US 6,551,611 B2Granted

Hormone replacement therapy method

AssigneeSchering Corporation

InventorsJörg Elliesen, Jutta Riedl

Life of this patent

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Abstract

Varying the daily dose of either or both of the estrogen and the progestogen administered for hormone replacement therapy (HRT) is readily and inexpensively accomplished, without the necessity of the physician prescribing a new product each time the daily dose of the estrogen or progestogen is changed, by administering preferably transdermally the estrogen and the progestogen contained in separate extrudable pharmaceutical compositions from a dispenser which contains means, preferably adjustable only by the attending physician or dispensing pharmacist, for varying the volume of either or both of the respective compositions which is dispensed as a single dose from the dispenser in response to a defined digital dispensing manipulation of the dispenser thereby facilitating optimal compliance to a combination of HRT with individually adjusted dosages of the estrogen and progestogen.

Claims16

Dependent claims

A method for self-administration by a human female of a plurality of successive doses of an estrogen and a plurality of successive doses of a progestogen according to a protocall of self administration, wherein the female dispenses and self-administers successive individual doses of a selected volume of the estrogen and a selected volume 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, the method comprising:

providing a first containerized source of a first extrudable pharmaceutically acceptable composition containing a plurality of non-discrete doses of the estrogen,
providing a first meter for measuring and determining the volume of the dispensed doses of estrogen and varying the volume according to the protocall of self-administration;
providing a second containerized source of a second extrudable pharmaceutically acceptable composition containing a plurality of non-discrete doses of the progestogen;
providing a second meter for measuring and determining the volume of the dispensed doses of progestogen and varying the volume according to the protocall of self-administration;
placing the first and second meters in proximity with one another wherein measured doses of estrogen and progestogen are immediately available for topical application by the patient so as to facilitate a the protocol for self-administration of the estrogen and progestogen on a repeated schedule, periodically in response to the physiological symptoms associated with menopause or the hormone replacement therapy currently exhibited by the female, so that the metered volume of at least one of the first and second compositions may be dispensed.

2 more elements

A method for using an HRT kit for self-administration by a human female of a plurality 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 kit comprises:

a first containerized source of a first extrudable pharmaceutically acceptable composition containing a plurality of non-discrete doses of the estrogen,
a second containerized source of a second extrudable pharmaceutically acceptable composition containing a plurality of non-discrete doses of the progestogen,
first and second meters in proximity with one another for receiving and indicating measured volumes of the first and second compositions thereon, wherein first and second measured doses of estrogen and progestogen are immediately available from the meters for topical application by the patient so as to facilitate a protocol for self-administration of the estrogen and progestogen on a repeated schedule, periodically in response to the physiological symptoms associated with menopause or the hormone replacement therapy currently exhibited by the female, so that a metered volume of at least one of the first and second compositions may be dispensed and applied.

Dependencies are inferred from the claim text.

Facts

Application: 09/562,316Filed 1 May 2000 · continuation
Priority: 28 Sep 1995
Published: US 2002/0142028 A13 Oct 2002
Granted: 22 Apr 2003
Term ends: Not estimatedThe source records don’t support an estimate.

Classification9 codes

B65D 83/761
For dispensing fluent contents by means of a piston: the piston being actuated by a screw-shaft
A61K 9/06
Medicinal preparations characterised by special physical form: ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
A61K 31/565
Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids: not substituted in position 17 beta by a…
A61K 31/57
Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids: substituted in position 17 beta by a chain…

Family

Application08/535,402Parent of this continuation-in-part · filed 28 Sep 1995
Application08/721,968Parent of this division · filed 27 Sep 1996
Application60/077,182Us provisional application · filed 27 Sep 1996
Application09/288,225Parent of this continuation · filed 8 Apr 1999
US 2002/0142028 A1Pre-grant publication · published 3 Oct 2002
US 6,083,528 AParent of this continuation
Application09/288,225Parent of this division
US 5,922,349 AParent of this division
Application08/721,968Parent of this continuation-in-part
US 6,551,611 B2This patent

From the US filing history. Foreign family members aren’t listed.