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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 Corporation (Scottsdale, AZ)|
1. A minocycline oral dosage form for the treatment of acne, comprising: (i) an intragranular blend of: 90 mg of minocycline hydrochloride; 108 mg of the matrix-forming
polymer hydroxypropyl methylcellulose; and 152 mg of an intragranular lactose, wherein the matrix-forming polymer hydroxypropyl methylcellulose is a slow dissolving carrier; and (ii) 41 mg of extragranular lactose monohydrate, wherein the extragranular
lactose is a fast dissolving carrier, a portion of which completely or partially encapsulates or coats the intragranular blend; (iii) 3.0 mg of silicon oxide; and (iv) 6.0 mg of magnesium stearate, wherein the dosage form has a total weight of 400 mg
and provides a patient with about 1 mg/kg of the minocycline 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.
2. A kit comprising: the minocycline oral dosage form of claim 1; and information that the oral dosage form may cause one or more adverse effects.
3. The kit of claim 2, wherein the one or more adverse effects is selected from group consisting of one or more of: headache, fatigue, dizziness, pruritus, malaise, mood alteration, somnolence, urticaria, tinnitus, vertigo, dry mouth, and myalgia.
4. The kit of claim 3, further comprising additional information about one or more deleterious effects selected from the group consisting of: gastrointestinal disorders, blurred vision, autoimmune syndromes, and adverse renal reactions.
5. The kit of claim 2, further comprising instructions for administering the oral dosage form.
6. The minocycline oral dosage form of claim 1, further comprising a film coat.