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Claims for Patent: 5,294,615

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Claims for Patent: 5,294,615

Title: Terazosin polymorph and pharmaceutical composition
Abstract:A novel anhydrous crystalline polymorph of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-tetrahydrofuroyl)piperazine monohydrochloride is disclosed, together with pharmaceutical formulations containing the compound. The novel polymorph exhibits a diminished food effect when administered to human subjects.
Inventor(s): Meyer; Glenn A. (Waukegan, IL), Bauer; John F. (Lake Bluff, IL)
Assignee: Abbott Laboratories (Abbott Park, IL)
Application Number:08/090,721
Patent Claims: 1. A crystalline polymorph of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-tetrahydrofuroyl)piperazine monohydrochloride characterized by peaks in the powder X-ray diffraction pattern at values of 2 theta of 5.5.degree..+-.0.2.degree., 10.6.degree..+-.0.2.degree., 11.1.degree..+-.0.2.degree., 16.7.degree..+-.0.2.degree., 19.4.degree..+-.0.2.degree., 21.3.degree..+-.0.2.degree., 22.0.degree..+-.0.2.degree., 22.7.degree..+-.0.2.degree., 23.1.degree..+-.0.2.degree., 24.4.degree..+-.0.2.degree., 24.9.degree..+-.0.2.degree., 25.5.degree..+-.0.2.degree., and 27.8.degree..+-.0.2.degree..

2. A pharmaceutical composition comprising a therapeutically effective amount of a compound as defined by claim 1 in combination with a pharmaceutically acceptable carrier.

3. A pharmaceutical composition as defined by claim 2 in unit dosage form comprising

an outer soft elastic gelatin shell, and

an inner composition filling said shell comprising

a) an active drug component comprising a crystalline polymorph of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-tetrahydrofuroyl)piperazine monohydrochloride characterized by principal peaks in the powder X-ray diffraction pattern at values of 2 theta of 5.5.degree..+-.0.2.degree., 10.6.degree..+-.0.2.degree., 11.1.degree..+-.0.2.degree., 16.7.degree..+-.0.2.degree., 19.4.degree..+-.0.2.degree., 21.3.degree..+-.0.2.degree., 22.0.degree..+-.0.2.degree., 22.7.degree..+-.0.2.degree., 23.1.degree..+-.0.2.degree., 24.4.degree..+-.0.2.degree., 24.9.degree..+-.0.2.degree., 25.5.degree..+-.0.2.degree., and 27.8.degree..+-.0.2.degree., and

b) a pharmaceutically acceptable non-aqueous liquid carrier.

4. A pharmaceutical composition as defined by claim 3 wherein said non-aqueous liquid carrier comprises poly(ethylene glycol).

5. A pharmaceutical dosage form as defined by claim 3 wherein said active drug component is present in an amount ranging between 1 mg and 20 mg.

6. A method of treating hypertension comprising administering to a host mammal in need of such treatment a therapeutically effective amount of a pharmaceutical dosage form as defined by claim 3.

7. A method of treating benign prostatic hyperplasia comprising administering to a host mammal in need of such treatment a therapeutically effective amount of a pharmaceutical dosage form as defined by claim 3.

8. A method of treating congestive heart failure comprising administering to a host mammal in need of such treatment a therapeutically effective amount of a pharmaceutical dosage form as defined by claim 3.
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