WO2007041772A1 - Preparation for the treatment of diarrhoea - Google Patents

Preparation for the treatment of diarrhoea Download PDF

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Publication number
WO2007041772A1
WO2007041772A1 PCT/AU2006/001469 AU2006001469W WO2007041772A1 WO 2007041772 A1 WO2007041772 A1 WO 2007041772A1 AU 2006001469 W AU2006001469 W AU 2006001469W WO 2007041772 A1 WO2007041772 A1 WO 2007041772A1
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WO
WIPO (PCT)
Prior art keywords
preparation
treatment
agent
diarrhoea
diarrhoeal
Prior art date
Application number
PCT/AU2006/001469
Other languages
French (fr)
Inventor
Michael David Levitt
Original Assignee
Colocaps Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2005905533A external-priority patent/AU2005905533A0/en
Application filed by Colocaps Pty Ltd filed Critical Colocaps Pty Ltd
Priority to CA002624943A priority Critical patent/CA2624943A1/en
Priority to EP06790339A priority patent/EP1942894A4/en
Priority to AU2006301919A priority patent/AU2006301919B2/en
Priority to NZ568064A priority patent/NZ568064A/en
Priority to US12/089,448 priority patent/US20090175933A1/en
Publication of WO2007041772A1 publication Critical patent/WO2007041772A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/451—Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/717—Celluloses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals

