Formulation and evaluation of chrono modulated pulsatile drug delivery system of doxofylline

Abstract

Chronotherapy defined as the treatment in which the drug release in the body is allowed to suite with the circadian rhythm of the disease, such that the involved action of the drug is shown with minimal side effects. Doxofylline core tablets prepared by direct compression method. These core tablets followed by preparation of pulsatile doxofylline tablets using press -coated technology. Doxofylline core tablets were prepared by using various excipients such as Sodium sta rch glycolate as superdisintegrant and MCC as diluents. The core tablets were then compressed into pulsatile tablets using combinations of HPMC K 100M and Eudragit L 100 in various  concentrations.  These  Core  tablets  were  evaluated  for  weight  variation,  thi ckness,  drug  content, disintegration and drug release studies. These core tablets evaluated based on the dissolution studies. The optimized formulation shows lower disintegration time and faster drug release. Then the pulsatile tablets were evaluated for various tests and drug release studies were conducted for pH 6.8 buffer and optimized formulation which showed satisfactory greater lag time of about 6 hours with satisfactory drug release which contains a combination  of  HPMC  K15M  ,  Eudragit  L  100.  Pulsatil e  tablets  were  formulated  utilizing  press  coated technology and the combination of polymers provided required lag time with satisfactory dissolution profile.