Content area
Full Text
METHOD OF PREPARATION
1 . Calculate the required quantity of each ingrethent for the total amount to be prepared.
2. Weigh and/or measure each ingredient accurately.
3. Dissolve the nicotine tartrate in about 95 mL of purified water.
4. Sprinkle the Carbopol 974P slowly onto the rapidly agitated solution.
5. Add sufficient purified water to volume and mix well.
6. Add trolamine to the solution dropwise if a thicker preparation is required.
7. Package and label.
PACKAGING
Package in tight, light-resistant containers.1
LABELING
Keep out of reach of children. Use only as directed. For rectal use only.
STABILITY
A beyond-use date of 30 days when stored in a refrigerator can be used for this preparation.1
USE
Nicotine retention enemas have been used in the treatment of ulcerative colitis.2-4
QUALITY CONTROL
Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, clarity, rheological properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).5
DISCUSSION
One early study showed that, in the 10 patients with active Crohn's colitis, 6-mg nicotine enemas were associated with clinical improvement...