A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/20 (2006.01) A61K 9/14 (2006.01) A61K 9/28 (2006.01) A61K 9/68 (2006.01)
Patent
CA 2556450
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.
La présente invention concerne de nouvelles compositions permettant d'administrer un agent hypnotique dans la muqueuse orale. L'invention concerne, en particulier, le système tampon desdites compositions, qui permet d'augmenter le pH de la salive jusqu'à obtenir un pH supérieur à environ 7,8, facilitant ainsi la conversion sensiblement complète de l'agent hypnotique, de sa forme ionisée à sa forme non ionisée. La dose d'agent hypnotique est ainsi absorbée rapidement et efficacement par la muqueuse orale avec une faible variabilité inter-sujet. L'administration de l'agent hypnotique dans la muqueuse orale permet, de plus, de dériver de manière avantageuse le mécanisme de premier passage hépatique du médicament, et évite la dégradation enzymatique du médicament dans le tractus gastro-intestinal. L'invention concerne également des méthodes d'utilisation de la présente invention dans le traitement des troubles du sommeil tels que l'insomnie.
Sim & Mcburney
Transcept Pharmaceuticals Inc.
Transoral Pharmaceuticals Inc.
LandOfFree
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