Sterilized preserved, stable mucine-containing solutions

Drug – bio-affecting and body treating compositions – Fermentate of unknown chemical structure – Having a known elemental analysis

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424130, A61K 3538, A61K 3340

Patent

active

044381000

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to sterilized, preserved, stable mucine-containing compositions and methods for their preparation.
The compositions of the present invention, which are in particular aqeuous solutions (colloid solutions), utilize unique advantageous properties of mucines, especially particular kinds of mucines described below, and relate to sterilized solutions of mucine, in particular for a number of applications where the special nature of glycoproteins--together with the fact that glycoproteins constitute natural products which are extracted from animals and which, with respect to their properties, are closely related to the properties of the glycoprotein solutions secreted in the human system--has been found to be particularly beneficial. In all of the applications contemplated, special properties of mucines--including viscosity properties, surface active properties, polar
on-polar properties, lubrication properties, and ability to be effectively sterilized and preserved and even imparted bactericidal properties and to resist enzymatic degradation without to any substantial degree loosing their valuable properties--render the solutions of the invention particularly well suited for direct or indirect application to sensitive human mucous membranes such as the mucous membranes of the oral cavity, the nasal system, and the eye epithel.
Thus, the solutions of the invention are, in particular, adapted for oral or nasal administration to human beings, or for closely related applications, such as for use as ophthalmic solutions. For these purposes, the solutions should be sterilized and should contain a preservative so that they will maintain sterility even when exposed to a certain contamination during storage and application.
Hence, one of the main aspects of the invention is constituted by aqueous muchine-containing compositions, in particular for application to human mucous membranes and/or for use as an ophthalmic solution, comprising a non-human mammalian mucine selected from the group consisting of buccal and gastrointestinal mucines, the composition having a viscosity of at the most 50 relative to water, as measured with an Oswald viscosimeter, said composition being sterilized and containing a preservative which is present in a physiologically tolerable concentration with respect to the application of the composition.
One of the main utilities of this aspect of the present invention is constituted by solutions for oral administration to human beings. This aspect will now be dealt with in greater detail:
It is well-known that dryness of the mouth is a frequently occurring condition. The dryness may vary from slight dryness with transitory inconvenience to a total xerostomia with severe concomitant symptoms (problems in connection with speech, mastication, swallowing, digestion and physical and psychic indisposition) and serious consequences for the buccal cavity of the patient (destruction of the teeth because of carial and/or marginal parodontite), fungal infection and a very sensitive mucous membrane with consequent difficulties in accepting dentures.
The reasons for mouth dryness may be physiological (age, menopause, postoperative conditions, dehydration), psychic (nervousness), pharmacological (anti-cholinergica, anti-histaminica, anti-hypertensiva, sedativa and neuroleptica) and radiotherapeutic (after irradiation of tumours on head and neck). Especially irradiation drastically reduces the normal saliva secretion.
Normally, human beings have a salivary secretion varying between 1000 and 1500 ml in the course of 24 hours. This secretion is a mixture of scretions from the submandibular, sublingual, and parotidal glands. More than 98% of the mixed salivary secretion is water, 0-3% is constituted by organic substances, and about 0.25% are inorganic substances.
Among the inorganic and organic components of the natural salivary secretion, a number of substances are not normally taken together with the daily food, and therefore, deficiencies may occur in the organism if they are not suppli

REFERENCES:
patent: 2276882 (1942-03-01), Schneiderwirth
patent: 3567821 (1971-03-01), Nouvel
Rokos et al.--Chem. Abst., vol. 64 (1966) p. 5625h.
Sizer--Chem. Abst., vol. 44 (1950) p. 10,002d.

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