SA90100200B1 - Preparations containing the plant "flea herb" - Google Patents

Abstract

Abstract: The invention relates to the husk of the plant “psyllium husk” (the plant is also called “Al-Rabel” or “Patonia seed” or “plantain”) containing granules distributed according to size as follows: less than about 15% Of these, its size is greater than about 80 mesh (mesh) mesh: it is the unit of the size of the granules that pass through a sieve mesh, or the unit of measurement of the size of the hole in the sieve mesh, expressed in the number of mesh holes per inch) and at least 45% of it is its size in The range is from about 80 mesh eyes to about 200 mesh eyes, and less than about 40% of them are smaller than about 200 mesh eyes. In addition, preparations containing psyllium for oral administration comprising small granules of psyllium peel are described according to this invention. 0

Description

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Preparations containing the plant "flea herb" Full description Background of the invention: This invention deals with the peel of the plant "flea herb 15 psyllium" (the plant is also called "Rubal" or "Patonia seed" or "plantain") in the form of Small granules in a well-defined size distribution and preparations containing “fleaweed” peel granules of this size are suitable for oral administration, in particular preparations made up of Sana to be mixed in liquids to form drinks containing “fleaweed”. psyllium seed husk Well-known cosmetics Jie) Metamucil "trademark" Metamucil® marketed by The Procter & Gamble Company (. And such as these 0 - The preparations are useful for normalizing bowel function and for treating constipation.In addition to that, recent research has shown the effectiveness of psyllium seed husk fiber in lowering cholesterol levels in human serum pall and in controlling blood glucose levels in diabetic patients 01856005; See e.g. » J. W. Anderson (© J. W. Anderson) et al.; AVY £7 ¢ Federation Proceedings (9891); And the. Anderson et al.; American Journal of Gastro Anthrology Am. J. Gastroenterol (American Journal of Gastroenterology) 1l 114-4097 ((V4AT) as well as S. Faberberg “CurrenT Therapeutic Research”; VAAY (110 oF) and Yo is fully referenced here. The taste of preparations containing "flea herb" depends on the form used and of course on the consumer's preference. But more often v preparations containing "flea weed" are considered to be unpleasant tasting. In particular, preparations that are mixed with a liquid to form a drink and contain "flea herb", as many consider it undesirable in terms of acceptance for one or more of several reasons; structure analogy (eg: “roughness of the grains”; general mouth feel); viscosity; The appearance; Etc. texture with a © Therefore, improving the taste of preparations containing "flea herb" is an ongoing need that will benefit a large number of drug consumers. And preparations that are more acceptable in terms of taste will lead to better adherence to the prescribed dosing regimen, which may include several doses or a prolonged treatment period. And so on ; Although "flea herb" can be combined (and this has already been done in flavoring agents and carriers) with many carriers in many forms; There is still a need for improved, good-tasting preparations that contain “flea herb.” The current preparations containing “flea herb” are such as preparations intended to be mixed with a liquid to form a syrup; It is based largely on VO husk granules of a larger size. It has been discovered - by means of the present invention - that by selecting a certain range of smaller sized "flea herb" granules, the acceptability (palatability) of preparations containing "flea herb" is greatly improved. In addition to cl, in light of the large amount of reference materials that mention or confirm that reducing the particle size of other fiber materials (such as wheat bran) reduces the effectiveness of the fiber (see, for example: Dietary fiber in health and disease Ye pp. 10-11 (Edited by Vahoney and Kritchevsky No. 800/ Plenum Press ¢ New York YAAY) and book

CRC Handbook of Dietary CRC Handbook of Dietary Fiber in Human Nutrition;

JV; C. Spiller Press. Edited by Spiller (Y14-Y1V). “Fiber in Human Nutrition and Handbook” pages (VAAN, Florida). An Applied Approach to Dietary Fibers » An Applied Introduction Yo

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¢ pp. 1517-157 (Dreher; Marcel Dekker, Inc. “NY (YAAY), Kirwan, et al.” British Medical Journal JU sa “¢” pp. 1897-184 ¢ (VAVE), Brodribb et al.; Gut V4 pp. 001-17 (81/997); Cummings et al. © CMA Journal NYY pg 1114 -15 (1980)); However, the current invention shows an amazing thing represented in the “flea herb” in this invention that is no less effective than the “flea herb” with granules that are significantly larger in size previously used. Therefore, one of the purposes of this invention is to provide peel. Flea herb" and preparations containing "flea herb" for oral administration have improved palatability properties. Another purpose of the invention is to provide peels of "flea herb" and preparations containing "flea herb" for mixing with a liquid to form a syrup so that they are effective and have Improved palatability properties including texture, mouthfeel, palatability, graininess and/or visual appearance.These purposes of the present invention will appear from the detailed description that follows.All percentages and ratios Used here is by weight unless otherwise noted. General description of the invention: The invention is related to the “flea herb” peel, which contains granules distributed according to size as follows: less than about 15 of them are of a size greater than about 80 mesh eyes; And at least Ye 140 of them are of size in the range of about Av eye. or the unit of measure for the size of a hole in a mesh (Rie expressed in mesh holes per inch) to about 100 mesh eyes; Less than about 76 of them are smaller than about 100 eyes of Ad Y ¢

