Der Pharmacia Lettre
Abstract
Author(s): Pravin Kumar, Rajendra Awasthi, Puneet Kumar Rai, Manish Kumar, T. M Pramod Kumar
The present study was carried out to formulate mucoadhesive in situ gels of local anaesthetics
for administering into periodontal pocket that gives fast onset of anaesthesia lasting throughout
the dental procedure, which is painless. Temperature sensitive mucoadhesive in situ gelling
system containing 5% w/v lidocaine hydrochloride (Lidocaine HCl) was formulated by cold
method using combination of pluronic F 127 (PF 127) and carbopol 934 (C 934). The gels were
evaluated for drug content, gelation temperature, viscosity, mucoadhesive strength, sterility, in
vitro release and clinical studies. The drug content in all the formulations was found to be
satisfactory. The formulations containing 18% w/v of PF 127 showed gelation near to body
temperature. Viscosity studies showed a marked increase in viscosity of the gels at 370C due to
sol-gel conversion with increase in temperature. The viscosity and mucoadhesiveness increased
with increase in C 934. In vitro release studies showed that as the concentration of PF 127
increased the rate of drug release decreased. The drug release from the formulations was
diffusion controlled without swelling. A placebo-controlled, double-blind clinical trial was
conducted to assess the safety and efficacy of the Lidocaine HCl gel during scaling and root
planing (SRP). In the study population, local anaesthetic gel 5% was statistically significant and
more effective than the placebo. The results suggested that Lidocaine HCl 5% in situ gel may be
a suitable formulation as it was clinically effective in reducing SRP pain for those patients who
perceive the procedure to be painful.
