US 5,785,989 A · Compositions and methods of manufacturing of oral dissolvable medicaments

Abstract

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.

Claims198

Dependent claims

A solid drug-containing dosage-from for use in the transmucosal oral and sublingual delivery of the drug to a patient, said solid dosage-form consisting essentially of:

a soluble matrix selected from the group consisting of a carbohydrate, wax, fat, protein, or mixture thereof;
buffers dispersed throughout the soluble matrix;
a pharmacologically effective dose of a drug being capable of absorption through mucosal tissues of the mouth, pharynx, and esophagus and being dispersed throughout the matrix and formed into a solid integral mass which is capable of being sucked on while held within the mouth to dissolve the integral mass in the mouth of the patient to release the drug for absorption through mucosal tissues of the mouth, pharynx, and esophagus during the period of holding within the mouth resulting in dissolution of the integral mass in the mouth of the patient;
and
attached holder means secured to the integral mass so as to form a drug-containing dosage-form, the holder means being configured to permit convenient insertion and removal of the drug-containing integral mass into and out of the mouth of the patient and to permit administration of the dosage form in a dose-to-effect manner.

2 more elements

Dependencies are inferred from the claim text.

Compositions and methods of manufacturing of oral dissolvable medicaments

Life of this patent

Compositions and methods of manufacturing of oral dissolvable medicaments

Life of this patent

Abstract

Claims198