title: [Controlled release of prednisolone from suppository prepared using powder of pulverized tablet].
abstract: Prednisolone suppositories have been used successfully for the treatment of ulcerative colitis in hospital settings. However, the raw material of prednisolone suppository, JP prednisolone powder (JP Powder), was recently removed from the market. Therefore we studied the effects of raw material and suppository base on the release of prednisolone suppository for the purpose of designing a new suppository with similar effects to those of suppository prepared using JP powder (old suppository). New suppositories consisting of the powder of pulverized tablet as raw material and Witepsol H-15 and Witepsol E-75 as suppository base were prepared according to the fusion method. Suppository release test was performed by reciprocating dialysis tube method with tapping (RDT method) and dialysis tubing method (DT method). Both RDT method and DT method were performed using a suppository dissolution apparatus (modified JP disintegration apparatus) and a JP15 paddle apparatus, respectively. The test fluid was 50 mM phosphate buffer solution (pH 7.4) maintained at 37+/-0.5 degrees C. The results of release test by RDT method were similar to those of DT method. Release rate of prednisolone from the new suppository was much faster than that of old suppository. The addition of Witepsol E-75 to new suppository base markedly delayed the release of prednisolone from the new suppository. Release rate of prednisolone from the new suppository, consisting of pulverized tablet and Witepsol H-15 and Witepsol E-75 (76:24), corresponded well with that of the old suppository. It was suggested that this suppository could be used as incoming preparation of suppository prepared using JP powder.
authors: Department of Pharmacy, The Hospital of Hyogo College of Medicine, Nishinomiya City, Japan. yktatua@hyo-med.ac.jp
authors: Akitoshi
authors: A
authors: Tatsumi
authors: Shoko
authors: S
authors: Oda
authors: Tomoko
authors: T
authors: Nakamoto
authors: Reiko
authors: R
authors: Muraoka
authors: Yoshiko
authors: Y
authors: Takahashi
authors: Kuniyoshi
authors: K
authors: Tanaka
authors: Toshiyuki
authors: T
authors: Shikata
authors: Sumiyo
authors: S
authors: Tatsumi
authors: Noriko
authors: N
authors: Tagawa
authors: Yoshiharu
authors: Y
authors: Kobayashi
authors: Tsuneo
authors: T
authors: Hamaguchi
authors: Muneo
authors: M
authors: Kadobayashi
mesh_terms: D000277:Adjuvants, Pharmaceutic; D003692:Delayed-Action Preparations; D004339:Drug Compounding / Q000379:methods*; D011208:Powders; D011239:Prednisolone; D012995:Solubility; D013488:Suppositories; D013607:Tablets; D014280:Triglycerides
chemical_list: D000277:Adjuvants, Pharmaceutic; D003692:Delayed-Action Preparations; D011208:Powders; D013488:Suppositories; D013607:Tablets; D014280:Triglycerides; C009683:witepsol; D011239:Prednisolone