DEVELOPMENT, OPTIMIZATION AND EVALUATION OF PULSATILE DRUG DELIVERY CAPSULES LOADED WITH CARVEDILOL BY APPLYING QUALITY BY DESIGN

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.

Prepartion And Bio Pharmaceutical Evaluation Of Chronopharmaceutical Drug Delivery System Of Metoprolol

The basic purpose of constructing drug delivery systems is to design when and where the drug will be released. The episode of many biological events is really important for such knowledge. Metoprolol pulsatile drug delivery system was developed for this purpose, which can release the drug when blood pressure needs to be modulated in the early morning. The Cup and core techniques were used to build this system, which included immediate release (IR), sustained-release (SR), and a polycaprolactone plug layer. The formulation of the ingredients was facilitated by various preformulation studies. The IR and SR tablets were bilayered, with polycaprolactone entirely coating the IR layer. The IR and SR tablet release profiles were optimised for the F5 batch, which was then used to construct a pulsatile drug delivery system. Clinical trials were conducted with the prepared tablet, which included the use of BaSO4 tagged tablets for X-ray examinations. All of the findings indicated the optimal drug release of metoprolol, which can be used for individuals who are more prone to blood pressure abnormalities in the morning.

A Concise Insight on Pulsatile Drug Delivery System: An Outlook towards its Development

In pharmaceutical science, the pulsatile drug delivery system gains more attraction because of their number of benefits over the other dosage forms. In these systems, the drug is released at right time at the right site of action, and in the right amount, it is the most beneficial and important characteristic of the PDDS system due to that the patient compliance is increased, and the drug release is after a well-defined lag time. Moreover, this system is designed according to the circadian rhythm of the body. Because the disease has a predictable cyclic rhythm, such as Arthritis, diabetes mellitus, asthma, peptic ulcer, hypertension, cardiovascular disease the PDDS is more effective than other dosage forms.This system is a more time-specific and site-specific drug delivery system. In this system the drug is released as a pulse. The mechanism of PDDS is first diffusion then erosion and then osmosis. For the drug having a high first-pass effect and having a high risk of toxicity and side effects, these systems can be very useful. And to reduce dosing frequency and improve patient compliance this system is very helpful. There are various methods present like, single-unit systems and multiple-unit systems – which included capsular system, pulsatile delivery by osmosis, pulsatile delivery by erosion of membrane, delivery by rupture of membrane, etc.

REVIEW ARTICLE ON PULSATILE DRUG DELIVERY SYSTEM

Pulsatile drug delivery systems (PDDS) are acquiring a lot of interest as they deliver the medication at the perfect place at the perfect time and in the perfect amount, subsequently giving spatial and transient delivery and increasing patient consistency. These systems are designed by the circadian rhythm of the body. The primary reasoning for the utilization of pulsatile arrival of the medications is the place where a consistent medication release is not desired. A pulse must be planned so that a complete and rapid medication release is accomplished after the lag time. A different system such as capsular system, osmotic system, single-and multiple unit system dependent on the utilization of soluble or erodible polymer coating, and the utilization of rupturable films has been managed in the article. It sums up the most recent technology development, formulation parameter, and delivery profiles of this system. PDDS is helpful for the medications having chronopharmacological conduct where night-time dosing is required, such as anti-arrhythmic, anti-ulcerative, and anti-asthmatic, and so on The momentum survey article talked about the explanations behind the advancement of the PDDS, benefits, limitation, mechanism of medication release, need for pulsatile drug delivery, a disease that requires pulsatile technology, classification, and future parts of PDDS.

PULSATILE DRUG DELIVERY SYSTEM-A TECHNIQUE OF DELIVERING DRUG IN ACCORDANCE WITH BIOLOGICAL CLOCK - A REVIEW

Over last 30 years pulsatile drug delivery system has achieved a lot of importance in drug delivery technology. And the reason why this pulsatile drug delivery is gaining importance is because of its strategy of delivering drug molecule at right place, right time. There are certain diseases which are controlled by biological clock of our body and follow circadian rhythms like congestive heart failure, asthma, rheumatoid arthritis ,osteoarthritis, inflammatory disorders and other hormonal disorders, for this type of diseases conventional solid dosage forms like immediate release tablets or modified dosage forms like sustained, controlled release tablets cant give the required therapeutic response and also for such diseases delivering the drug at right time in right amount is very important. And that task is accomplished by this pulsatile drug delivery system. These pulsatile drug delivery framework is planned by the organic mood i.e., biological rhythms of the body, and medication conveyance is worked with by as per disease cadence. The rule for the utilization of pulsatile drug delivery of the medications is the place where a consistent drug discharge isnt wanted. The principle for the utilization of pulsatile release of the medications is the place where a steady drug discharge isnt wanted, yet drug release must be planned in such a way that, quick medication discharge is accomplished after the lag time. Current review examined the clarifications for improvement of pulsatile drug delivery framework in accordane with body circadian rhythm, kinds of the illness during which pulsatile discharge is required, order, assessments, benefits, impediments.

A REVIEW ON RECENT ADVANCEMENT IN PULSATILE DRUG DELIVERY SYSTEMS

Delivery systems with a pulsatile-release method are particularly involved in designing medicines for which traditional managed drug-release systems with the continuous release are not suitable. This medication also has a high first-pass impact or special conditions for chrono-pharmacology. These medications also have a high first-pass or unique chronopharmacological effect. The pulsatile release profile is characterised by a duration of no release (lag time) followed by a fast and full release of the drug. Pulsatile drug delivery systems may be classified into site-specific systems in which the drug is released inside the gastrointestinal system (e. g. colon) or time-controlled devices wherein the drug is released after a well-defined time period. Site-regulated release is typically controlled by environmental factors, such as pH or enzymes found in the intestinal tract, whereas drug release from time-controlled processes is controlled mainly by the delivery system and, preferably, not by the environment. This review covers various single-and multiple-unit oral pulsatile drug-delivery systems with an emphasis on time-controlled drug-release systems.

Formulation and In Vitro Evaluation of Compressed Coated Tablets of Simvastatin for Pulsatile Drug Delivery

Pulsatile drug delivery system is one type of drug delivery system, where the delivery device is capable of releasing drugs after a predetermined time-delay (i.e. lag time). This system has a peculiar mechanism of delivering the drug rapidly and completely after a "lag time," i.e., a period of "no drug release." These systems are beneficial for drugs having high first-pass effect drugs administered for diseases that follow chrono pharmacological behavior such as drugs having specific absorption sites in GIT, targeting to colon; and cases where nighttime dosing is required. The objective of the present study was to formulate and evaluate a press coated pulsatile drug delivery system of simvastatin in order to attain a time controlled release to lower the blood cholesterol level by releasing the drug with a distinct predetermined lag time of five hrs. Simvastatin is a water insoluble drug and its absorption is dissolution rate limited. The core formulations were composed of simvastatin and disintegrants like lycoat, SSG, ludiflash in different ratios and was coated with xanthan gum, guar gum, HPMC K4M, HPMC K15M as a release modifier. Press coated tablets were evaluated for hardness, friability, drug content, and in vitro drug release. Result of in vitro dissolution study of the prepared tablet suggested that, the release of drug from press coated tablets match with chrono-biological requirement of disease.