title: Formulation development and evaluation of lamivudine controlled release tablets using cross-linked sago starch.
abstract: OBJECTIVE
  Modified starches based polymeric substances find utmost applicability in pharmaceutical formulation development. Cross-linked starches showed very promising results in drug delivery application. The present investigation concerns with the development of controlled release tablets of lamivudine using cross-linked sago starch.
  
  
  METHODS
  The cross-linked derivative was synthesized with phosphorous oxychloride and native sago starch in basic pH medium. The cross-linked sago starch was tested for acute toxicity and drug-excipient compatibility study. The formulated tablets were evaluated for various physical characteristics, in vitro dissolution release study and in vivo pharmacokinetic study in rabbit model.
  
  
  RESULTS
  In vitro release study showed that the optimized formulation exhibited highest correlation (R) in case of zero order kinetic model and the release mechanism followed a combination of diffusion and erosion process. There was a significant difference in the pharmacokinetic parameters (T(max), C(max), AUC, V(d), T(1/2), and MDT) of the optimized formulation as compared to the marketed conventional tablet Lamivir®.
  
  
  CONCLUSIONS
  The cross-linked starch showed promising results in terms of controlling the release behavior of the active drug from the matrix. The hydrophilic matrix synthesized by cross-linking could be used with a variety of active pharmaceutical ingredients for making their controlled/sustained release formulations.
authors.affiliation: Indian Institute of Science, Department of Materials Engineering, Biomaterials Lab, Bangalore, Karnataka, 560012, India. akhileshvikram@gmail.com
authors.forename: Akhilesh Vikram
authors.initials: AV
authors.lastname: Singh
authors.forename: Lila Kanta
authors.initials: LK
authors.lastname: Nath
mesh_terms: D000818:Animals; D019380:Anti-HIV Agents / Q000737:chemistry* / Q000493:pharmacokinetics; D019540:Area Under Curve; D028023:Arecaceae; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004339:Drug Compounding; D016503:Drug Delivery Systems; D005079:Excipients / Q000737:chemistry; D019259:Lamivudine / Q000737:chemistry* / Q000493:pharmacokinetics; D011817:Rabbits; D017550:Spectroscopy, Fourier Transform Infrared; D013213:Starch / Q000737:chemistry*; D013607:Tablets
chemical_list: D019380:Anti-HIV Agents; D003692:Delayed-Action Preparations; D005079:Excipients; D013607:Tablets; D019259:Lamivudine; D013213:Starch