Abstract
Benzalkonium chloride (BKC), an antimicrobial preservative, commonly used in nasal drops, has been reported for its many adverse effects especially when used in pediatrics formulations. Therefore it is the need to find out safe and effective antimicrobial preservative. The aim of this study was to evaluate antimicrobial preservative efficacy of sodium perborate in 0.9% sodium chloride nasal drops. Trials A, B and C were prepared with 0.01, 0.02, and 0.04%, w/v sodium perborate at pH between 5.5- 6.5. Trials D, E and F, manufactured at pH ranges 6-7, 7-8 and 8-9.Trial H was made with benzyl alcohol and disodium EDTA in addition to sodium perborate, Trial K was with addition of benzyl alcohol and sodium perborate. Antimicrobial preservative efficacy was determined as per United State Pharmacopoeia (USP). Marketed formulation, sodium chloride nasal drops with 0.02% BKC (Trial G, I and J) were used as control. All the trial samples complied with acceptance criteria except A and B. Thus sodium perborate can be used in sodium chloride nasal drops at 0.04% concentration at all pH ranges as substitute of BKC. Furthermore, the addition of benzyl alcohol and disodium EDTA also enhanced the antimicrobial preservative efficacy of sodium perborate.