° The present invention also relates to preparations containing “flea weed” for oral administration comprising: (a) from about #1 to about 799 peels of “flea weed” with granules whose size distribution is according to the present invention © (b) ) from about 1 to about 749 carriers suitable for oral administration to humans. ° Preferably preparations containing "flea herb" that contain "flea herb" with a purity of at least 790. Preparations containing "flea herb" that are in a form suitable for mixing with a liquid to form a syrup are also preferred, especially preparations in which the "flea herb" is agglomerated. The present invention, Loaf, relates to methods of providing laxatives 188,000 comprising the oral administration to a person in need of a laxative a safe and effective amount of “flea herb” in the form of granules of a dispensing size as described in the invention. 1- Dude “flea herb” husk limited in granular size The present invention relates to “flea herb” husk in the form of granules of a certain small VO size and it is from the seed of the “flea herb” plant; it is a plant of the genus Plantain ( Plantago 0180590. Several species are known such as plantago lanceolate (Plantago rugeliigl lias) (Plantago major) and commercial psyllium husk. It includes the French (Black: Plantago indica), the Spanish (Plantago To milium) and the Indian (blond). Its purity is about de, and it is more preferable that its purity is more than about 46, and it is more preferable that the purity is not less than about JAY.

And the “flea dude” peel in this invention includes granules distributed according to size as follows: Less than about 216 of them are of a size greater than about Ar mesh eye; and over 100 mesh eyes to about Av about 745 of them are of size in The range is from about JAY a mesh eye; less than about 460 of them are smaller than about 10010 mesh eyes © Preferably, the grain size distribution should be as follows: Less than about 10 of them are of a larger size than about Ar a mesh eye and at least about 715 of them having a size in the range from about 80 mesh meshes to about 7001 mesh meshes, and less than about © of them being smaller than about 100 mesh meshes. 78 of them are larger than about 80 mesh eyes; at least

IX mesh eyes and less than about 100 are of size in the range from about 880 to 0 9 of which are smaller than about 100 mesh eyes. It is preferable, Lad, that the peel of the "flea herb" also includes a lesser percentage of about 78 granules of the same size that exceeds about 10 mesh eyes; and more preferably no granules substantially larger than about 10 mesh eyes; It is also preferable that it be less than about 10 Slade VO with a size greater than an Ar mesh eye; Most preferably having no intrinsic granules larger than about 80 mesh eyes; Less than about 7 of them are of a size greater than 100 mesh eyes. Achieving the determination of the pas of the grains and the distribution of the grain size can be easily done by the average practitioner of this skill”; For example, sifting using an Alpine Laboratory Air Jet Sieve “Type 001 Ve LS 20015” (sold by Alpine American Corporation: 00 Alpine American » Natick Mass. ).

No, and husk "flea herb" is obtained from the seed coat of the seed of flea herb. It is customary to remove the seed coat from the rest of the seed by means of; For example (Jal) light mechanical pressure, then using the seed coat only. It is better to remove the seed coat and purify it by technically recognized methods (such as ethylene oxide) before reducing the size of the pellet © to what is described in the invention. specified in the invention are technically known or preferably accomplished by the use of stud mills (also known as “pin mills”) under conditions that selectively reduce the scale size of “flea weed” compared to impurities other than cdg ddl thereby Further piousness is permitted if desired. Ve “- Preparations containing “flea herb” The present invention also relates to preparations containing “flea dude”. These preparations include the peel of “flea herb” in a granular size distribution according to the invention It is recommended that these preparations include from about #1 to about 649 husks of the “flea herb” and from about 0 1 to about 794 carriers. The most Sait is from about 601 to about 754 husks of the "flea herb" and from about 7 to about 7400 Alda material, and the beneficial carrier materials for the preparations of the present invention must be safe for human oral use and can be tested by the ordinary experienced With this skill, as appropriate for the intended form and use of the preparation. Forms of preparations containing Yo, flea herb, methods of manufacture and useful carriers for these preparations; Described in a more thorough manner by eg US Patent 7858 £09 4 of Colliopoulos et al. of 01 July 19464 and US Patent OFA ALY ;;_ of Colliopoulos and others of YY Oct 1588 and Patent of Y¢

