Orally disintegrating solid dosage forms comprising progestin and methods of making and use thereof

A method of treating a female in need of emergency contraception, the method comprising:

• administering postcoitus to the female a first orally disintegrating solid pharmaceutical dosage form;
• and
• administering to the female within about 12 hours of administration of the first dosage form a second orally disintegrating solid pharmaceutical dosage form, wherein each of the first and second dosage forms comprises:
• (a) a progestin equivalent to about 0.75 mg of levonorgestrel;
• (b) an ionic disintegrant;
• and
• (c) a hydrophilic water-insoluble non-ionic excipient;
• wherein the ionic disintegrant is present in a concentration of greater than 8% to about 60% by weight of the dosage form and the hydrophilic water-insoluble non-ionic excipient is present in a concentration of about 1% to about 20% by weight of the dosage form.

A method of treating a female in need of emergency contraception, the method comprising administering postcoitus to the female an orally disintegrating solid pharmaceutical dosage form comprising:

• (a) a progestin equivalent to about 1.5 mg of levonorgestrel;
• (b) an ionic disintegrant;
• and
• (c) a hydrophilic water-insoluble non-ionic excipient;
• wherein the ionic disintegrant is present in a concentration of greater than 8% to about 60% by weight of the dosage form and the hydrophilic water-insoluble non-ionic excipient is present in a concentration of about 1% to about 20% by weight of the dosage form.

A process for preparing a non-effervescent, orally disintegrating solid pharmaceutical dosage form, the process comprising:

• mixing an ionic disintegrant and a progestin equivalent to about 0.5 mg to about 2 mg of levonorgestrel to form an initial mixture;
• adding to the initial mixture a hydrophilic water-insoluble non-ionic excipient to form a final mixture;
• and
• compressing the final mixture to produce the pharmaceutical dosage form;
• wherein the ionic disintegrant is present in a concentration of greater than 8% to about 60% by weight of the dosage form and the hydrophilic water-insoluble non-ionic excipient is present in a concentration of about 1% to about 20% by weight of the dosage form.