ABSTRACT
Although tulobuterol tape is provided to patients in an inner package, information regarding the stability of the tape after opening the packaging may be requested by patients. This study was performed to generate underlying data on the storage stability after package opening or liner peeling with package opening. Tulobuterol tapes were stored at 25â, 60% relative humidity (RH); 40â, 75%RH; or in a refrigerator (2-4â, 10-30%RH) for 1 day or 3 days. In a peel adhesive strength test after package opening, storage at 25â, 60%RH had a low effect on the adhesive strength of the tape. Storage after liner peeling with package opening resulted in variable adhesive strength of the tape. Regarding drug release properties, for storage after package opening, the f2 values of tapes stored in the three different conditions were over 50, except for tapes stored at 25â, 60%RH for 3 days. For the tapes stored at 25â, 60%RH or 40â, 75%RH after liner peeling with package opening, the release rate and the ratio of drug released at 24 h may be decreased because the drug content decreased due to drug sublimation. This study suggested that tulobuterol tapes can be stored after package opening at 25â, 60%RH for 1 d.