University of Utah Research Foundation

Theratech, Inc.

Anesta Corporation

Stanley Research Foundation

Theodore H Stanley

Brian I Hague

Jie Zhang

Charles D Ebert

Jerrold L Foote

William I Higuchi

Brian Haque

Compositions and methods of manufacture for producing a medicament composition capable of absorption through the mucosal tissues of the mouth, pharynx, and esophagus. The present invention relates to such compositions and methods which are useful in administering lipophilic and nonlipophilic drugs in a dose-to-effect manner such that sufficient drug is administered to produce precisely a desired effect. The invention also relates to manufacturing techniques that enable therapeutic agents to be incorporated into nondissolvable drug containment matrixes which are capable of releasing the drug within a patient's mouth. An appliance or holder is preferably attached to the drug containment matrix. Employing the present invention the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods. The nondissolvable drug containment matrix may include permeation enhancers to increase the drug absorption by the mucosal tissues of the mouth. The matrix composition may also include pH buffering agents to modify the salival pH thereby increasing the absorption of the drug through the mucosal tissues.

Non-dissolvable drug-containing dosage-forms for use in the transmucosal

The present invention relates generally to a cigarette substitute for administering a dose of nicotine. More specifically, the present invention is directed to a nicotine-containing dosage-form comprising a holder member which may be used as part of an effective smoking cessation program or in situations where smoking is undesirable or not permitted. The dosage form is configured as a dosage form having a nicotine-containing composition attached to a holder member. Nicotine is released from the dosage form and absorbed through the intra-oral mucosal surfaces as the nicotine-containing composition releases nicotine within a user's mouth. The holder member facilitates insertion and removal of the dosage form into and out of a user's mouth. The user can selectively insert and remove the dosage form as desired to selectively control the release of nicotine. In addition, the user can insert and remove the dosage form in a manner which meets the user's psychological need or desire for ritualistic oral stimulation similar to cigarette smoking.

Tobacco substitute

Compositions and methods of manufacture for producing a medicament composition capable of absorption through the mucosal tissues of the mouth, pharynx, and esophagus. The present invention relates to such compositions and methods which are useful in administering lipophilic and nonlipophilic drugs in a dose-to-effect manner such that sufficient drug is administered to produce precisely a desired effect. The invention also relates to a manufacturing technique that enables a therapeutic agent or drug to be incorporated into a flavored dissolvable matrix. An appliance or holder is preferably attached to the dissolvable matrix. Employing the present invention the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods. The present invention achieves these advantages by incorporating the drug into a carbohydrate, fat, protein, wax, or other dissolvable matrix composition. The dissolvable matrix may include permeation enhancers to increase the drug absorption by the mucosal tissues of the mouth. The matrix composition may also include pH buffering agents to modify the salival pH thereby increasing the absorption of the drug through the mucosal tissues.

Compositions and methods of manufacturing of oral dissolvable medicaments

The present invention relates to a selectively removable nicotine-containing dosage form for use in the transmucosal delivery of nicotine to a patient. More specifically, the present invention is directed to a nicotine-containing dosage-form comprising an attached holder member which may be used to manipulate the dosage form within the mouth of the patient as part of an effective smoking cessation program or in situations where smoking is undesirable or not permitted. Nicotine is released from a dosage form and absorbed through the intra-oral mucosal surfaces as the nicotine-containing matrix releases nicotine within the user's mouth. The user may selectively insert and remove the dosage form as desired to control the release of nicotine. In addition, the user may manipulate the dosage form by use of the holder means in such a manner to meet the user's psychological need or desire for ritualistic oral stimulation similar to cigarette smoking.

