title: Development of time controlled chronomodulated tablet with swelling and rupturable layers: Optimization of factors influencing lag-time and drug release.
abstract: BACKGROUND
  A tablet system consisting of cores coated with two layers of swelling and rupturable coatings was prepared and evaluated as time controlled chronomodulated tablet.
  
  
  METHODS
  Cores containing Montelukast sodium as model drug were prepared by direct compression and then coated sequentially with an inner swelling layer containing a HPMC E 5 and an outer rupturable layer of Eudragit RL/RS (1:1). A three-factor, two-level, full factorial design was used to investigate the influence of amount of HPMC E 5 and Eudragit RL/RS (1:1) on the responses, i.e., lag time to release and time required for 80% of drug to releases. The dissolution tests were studied using the USP paddle method at 50 rpm in 0.1 N HCL for 2 hr and than in phosphate buffer pH 6.8.
  
  
  METHODS
  Cores containing Montelukast sodium as model drug were prepared by direct compression and then coated sequentially with an inner swelling layer containing a HPMC E 5 and an outer rupturable layer of Eudragit RL/RS (1:1). A three-factor, two-level, full factorial design was used to investigate the influence of amount of HPMC E 5 and Eudragit RL/RS (1:1) on the responses, i.e., lag time to release and time required for 80% of drug to releases. The dissolution tests were studied using the USP paddle method at 50 rpm in 0.1 N HCL for 2 hr and than in phosphate buffer pH 6.8.
  
  
  RESULTS
  The lag time of the drug release decreased by increasing the inner swelling layer and increased by increasing the rupturing layer level.
  
  
  CONCLUSIONS
  The results obtain from present study suggest that swelling come reputable coating approach gives desire drug release after lag time.
authors.affiliation: Department of pharmaceutics, C. U. Shah College of Pharmacy & Research, Wadwan, Gujarat, India.
authors.forename: Mayur
authors.initials: M
authors.lastname: Desai
authors.forename: Rishad R
authors.initials: RR
authors.lastname: Jivani
authors.forename: Laxman D
authors.initials: LD
authors.lastname: Patel
authors.forename: Noordin P
authors.initials: NP
authors.lastname: Jivani
authors.forename: Bhavin
authors.initials: B
authors.lastname: Sonagara
keywords: Asthma; Montelukast sodium; cronomodulated drug delivery; swelling layer