Claims
- 1. An HRT method of self-administration by a human female of successive doses of an estrogen and a plurality of successive doses of a progestogen, wherein the female dispenses and self-administers successive individual doses of the estrogen and of the progestogen over a protracted period of time, during which period of time the amount of at least one of which doses is changed, which method comprises the steps of:
a) dispensing to a delivery surface, from a first source of a first semisolid of viscous liquid pharmaceutically acceptable composition containing a plurality of non-discrete doses of the estrogen, a metered volume of the first composition as a single dose of the estrogen; b) concurrently dispensing to the delivery surface, from a second source of a second semisolid or viscous liquid pharmaceutically acceptable composition containing a plurality of non-discrete doses of the estrogen, a metered volume of the second composition as a single dose of the progestogen; c) transporting the dispensed doses of the first and second compositions from the delivery surface simultaneously to the site of administration of the estrogen and progestogen and administering the dispensed estrogen and progestogen thereat; d) repeating steps a)-c) on a predetermined schedule; and e) periodically, in response to the physiological symptoms associated with menopause or the HRT currently exhibited by the female, changing the metered volume of at least one of the first and second compositions which is dispensed onto the delivery surface as a single dose thereof.
- 2. A method according to claim 1, wherein the predetermined schedule of Step d) is daily.
- 3. A method according to claim 1, wherein the site of administration is an area of the skin of the female and the first and second pharmaceutically acceptable compositions are adapted to transdermal administration.
- 4. A method according to claim 3, wherein the delivery surface is the female's hand and the compositions thereon are administered at the selected site of transdermal administration on the skin of the female by rubbing the hand against the the skin.
- 5. A method according to claim 1, wherein the pharmaceutical compositions are semi-solids which are dispensed as extrudates.
- 6. A method according to claim 1, wherein the first and second pharmaceutically acceptable compositions are dispensed simultaneously from the respective sources thereof.
- 7. A method according to claim 1, wherein the dispensed doses of the first and second pharmaceutically acceptable compositions are mixed before being dispensed onto the delivery surface.
- 8. A method according to claim 1, wherein the predetermined schedule of Step d) is daily; wherein the site of administration is the skin of the female and the first and second pharmaceutically acceptable compositions are adapted to transdermal administration; wherein the compositions thereon are delivered to the selected site of transdermal administration on the skin of the female by rubbing; wherein the pharmaceutical compositions are semi-solids and are dispensed as extrudates simultaneously from the respective sources thereof; and wherein the metered doses of the first and second pharmaceutically acceptable compositions are mixed before being extruded onto the delivery surface.
- 9. A method according to claim 1, wherein the source of the first pharmaceutical composition is a first compartment of a unitary dispensing means and the source of the second pharmaceutical composition is a second compartment of the dispensing means; wherein the first and second pharmaceutical compositions are first extruded from their respective compartments into first and second metering chambers, respectively; and wherein the contents of the metering chambers are then formed into a single extrudate which is then dispensed from the dispensing means.
- 10. A method according to claim 1, wherein either the length of the extrudates of the first and second pharmaceutical compositions which are extruded from the respective sources thereof is constant and the dosage of the hormones therein is changed in Step (e) by changing the diameter of one or both of the extrudates, or wherein the diameter of the extrudates of the first and second pharmaceutical compositions which are extruded from the respective sources thereof is constant and the dosage of the hormones therein is changed in Step (e) by changing the length of one or both of the extrudates.
- 11. A method according to claim 1, wherein the estrogen is ethinyl estradiol or estradiol or an ester thereof, estrone, estrone sulfate or conjugated estrogens and the progestogen is micronized progesterone, norethindrone or ester thereof, norgestrel, chlormadione acetate, cyproterone acetate, desogestrel, 3-ketodesogestrel, drospirenone, norethindrone, norgestimate, levonorgestrel or gestodene.
- 12. A method according to claim 1, wherein the estrogen is ethinyl estradiol or 17β-estradiol and the progestogen is gestodene, levonorgestrel or 3-ketodesogestrel.
- 13. A method according to claim 12, wherein the predetermined schedule of Step d) is daily; wherein the pharmaceutical compositions are semi-solids; wherein the pharmaceutical compositions are metered from a dispenser in which the first and second containers both are housed, which the dispenser comprises mechanical means for changing the volumes of the pharmaceutical compositions which are dispensed from the containers in response to a defined constant digital manipulation employed to extrude from the container.
