Abstract

Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles

Author(s): McPherson Timothy B, Neumann William L, Kolling William M

Issue: Nov/Dec 2013 - Volume 17, Number 6

Page(s): 508-511

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  • Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles Page 1
  • Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles Page 2
  • Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles Page 3
  • Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles Page 4

Abstract

Tetracaine topical solution may improve patient adherence with topical clotrimazole therapy for fungal otitis externa. The chemical stability of tetracaine 1% and combination clotrimazole 1% with tetracaine 1% topical solutions was determined using a stability-indicating high-performance liquid chromatography assay. Propylene glycol and polyethylene glycol 400 were used as anhydrous solvents. Standard curves for tetracaine and clotrimazole were linear with r2 = 0.999. Clotrimazole did not degrade in either propylene glycol or polyethylene glycol 400 throughout the 90-day study period. Tetracaine degraded significantly in propylene glycol but not in polyethylene glycol 400. A beyond-use date of 90 days is supported for tetracaine and the combination clotrimazole-tetracaine solution in polyethylene glycol 400. A beyond-use date of 60 days is supported for tetracaine and the combination clotrimazole–tetracaine in propylene glycol.

Related Keywords

  • tetracaine
  • clotrimazole
  • topical solutions
  • topical preparations
  • patient adherence
  • fungal otitis externa
  • stability
  • propylene glycol
  • polyethylene glycol 400
  • PEG 400
  • topical anesthetic
  • drug admixtures

Related Categories

  • EXCIPIENTS
  • PACKAGING
  • PAIN MANAGEMENT
  • PEER-REVIEWED
  • STABILITIES, COMPATIBILITIES
  • INFECTIOUS DISEASE

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