4-DESIGN,CHARACTERISATION AND CLINICAL EVALUATION OF MELOXICAMDENTO-ORAL GEL

m.f. el miligi1, m. a. el-nabaraw1, s.a.abd el-halm1,a.e. abd el-latif2 and f.a. el shehaby2

1- Department of pharmaceutics and industrial pharmacy, faculty of pharmacy,

2-Department of Pedodontics and community dentistry, faculty of oral and dental medicine, cairo university, Cairo, Egypt

Received:5-2-2003

Accepted: 10-6-2003

 

Abstract:

Aiming todesing meloxicam dento0oral gel, several polymers were used in thisstudy (hydroxypropyl methylcellulose HPMC, carbopol 934,carbopol 940, polyvinyl alcohol and hydroxypropyl cellulose) in three different concentrations. Meloxicam dento-oral gels were evaluated by determination of actual meloxicam content, pH  measurements and viscosity. Release studies were done in either simulated saliva fluid SSF (pH=6.8) and simulated gastric fluid SGF (pH =1.2), kinetic analysis of release data stability studies and anti-inflammatory efficacy of the selected dento-oral gel (rat paw oedema). Medicated HPMC 3% gel exhibited the highest percent of drug released in either SGF or SSF. Also thisdento-oral gel showed the maximum percentage of inhibition of rat paw oedema equal to 67.99% and was reached after 2 hours from oral administration while for Mobic tablet it was 43.55% and was reached after 3 hours. Clinical study of HPMC 3% dento-oral gel containing meloxicam was done  on ten human patients suffering  from gingivitis admitted to Faculty of Oral and Dental Medicine.  The gingival index was measured for each patient before and after application of gel. The dento-oral has very good effect in improvement of the gingival inflammation. It can be used safely in treatment of gingival pain conditions.