Contraceptive vaginal tablets

Details Contraceptive vaginal tablets Contraceptive vaginal tablets

1984-06-07

1986-01-21

Schenkman, Leonard

Drug, bio-affecting and body treating compositions

Lymphokine

514577, 514682, 514843, A61K 3179

Patent

active

045656940

DESCRIPTION:

BRIEF SUMMARY
The invention relates to contraceptive vaginal tablets being free from hormones as well as to a process for preparing them.
Three methods are known--except for operations--which hinder the occurrence of undesirable pregnancy. These methods are the use of condoms, the insertion of intrauterine instruments and the insertion of vaginal pessaries (mechanical instruments) which hinder the occurrence of the pregnancy by using hormonal preparations or local spermicidal preparations free from hormones.
All the known methods have, however, certain disadvantages which do not make possible general application. It is known that not every conceptive age-group may use the preparations containing hormones. However, certain persons, who could take these preparations in view of their age, are deprived of employing them owing to the side effects. From among the mechanical instruments the condom and the vaginal pessary cause in certain cases uncomfortable feeling or require preparation which destroys the illusion. The intrauterine instruments are free from these disadvantages, but have the disadvantage that not all persons may wear them as well as the fact that the youngest age-group may not use them. A further disadvantage of these instruments is that they may be inserted only by the physician. In case of the hormone free preparation no contraindication of the age-group exists. These are rarely applied per se, however since they are not reliable enough.
The efficiency of the known contraceptive instruments and methods is characterized by the so-called Pearl-index. This is a number which shows that from among 100 conceptive women using the instrument or method in question how many will be pregnant during a year. The Pearl-index of the contraceptive instruments and methods is stated in the following Table.


TABLE ______________________________________ vaginal irrigation 29.3-40.8 coitus interrupted 12-38 Ogino-Knaus rule 12-34.5 foam tablet 11.9-42.8 vaginal pellet 7.7-42.3 diaphragm 6.1-33.6 jelly 6.4-41 vaginal pessary 6.0-29 condom 6-28 intrauterine instrument 0.9-8 hormonal preparation 0-1.7 ______________________________________
From the data of this Table it can be seen that only the hormonal preparation possess the safety desired, the efficiency of the preparations containing only chemical substances fall far behind that of the hormonal preparations.
The aim of the present invention is to find a vaginal tablet being free from hormones which possess the same efficiency as the hormonal preparations and do not show the disadvantages thereof, which tablets may be used without any limitation of the age or the physical condition of the person using them.
The vitamin K.sub.3 and the adduct thereof with sodium bisulfite are widely used in the therapy e.g. for treating icterus occlusion, pre- and postoperative treatment in cholemia, biliary fistula, ulcerative colitis, dysentery, steatorrhea, sprue, celiac disease, hemophilia of the newborn, jaundice, salicylism, purpura, thormbophenia, serum sickness, urticaria, haemoptoe. The contraceptive effect of these compounds has not been described yet.
The therapeutic use of boric acid and tartaric acid is also known. The boric acid is used for rinsing cavities owing to its weak disinfectant effect, the tartaric acid is applied for regulating the pH of the preparations due to its weak acidic reaction.
It was surprisingly found that a preparation, which correspond to the above requirements, may be obtained when
0.2 to 3.0 parts by weight of boric acid.
10.0 to 20 parts by weight of tartaric acid.
1 to 2 parts by weight of vitamin K.sub.3 -sodium bisulfite adduct,
0.8 to 1.2 parts by weight of polyvinyl pyrrolidone.
2 to 5 parts by weight of magnesium stearate,
8 to 12 parts by weight of carboxymethyl cellulose,
8 to 12 parts by weight of lactose and
50 to 65 parts by weight of microcrystalline cellulose are homogenized and thereafter pressed to tablets.
The tablets contain preferably 5 mg of vitamin K.sub.3 -sodium bisulfit adduct per

REFERENCES:
patent: 3062715 (1962-11-01), Reese
patent: 4031202 (1977-06-01), Laughlin et al.
patent: 4242359 (1980-12-01), Cooper et al.
patent: 4323548 (1982-04-01), Scherm
patent: 4432967 (1984-02-01), Szymanski
patent: 4439441 (1984-03-01), Hallesy et al.
Chemical Abstracts, 76:42280r (1972).
Merck Index, p. 5652 ( 5653), 9th ed. 1976.

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