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Claims for Patent: 7,790,705

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Claims for Patent: 7,790,705

Title:Minocycline oral dosage forms for the treatment of acne
Abstract:Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
Inventor(s): Wortzman; Mitchell (Scottsdale, AZ), Plott; R. Todd (Scottsdale, AZ), Bhatia; Kuljit (Melville, NY), Patel; Bhiku (Chandler, AZ)
Assignee: Medicis Pharmaceutical Corporation (Scottsdale, AZ)
Application Number:12/253,845
Patent Claims: 1. A method of administering an oral dosage form for the treatment of acne comprising: administering to a patient with acne the oral dosage form, the oral dosage form comprising: minocycline or a pharmaceutically acceptable salt thereof, wherein the oral dosage form, administered once daily to the patient, provides the patient with 0.7 mg/kg/day to 1.3 mg/kg/day of the minocycline or the pharmaceutically acceptable salt thereof; and a carrier that comprises a fast dissolving carrier and a slow dissolving carrier, wherein the fast dissolving carrier has an intragranular fast dissolving carrier, and an extragranular fast dissolving carrier, wherein the extragranular fast dissolving carrier and the slow dissolving carrier are at a weight ratio of 0.3 to 0.5, and wherein the minocycline or a pharmaceutically acceptable salt thereof is released in a slow, continuous release in the patient, without an initial load dose, and at a release rate in gastric fluid that is either 25% to 52% within 1 hour, 53% to 89% within 2 hours, and at least 90% at 4 hours, or 30% to 52% within 1 hour, 53% to 84% within 2 hours, and at least 85% at 4 hours.

2. The method of claim 1, wherein the weight ratio of extragranular fast dissolving carrier to slow dissolving carrier is 0.30 to 0.45.

3. The method of claim 1, wherein the weight ratio of extragranular fast dissolving carrier to slow dissolving carrier is 0.36 to 0.40.

4. The method of claim 1, wherein said intragranular fast dissolving carrier and said slow dissolving carrier are each in an amount greater than said extragranular fast dissolving carrier.

5. The method of claim 1, wherein the 0.7 mg/kg/day to 1.3 mg/kg/day is about 1.0 mg/kg/day.

6. The method of claim 5, wherein the minocycline or the pharmaceutically acceptable salt thereof is an amount selected from the group consisting of 45 mg, 90 mg, and 135 mg.

7. The method of claim 1, wherein the carrier releases the minocycline or the pharmaceutically acceptable salt thereof so that the minocycline or the pharmaceutically acceptable salt thereof reaches C.sub.max in the patient's blood in a range of from 3.2 hours to 4.5 hours after administration.

8. The method of claim 1, wherein the acne is selected from the group consisting of acne vulgaris, acne rosacea, acne conglobata, acne fulminans, gram-negative folliculitis, and pyoderma faciale.

9. A method of administering an oral dosage form for the treatment of acne comprising: selecting an oral dosage form from amongst at least 45 mg, 90 mg and 135 mg named dosage forms, the oral dosage form having an amount of minocycline that is the amount of the named dosage form and a controlled-release carrier, the controlled-release carrier being present in the range between 20% to 30% by weight based on the total weight of the oral dosage form, wherein said controlled-release carrier provides a release rate in gastric fluid of the minocycline that is either 25% to 52% within 1 hour, 53% to 89% within 2 hours, and at least 90% at 4 hours, or 30% to 52% within 1 hour, 53% to 84% within 2 hours, and at least 85% at 4 hours; and administering to a patient the oral dosage form once daily, wherein the patient is provided with 0.7 mg/kg to 1.3 mg/kg of the minocycline in a slow, continuous fashion, without an initial load dose, that effectively treats acne of the patient and with a reduction in adverse vestibular side effects by the once daily administration of the oral dosage form, as compared to administration of an immediate-release dosage form.

10. The method of claim 9, further comprising instructions for administering the oral dosage form.

11. The method of claim 9, wherein the controlled-release carrier is hydroxypropyl methylcellulose.

12. The method of claim 11, wherein the hydroxypropyl methylcellulose is present in an amount of 108 mg for the 45 mg and the 90 mg named oral dosage forms, and present in an amount of 94 mg for the 135 mg named oral dosage form.

13. The method of claim 11, wherein the hydroxypropyl methylcellulose is present in an amount 26% to 28% by weight based on the total weight of the oral dosage form when the named oral dosage form is 45 mg or 90 mg.

14. The method of claim 11, wherein the hydroxypropyl methylcellulose is present in an amount 22% to less than 25% by weight based on the total weight of the oral dosage form when the named oral dosage form is in an amount of 135 mg.

15. The method of claim 9, further comprising an extragranular lactose monohydrate and an intragranular lactose monohydrate, and wherein the weight ratio of extragranular lactose monohydrate to the controlled-release carrier is 0.35 to 0.45.

16. The method of claim 15 , wherein when the oral dosage form is 45 mg, the controlled-release carrier is present at 108 mg, the intragranular lactose monohydrate is present at 197 mg, and the extragranular lactose monohydrate is present at 41 mg, and wherein the named oral dosage form provides a patient with about 1 mg/kg of the minocycline.

17. The method of claim 15 , wherein when the named oral dosage form is 135 mg, the controlled-release carrier is present at 94 mg, the intragranular lactose monohydrate is present at 121 mg, and the extragranular lactose monohydrate is present at 41 mg, and wherein the named oral dosage form provides a patient with about 1 mg/kg of the minocycline.

18. A method of treating acne vulgaris, comprising administering to a person suffering from acne vulgaris a continuous slow release oral dosage form based on body weight of the person, the continuous slow release dosage form comprising: an amount of an oral minocycline based on the body weight that provides the person, upon administration once daily without a loading dose, from 0.7 mg/kg/day to 1.3 mg/kg/day of said oral minocycline; and a delivery vehicle, the delivery vehicle comprising a combination of a slow dissolving carrier and at least one fast dissolving carrier, wherein the delivery vehicle releases said oral minocycline antibiotic at a rate of: A) 25% to 52% within 1 hour, 53% to 89% within 2 hours, and at least 90% at 4 hours; or B) 30% to 52% within 1 hour, 53% to 84% within 2 hours, and at least 85% at 4 hours, and wherein the release rate is measured in gastric fluid.

19. The method of claim 18, wherein the fast dissolving carrier to the slow dissolving carrier are at a weight ratio of 0.30 to 0.45.
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