FORMULATION AND EVALUATION OF ERODIBLE PULSATILE DRUG DELIVERY SYSTEM OF THEOPHYLLINE FOR NOCTURNAL ASTHMA

Abstract

Theophylline, an asthmatic drug is based on the relaxation of bronchi. This drug has a great variability in clearance
(elimination t½ 2-6 h, adults 6-12 h) and a narrow therapeutic range (7.5-20 μg/ml). Once or twice daily
administration of controlled release preparations in patients with chronic obstructive pulmonary disease (COPD) is
recommended for better patient compliance. The commonest side effects are headache, nausea and vomiting,
abdominal discomfort and restlessness. There may also be increased acid secretion, gastroesophageal reflux and
diuresis. At high concentrations convulsions and cardiac arrhythmias may occur. Hence, in the present investigation,
an attempt has been made to fabricate a Formulation and Evaluation of Erodible Pulsatile Drug Delivery System of
Theophylline for Nocturnal Asthma. Aim of the present work was to formulate and evaluate an oral, pulsatile drug
delivery system to achieve time release of Theophylline, based on chronopharmaceutical approach for the treatment
of nocturnal asthma. An asthmatic attack mainly takes place in the early morning at 4 o'clock. Pulsatile delivery
system is an ideal approach for delivering drug when and where it required most. The basic design consists of a core
tablets prepared by wet granulation method and it containing with an inner swellable polymers like HPMC K100
M& CARBOPOL 971P. The entire device was enteric coated with 5% cellulose acetate phthalate, which overcomes
the gastric emptying time. The prepared Pulsatile tablets were evaluated for the drug content, and in-vitro release
profile and other parameters.