag time decreases with increase in concentration of HPMC K4M. When the concentration of hydrophilic polymer was increased, i.e. HPMC K4M, hydration property of the system increases, causing more rapid dissolution or rupturing of the external shell resulting in the reduction in lag time.
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