Physical state of misoprostol in hydroxypropyl methylcellulose films.
Scanning electron (SEM) and light microscopy (LM), differential scanning calorimetry (DSC), and dynamic mechanical analysis (DMA) techniques were utilized to determine the miscibility of misoprostol and HPMC in the films with a misoprostol content from 0 to 29%, prepared using ethanol and methylene chloride/methanol (MeCl2/methanol, 50:50). Transmission infrared (TIR) analysis was used to look for evidence of any interaction between misoprostol and HPMC. The LM and SEM analysis of the ethanol cast films indicated no oil droplets. The DSC thermograms of the films showed no evidence of a -33 degrees C transition, which is characteristic of pure misoprostol. The DMA showed that the glass-rubber transition temperature (Tg) of the pure HPMC was lowered from 163 to 125-130 and 85-87 degrees C in the presence of 10 and 27-28% misoprostol. Based on these results it is suggested that misoprostol is solubilized in HPMC at concentrations up to 29%. The TIR analysis of the films showed no evidence of interaction between misoprostol and HPMC.
Kararli
T T
TT
Searle Product Development, Skokie, Illinois 60077.
Needham
T E
TE
Seul
C J
CJ
Finnegan
P M
PM
Hidvegi
M I
MI
Hurlbut
J
J
D000527:Alprostadil / Q000031:analogs & derivatives* / Q000737:chemistry; D002152:Calorimetry, Differential Scanning; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D000431:Ethanol; D065347:Hypromellose Derivatives; D008567:Membranes, Artificial; D008737:Methyl Chloride; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D008854:Microscopy, Electron; D008855:Microscopy, Electron, Scanning; D016595:Misoprostol; D012997:Solvents
D008567:Membranes, Artificial; D012997:Solvents; D016595:Misoprostol; D000431:Ethanol; D065347:Hypromellose Derivatives; D008747:Methylcellulose; D008737:Methyl Chloride; D000527:Alprostadil