Minocycline oral dosage forms for the treatment of acne
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First Claim
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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, andwherein 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.
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Abstract
Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
104 Citations
19 Claims
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1. A method of administering an oral dosage form for the treatment of acne comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of administering an oral dosage form for the treatment of acne comprising:
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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. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17)
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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;
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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. - View Dependent Claims (19)
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Specification
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Litigation Data
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Current AssigneeMedicis Pharmaceutical Corporation (Bausch Health Cos., Inc.)
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Original AssigneeMedicis Pharmaceutical Corporation (Bausch Health Cos., Inc.)
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InventorsPlott, R. Todd, Bhatia, Kuljit, Patel, Bhiku, Wortzman, Mitchell
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Primary Examiner(s)Marschel; Ardin
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Assistant Examiner(s)Rao; Savitha
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Application NumberUS12/253,845Publication NumberTime in Patent Office690 DaysField of Search424/482, 424/457, 424/458, 424/455, 424/474, 424/490, 424/497, 424/495, 424/489, 424/498, 514/152US Class Current514/152CPC Class CodesA61K 31/65 TetracyclinesA61P 17/10 Anti-acne agents
