Formulation and evaluation of Alendronate Sodium gel for the treatment of bone resorptive lesions in Periodontitis.
Alendronate sodium is formulated into gels and evaluated for the treatment of bone resorptive lesions in periodontitis. Carbopol 934P was used for the preparation of gels in three different concentrations. The prepared gel was evaluated for various properties such as preformulation, content uniformity, viscosity, compatibility, sterility, in vitro diffusion, and in vivo studies. The drug and the polymer were found to be compatible and confirmed by Fourier transform infrared spectroscopy. Viscosity of the gels increased with the increase in the polymer concentration. The formulations were found to be sterile. In vitro release study revealed that drug released from the gel follows non-Fickian diffusion followed by first-order release. In vivo studies were carried out for 6 months in patients. The results revealed a significant improvement in the clinical parameters such as gingival index, probing pocket depth, clinical attachment level, and potent inhibitory effect on bone resorption by inhibition of osteoclasts. In addition, there was increase in the new bone formation.
Reddy
G Thirumal
GT
Department of Pharmaceutics, J.S.S. College of Pharmacy, Mysore, India.
Kumar
T M Pramod
TM
Veena
D000278:Administration, Buccal; D000328:Adult; D019386:Alendronate / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D050071:Bone Density Conservation Agents / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D001862:Bone Resorption / Q000188:drug therapy* / Q000503:physiopathology; D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D002908:Chronic Disease; D004340:Drug Contamination / Q000517:prevention & control; D004355:Drug Stability; D005782:Gels; D006801:Humans; D008875:Middle Aged; D010316:Particle Size; D010518:Periodontitis / Q000188:drug therapy* / Q000503:physiopathology; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods; D016896:Treatment Outcome; D014783:Viscosity
D050071:Bone Density Conservation Agents; D005782:Gels; D019386:Alendronate