title: Formulation development and systematic optimization of stabilized ziprasidone hydrochloride capsules devoid of any food effect.
abstract: OBJECTIVE
  The objective of the study was to develop a stable capsule formulation of ziprasidone hydrochloride which can be administered without regards to food intake.
  
  
  METHODS
  The unstable anhydrous form of ziprasidone hydrochloride was stabilized employing hot-melt extrusion and further optimized by 32central composite design. The formulation was optimized after establishing acceptable ranges for response variables like disintegration time, dissolution and impurity profile. A crossover fasted and fed in vivo study was conducted in human volunteers to assess the food-effect of optimized formulation vis-à-vis the marketed brand.
  
  
  CONCLUSIONS
  The optimized formulation met in-house specifications for various response variables. Further, high values of correlation coefficient vouch the adequate selection of experimental design and its high prognostic ability. In our study, no significant difference was observed between the Cmaxand AUC values after administration of the optimized formulation in fasted and fed states. On the contrary, there was a statistically significant increase in the Cmaxand AUC values after oral administration of Zeldox in fed state in comparison to fasted state.
  
  
  CONCLUSIONS
  The present study describes the successful development of a stable formulation of 20 mg of ziprasidone devoid of any food-effects.
authors.affiliation: a CPS Formulations, Dr. Reddy's Laboratories Ltd , Hyderabad , Andhra Pradesh , India.|b Department of Pharmacy , Jawarhalal Nehru Technological University Kakinada , Kakinada , Andhra Pradesh , India.
authors.forename: Sabyasachi
authors.initials: S
authors.lastname: Banerjee
authors.affiliation: c Department of Pharmacology , Sri Sai Aditya Institute of Pharmaceutical Sciences and Research , Surampalem , Andhra Pradesh , India , and.
authors.forename: K Ravi
authors.initials: KR
authors.lastname: Shankar
authors.affiliation: d University College of Pharmaceutical Sciences, Andhra University , Visakhapatnam , Andhra Pradesh , India.
authors.forename: Rajendra
authors.initials: R
authors.lastname: Prasad Y
mesh_terms: D000284:Administration, Oral; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules / Q000008:administration & dosage* / Q000737:chemistry* / Q000378:metabolism; D002626:Chemistry, Pharmaceutical / Q000379:methods; D018592:Cross-Over Studies; D004435:Eating / Q000502:physiology; D005502:Food; D018565:Food-Drug Interactions; D006801:Humans; D010879:Piperazines / Q000008:administration & dosage* / Q000737:chemistry* / Q000378:metabolism; D013844:Thiazoles / Q000008:administration & dosage* / Q000737:chemistry* / Q000378:metabolism
chemical_list: D002214:Capsules; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone
keywords: Central composite design; XRD; food-effect; hot-melt; pharmacokinetics