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Details for Patent: 5,824,334

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Details for Patent: 5,824,334

Title: Tobacco substitute
Abstract: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.
Inventor(s): Stanley; Theodore H. (Salt Lake City, UT), Hague; Brian I. (West Valley City, UT)
Assignee: University of Utah Research Foundation (Salt Lake City, UT)
Filing Date:Apr 19, 1996
Application Number:08/636,828
Claims:1. A selectively removable nicotine-containing dosage form for use in the transmucosal delivery of nicotine to a patient, the dosage form comprising:

(a) a powdered compressed carbohydrate matrix dissolvable in the oral cavity of a patient;

(b) a pharmacologically effective dose of nicotine dispersed in the matrix such that when the matrix dissolves in the mouth of the patient, the pharmacologically effective dose of nicotine is released for absorption through the mucosal tissue of the mouth, pharynx, and esophagus of the patient;

(c) a buffering agent to modify the saliva pH in the mouth of the patient; and

(d) a holder member secured to the matrix, said holder member being so configured as to facilitate manipulation of the nicotine-containing dosage form in and to permit the selective removal and insertion of the dosage form into and out of the patient's mouth.

2. A selectively removable nicotine-containing dosage form as recited in claim 1, wherein the dose of nicotine free base equivalents is within the range of about 0.1 mg to 30 mg.

3. A selectively removable nicotine-containing dosage form as recited in claim 1, wherein the nicotine is present within the matrix in the form of nicotine free base.

4. A selectively removable nicotine-containing dosage form as recited in claim 1, wherein the nicotine is present within the matrix in the form of a nicotine salt.

5. A selectively removable nicotine-containing dosage form as recited in claim 4 further comprising a buffering agent dispersed into the matrix, said buffering agent being capable of increasing the pH within the oral cavity and thereby increasing the unionized portion of the drug for improved absorption through the oral mucosa.

6. A selectively removable nicotine-containing dosage form as recited in claim 1, wherein the matrix further comprises multiple layers of compositions.

7. A selectively removable nicotine-containing dosage form as recited in claim 6, wherein the multiple layers contain different quantities of nicotine.

8. A selectively removable nicotine-containing dosage form as recited in claim 1, further comprising a coating layer containing an absorption enhancing agent.

9. A selectively removable nicotine-containing dosage form as recited in claim 1, further comprising an outer coating layer containing nicotine.

10. A selectively removable nicotine-containing dosage form as recited in claim 1, wherein the nicotine is dispersed into the matrix so that the concentration of nicotine available for absorption through the mucosal tissues of the mouth, pharynx, and esophagus varies over time as the matrix is dissolved in the mouth of the patient.

11. A selectively removable nicotine-containing dosage form as recited in claim 6, wherein the concentration of nicotine within an outer layer of the matrix is greater than the concentration of nicotine within an inner layer of the matrix.

12. A method for producing a selectively removable nicotine-containing dosage form for use in transmucosal delivery of nicotine to a patient, said method comprising the steps of:

(a) obtaining a pharmacologically effective dose of nicotine;

(b) dispersing said nicotine within a mixture of powdered compressed carbohydrate matrix material, said matrix material capable of dissolving within the mouth of a patient;

(c) forming said matrix material and nicotine into a solid integral mass;

(d) securing a holder member to said solid integral mass.

13. A selectively removable nicotine-containing dosage form for use in the transmucosal delivery of nicotine to a patient, the dosage form comprising:

(a) a soluble, powdered compressed carbohydrate matrix;

(b) nicotine disbursed within the carbohydrate material, the nicotine being capable of absorption through mucosal tissues of the mouth, pharynx, and esophagus and being disbursed substantially uniformly throughout the carbohydrate material at a temperature below the melting point of the nicotine and the carbohydrate material and compressed with the carbohydrate material into a solid integral mass which is capable of dissolving in the mouth of the patient so that the nicotine is released for absorption through mucosal tissues of the mouth, pharynx, and esophagus upon dissolution of the integral mouth mass in the mouth of the patient;

(c) a microencapsulated buffering agent which is also disbursed substantially uniformly throughout the integral mass, the buffer being capable of modifying and maintaining the pH in the mouth such that a majority of the drug remains non-ionized in order to facilitate transmucosal absorption of the drug; and

(d) a holder secured to the integral mass so as to form a nicotine-containing dosage form, the holder means being configured so as to permit convenient insertion and removal of the nicotine-containing integral mass into and out of the mouth of the patient.

14. A selectively removable nicotine-containing dosage form as recited in claim 13, wherein the microencapsulation is water soluble so as to dissolve in the mouth of the patient.

15. A selectively removable nicotine-containing dosage form as recited in claim 13, wherein the buffering agent is encapsulated in a water soluble material.

16. A selectively removable nicotine-containing dosage form as recited in claim 13, wherein the nicotine is in the form of a nicotine salt.

17. A selectively removable nicotine-containing dosage form as recited in claim 13, wherein the nicotine is in a free base form.
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