Abrasive tool making process – material – or composition
Patent
1996-12-16
1998-05-26
Jordan, Kimberly
Abrasive tool making process, material, or composition
514843, A61K 3156
Patent
active
057564906
DESCRIPTION:
BRIEF SUMMARY
DESCRIPTION
This invention relates to a pharmaceutical combination preparation with two hormone components which are manufactured physically separately in a packaging unit and are intended for oral administration that is sequential in time and which consist in each case of a number of physically separate and individually removable daily dosage units placed in the packaging unit, whereby as a hormonal active ingredient a first hormone component contains in combination an,estrogen preparation and, in a dosage that is sufficient at least to inhibit ovulation, a gestagen preparation in either one-phase or multiple-phase structuring and as a hormonal active ingredient the second hormone component contains only an estrogen preparation, whereby the first hormone component comprises 23 or 24 daily units and the second hormone component comprises 4 to 8 daily units; the daily units of the first hormone component do not contain the combination of a biogenic estrogen and a synthetic estrogen, and the total number of hormone daily units is equal to the total number of days of the desired cycle, but at least 28-days in length, and a corresponding packing that contains this combination preparation.
Oral contraceptives in the form of combination preparations have been known as so-called one-phase preparations since 1960.
These preparations consist of 21 active ingredient-containing dosage units and 7 active ingredient-free tablets or coated tablets. The daily dosage unit consists of an estrogen and a gestagen. In one-phase preparations, the dose of the active substance that is to be administered daily is equally high in each dosage unit. If the dose of the active components that is to be administered daily is different in the individual dosage units in individual sections over the administration cycle, these are so-called multiple-phase preparations. Triquilar.RTM. can be cited as an especially well-known representative (DE-A 23 65 103).
The daily gestagen dosage has been continuously reduced through the development of new, more effective gestagens than those contained in the first oral contraceptives. It was also possible to lower, the daily estrogen dosage, although in most cases ethinylestradiol is still contained as an estrogen in hormonal contraceptives.
Because of the development of new, improved oral contraceptives, the following three points were (and are) emphasized: bleeding and
Contraceptive reliability is mainly provided by the gestagen component. The amount of its daily dosage corresponds in each case to at least the maximum dose that is considered necessary for the gestagen in question to inhibit ovulation. The ethinylestradiol that is used in most cases as an estrogen in combination preparations is supposed to. increase the ovulation-inhibiting effect of the gestagen and mainly to ensure cycle stability. The daily dose in the case of ethinylestradiol administered alone, which must be used to inhibit ovulation, is 100 .mu.g.
Combination preparations with the most recent generation of gestagens are, e.g., the one-phase preparation Femovan (DE-PS 2546062) or Marvelon (DE-OS 2361120). Milvane.RTM. can be mentioned (EP-0 148 724) as an example of a multiple-phase preparation whose dosage units contain a gestagen of the most recent generation, namely gestodene. In the case of these three-phase preparations, in most cases 4-6 coated tablets are administered in the first phase, in which each coated-tablet contains an amount of estrogen in a low dose and a gestagen in a low dose. In the second phase of 4-6 coated tablets, each dosage unit contains an estrogen at a dose that is equal or slightly raised, increased to a maximum up to 2-fold, and a gestagen at a dose that is equal or slightly raised, increased to a maximum up to 1.5-fold. In a third phase of 9-11 units, each coated tablet contains an estrogen at a dose that is equal or is further raised, increased to a maximum of 3 times the initial value. Then come 7 pill-free days.
Recently, multiple-phase combination preparations were also proposed which can provid
REFERENCES:
patent: 3502772 (1970-03-01), Ijzerman
patent: 3639600 (1972-02-01), Hendrix
patent: 4921843 (1990-05-01), Pasquale
patent: 5262408 (1993-11-01), Bergink
patent: 5280023 (1994-01-01), Ehrlich et al.
Dusterberg Bernd
Lachnit Ursula
Spona Jurgen
Jordan Kimberly
Schering Aktiengesellschaft
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