Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1997-02-04
1998-10-06
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424441, 424400, 424451, 424456, 426271, A61K 900
Patent
active
058173307
DESCRIPTION:
BRIEF SUMMARY
This application is a continuation of PCT/FR95/00219 published Feb. 25, 1995.
SCOPE OF THE INVENTION
The object of the present invention is a new emulsified composition based on liquid paraffin oil and lactulose, produced in the form of a smooth, non-sticky jelly and intended for oral administration for the treatment of constipation in humans.
TECHNOLOGICAL BACKGROUND OF THE INVENTION
Constipation is a common pathological phenomenon which affects a considerable number of individuals with no real distinction as to sex or age. Recent publications indicate that this phenomenon chronically affects at least 10% of the French and British populations (Chaussade, S. and Encycl. Med. Chir., Paris, France, Estomac-Intestin, 9071 A.sup.10, 6-1985, 6 pp.; Taylor, R., Br. Med. J., 1990, 300, 1063-64), and that his percentage is even higher in the United States, Japan, and the northern European countries. It is also known that almost 50% of persons afflicted medicate themselves with laxatives, some of which are considered potentially dangerous.
Aside from the simplest cases, in which a dietary correction, in particular by administration of natural or dietetic fiber, is sufficient to correct the situation, it is frequently necessary to apply treatment by laxative means, one of the oldest and least harmful of which consists of ingestion of a mineral oil, more particularly liquid paraffin oil.
It is acknowledged that his oil, which is not absorbed, acts by way of its lubricating and emollient properties, thus promoting the evacuation of feces. This activity has been and still is widely utilized, since the French dictionary of pharmaceutical preparations (Dictionnaire Vidal, 1993, Editions du Vidal) lists a dozen preparations containing paraffin oils of various viscosities, alone or in association with other compounds, and offered in liquid or jellied form or as solid powders.
The liquid products are in fact most often pure or flavored paraffin oil. These are the least complex. However, aside from the practical difficulties in handling them, administering them to bedridden persons or to young children is tricky, since if difficulties in swallowing exist, involuntary inhalation of them can cause bronchial and/or pulmonary disorders. It is also known that in large doses, these liquid products entail undesirable risks of anal leakage and perianal irritation.
Jellied products are easier to handle. They are generally produced either by mixing liquid paraffin with semi-solid to solid paraffins, or by emulsifying liquid paraffin with an aqueous phase containing suitable excipients. Regarding emulsions of this kind, in 1921 Rector, in U.S. Pat. No. 1,389,161, described the means for producing transparent emulsions by adjusting the refractive index of the aqueous phase to that of the oil phase. W. FF. Whitmore and R. E. Linehan (Ind. and Eng. Chemistry, 21, pp. 878-880, 1929) generalize this teaching by describing modification of the refractive index of one or the other phase to obtain this transparent state. This principle has generated formulas for a variety of applications, including recently: 216 557 concerns translucent oil-in-water emulsions of semi-solid paraffin, similar in appearance to jelly and intended for application to the skin. Their aqueous phase contains a humectant agent, and the oil phase an agent suitable for the preparation of water-in-oil emulsions and semi-solid paraffin (m.p. >38.degree. C.), to which a mineral oil is optionally added. In the Examples illustrating the invention, the oil phase does not exceed 70%, and the emulsifying agent specific to the water-in-oil emulsions is dissolved in the oil phase during preparation. published under no. 2 618 351 is a jellied, transparent oil-in-water emulsion consisting of 50 to 80% by weight of a hydrophobic oily liquid, 0.5 to 5% of a water-soluble surfactant agent, 2 to 10% of a hydrocolloid, water-soluble agents, and water; it is specified that the difference between the refractive indices of the aqueous and oil phases is no greater than 0.005. These je
REFERENCES:
patent: 5604207 (1997-02-01), DeFrees
patent: 5624906 (1997-04-01), Vermeer
Database WPI Week 9330, Derwent Publications Ltd., London, GB--Japanese Abstract JP,A,05 163 151, (Teikoku Seiyaku KK) 26 Jun. 1993.
"Traitement de la constipation" (Chaussade S., Guerre J.--Encyl. Med. Chir. Paris, Frace, Estomac-Intestin, 9071 A.sup.10, Jun. 1985, 6pp.).
"Management of constipation" (Taylor R.--Br. Med. J., 1990, 300, 1063-64).
Vidal dictionary 1993.
"Transparent Emulsions of Some Essential Oils" (Whitmore W.F., R.E. Linehan--Ind. and Eng. Chemistry, 21, pp. 878-880, 1929.
"Gelatin", European Pharmacopeia, 2nd ed. 330, 1986.
Barish Jean B.
Faulkner D.
Page Thurman K.
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