Definitions

  • the present invention relates to a preparation particularly suited to oral administration for the treatment of diarrhoea and other conditions associated with, or aggravated by, soft or liquid stool consistency.
  • dietary fibre supplements are quite unpalatable and need to be combined with flavourings and then dissolved in water to be ingested. Too little fluid and the resulting mixture of fibre supplement and fluid is thick and difficult to ingest; too much fluid and the volume of the drink only highlights the indifferent taste. Further still, the texture of the drink can be somewhat granular regardless of the volume of water used, adding to the consumption problems. Even with the addition of flavourings, dietary fibre supplements remain difficult to consume as the flavourings do not completely mask the taste of the fibre.
  • fibre supplements are also reputed to be of use in individuals suffering from diarrhoea or high stool frequency and soft stool consistency. These ailments are characteristically seen in the Irritable Bowel Syndrome or in individuals who have undergone extensive large bowel resection. Soft stool consistency is also common in the general population, especially amongst men.
  • the proposed method of action of fibre supplements in these circumstances is by absorbing the liquid faeces and providing it with some bulk. Regrettably, this is a genuinely mild action and is often overwhelmed by the vigorous intestinal motility that underlies the high stool frequency and liquid stool consistency in these individuals.
  • the undeniable tendency of fibre supplements to speed up colonic transit can sometimes mean that these agents are disadvantageous in these clinical situations.
  • anti- diarrhoeal agents An alternative and yet more active agent for the treatment of individuals suffering from diarrhoea or high stool frequency and soft stool consistency are the anti- diarrhoeal agents. These drugs are designed to thicken stools and so to reduce diarrhoea. They will also firm up slightly soft stools.
  • An example of such an agent is loperamide hydrochloride, generally referred to as loperamide, available commercially in 2 mg capsules and tablets under the trade mark Imodium ® . Due to its mode of action, loperamide belongs to a class of anti-diarrhoeals known as anti-motility agents.
  • Loperamide is a synthetic opiate-analogue with negligible systemic absorption, no ability to cross the blood-brain barrier and no known systemic side-effects, it has no tendency for the development of tolerance or addiction and is a potent anti-diarrhoeal by virtue of its tendency to slow down intestinal peristalsis by acting on both the cholinergic and prostaglandin phases of peristaltic activity.
  • diarrhoea refers to any intestinal disorder characterised by an increase in volume, fluidity or frequency of faecal discharge.
  • a preparation for the treatment of diarrhoea comprising a bulking agent and an antkJiarrhoeal agent wherein the anti-diarrhoeal agent is provided in the form of an anti-motility agent
  • the antagonistic modes of action of bulking agents and anti-diarrhoeal agents provides a preparation that reduces stool frequency but with the maintenance of a more satisfactory stool consistency.
  • anti-diarrhoeal agents adapted to dehydrate stools and slow peristalsis and to enhance water re-absorption from the gastro-intestinal tract and bulking agents adapted to retain water in stools and speed intestinal transit teaches away from their use together, yet the combination of the two agents deals effectively with the frequency and urgency of faecal discharge while reducing the tendency of anti- diarrhoeal agents alone to constipate the individual and produce a desiccated and unsatisfactory stool. That is, the propulsion of the stool is slowed by the anti- diarrhoeal agent while the bulking agent retains water and bulk to the stool. Further, the use of a bulking agent in combination with an anti-diarrhoeal agent reduces the likelihood of constipation that can result from the use of an anti- diarrhoeal agent alone.
  • the preparation is provided in the form of a discrete unit comprising bulking agent and anti-diarrhoeal agent.
  • the discrete unit of bulking agent and anti-diarrhoeal agent is encapsulated in a pharmaceutically acceptable coating.
  • said unit may be provided in the form of a capsule or a cachet.
  • the discrete unit is provided in the form of a tablet.
  • each discrete unit contains a predetermined amount of bulking agent and anti-diarrhoeal agent.
