Product: Tabletted
chewing gum, each piece contains 262 mg of bismuth
subsalicylate (BSS)
Dosage:
Two tablets four times per day (max dose 2062mg BSS per
day)
Regulatory
Status: OTC Monograph allows any oral dosage form.
Product Claim:
“For the soothing relief of upset stomach, indigestion,
heartburn, nausea due to overindulgence in food and
drink, and diarrhea”.
Consumer
Directions: “Chew one or two pieces of gum up to a
maximum of four times per day to treat symptoms. The
dose may be repeated every 30 minutes to one hour as
needed but no more than eight pieces of gum should be
taken in a 24 hour period.”
Patents: Covered
by six United States Patents
Packaging:
currently 12 tablets per blister pack, 3 blister packs
per carton (36 tablets)
Manufacturing:
GMP commercial scale-up complete and commercial
quantities can be supplied almost immediately.
Product
Advantages: There are reasons to believe that a chewing
gum form that delivers BSS to the saliva gradually over
a period of minutes is a very efficacious way of
delivering the active ingredient.
Contact JASRA regarding any licensing interest.
