Process for providing therapeutic composition

• US 5,595,759 A
• Filed: 11/10/1994
• Issued: 01/21/1997
• Est. Priority Date: 11/10/1994
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Barclay, Brian L., Wright, Jeri D., Atkinson, Linda E.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): HOWARD, SHARON LEE
• Application Number:
  US08/337,701
• Time in Patent Office: 803 Days
• Field of Search: 424/464, 424/465, 424/473, 424/474, 424/479, 424/484, 424/486, 424/426
• US Class Current: 424/464
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• 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 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A process is disclosed and claimed for preparing a therapeutic composition comprising asteroid or a dosage form comprising the composition, which therapeutic composition or dosage form is indicated for human administration.

Claims

1. A process for preparing a therapeutic composition for administering to a human, wherein the process comprises the steps of:

a) blending an estrogen with ethanol to produce a wet granulation;

b) blending separately a hydroxyalkylcellulose of 7,500 to 175,000 molecular weight with a poly(alkylene oxide) of 100,000 to 650,000 molecular weight to produce a dry granulation;

c) mixing the wet granulation and the dry granulation to produce a homogenous wet mixture;

d) evaporating the solvent from the mixture to produce dry granules; and

,

e) compressing the dry mixture into a shape and size adopted for oral administration to the human for delivering the therapeutic composition to the human.

2. The process for preparing the therapeutic composition of administering to a human according to claim 1, wherein the therapeutic composition comprises a progestin.

3. The process for preparing the therapeutic composition for administering to a human according to claim 1, wherein the process consists essentially of preparing step (b) prior to preparing step (a).

4. A process for preparing a dosage form, wherein the process comprises:

a) blending an estrogen with ethanol to provide a wet granulation;

b) blending an osmopolymer with the wet granulation to provide a homogenous wet blend;

c) evaporating the solvent from the blend to produce dry granules;

d) pressing the dry granules into a shaped composition;

e) coating the shaped composition with a semipermeable composition; and

f) forming an exit in the semipermeable coating to provide the dosage form.

5. The process for preparing the dosage form according to claim 4, wherein the estrogenic steroid is blended with a progestin.

6. A process for preparing a dosage form, wherein the process comprises the step of:

a) blending an osmopolymer and a hydroxyalkylcellulose polymer to produce a dry blend;

b) blending estrogen with ethanol to form a wet granulation;

c) blending the wet granulation and the dry blend to provide a homogenous wet blend;

d) evaporating the solvent from the homogenous wet blend;

e) pressing the homogenous blend into a tablet-shaped composition;

f) coating the tablet-shaped composition with a semipermeable composition; and

g) forming an exit means in the coating for delivering the estrogenic steroid from the dosage form.

7. The process for preparing the dosage form according to claim 6, wherein the estrogen is blended with a progestin.