  • the coating negates any unpalatable taste that may be associated with the bulking laxative and the anti-diarrhoeal agent, thereby improving palatability.
  • the bulking agent may be provided in the form of soluble or insoluble fibre.
  • Soluble fibres are known to include pectins, gums, such as guar gum, mucilage, betaglucans, some forms of cellulose, brans, as well as ispaghula husk, psyllium, polycarbophil.
  • Insoluble fibres are known to include polysaccharides, cellulose, • ligni ⁇ , brans, and pectin.
  • the bulking agent is provided in the form of guar gum.
  • the bulking agent may be dehydrated prior to encapsulation in a pharmaceutically acceptable coating or incorporation into a tablet.
  • the coating preferably substantially inhibits absorption of atmospheric water, thereby substantially inhibiting rehydration of the bulking agent.
  • dehydrated is intended to encompass partial removal of water from the bulking agent.
  • the anti-diarrhoeal agent is provided in the form of an antimotility agent and may be selected from loperamide, loperamide hydrochloride (such as that sold under the trade marks Imodium ® and Gastro-stop Loperamide ® ), loperamide oxide, diphenoxylate (such as that sold under the trade marks Lomotil ® , Lofenoxal ® , Lonox and Motofen), cholestyramine (such as that sold under the trade mark Questran ® ) and codeine.
  • loperamide shall be used to refer to loperamide, loperamide oxide and loperamide hydrochloride.
  • the coating of the preparation preferably substantially inhibits ingress of water.
  • the preparation preferably comprises fillers and/or binders as known in the art.
  • each tablet of may be coated to substantially inhibit absorption of atmospheric water.
  • the coating is provided in the form of the cachet, the bulking agent and the anti-diarrhoeal agent being contained therein.
  • the coating is provided in the form of the capsule, the bulking agent and the anti- diarrhoeal agent being contained therein.
  • the capsules may be provided in the form of standard pharmaceutical capsules, 1 such as those formed from gelatine or cellulose.
  • the capsules are provided in the form of soft gelatine capsules.
  • the discrete units each preferably comprise between about 250 mg to 1000 mg of bulking agent and between about 0.1 mg to about 5.0 mg of anti-diarrhoeal agent.
  • the final amount of bulking agent will be influenced by the size of the discrete unit, especially when provided in the form of a tablet or a capsule.
  • the amount of anti-diarrhoeal will depend on the nature of the anti-diarrhoeal and will take into account the likelihood of over consumption and the side effects related thereto. It will be appreciated that given the potency of anti-diarrhoeal agents such as loperamide, great care should be taken to avoid over dose.
  • the discrete units each comprise between about 300 mg to about 500 mg of bulking agent and between about 0.3 mg to about 0.5 mg of anti- diarrhoeal agent.
  • the discrete units each comprise about 500 mg of bulking agent and about 0.5 mg of anti-diarrhoeal agent.
  • a method of treating a patient requiring such treatment, to cure diarrhoea which comprises treating said patient with an effective amount of a preparation comprising a bulking agent and an anti-diarrhoeal agent to the patient.
  • the preparation of the present invention is particularly suitable for sufferers of irritable bowel syndrome or individuals who have undergone extensive large bowel resection.
  • a daily dose of the preparation will comprise between about 3 to 6 g of bulking agent and 0.5 to 12 mg of anti-diarrhoeal agent..
  • the present invention further provides a method for the preparation of a medicament for the treatment of a patient suffering from diarrhoea, using a preparation comprising a bulking agent and an anti-diarrhoeal agent.
  • the patient is human.
  • the recommended daily dose of loperamide is 0.5 to 12 mg, depending on the individual's requirements.
  • the recommended daily dose of Benefiber ® (78 % guar gum) is 4 to 8 g, which translates to a dose of guar gum of approximately 3 to 6 g, depending on the individual's requirements.
  • recommended daily dosages for loperamide are about 4 mg and guar gum about 4 g.
  • a preparation in accordance with the present invention could comprises loperamide and guar gum an a 1:1000 ratio.
  • each capsule could comprises between about 300 to 500 mg of guar gum and 0.3 to 0.5 mg of loperamide and it would be necessary to consume between up to 20 of the smaller capsules per day and up to 10 of the larger capsules per day.

