Progestin tablet

• US 5,620,705 A
• Filed: 05/16/1995
• Issued: 04/15/1997
• Est. Priority Date: 08/04/1994
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.-L., Espinal, Steven, Dong, Liang C.
• Primary Examiner(s): JORDAN, KIMBERLY R
• Application Number:
  US08/441,889
• Time in Patent Office: 700 Days
• Field of Search: 424/472, 424/473, 514/177
• US Class Current: 424/472
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084

Abstract

A hormone replacement composition, a hormone replacement dosage form, and a method of hormone replacement are disclosed and indicated for the management of hormone replacement therapy.

Claims

1. A therapeutic bilayer tablet for hormone replacement therapy, wherein the bilayer comprises a drug layer comprising 60 wt % progesterone, 10.0 wt % sodium croscarmellose, 5.0 wt % polyethylene 40 stearate, 3.0 wt % hydroxypropylmethylcellulose and 21 wt % mannitol;

and a displacement layer comprising 58.75 wt % sodium carboxymethylcellulose, 30 wt % sodium chloride, and, 5.0 wt % hydroxypropylethylcellulose.

2. A therapeutic bilayer tablet for hormone replacement therapy, wherein the bilayer comprises a drug layer comprising 10 ng to 1200 mg of a progestin, 1 mg to 30 mg of a surfactant, 5 mg to 225 mg of an alkali carboxymethylcellulose possessing a 75,000 to 350,000 molecular weight, 0.05 ng to 20 mg of a disintegrant, and 0.5 mg to 75 mg of an osmagent;

and a displacement layer comprising 50 mg to 200 mg of an alkali carboxymethylcellulose of 500,000 to 1,000,000 molecular weight, 1 mg to 20 mg of hydroxypropylmethylcellulose of 9,000 to 150,000 molecular weight and 0.5 mg to 100 mg of an osmagent.