Selectively removable nicotine-containing dosage form for use in the

The present invention is directed to methods and compositions for noninvasively administering drugs in a dose-to-effect manner to produce a cardiovascular or renal vascular activity. A cardiovascular or renal vascular drug, which is capable of absorption through mucosal tissues of the mouth, pharnyx, and esophagus is incorporated into a matrix which is in the form of a lollipop. A patient is put at ease when given the lollipop, and the drug rapidly enters the patient's bloodstream as the lollipop is sucked. When treating the patient, the physician can observe the patient's condition and remove the lollipop when it has had a desired effect on the patient. A lollipop into which a cardiovascular or renal vascular drug has been dispersed is particularly useful for achieving rapid vasodilating, calcium channel blocking, beta-blocking, seritonin receptor blocking, angina blocking, antihypertensive, and cardiac stimulating effects and for controlling urine output.

Methods and compositions for noninvasive dose-to-effect administration

The present invention is directed to novel methods and apparatus for noninvasively collecting substances through mucosal tissues. The concentration of a substance in blood is monitored noninvasively by correlation with the amount of the substance which permeates a mucosal membrane into a substance receiving medium over a specified time period. The substance receiving medium may include an substance permeation enhancer capable of increasing the substance permeability across the mucosal membrane. The substance receiving medium is positioned against the mucosal membrane. After sufficient time delay, the substance receiving medium is removed and analyzed for the concentration of a substance to be measured using known analytical techniques. The apparatus within the scope of the present invention includes means for supporting the substance receiving medium. The means for supporting the receiving medium provides an added benefit of isolating the substance receiving medium from contamination sources. Such means for supporting the substance receiving medium may include a housing defining a receiving chamber therein which holds the substance receiving medium and an opening to the receiving chamber. The apparatus also preferably includes means for temporarily positioning the substance receiving medium against the mucosal membrane. The present invention also naturally utilizes the mucosa as filter membrane to exclude compounds in plasma that would interfere with any analysis or make any analysis more difficult. Analysis of substances in receiving medium may be significantly easier than in plasma. An artificial membrane may be used to further exclude other undesirable compounds.

Apparatus and methods for noninvasive blood substance monitoring

Compositions and methods of manufacture for producing a medicament composition capable of absorption through the mucosal tissues of the mouth, pharynx, and esophagus. The present invention relates to such compositions and methods which are useful in administering lipophilic and nonlipophilic drugs in a dose-to-effect manner that sufficient drug is administered to produce precisely a desired effect. The invention also relates to a manufacturing technique that enables a therapeutic agent or drug to be incorporated into a flavored dissolvable matrix. An appliance or holder is preferably attached to the dissolvable matrix. Employing the present invention the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods. The present invention achieves these advantages by incorporating the drug into a carbohydrate, fat, protein, wax, or other dissolvable matrix composition. The dissolvable matrix may include permeation enhancers to increase the drug absorption by the mucosal tissues of the mouth. The matrix composition may also include pH buffering agents to modify the salival pH thereby increasing the absorption of the drug through the mucosal tissue.

Compositions of oral dissolvable medicaments

Compositions and methods of manufacture for producing a medicament composition capable of absorption through the mucosal tissues of the mouth, pharynx, and esophagus. The present invention relates to such compositions and methods which are useful in administering lipophilic and nonlipophilic drugs in a dose-to-effect manner such that sufficient drug is administered to produce precisely a desired effect. The invention also relates to manufacturing techniques that enable therapeutic agents to be incorporated into nondissolvable drug containment matrixes which are capable of releasing the drug within a patient's mouth. An appliance or holder is preferably attached to the drug containment matrix. Employing the present invention the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods. The nondissolvable drug containment matrix may include permeation enhancers to increase the drug absorption by the mucosal tissues of the mouth. The matrix composition may also include pH buffering agents to modify the saliva pH thereby increasing the absorption of the drug through the mucosal tissues.

Compositions of oral nondissolvable matrixes for transmucosal

The present invention is directed to novel methods and apparatus for noninvasive blood glucose monitoring. Blood glucose is monitored noninvasively by correlation with amount of glucose which permeates an epithelial membrane, such as skin or a mucosal membrane, into a glucose receiving medium over a specified time period. The glucose receiving medium preferably includes a glucose permeation enhancer capable of increasing the glucose permeability across the epithelial membrane. The glucose receiving medium is positioned against the epithelial membrane so that the permeation enhancer alters the permeability of the membrane. After sufficient time delay, the glucose receiving medium is removed and analyzed for the presence of glucose using conventional analytical techniques. The apparatus within the scope of the present invention includes means for supporting the glucose receiving medium. Such means for supporting the glucose receiving medium may include a housing defining a receiving chamber therein which holds the glucose receiving medium and an opening to the receiving chamber. The means for supporting the glucose receiving medium may also include a hydrogel. The apparatus also preferably includes means for temporarily positioning the glucose receiving medium against the epithelial membrane.

