Abstract
Objective: The purpose of this research is to find the best way for designing carvedilol pulsatile drug delivery system capsules. Methods: The research paves the way to improve the method of preparing carvedilol pulsatile drug delivery by adjusting critical material attributes (CMA) such as coating polymer concentration, critical process parameters (CPP) such as inlet temperature and atomizing air pressure, and their impact on critical quality attributes (CQA) like particle size (PS in nm), entrapment efficiency in percentage (% EE) and amount of drug delivered in percent (%ADR) at 12 h in the carvedilol pulsatile pellets filled capsules by applying the Box-Behnken design. By varying the polymer concentration and process parameters, nearly 15 formulations were created. Results: Based on the influence of CMA, CPP on CQA, the formulation CP13 was determined to be the most optimized formulation among the 15 formulations. The optimized levels of CMA were found to be-1 level of coating polymer concentration and CPP was found to be-1 level of inlet temperature, 0 level of atomizing air pressure and it optimized CQA like PS was found to be 1017.5±8.4 nm, % EE was found to be 96.8±2.8 %, % ADR at 12 h was found to be 88.4±3.4 %. Carvedilol Pulsatile drug delivery system was designed by using optimized fluidized bed coater in order to decrease the usage of attributes, decrease the productivity cost and enhance the usage of specific attributes at fixed concentration for further manufacturing scale. Conclusion: By the current results it was concluded that the optimized CMA and CPP that shown in the results are the suitable attributes for the best formulation of carvedilol pulsatile drug delivery system capsules.
Highlights
The circadian behavior of the disease helps to release the drug in a pulsatile form, which may release the drug at a particular time
It was inferred that on performing the differential scanning calorimetry (DSC) studies for pulsatile formulation, which ensures that the drug was effectively miscible in physical mixture
This thermal behavior confirms that both drugs exist in an amorphous form or molecularly dispersed in nature and the excipients used in the formulation like polyvinyl pyrrolidone, Aerosil, Ethylcellulose EC7 CPS, Kollicoat SR 30 D, Eudragit L 100, Di-octyl-phthalate (DOP) %, Isopropyl alcohol are highly compatible to the drug i.e., the drug property will not be affected by the excipients used in the pulsatile formulation [10,11,12]
Summary
The circadian behavior of the disease helps to release the drug in a pulsatile form, which may release the drug at a particular time. A pulsatile drug delivery system is defined as the delayed or fastens the release of drug in pulsatile form, which releases a certain amount of active pharmaceutical ingredients molecule at a pre-determined release period. These systems are designed based on the body circadian cycle [1]. Metabolic and other functions of the body’s vary considerably in a day These variations in body system reason alteration in diseased state and in the concentration of drug plasma. Some of the above diseases are worse during the day for example, osteoarthritis, while some of them are worse in the evening and nights during sleep, for example, cough [2]
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