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Melress YY et al. Powell; Powell 711 yay Invention | YAAY The preparations of this invention are in the form of a dry powder suitable for mixing preferably with a liquid (usually water) to form a syrup containing flea herb. The preferred carriers of the invention el in Jia for this powder form are known and described in detail by way of the foregoing referenced and preferably § OSA AT 4 £04 7860 The Americas. Those powders (preferably sugar-free) containing maltodextrin, especially powders containing agglomerates of Lad and preferably maltodextrin coated psylliumdileall of "flea herb" and/or "flea herb" agglomerates, especially those agglomerated with maltodextrin and/or sucrose 5000088 (cane sugar). Vo Preferably powders containing “flea weed” suitable for mixing in liquid to about 798 husks of “flea weed” having granule sizes 0 containing from about te” to About 45 peels 171 and better than about ( Jad distributed according to the invention +7 maltodextrin ( and better than about 7010 fleas") and from about zero / to about maltodextrin). Preparations containing flea weed according to this 8 0 to approx. VO to 701 of the invention containing sugar (for example sucrose) comprise of approx. and cue ge of the herb peel (1.0 º to approx. 0" 0 (best from approx. 0 1 0 approx. maltodextrin jo approx. 90 sugar and approx. zero + to approx. Jive approx. 7 aA). Sugar-free preparations typically include from approx. 0 to approx. to approx. 755) peel “flea herb” according to the present invention; 0 15 (best of approx. Ye of approx. YAY to approx. 10 (best of approx. About agglomerated maltodextrin and preferred formulations include agglomerated "flea weed"

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psyllium, and formulations that include the carrier material Led, citric acid, are also preferred »-_ The method of laxation (preventing or treating constipation) This treatment. © These methods include administering to the person in need of this treatment a safe and effective amount of “flea herb” in granule sizes distributed according to this invention »and the best is in the form of one of the preparations of the present invention containing flea herb (for example, a drink containing flea herb). Daily intakes of about 1 gram to about 1 gram of Veg of "flea herb" according to the present invention are in most cases suitable for inducing Ve softening; However, this may vary according to the weight and condition of the patient, and these matters are of course left to the discretion of the attending physician. However, since the "flea herb" is non-toxic, larger quantities can be taken without causing unpleasant side effects. A typical dose for softening purposes includes the administration of about 0 JY about 11 grams of de flea husk in a single dose. Yo and the following examples further describe and illustrate the implications within the scope of this invention. These examples are given only for illustrative purposes and should not be construed as a limitation of the present invention; As it is possible to obtain many variations of them without deviating from the spirit and scope of the invention. Example 1 Ye Raw blond psyllium husk crushed (Ethylene Oxide Purity “Particle Size Distribution Approx: greater than 10 mesh eye AED) = 7R; ); 71 to 50 mesh eye (EY (micron) = 767.1 0 to 01 mesh eye YO (micron) - 77.1 and 01 to 01 mesh eye (VEQ) micron) = YY and from 001 to VE mesh eye (100 micron) = R 1 ¢ and from Y ¢

1 0 mesh eye (less than 001 and smaller than ln SV = µm) VE) mesh eye 001 to Alpine pin model number µm = ;r./) selectively using pin mill Cuneiform 0/111 VE kg/hr; maximum cuneiform density Ve = flow rate ; Flow Rate UPZ ZYBOI 0 rpm; Sold by Alpine American Corporation; Natick; 18000 full pin density set mesh to max. Yoo Massachusetts) in order to increase the section size from 80 to © The crushed “flea weed” peel obtained has the following size distribution to 1 micron ) = 719 mesh 17/7 grit: greater than 80 mesh eye (greater than ! 111 mesh eye to 001 mesh eye (9-177;1 μm) = #r 1/7 0 mesh V+ 0-10 µm) mesh 0 1 to 171 of EY (µm)-V YO (9 £9)- 171 of IVY = eye of the grid 00-10 µm 171 to 01400 and from 1-r-Ye;) Mesh Eye YYo Gage to Yoo Gage = Mesh Eye (5 μm) Yoo to = μm) = 11 t ) and smaller than 775 mesh eyes (less than 775 mesh eyes (less than 6-VE) £6). Dark-colored material 'then 0 sieve size eye mesh according to this Yoo Peel the 'flea herb' which varies in size from 80 to cla VO of the invention. Then this 'flea herb' is used to prepare the following preparation sweetened with intoxicating (Model No. N-* Hobart Mixer) Prepared by dry mixing of the ingredients in a Hobart Mixer (N-50). The component percentage of the composition is sucrose, sucrose, Ye.

