STABILIZED ZOLPIDEM PHARMACEUTICAL COMPOSITIONS
Methods of inducing antinociception in a human are described. The method includes the step of administering an effective dose of a polypeptide comprising L-neo-tryptophan to the human extracranially. The polypeptide containing L-neo-tryptophan could be, but is not limited to, NT64L, NT65L, NT66L, NT67L, NT69L, NT69L′, NT71, NT72, NT73, NT74, NT75, NT76, or NT77.
1 . A pharmaceutical composition for buccal and/or sublingual delivery of a therapeutic agent, said composition comprising:
an effective amount of zolpidem; and
a carbonate and bicarbonate buffer system in an amount sufficient to raise the of saliva to at least 8.5, and wherein the carbonate forms a coating on the bicarbonate wherein the amount of carbonate coating is at least 30% (w/w) of the total buffer amount.
2 . The pharmaceutical composition of claim 1 , wherein the zolpidem is zolpidem hemitartrate.
3 . The pharmaceutical composition of claim 2 , wherein the zolpidem hemitartrate is present in an amount of less than 5 mg.
4 . The pharmaceutical composition of claim 2 , wherein the zolpidem hemitartrate is present in an amount less than 1.30×10 −5 moles.
5 . The pharmaceutical composition of claim 1 , wherein the buffer system produces a pH of at least 8.5 in a patient's saliva.
6 . The pharmaceutical composition of claim 1 , wherein the carbonate coating is from 40% to 46% (w/w) of the total buffer amount.
7 . The pharmaceutical composition of claim 1 , wherein the buffer system is present in particles having an average diameter of from 60 to 90 microns.
8 . The pharmaceutical composition of claim 1 , wherein the buffer system comprises sodium carbonate and sodium bicarbonate.
9 . The pharmaceutical composition of claim 1 , wherein the composition is a quirk-dissolving lozenge or tablet.
10 . A pharmaceutical composition for buccal and/or sublingual delivery of a therapeutic agent, said composition comprising:
an effective amount of zolpidem; and
a binary buffer system comprising carbonate and bicarbonate, wherein the carbonate and bicarbonate are co-located in a single particle, wherein the bicarbonate is coated with the carbonate, wherein the amount of carbonate coating is at least 30% (w/w) of the binary buffer system.
11 . The pharmaceutical composition of claim 10 , wherein the zolpidem is zolpidem hemitartrate.
12 . The pharmaceutical composition of claim 11 , wherein the zolpidem hemitartrate is present in an amount of less than 5 mg.
13 . The pharmaceutical composition of claim 11 , wherein the zolpidem hemitartrate is present in an amount less than 1.30×10 −5 moles.
14 . The pharmaceutical composition of claim 10 , wherein the buffer system produces a pH of at least 8.5 in a patient's saliva.
15 . The pharmaceutical composition of claim 10 , wherein the carbonate coating is from 40% to 48% (w/w) of the total buffer amount.
16 . The pharmaceutical composition of claim 10 , wherein the buffer system is present in particles having an average diameter of from 60 to 90 microns.
17 . The pharmaceutical composition of claim 10 , wherein the buffer system comprises sodium carbonate and sodium bicarbonate.
18 . The pharmaceutical composition of claim 10 , wherein the composition is a quick-dissolving lozenge or tablet.