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  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract

A preparation for the treatment of diarrhoea comprising a bulking agent and an anti-diarrhoeal agent wherein the anti-diarrhoeal agent is provided in the form of an anti-motility agent.

Description

PREPARATION FOR THE TREATMENT OF DIARRHOEA
Field of the Invention
The present invention relates to a preparation particularly suited to oral administration for the treatment of diarrhoea and other conditions associated with, or aggravated by, soft or liquid stool consistency.
Background Art
Bulking laxatives such as fibre supplements are widely recommended as laxatives largely because they are free of any tendency to induce tolerance (increasing dose requirements). They cause a mild acceleration of colonic transit (i.e. they have only a mild laxative action) and tend to encourage bowel actions to be bulky, formed and soft. They have the additional benefit of serving to lower serum cholesterol levels. They are considered to be "natural" and are held in high regard by the general population as being a safe and reliable group of products.
However, dietary fibre supplements are quite unpalatable and need to be combined with flavourings and then dissolved in water to be ingested. Too little fluid and the resulting mixture of fibre supplement and fluid is thick and difficult to ingest; too much fluid and the volume of the drink only highlights the indifferent taste. Further still, the texture of the drink can be somewhat granular regardless of the volume of water used, adding to the consumption problems. Even with the addition of flavourings, dietary fibre supplements remain difficult to consume as the flavourings do not completely mask the taste of the fibre.
Despite their tendency to speed up colonic transit, fibre supplements are also reputed to be of use in individuals suffering from diarrhoea or high stool frequency and soft stool consistency. These ailments are characteristically seen in the Irritable Bowel Syndrome or in individuals who have undergone extensive large bowel resection. Soft stool consistency is also common in the general population, especially amongst men. The proposed method of action of fibre supplements in these circumstances is by absorbing the liquid faeces and providing it with some bulk. Regrettably, this is a genuinely mild action and is often overwhelmed by the vigorous intestinal motility that underlies the high stool frequency and liquid stool consistency in these individuals. Perhaps unsurprisingly, the undeniable tendency of fibre supplements to speed up colonic transit can sometimes mean that these agents are disadvantageous in these clinical situations.
An alternative and yet more active agent for the treatment of individuals suffering from diarrhoea or high stool frequency and soft stool consistency are the anti- diarrhoeal agents. These drugs are designed to thicken stools and so to reduce diarrhoea. They will also firm up slightly soft stools. An example of such an agent is loperamide hydrochloride, generally referred to as loperamide, available commercially in 2 mg capsules and tablets under the trade mark Imodium®. Due to its mode of action, loperamide belongs to a class of anti-diarrhoeals known as anti-motility agents. Loperamide is a synthetic opiate-analogue with negligible systemic absorption, no ability to cross the blood-brain barrier and no known systemic side-effects, it has no tendency for the development of tolerance or addiction and is a potent anti-diarrhoeal by virtue of its tendency to slow down intestinal peristalsis by acting on both the cholinergic and prostaglandin phases of peristaltic activity. It is further able to enhance water re-absorption from the gastro-intestinai tract via mechanisms including opiate receptor stimulation, calcium channel blockade, calmodulin inhibition and a reduction in paracellular permeability, It also exerts an anti-secretory action by inhibition of secretory actions of numerous known stimuli for secretion such as Cholera Toxin and prostaglandins further reducing intra-intestinal fluid.
Difficulties encountered with the use of many anti-diarrhoeal agents relate to their very potency and it is a significant challenge when using anti-diarrhoeal agents to provide the correct dosage, as too much may induce severe constipation. Even low doses can be too strong and many individuals are unable to ingest, for example, even 2 mg of loperamide without becoming (or feeling as if they have become) constipated.
The preceding discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be apprecfated that the discussion is not an acknowledgement or admission that any of the material referred to was part of the common general knowledge in Australia as at the priority date of the application.
Throughout the specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.
Throughout this specification, unless the context requires otherwise, the term diarrhoea refers to any intestinal disorder characterised by an increase in volume, fluidity or frequency of faecal discharge.
Disclosure of the Invention
In accordance with the present invention, there is provided a preparation for the treatment of diarrhoea comprising a bulking agent and an antkJiarrhoeal agent wherein the anti-diarrhoeal agent is provided in the form of an anti-motility agent
The tendency of bulking agents to speed up colonic transit suggests that these agents would be disadvantageous in the treatment of diarrhoea. Advantageously though, the antagonistic modes of action of bulking agents and anti-diarrhoeal agents provides a preparation that reduces stool frequency but with the maintenance of a more satisfactory stool consistency. The modes of action of anti-diarrhoeal agents adapted to dehydrate stools and slow peristalsis and to enhance water re-absorption from the gastro-intestinal tract and bulking agents adapted to retain water in stools and speed intestinal transit teaches away from their use together, yet the combination of the two agents deals effectively with the frequency and urgency of faecal discharge while reducing the tendency of anti- diarrhoeal agents alone to constipate the individual and produce a desiccated and unsatisfactory stool. That is, the propulsion of the stool is slowed by the anti- diarrhoeal agent while the bulking agent retains water and bulk to the stool. Further, the use of a bulking agent in combination with an anti-diarrhoeal agent reduces the likelihood of constipation that can result from the use of an anti- diarrhoeal agent alone.
