Pulsatile drug delivery systems (PDDS) are gaining importance as these systems deliver the drug at specific time as per the pathophysiological need of the disease, resulting in improved patient therapeutic efficacy and compliance. These systems are beneficial for the drugs having chronopharmacological behaviour (where night time dosing is required), firstpass effect and having specific site of absorption in gastro intestinal tract (GIT). From the viewpoint of therapeutic optimization, maintaining a constant blood level for a drug in the human body is questionable.1) Long-term constant drug concentration exposed in blood and tissues may induce many problems such as tolerance of drug and activation of physiological system.2) Recently, chronotherapy has been extensively applied in clinical therapy by modulating the dosing regimen of drug administration according to physiological needs.3) Diseases wherein PDDS are promising include asthma, peptic ulcer, cardiovascular diseases, arthritis, and hypercholesterolemia. The pathophysiology of arthritis and patients with osteoarthritis tend to have less pain in the morning and more at night; while those with rheumatoid arthritis, have pain that usually peaks in the morning and decreases throughout the day.
4)A dry-coated tablet was recently renewed as a novel system to deliver a drug in a pulsatile way, at predetermined times following oral administration. 4,5) This novel system is not only rate controlled but is also time controlled. The dry-coated tablets were prepared by a direct compression method. This compression method eliminates the time-consuming and complicated coating or granulation processes and also improves the stability of the drug by protecting it from moisture.
6)There are various problems with pH dependent drug delivery; however the pH in the gastrointestinal tract varies between and within individuals. [7][8][9] It is affected by diet and disease.10) During acute stage of inflammatory bowel disease colonic pH has been found to be significantly lower than normal.11) In ulcerative colitis pH values 2.3-4.7 have been measured in the proximal parts of the colon.12)The purpose of this study was to develop press coated tablets for pulsatile drug delivery of ketoprofen. The oral press coated tablet was developed to achieve the time-controlled disintegrating or rupturing function with a distinct predetermined lag time. Press-coated tablet containing ketoprofen and other excipients in the inner core was formulated with an outer shell by different weight ratios of hydrophobic polymer (micronized ethylcellulose powder) and hydrophilic polymers (glycinemax husk, sodium alginate). Ethylcellulose (EC) is a well-known water-insoluble polymer that has been used as a rate-controlling membrane to regulate drug release. EC powder with different micronized sizes has been directly compressed to form compact EC in which plastic deformation is the predominant consolidation mechanism.13) Glycinemax containing dry matter (DM), crude protein (CP), crude fiber (CF), ether extract ...