• ISSN : 2231 - 0541 (Online)
  • 0976 - 3090 (print)
  • NLM ID : 101613942
  • CAS CODEN : PHARN8
  • Frequency : Bi-Monthly

FORMULATION AND IN VITRO EVALUATION OF COLON SPECIFIC DRUG DELIVERY OF NAPROXEN SODIUM BY USING PULSINCAP TECHNOLOGY

FORMULATION AND IN VITRO EVALUATION OF COLON SPECIFIC DRUG DELIVERY OF NAPROXEN SODIUM BY USING PULSINCAP TECHNOLOGY

The purpose of the present study was to design and evaluate an oral, site specific, and pulsatile drug delivery system containing Naproxen sodium as a model drug, which can be targeted to colon in a pH and time dependent manner, to modulate the drug level in synchrony with the circadian rhythm of Rheumatoid arthritis based on chronopharmaceutical considerations.The basic design consists of an insoluble hard gelatin capsule body, filled with powder blend and sealed with a hydrogel plug. The powder blend containing Naproxen sodium, sodium starch glycolate, sodium bicarbonate, vivapur302 and talc was prepared and evaluated for flow properties and FTIR studies. From the obtained results, G7 powder blend formulation was selected for further fabrication of pulsatile capsules. Hydrogel plug was formulated in a combination of hydrophobic polymer like ethyl cellulose with hydrophilic polymers like guar gum, xantural and HPMC K100M in 1:1, 1:1.5, 1:2, 1:2.5 and 1:3 ratios to maintain a suitable lag period and it was found that the drug release was controlled by the proportion of polymers used.The prepared pulsincaps were evaluated for drug content, weight variation and Invitro release studies. FTIR studies confirmed that there was no interaction between drug & polymers and Invitro release studies of pulsatile device revealed that increasing hydrophilic polymer content resulted in delayed release of Naproxen sodium from the pulsincap after a predetermined lag time of 6hrs. Based on invitro studies performed, F18 was found to be optimized formulation.