Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Milk or colostrum
Patent
1998-08-24
2000-11-07
Minnifield, Nita
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Milk or colostrum
4241841, 4241871, 4242821, 4242781, 4241301, 424435, 424529, 424530, 424531, 424 933, 604 77, 604 76, A61K 3520, A61K 3516, A61K 4500, A61K 39395, A61J 700
Patent
active
061433306
DESCRIPTION:
BRIEF SUMMARY
This invention relates to an immune milk preparation for the prevention of middle ear infections (otitis media) in children. The preparation contains antibodies produced against bacteria which cause middle ear infections and, if desired, also dental caries inhibiting agents.
So called immune milk can be produced by vaccinating a pregnant cow against certain pathogens whereby the cow organism forms antibodies to these diseases, which antibodies are transferred to the colostrum. The remedying effects of immune milk have been known for a long time. Already since the beginning of the century immunized goat or cow milk has been tested in the treatment of various bacterial and viral diseases. The most important of the more recent studies are concentrated on the diseases dependent on the microbes of the gastrointestinal tract, i.a. rheumatoid arthritis, dental caries, gingivitis, diarrheas, dysentery, gastritis and cryptosporidiosis. A dental caries inhibiting product of immunized cow's milk, which contains specific antibodies to killed Streptococcus mutans cells, is known (U.S. Pat. No. 4,324,782). In the United States usual immune milk is produced by maintaining the antibody level with boosters. The amount of antibodies is rather small, and the effect is based on daily administration. In Taiwan immune milk is sold as a health drink. In Australia powder containing antibodies to rotavirus has been mixed into i.a. infant formulas (Murtomaa-Niskala, 1994). Whole milk products also contain non-specific antibacterial factors which may have effect of microbial flora (Takahashi et al., 1992).
In Finland immune milk has been prepared against i.a. Helicobacter pylori infection (Oona et al., 1994), and antibodies to Streptococcus mutans and Streptococcus sobrinus, obtained from the colostrum of an immunized bovine (Loimaranta et al., 1996), have been studied at the Dental Department of the University of Turku (Prof. Jorma Tenovuo, personal communication). This immune milk has been produced at the Centre of Agricultural Research in Jokioinen.
An anti-mutans streptococci antibody preparation, isolated from immune colostrum, has been shown to inhibit infection of tooth surfaces by mutans streptococci and to protect teeth from caries when added to a cariogenic diet of gnotobiotic rats (Michalek et al., 1987). The use of a lyophilized, on the same technique based immune whey powder dissolved in water for rinsing of mouth for a minute mornings and evenings for a fortnight significantly reduced the proportion of S. mutans in dental plaque of young adult humans as compared to the control group (Filler et al., 1991). However, rinsing out is not a suitable way of administration for small children who, however, would probably most benefit from an increased immune protection (Aaltonen et al., 1987).
Suhonen (1992) has presented the theoretical background for the use of a pacifier like administration device which slowly releases fluorides, xylitol, monoclonal caries antibodies or components of lactoperoxidase system into the mouth, in a prophylactic method for the prevention of dental caries. The operability of a dispensing pacifier as a releaser of sodium fluoride, xylitol and sorbitol from a tablet has been established in vitro, and the administration of passive vaccines via a pacifier against microbes which cause oral diseases has been suggested (Suhonen et al., 1994). A pacifier prototype for dispensing sodium fluoride, xylitol and sorbitol has in our field trial in the Lohja District Health Centre with children of 16 months of age proved to be a functioning means with potential for development for the treatment of diseases of the mouth and throat of children in the sucking-age. In our follow-up study it became evident that the group where children well accepted the test pacifier showed significantly less frequently middle ear infections before 18 months' age (48% versus 78%) than the comparable group which for some reason or another did not use the test pacifier (Suhonen J., Aaltonen A. S., Tenovuo J., "Fall-asleep pacifier in to
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Aaltonen Antti Sakari
Suhonen Jouko
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