COMPOSITIONS FOR DELIVERING HYPNOTIC AGENTS ACROSS THE ORAL MUCOSA AND METHODS OF USE THEREOF
First Claim
1. A method for treating insomnia, comprising the steps of:
- administering a pharmaceutical composition comprising zolpidem in an amount from about 1 mg to about 5 mg, a carbonate buffer, and a bicarbonate buffer to a subject prone to insomnia, wherein the pharmaceutical composition provides delivery of zolpidem across the subject'"'"'s oral mucosa, wherein the carbonate buffer and bicarbonate buffer are present in a carbonate;
bicarbonate weight ratio of about 1;
1 to about 1;
10, wherein the pharmaceutical composition is a solid pharmaceutical composition, and wherein at least 75% of the solid pharmaceutical composition dissolves within about 10 minutes or less within an oral cavity following administration.
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Abstract
The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.
124 Citations
23 Claims
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1. A method for treating insomnia, comprising the steps of:
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administering a pharmaceutical composition comprising zolpidem in an amount from about 1 mg to about 5 mg, a carbonate buffer, and a bicarbonate buffer to a subject prone to insomnia, wherein the pharmaceutical composition provides delivery of zolpidem across the subject'"'"'s oral mucosa, wherein the carbonate buffer and bicarbonate buffer are present in a carbonate;
bicarbonate weight ratio of about 1;
1 to about 1;
10,wherein the pharmaceutical composition is a solid pharmaceutical composition, and wherein at least 75% of the solid pharmaceutical composition dissolves within about 10 minutes or less within an oral cavity following administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A pharmaceutical composition comprising:
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about 1 mg to about 5 mg of zolpidem;
a carbonate buffer; and
a bicarbonate buffer, wherein the carbonate buffer and bicarbonate buffer are present in a carbonate;
bicarbonate weight ratio of about 1;
1 to about 1;
10, andwherein the pharmaceutical composition is a solid pharmaceutical composition capable of dissolving within about 2 minutes within an oral cavity following administration. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23)
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Specification