Methods:This work was conducted in the college of Dentistry and Pharmacy of Qassim University (Buraydah, Saudi Arabia) in collaboration with College of Pharmacy of King Saud University (Riyadh, Saudi Arabia). Bioadhesive materials and lidocaine containing tablets are been developed by direct compression, tablets are one side coated with a thin layer or film of polymeric substance in order to guide local anesthesia release towards oral tissues,At this step of the tablet development, final composition of the mucoadhesive local anesthetic tablet is determined, tablet was fabricated in the college laboratories, and local anesthesia release in studied and evaluated using US Paddle release study machine .Tablet efficacy was tested clinically by applying it on the left mental foramina of voluntary participants (laboratory personals), a clinical study will be the next and final step of the tablet development.
Results:The sustained release of lidocaine from the final tablets was obtained and clinical test on the voluntary subjects says to have numbs in the buccal mucosa mental area and the lift lower lips, no other area was affected by local anesthesia (Tablet coating prevented lidocaine release into saliva.
Conclusion:The hardest step in new drug development is now passed, a well organized and subjective clinical study in now planned in order to confirm clinical benefits of the new pharmaceutical form.