Y ot Citric Acid 4.10 Orange Flavor

YY bitter Psyllium flea dude

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BE FD&C Yellow No.6 Yellow No. 7 (according to the Food and Drug Control System) ml (water) (YYLA) ounces A A tablespoonful of this preparation is dispersed in to obtain a syrup containing approximately 1 teaspoon gm of “flea herb” The use of this drink by humans is effective for producing emollient benefits. 1 example o which was collected through a sieve (1) using peeled “flea herb” ground according to the example size 80 eyes net; the following sugar-free preparation has been prepared. Ingredient is the percentage of formulation

Yo A. Psyllium © 40. Maltrin Vo 8.11 Citric Acid Potassium Citrate 2 Ara Aspartame EA Flavor Flavoring ey Yellow No. © (according to the specifications of the Food and Drug Act and Articles VO

FD&C Yellow No.5 (American Cosmetics).

SrA Yellow No. 6 (according to the specifications of the Food and Drug Law and Articles

FD&C Yellow No. 6 American cosmetics) The formula is prepared by dry mixing of the components, removing about 77% of the maltrin from it, then (making it accumulate) with the remaining maltrin (an aqueous solution) in an agglomerating agglomerate with Yo agglomerates, and a teaspoon of top spray is dispersed. fluid bed agglomerator raised spray with liquid bed (g) of water for syrup (TYTN) of this preparation in + ounces contains approximately 200 g of flea weed. The use of this drink for humans is effective in causing softening. Y4

Claims (1)

VY 1 PROTECTION ALERT 'or 'Lad seed' (the plant is called Psyllium husk flea dude husk 1-1 psyllium 'or 'plantain') contains granules whose size distribution is as follows: less than 710 of which 7 ; And at least 7406 of them are of a size in the range of Mesh Av with a size greater than 001, and less than 460 of them are smaller than Mesh with a Yoo mesh size from 80 to .Mesh Eye of a net © E! Contains 1 according to Claim No. Psyllium husk flea herb cil 7?- peel 1 z eye 01 granules distributed as follows: less than 10 of them are with a size greater than ¥; and on Meshiud the eye of Av and less than + 7 of them are of a size greater than Mesh 1 eye of 001 eye of Mesh 10680 to Av less than 7715 of which they are of a size in the range of ¢ 001 mesh eye and less than 76 of them being smaller than Mesh © Mesh 1 of claim No. 1 includes Psyllium husk -#*1 Mesh Tee Granules, the size of which is distributed as follows: No granules of more than Y size, of which Ve and at least Mesh, and less than 70 of which are greater than 80 mesh eyes ¥ and less than MeshaSas eye 001 to Mesh A mesh eye of Av is in the range of ¢ Mesh A mesh eye of 0 of which is smaller than 10 of o contains Va 8.4 lal according to the element Psyllium husk flea herb peel —¢ 1 Mesh Av granules, the distribution of their sizes is as follows: No granules larger than Y to Mesh Av, and at least 80 of them have a size in the range of v 001 eye and less Of the 170 of them, the size is smaller than a mesh of 0 ¢. mesh © Y¢ VY Oral Chestomil Uae Mpsyllium Preparations containing flea plant —0 1 on: Y size distribution of Psyllium husk flea dade to 799 Ve - A-1; 1-4 shells Granules according to any of the claims ¢ are suitable for oral administration to humans. carriers B- | 1) to 94 © Carriers of claim No. Psyllium Preparations containing flea herb ©Y 1 —in powder form suitable for mixing with liquid to form a syrup containing flea herb ©Y Y. 1 For any of Elemental lida Psyllium flea dude Preparations containing plant —Y 1 of the flea herb Agglomerates containing conglomerates Psyllium 1 © or Y Psyllium 1 of any of the ingredients Gis Psyllium Preparations containing Flea herb plant =A) where the carriers include substances selected from the group consisting V=0 protection number Y and acid ¢” Maltodextrin; and maltodextrin sucrose from sucrose 3 and mixtures thereof 0106 citric acid ¢ in the form of a suitable powder Psyllium Preparations containing flea weed 4-1: For mixing in a liquid According to which of Claims 4-8 includes Y psyllium husk (11 to) 01 oe l a - | sugar Sw 50 b - from *#?) to ¢ . maltodextrin to 0 maltodextrin [pa c - from © Image Psyllium powder Preparations containing flea plant 01-1 Suitable for mixing in liquid in accordance with any Claims 8-5 Comprises: and Psyllium 460 to 798 flea herb husk?) 05i 3 .maltodextrin Maltodextrin 77618 to 1 of ¢ Y¢