- 14. A dispenser adapted for dispensing and self-administering a plurality of successive individual doses of an estrogen and a progestogen from a dispenser containing multiple doses of thereof in separate extrudable pharmaceutically acceptable compositions, in metered single dosage amounts which can be varied by mechanically modifying the dispenser, which comprises:
a) a first container comprising:
(i) a first chamber containing a plurality of doses of the estrogen in a first extrudable pharmaceutically acceptable composition; (ii) a discharge port through which a volume of the first pharmaceutical composition in the first chamber can be discharged therefrom when discharging pressure is applied to the first container; (iii) means for applying discharging pressure to the first chamber; b) a second container comprising:
(i) a second chamber containing a plurality of doses of the progestogen in a second extrudable liquid pharmaceutically acceptable composition; (ii) a discharge port through which a volume of the second extrudable pharmaceutical composition in the second chamber can be discharged therefrom when discharging pressure is applied to the second container; (iii) means for applying discharging pressure to the second chamber; c) a first metering means adapted to receive a volume of the first extrudable pharmaceutical composition extruded thereinto from the first chamber and digitally reciprocally convertible from a receiving mode, where it communicates with the first chamber through the first port and where it can be filled with a volume of the first extrudable pharmaceutical composition, to a discharging mode, where a volume of the first extrudable pharmaceutical composition therein can be discharged therefrom and dispensed from the dispenser, which first metering means comprises:
(i) a first adjusting means for varying the volume of the first extrudable pharmaceutical composition which can be extruded thereinto; d) a second metering means adapted to receive a volume of the second extrudable pharmaceutical composition extruded thereinto from the second chamber and digitally reciprocally convertible from a receiving mode, where it communicates with the second chamber through the second port and where it can be filled with a volume of the second extrudable pharmaceutical composition, to a discharging mode, where a volume of the second extrudable pharmaceutical composition therein can be discharged therefrom and dispensed from the dispenser, which second metering means comprises:
(i) a second adjusting means for varying the volume of the second extrudable pharmaceutical composition which can be extruded thereinto as a single dose of the progestogen; and e) dispensing means for dispensing a volume of the first pharmaceutical composition and a volume of the second pharmaceutical composition from the first and second metering means, respectively, from the dispenser as a single dose of the estrogen and the progestogen.
- 15. A dispenser according to claim 14 which comprises means for blending the single dose of the estrogen and the single dose of the progestogen discharged from the first and second metering means into a single extrudate prior to being dispensed from the dispenser.
- 16. A dispenser according to claim 14, wherein the first and second adjusting means are positioned internally in the dispenser and not readily accessible by an individual dispensing single doses of the estrogen and the progestogen therefrom.
- 17. A dispenser according to claim 14, wherein the estrogen is ethinyl estradiol or estradiol or an ester thereof, estrone, estrone sulfate or conjugated estrogens and the progestogen is micronized progesterone, norethindrone or ester thereof, norgestrel, chlormadione acetate, cyproterone, cyproterone acetate, desogestrel, 3-ketodesogestrel, drospirenone, norethindrone, dinorgestrel, norgestimate, levonorgestrel or gestodene.
- 18. A dispenser according to claim 14, wherein the estrogen is ethinyl estradiol or 17β-estradiol and the progestogen is gestodene, levonorgestrel or 3-ketodesogestrel.
- 19. A dispenser according to claim 18, which comprises means for blending the single dose of the estrogen and the single dose of the progestogen discharged from the first and second metering means into a single extrudate prior to being dispensed from the dispenser, wherein the estrogen is ethinyl estradiol or 17β-estradiol, the progestogen is gestodene, levonorgestrel or 3-ketodesogestrel.
Parent Case Info
[0001] This application is a continuation-in-part of U.S. application Ser. No. 08/535,402, filed Sep. 28, 1995, which is hereby incorporated by reference.
Provisional Applications (1)
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Number |
Date |
Country |
|
60077182 |
Sep 1996 |
US |
Divisions (2)
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Number |
Date |
Country |
Parent |
08721968 |
Sep 1996 |
US |
Child |
09288225 |
Apr 1999 |
US |
Parent |
08535402 |
Sep 1995 |
US |
Child |
09288225 |
Apr 1999 |
US |
Continuations (1)
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Number |
Date |
Country |
Parent |
09288225 |
Apr 1999 |
US |
Child |
09562316 |
May 2000 |
US |