2020 年 46 巻 2 号 p. 109-117
Esflurbiprofen (SFP) mentha oil formulation (SFP tape) is a tape-type patch containing a non-steroidal anti-inflammatory drug (NSAID) SFP, as the active ingredient. In clinical practice, there is a perception that SFP tape is not always easy to remove from the applied site. In this study, we evaluated the adhesive performance, tack and peel strengths of a formulation modified SFP tape prepared with the aim of reducing peel strength to improve the “difficulty of removal” after application. Prior to evaluation, bioequivalence between the modified SFP tape and the commercial SFP tape was verified. In vitro drug release-rate and skin permeation profiles of both formulations were shown to be comparable, as were the drug plasma concentration-time profiles in hairless rats after application. Tack and peel strengths were evaluated using the ball tack and 180° peel tests, respectively. Our results demonstrated that the formulation modified SFP tape while retaining tack strength (difficult to pull apart on application) reduced peel strength when compared with the commercial SFP tape. Furthermore, peel strength was determined to be comparable to representative marketed NSAID tape-type patches. In conclusion, the formulation modified SFP tape with demonstrated bioequivalence to the commercial SFP tape showed improved “difficulty of removal” after application while retaining sufficient tack strength.
