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|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 (Briscoe, TX), Bhatia; Kuljit (Nesconset, NY), Patel; Bhiku (Chandler, AZ)|
|Assignee:||Medicis Pharmaceutical Coropration (Scottsdale, AZ)|
1. A method of administering an oral dosage form for the treatment of acne comprising: (i) administering to a patient the oral dosage form, the oral dosage form comprising:
(a) an intragranular blend of: 90 mg of minocycline hydrochloride; 108 mg of the matrix-forming polymer hydroxpropyl methylcellulose, wherein the matrix-forming polymer hydroxypropyl methylcellulose is a slow dissolving carrier; and 152 mg of an
intragranular lactose; and (b) 41 mg of extragranular lactose monohydrate, wherein the extragranular lactose monohydrate is a fast dissolving carrier, a portion of which completely or partially encapsulates or coats the intragranular blend; (c) 3.0 mg
of silicon oxide; and (d) 6.0 mg of magnesium stearate, wherein the dosage form has a total weight of 400 mg; wherein the dosage form provides a patient with 0.75 mg/kg to 1.5 mg/kg of the minocycline hydrochloride in a slow, continuous fashion,
without an initial load dose, that effectively treats acne of the patient by the once daily administration of the dosage form, and (ii) providing information to the patient, which information comprises results of the performed clinical trials including a
comparison of the oral dosage form to placebo with respect to an aspect of at least one adverse effect.
2. The method of claim 1, wherein the at least one adverse effect is selected from the group consisting of one or more: headache, fatigue, dizziness, pruritus, malaise, mood alteration, somnolence, urticaria, tinnitus, vertigo, dry mouth, and myalgia.
3. The method of claim 1, wherein the oral dosage form provides the patient with about 1.0 mg/kg/day of the minocycline hydrochloride.
4. The method of claim 1, wherein the minocycline hydrochloride is released so that the minocycline hydrochloride reaches C.sub.max in a person's blood from about 3.2 hours to about 4.5 hours after administration.
5. 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.
6. The method of claim 1, wherein the information includes information about one or more deleterious effects selected from the group consisting of: gastrointestinal disorders, blurred vision, autoimmune syndromes, and adverse renal reactions.