Preferably, the preparation is provided in the form of a discrete unit comprising bulking agent and anti-diarrhoeal agent.
In one form of the invention, the discrete unit of bulking agent and anti-diarrhoeal agent is encapsulated in a pharmaceutically acceptable coating. Where the discrete unit of bulking agent and anti-diarrhoeal agent is encapsulated in a pharmaceutically acceptable coating, said unit may be provided in the form of a capsule or a cachet.
In a second form of the invention, the discrete unit is provided in the form of a tablet.
Preferably, each discrete unit contains a predetermined amount of bulking agent and anti-diarrhoeal agent.
Advantageously, the coating negates any unpalatable taste that may be associated with the bulking laxative and the anti-diarrhoeal agent, thereby improving palatability.
The bulking agent may be provided in the form of soluble or insoluble fibre. Soluble fibres are known to include pectins, gums, such as guar gum, mucilage, betaglucans, some forms of cellulose, brans, as well as ispaghula husk, psyllium, polycarbophil. Insoluble fibres are known to include polysaccharides, cellulose, • ligniπ, brans, and pectin. In a preferred from of the invention, the bulking agent is provided in the form of guar gum.
In one form of the invention, the bulking agent may be dehydrated prior to encapsulation in a pharmaceutically acceptable coating or incorporation into a tablet. Where the bulking agent is dehydrated, the coating preferably substantially inhibits absorption of atmospheric water, thereby substantially inhibiting rehydration of the bulking agent.
In the context of the present invention, the term dehydrated is intended to encompass partial removal of water from the bulking agent.
Preferably, the anti-diarrhoeal agent is provided in the form of an antimotility agent and may be selected from loperamide, loperamide hydrochloride (such as that sold under the trade marks Imodium® and Gastro-stop Loperamide®), loperamide oxide, diphenoxylate (such as that sold under the trade marks Lomotil®, Lofenoxal®, Lonox and Motofen), cholestyramine (such as that sold under the trade mark Questran®) and codeine. In the context of the present invention, the term loperamide shall be used to refer to loperamide, loperamide oxide and loperamide hydrochloride.
The coating of the preparation preferably substantially inhibits ingress of water.
Where the preparation is provided in the form of a pressed tablet, the preparation preferably comprises fillers and/or binders as known in the art.
Where the discrete units are provided in the form of tablets, each tablet of may be coated to substantially inhibit absorption of atmospheric water. Where the discrete units are provided in the form of cachets, the coating is provided in the form of the cachet, the bulking agent and the anti-diarrhoeal agent being contained therein. Where the discrete units are provided in the form of capsules, the coating is provided in the form of the capsule, the bulking agent and the anti- diarrhoeal agent being contained therein.
Where the discrete units are provided in the form of capsules, the capsules may be provided in the form of standard pharmaceutical capsules,1 such as those formed from gelatine or cellulose. Preferably, the capsules are provided in the form of soft gelatine capsules. The discrete units each preferably comprise between about 250 mg to 1000 mg of bulking agent and between about 0.1 mg to about 5.0 mg of anti-diarrhoeal agent.
The final amount of bulking agent will be influenced by the size of the discrete unit, especially when provided in the form of a tablet or a capsule. The amount of anti-diarrhoeal will depend on the nature of the anti-diarrhoeal and will take into account the likelihood of over consumption and the side effects related thereto. It will be appreciated that given the potency of anti-diarrhoeal agents such as loperamide, great care should be taken to avoid over dose.
More preferably, the discrete units each comprise between about 300 mg to about 500 mg of bulking agent and between about 0.3 mg to about 0.5 mg of anti- diarrhoeal agent.
Most preferably, the discrete units each comprise about 500 mg of bulking agent and about 0.5 mg of anti-diarrhoeal agent.
In accordance with the present invention, there is further provided a method of treating a patient requiring such treatment, to cure diarrhoea, which comprises treating said patient with an effective amount of a preparation comprising a bulking agent and an anti-diarrhoeal agent to the patient.
The preparation of the present invention is particularly suitable for sufferers of irritable bowel syndrome or individuals who have undergone extensive large bowel resection.
The skilled addressee will appreciate that the dosage rate will depend on the individual's requirements. Without being limited by theory, it is expected that a daily dose of the preparation will comprise between about 3 to 6 g of bulking agent and 0.5 to 12 mg of anti-diarrhoeal agent..
The present invention further provides a method for the preparation of a medicament for the treatment of a patient suffering from diarrhoea, using a preparation comprising a bulking agent and an anti-diarrhoeal agent. In a preferred form of the invention, the patient is human.
Best Mode(s) for Carrying Out the Invention
The best mode for performing the invention will now be described. It should be noted that the following description does not limit the scope of the invention as described in the preceding disclosure.
The recommended daily dose of loperamide is 0.5 to 12 mg, depending on the individual's requirements. The recommended daily dose of Benefiber® (78 % guar gum) is 4 to 8 g, which translates to a dose of guar gum of approximately 3 to 6 g, depending on the individual's requirements. Using midpoints of the ranges, recommended daily dosages for loperamide are about 4 mg and guar gum about 4 g. On this basis, a preparation in accordance with the present invention could comprises loperamide and guar gum an a 1:1000 ratio.
Where the preparation is provided in the form of a capsule, it is expected that each capsule could comprises between about 300 to 500 mg of guar gum and 0.3 to 0.5 mg of loperamide and it would be necessary to consume between up to 20 of the smaller capsules per day and up to 10 of the larger capsules per day.
Modifications and variations such as would be apparent to a skilled addressee are deemed to be within the scope of the present invention.

