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Claims for Patent: 5,869,100

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Claims for Patent: 5,869,100

Title: Extended release clonidine formulation (tablet)
Abstract:A method of providing a patient needing clonidine with an extended dosage of clonidine over a prolonged period of time. Such method involves administering to the patient an oral dosage unit comprising a homogenous mixture of a therapeutically effective amount of clonidine, about 30 to about 70 percent by weight of one or more cellulose ethers such as hydroxypropyl methylcellulose, and about 30 to about 70 percent by weight of an inert substance such as cornstarch. The oral dosage unit may be contained in a gelatin capsule or in the form of a tablet.
Inventor(s): Horacek; H. Joseph (Charlotte, NC)
Assignee:
Application Number:08/881,314
Patent Claims: 1. An oral pharmaceutical dosage unit formulation for the extended release of clonidine to effect central alpha-adrenergic stimulation over a prolonged period upon administration thereof wherein the oral dosage unit is a tablet, the tablet comprising:

a. a therapeutically effective amount of clonidine in the range of about 0.025 mg. to about 0.40 mg. for the treatment of attention deficit hyperactivity disorder;

b. from about 30 to about 70 percent by weight of a cellulose ether; and

c. a therapeutically inert, pharmaceutically acceptable adjunct material, wherein the adjunct material is selected from the group consisting of cornstarch, lactulose and dextrose.

2. The extended release clonidine formulation according to claim 1, wherein the tablet comprises from about 30 to about 40 percent by weight of the cellulose ether.

3. The extended release clonidine formulation according to claim 1, wherein the cellulose ether is selected from the group consisting of ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose, and mixtures thereof.

4. The extended release clonidine formulation according to claim 3, wherein the hydroxypropyl methylcellulose has a hydroxypropoxyl substitution of from about 7 to about 12 weight percent, a methoxyl substitution of from about 28 to about 30 weight percent, a number average molecular weight of about 86,000, a 2% aqueous solution viscosity of about 4000 cps.

5. The extended release clonidine formulation according to claim 3, wherein the hydroxypropyl methylcellulose has a hydroxypropoxyl substitution of from about 7 to about 12 weight percent, a methoxyl substitution of from about 19 to about 24 weight percent, a number average molecular weight of about 246,000, a 2% aqueous solution viscosity of about 100,000 cps.

6. The extended release clonidine formulation according to claim 1, wherein the amount of therapeutically inert, pharmaceutically acceptable adjunct material is from about 30 to about 70 percent by weight.

7. The extended release clonidine formulation according to claim 1, wherein the therapeutically inert, pharmaceutically acceptable adjunct material is cornstarch.

8. The extended release clonidine formulation according to claim 1, wherein the therapeutically inert, pharmaceutically acceptable adjunct material is lactulose.

9. The extended release clonidine formulation according to claim 1, wherein the therapeutically inert, pharmaceutically acceptable adjunct material is dextrose.

10. A method for effecting central alpha-adrenergic stimulation over a prolonged period in a mammalian specie which comprises administering the extended release clonidine formulation as defined in claim 1.

11. The extended release clonidine formulation according to claim 1, wherein the release period is from about 8 to about 12 hours.
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