Abstract: Methods for treating a patient with ondansetron are described. The method includes administering a solid pharmaceutical composition having ondansetron and a buffer to the patient. Ondansetron is absorbed across a permeable membrane of the patient's oral mucosa. The buffer may include two different buffering agents, such as sodium carbonate and sodium bicarbonate. The buffer may raise the pH of saliva to a pH of between 7.1 to 13. The patient may suffer from emesis, such as nausea and vomiting associated with cancer chemotherapy and radiotherapy.

Abstract: The present invention provides compositions for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: Pharmaceutical compositions for buccal delivery of zolpidem comprising an effective amount of zolpidem and a carbonate and bicarbonate buffer system in an amount sufficient to raise the pH 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 are described. Pharmaceutical compositions for buccal delivery of zolpidem comprising an effective amount of zolpidem and a binary buffer system of carbonate and bicarbonate, wherein the carbonate and bicarbonate are co-located in a single particle, wherein the bicarbonate is coated with the carbonate, and wherein the amount of carbonate coating is at least 30% (w/w) of the binary buffer system are also described.

Abstract: The present invention provides novel compositions comprising a combination of a 5-HT3 receptor antagonist and a selective dopamine D2 receptor antagonist for the treatment of alcohol dependence and other dopamine pathway-associated disorders or conditions. Preferably, the pharmaceutical compositions of the present invention comprise amounts of the 5-HT3 receptor antagonist ondansetron and the selective dopamine D2 receptor antagonist olanzapine that are sufficient to control a subject's craving for alcohol or other addictive substances. Kits comprising the combination of antagonists for the treatment of addictive disorders such as alcohol dependence are also provided.

Abstract: The present invention provides novel compositions comprising a combination of a 5-HT3 receptor antagonist and a selective dopamine D2 receptor antagonist for the treatment of obsessive, impulsive and compulsive behavioral activities and other dopamine pathway-associated disorders or conditions. Preferably, the pharmaceutical compositions of the present invention comprise amounts of the 5-HT3 receptor antagonist ondansetron and a selective dopamine D2 receptor antagonist, such as risperidone or olanzapine, that are sufficient to control a subject's obsessive, impulsive and compulsive behavioral activities. Kits comprising the combination of antagonists for the treatment of addictive disorders such as alcohol dependence are also provided.

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.

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.

Abstract: The present invention provides novel compositions for the delivery of pilocarpine or a pharmaceutically acceptable salt thereof across the oral mucosa, preferably across the buccal mucosa. In particular, the buffer systems in the compositions of the present invention contain an amount of a strong base that is less than the amount of a weak base, thereby increasing the stability of compositions such as chewing gum compositions and raising the pH of saliva to a pH greater than about 7.5 to facilitate the substantially complete conversion of pilocarpine from its ionized to its un-ionized form. Methods for using the compositions of the present invention for treating conditions such as dry mouth are also provided.

Abstract: Compositions, methods, and formulations for delivering 5-HT3 antagonists across the oral mucosa are described. In some variations, the described compositions comprise at least one 5-HT3 antagonist, which is at least partly in an ionized form, and a buffer system. The buffer system generally comprises at least two different buffering agents and is capable of changing the pH of saliva from an arbitrary initial pH to a predetermined final pH, and of sustaining the final pH for a period of time. The predetermined final pH favors substantially complete conversion of the ionized form to the un-ionized form. In other variations, the described compositions comprise a 5-HT3 antagonist, at least partly in an un-ionized form, and a buffer system. In these variations, the buffer system is capable of providing an adjusted salival pH such that the 5-HT3 antagonist remains in its un-ionized form. Dissolving tablets are also described.

Abstract: Pharmaceutical compositions for buccal delivery of zolpidem comprising an effective amount of zolpidem and a carbonate and bicarbonate buffer system in an amount sufficient to raise the pH of saliva to at least 8.5 irrespective of starting pH, 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 are described. Methods of treating insomnia in a subject are described, the method including the step of administering to the subject the pharmaceutical composition of the present invention, wherein the administering is on an as-needed basis. Method of treating MOTN insomnia in a subject are also described.

Abstract: The present invention provides novel compositions comprising a combination of a 5-HT3 receptor antagonist and a selective dopamine D2 receptor antagonist for the treatment of alcohol dependence and other dopamine pathway-associated disorders or conditions. Preferably, the pharmaceutical compositions of the present invention comprise amounts of the 5-HT3 receptor antagonist ondansetron and the selective dopamine D2 receptor antagonist olanzapine that are sufficient to control a subject's craving for alcohol or other addictive substances. Kits comprising the combination of antagonists for the treatment of addictive disorders such as alcohol dependence are also provided.

Abstract: Disclosed are oral pharmaceutical vehicle compositions comprising from about 0.05 to about 20% of a water-soluble mucoadhesive.

Abstract: A method of delivering ephedrine base in vapor form from a composition containing the ephedrine base and an alkyl salicylate. Methyl salicylate is the preferred alkyl salicylate. Optional ingredients in the composition include aromatic compounds such as menthol, camphor, and various other essential oils. The method is particularly useful in the treatment of nasal congestion and bronchial asthma. A preferred means of delivering the ephedrine base in vapor form in the treatment of nasal congestion and bronchial asthma is a vapor inhaler.