Claims

The Claims Defining the Invention are as Follows
1. A preparation for the treatment of diarrhoea comprising a bulking agent and an aπti-dϊarrhoeal agent wherein the anti-diarrhoea! agent is provided in the form of an anti-motility agent.
2. A preparation for the treatment of diarrhoea according to claim 1, wherein the preparation is provided in the form of a discrete unit comprising bulking agent and aπti-diarrhoeal agent.
3. A preparation for the treatment of diarrhoea according to claim 2, wherein the discrete unit is provided in the form of a capsule or a cachet,
4. A preparation for the treatment of diarrhoea according to claim 2, wherein the discrete unit is provided in the form of a tablet.
5. A preparation for the treatment of diarrhoea according to any one of claims 2 to 4, wherein the discrete unit contains a predetermined amount of bulking agent and anti-diarrhoeal agent
6. A preparation for the treatment of diarrhoea according to any one of the preceding claims, wherein the bulking agent is provided in the form of soluble or insoluble fibre.
7. A preparation for the treatment of diarrhoea according to claim 6, wherein the bulking agent is selected from the group comprising pectins, gums, such as guar gum, mucilage, betaglucans, some forms of cellulose, brans, as well as ispaghula husk, psyllium, polycarbophil.
8. A preparation for the treatment of diarrhoea according to claim 6, wherein the bulking agent is guar gum.
9. A preparation for the treatment of diarrhoea according to claim 6, wherein the bulking agent is selected from the group comprising polysaccharides, cellulose, ligniπ, brans, and pectin.
1ChA preparation for the treatment of diarrhoea according to any one of the preceding claims, wherein the bulking agent is dehydrated,
11. A preparation for the treatment of diarrhoea according to any one of the preceding claims, wherein the discrete unit is encapsulated in a pharmaceutically acceptable coating and the coating substantially inhibits absorption of atmospheric water.
12. A preparation for the treatment of diarrhoea according to any one of the preceding claims, wherein the anti-motility agent is selected from the group comprising loperamide, diphenoxylate, cholestyramine and codeine.
13.A preparation for the treatment of diarrhoea according to any one of claims 4 to 10, wherein the preparation comprises fillers and/or binders.
14. A preparation for the treatment of diarrhoea according to any one of claims
4 to 10 or 13, wherein the tablet is coated to substantially inhibit absorption of atmospheric water.
15.A preparation for the treatment of diarrhoea according to any one of claims
5 to 12, wherein the discrete unit is provided in the form of a cachet and the coating is provided in the form of the cachet, the bulking agent and the anti- diarrhoeal agent being contained therein.
16. A preparation for the treatment of diarrhoea according to any one of claims 5 to 12, wherein the discrete unit is provided in the form of a capsule and the coating is provided in the form of the capsule, the bulking agent and the anti-diarrhoeal agent being contained therein.
17.A preparation for the treatment of diarrhoea according to claim 16, wherein the capsule is a standard pharmaceutical capsule, such as those formed from gelatine or cellulose,
'18.A preparation for the treatment of diarrhoea according to claim 17, wherein the capsule is a soft gelatine capsules.
19.A preparation for the treatment of diarrhoea according to any one of claims 2 to 18, wherein the discrete units each comprise between about 100 mg to about 1000 mg of bulking agent and between about 0.1 mg to about 2.0 mg of anti-diarrhoeal agent.
20, A preparation for the treatment of diarrhoea according to any one of claims 2 to 18, wherein the discrete units each comprise between about 300 mg to about 500 mg of bulking agent and between about 0.3 mg to about 0.5 mg of anti-diarrhoeal agent.
21.A preparation for the treatment of diarrhoea according to any one of claims 2 to 18, wherein the discrete units each comprise about 500 mg of bulking agent and about 0.5 mg of anti-diarrhoeal agent.
22.A method of treating a patient requiring such treatment, to cure diarrhoea, which comprises treating said patient with an effective amount of a preparation comprising a bulking agent and an anti-diarrhoeal agent wherein the anti-diarrhoeal agent is provided in the form of an anti-motility agent to the patient.
23. A method for the preparation of a medicament for the treatment of a patient suffering from diarrhoea, using a preparation comprising a bulking agent and an anti-diarrhoeal agent wherein the anti-diarrhoeal agent is provided in the form of an anti-motility agent.
24.A preparation for the treatment of diarrhoea as hereinbefore described with reference to the accompanying Examples.
25.A method of treating a patient requiring such treatment, to cure diarrhoea, as hereinbefore described with reference to the accompanying [Examples.
PCT/AU2006/001469 2005-10-07 2006-10-06 Preparation for the treatment of diarrhoea WO2007041772A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA002624943A CA2624943A1 (en) 2005-10-07 2006-10-06 Preparation for the treatment of diarrhoea
EP06790339A EP1942894A4 (en) 2005-10-07 2006-10-06 Preparation for the treatment of diarrhoea
AU2006301919A AU2006301919B2 (en) 2005-10-07 2006-10-06 Preparation for the treatment of diarrhoea
NZ568064A NZ568064A (en) 2005-10-07 2006-10-06 Preparation for the treatment of diarrhoea comprising loperamide and a bulking agent selected from husks, mucilage, or brans
US12/089,448 US20090175933A1 (en) 2005-10-07 2006-10-06 Preparation for the treatment of diarrhoea

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EP (1) EP1942894A4 (en)
KR (1) KR20080068014A (en)
AU (1) AU2006301919B2 (en)
CA (1) CA2624943A1 (en)
NZ (2) NZ568064A (en)
WO (1) WO2007041772A1 (en)

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KR20110077671A (en) * 2009-12-30 2011-07-07 이해수 Composition for improving allergy disease using wheat bran

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US20030124088A1 (en) * 2000-04-10 2003-07-03 Kazuyoshi Masuda Preparation for preventing bile acid diarrhea

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WO1992011019A1 (en) * 1990-12-20 1992-07-09 The Procter & Gamble Company Psyllium and cholestyramine compositions with improved palatability
US20030124088A1 (en) * 2000-04-10 2003-07-03 Kazuyoshi Masuda Preparation for preventing bile acid diarrhea

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EP1942894A1 (en) 2008-07-16
AU2006301919B2 (en) 2011-09-22
NZ595865A (en) 2011-12-22
AU2006301919A1 (en) 2007-04-19
US20090175933A1 (en) 2009-07-09
KR20080068014A (en) 2008-07-22
NZ568064A (en) 2011-11-25
EP1942894A4 (en) 2011-02-09
CA2624943A1 (en) 2007-04-19

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