Apparatus and method for noninvasive blood glucose monitoring

Compositions and methods of manufacture for producing a medicament composition capable of absorption through the mucosal tissues of the mouth, pharynx, and esophagus. The present invention relates to such compositions and methods which are useful in administering drugs in a dose-to-effect manner such that sufficient drug is administered to produce precisely a desired effect. The invention also relates to a manufacturing technique that enables a therapeutic agent or drug to be incorporated into a flavored confectionary base and to compress or otherwise attach the solid confectionary mixture onto an appliance or holder. Employing the present invention the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods. The present invention achieves these advantages by incorporating the drug into a compressed powder 'candy' matrix. The pH and pKa of the powder matrix can be modified to increase the absorption of the drug through the mucosal tissues.

Compositions and methods of manufacture of compressed powder medicaments

Apparatus and methods for the dose-to-effect transmucosal administration of medicaments are disclosed. The present invention relates to such apparatus and methods which are useful in administering medicaments in a dose-to-effect manner such that sufficient drug is administered to produce precisely a desired effect. The invention also relates to an apparatus capable of placement directly on the patient's buccal mucosa having the capability of adjusting the drug surface area in direct contact with the mucosal tissue thereby enabling the proper amount of therapeutic agent or drug to be administered while accounting for individual needs and susceptibilities of the drug. Through the use of selected permeation enhancers, the present invention enables lipophilic and nonlipophilic medicaments, which are not suitable for oral administration, to be rapidly administered noninvasively. Employing the present invention the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods.

Apparatus and methods for use in administering medicaments by direct

Compositions and methods of manufacture for producing a medicament composition capable of absorption through the mucosal tissues of the mouth, pharynx, and esophagus. The present invention relates to such compositions and methods which are useful in administering drugs in a dose-to-effect manner such that sufficient drug is administered to produce precisely a desired effect. The invention also relates to a manufacturing technique that enables a therapeutic agent or drug to be incorporated into a flavored confectionary base and to compress or otherwise attach the solid confectionary mixture onto an appliance or holder. Employing the present invention, the drug may be introduced into the patient's bloodstream almost as fast as through injection, and much faster than using the oral administration route, while avoiding the negative aspects of both of these methods. The present invention achieves these advantages by incorporating the drug into a compressed powder 'candy ' matrix. The pH and pKa of the powder matrix can be modified to increase the absorption of the drug through the mucosal tissues.

The present invention is directed to methods and compositions for noninvasively administering drugs having a sedative, analgesic, or anesthetic effect. A drug capable of absorption through mucosal tissues in incorporated into a candy matrix, which is then advantageously formed into a lollipop. A patient is put at ease when given the lollipop, and the drug rapidly enters the patient's bloodstream as the lollipop is sucked. When sedating or anesthetizing the patient, the physician can observe the patient's condition and remove the lollipop when it has had a desired effect on the patient. Alternatively, the physican can alter placement of the lollipop to slow the rate of the drug release for absorption into the patient's system. An analgesic-containing lollipop can be self-administrated by a patient in response to his own subjective experience of pain and to the patient's susceptibility to the particular drug utilized.

Methods and compositions for noninvasive administration of sedatives,

An inflation and adjustable pressure relief apparatus for the inflatable cuff of an endotracheal tube, the apparatus having an adjustably spring-biased relief valve to automatically release gas pressures from the cuff above a preselected pressure level and a manually operable spring-biased valve for increasing the gas pressure in the cuff.

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Salt Lake City, UT, United States of America

Theodore H Stanley