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|Title:||Extended release clonidine formulation|
|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)|
|Filing Date:||Oct 13, 1993|
|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 gelatin capsule containing a homogenous mixture, the homogenous mixture comprising: |
a. a therapeutically effective amount of clonidine;
b. from about 30 to about 70 percent by weight of a cellulose ether, wherein the cellulose ether is selected from the group consisting of ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose having a hydroxypropoxyl substitution of from about 7 to about 12 weight percent and a methoxyl substitution of from about to about 30 weight percent and having a number average molecular weight of about 86,000 and a 2% aqueous solution viscosity of about 4000 cps hydroxypropyl methylcellulose having a hydroxypropoxyl substitution of from about 7 to about 12 weight percent, and a methoxyl substitution of from about 19 to about 24 weight percent and having a number average molecular weight of about 246,000 and a 2% aqueous solution viscosity of about 100,000 cps and mixtures thereof; and from about 30 to about 70 percent by weight of therapeutically inert, pharmaceutically acceptable adjunct materials, 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 amount of clonidine is in the range of about 0.025 mg. to about 0.40 mg.
3. The extended release clonidine formulation according to claim 1, wherein the homogenous mixture comprises about 30 to 40 percent by weight of the cellulose ether.
4. 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.
5. The extended release clonidine formulation according to claim 1, wherein the release rate is one that provides attention deficit hyperactivity disorder therapy.
6. 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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