Design and in vitro evaluation of a novel bioadhesive vaginal drug delivery system for clindamycin phosphate.
To develop more effective treatment for bacterial vaginosis, bioadhesive film formulations of clindamycin phosphate (CL) for vaginal delivery were studied. The bioadhesive films were prepared by solvent evaporation method. A 3(2) full factorial design was utilized for optimization of the effect of independent variables such as amount of hydroxypropyl cellulose (X1), amount of xanthan gum (X2) on mechanical properties, and % drug retained on vaginal mucosa. The films were evaluated for various aesthetic and physicodynamic properties. Batch F(86) showed highest overall desirability of 0.99. Batch F86 was considered optimal composition for a novel bioadhesive vaginal formulation, as they have good peelability, high % elongation at break, moderate tensile strength, and retained on vaginal mucosa up to 8 h. Also, films were non-cytotoxic as indicated by negligible decrease in cell viability. Our study may provide a potential vaginal delivery system of CL against bacterial vaginosis.
Pharmacy Department, Centre of Relevance and Excellence in Novel Drug Delivery Systems, G.H. Patel Building, The M.S. University of Baroda, Vadodara, India. dobarianitin@rediffmail.com
Nitin
N
Dobaria
Rajashree
R
Mashru
D000268:Adhesiveness; D000282:Administration, Intravaginal; D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000633:toxicity; D002470:Cell Survival / Q000187:drug effects; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002981:Clindamycin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D003692:Delayed-Action Preparations; D005079:Excipients / Q000737:chemistry*; D005260:Female; D006367:HeLa Cells; D006801:Humans; D009092:Mucous Membrane / Q000378:metabolism; D011135:Polysaccharides, Bacterial / Q000737:chemistry; D012756:Sheep; D013718:Tensile Strength; D013997:Time Factors; D016585:Vaginosis, Bacterial / Q000188:drug therapy
D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D005079:Excipients; D011135:Polysaccharides, Bacterial; D002981:Clindamycin; D002482:Cellulose; C008079:hydroxypropylcellulose; C007084:clindamycin phosphate; C002563:xanthan gum