Preparation and Evaluation of Diclofenac Sodium Tablet Coated with Polyelectrolyte Multilayer Film Using Hypromellose Acetate Succinate and Polymethacrylates for pH-Dependent, Modified Release Drug Delivery.
Polyelectrolyte multilayer (PEM) film formed due to the electrostatic interaction between oppositely charged polyelectrolytes is of considerable interest because of their potential applications as both drug carriers and surface-modifying agents. In this study, in vitro studies were carried out on polyelectrolyte complexes formulated with Eudragit E (EE) and hypromellose acetate succinate (HPMCAS). The complexes of EE and HPMCAS were formulated by non-stoichiometric method. The prepared IPCs were investigated using Fourier transform infrared spectroscopy. Diclofenac sodium (DS) tablets were prepared and were coated with polymer solution of HPMCAS and EE to achieve pH-dependent and sustained-release tablets. Tablets were evaluated for their physical characteristics and in vitro drug release. The results of pharmacokinetic studies in rabbits showed that the selected formulation (F6) exhibited a delayed peak plasma concentration and marked sustained-release effect of drug in the in vivo drug release in comparison with marketed tablet. The suitable combination of PEM film based on EE and HPMCAS demonstrated potential candidate for targeted release of DS in the lower part of the gastrointestinal (GI) tract.
Jawaharlal Nehru Technological University-Hyderabad, Telangana, 500 085, India. balamurugan.jeganathan@mylan.in.|Plot No.34A, Anrich Industrial Estate, Bollaram, Jinnaram (Mandal), Medak Dist, 502325, India. balamurugan.jeganathan@mylan.in.
Balamurugan
B
Jeganathan
Department of Pharmaceutics, Siddhartha Institute of Pharmacy, Korremula Road, Ghatkesar, Rangareddy, 501301, India.
Vijayalakshmi
V
Prakya
Plot No.34A, Anrich Industrial Estate, Bollaram, Jinnaram (Mandal), Medak Dist, 502325, India.
Abhijit
A
Deshmukh
D000818:Animals; D004008:Diclofenac / Q000097:blood / Q000138:chemical synthesis*; D016503:Drug Delivery Systems / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005260:Female; D006863:Hydrogen-Ion Concentration; D065347:Hypromellose Derivatives / Q000138:chemical synthesis* / Q000378:metabolism; D008297:Male; D000071228:Polyelectrolytes / Q000138:chemical synthesis* / Q000378:metabolism; D011109:Polymethacrylic Acids / Q000138:chemical synthesis* / Q000378:metabolism; D011817:Rabbits; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D013608:Tablets, Enteric-Coated
D000071228:Polyelectrolytes; D011109:Polymethacrylic Acids; D013608:Tablets, Enteric-Coated; D004008:Diclofenac; C030613:polymethacrylic acid; D065347:Hypromellose Derivatives
Polyelectrolyte complex; eudragit E; hypromellose acetate succinate; multilayer film; polyelectrolyte