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Treatment of allergic conditions

a technology for allergic conditions and treatment, applied in the field of treatment of allergic conditions, can solve the problems of inadequate effectiveness of cromoglycate, medical practitioners with enormous diagnosis and management problems, and cardiac and respiratory systems that can be compromised, and achieve the effect of reducing the risk of anaphylactic shock, and improving the safety of patients

Inactive Publication Date: 2007-02-15
THORNTON & ROSS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a treatment for allergic conditions, particularly those related to food or drink, by using a drug called sodium cromoglycate. The technical effect of this patent is to provide a more effective and reliable method for treating allergic conditions by improving the bioavailability of sodium cromoglycate through the use of enteric-coated formulations that release the drug in a more even and continuous manner. This allows for better absorption and dispersion of the drug in the body, leading to improved efficacy and management of allergic conditions.

Problems solved by technology

In addition, in severe food allergic reactions, the cardiovascular and respiratory systems can be compromised giving anaphylactic shock and in some cases death.
This vast array of symptoms and diseases presents the medical practitioner with tremendous problems of diagnosis and management.
In the absence of any reliable tests for food allergy other than double-blind, placebo-controlled, food challenges which are time-consuming, expensive and potentially dangerous, many practitioners are often reluctant to regard allergy as the cause, and rely on symptomatic treatment for management.
However, various clinical studies have failed to confirm that the oral formulation of sodium cromoglycate is adequately effective in inflammatory bowel disease and this indication was withdrawn in the early 1980's.
The enteric-coated formulations which have been proposed previously, at least on paper, similarly may be of low bioavailability because the sodium cromoglycate is released from the enteric coating into the duodenum in a lump that does not dissolve, rather than being dispersed evenly throughout the food material passing through the small intestine.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Granule Formation (1)

[0129] The following solutions are made up:

Formulation A1, A2 or A3:Formulation A1:Water (purified)1000g Sodium Cromoglycate 150 g {close oversize parenthesis} solids 14.29% Hydroxypropyl methyl cellulose 16.68 gFormulation A2: (for a larger and stronger granule)Water (purified)2000gSodium Cromoglycate300gHydroxypropyl methyl cellulose54g2354gFormulation A3: (for an even stronger granule)Water (purified)2000gHydroxypropylmethyl cellulose222g2222g

[0130] A coat of solids constituting 12% of the mass of the granules (12%(solids) coat) on 1000 g of granule requires 1065 g of a suspension having 11.27% solids.

[0131] 1000 g of powder Sodium Cromoglycate is placed into the bowl of an MPI Spray Granulator (Aeromatic-Fielder-UK) and fluidised using hot air at an inlet temperature of 70□C. The air rate used is approx 100 m3 / hr.

[0132] Once the material is fluidised and the powder bed has reached a temperature of 40□C, Formulation A1, A2 or A3 is sprayed through a two ...

example 2

Granule Formation (2)

[0137] Granulation is desirable in order to improve flow and compression characteristics when preparing a dosage form, such as a tablet or capsule.

Wet Granulation

[0138] Spray granulation in a fluid bed system is used to produce free flowing sodium cromoglycate granules:

[0139] Sodium cromoglycate is fluidised in the fluid bed with a diluent to aid fluidisation, for example microcrystalline cellulose. Onto the powder bed is sprayed a solution of binder and / or surfactant such as the amphoteric surfactant Miranol Ultra C32 or sorbitant trioleate. The binder may be sodium cromoglycate, PVP, HPMC, PEG or other water soluble binder.

[0140] Water may be used without additional binder or surfactant. This is because of the limited solubility of the sodium cromoglycate (freely soluble up to 5% and soluble with difficulty up to 10%).

[0141] A chelating agent such as EDTA at 0.1% may be included.

[0142] The strength and size of the granules may be changed by varying the...

example 3

Granulation—Gigh Shear Mixer Method

[0159] An alternative method involves the use of high shear mixer technology using a melt granulation technique.

[0160] Stage one—this process involves mixing SCG with a melt binder such as PEG under ambient conditions. The mixture is then heated to the melt point of the binder (approx 60□C) in a high shear mixer and mixed intensely to produce a round particle of approximate size 200 to 500 □m, and then cooled.

[0161] Stage two—these particles are then enteric-coated in a fluid bed spray coater (obtainable from Aeromatic-Fielder Ltd, Hampshire, UK) with AQOAT (Shin-Etsu), Aquateric (cellulose acetate phthalate aqueous redispersible powder and a suitable plasticizer, for example diethyl phthalate (DEP); FMC Corporation, Pharmaceutical Division, 1735 Market Street, Philadelphia, Pa. 19103) or one of the other commercially available coatings such as a CAP (FMC), CAT (Eastman Kodak), PVAP (Colorcon), or a Eudragit (R□hm Pharma).

Enteric Coating the I...

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Abstract

Orally administered sodium cromoglycate has been found to be effective in the treatment of allergic conditions such as asthma, general food allergies, ulcerative colitis, atopic eczema, chronic urticaria and irritable bowel syndrome if it is presented such that the sodium cromoglycate becomes bioavailable within 10 minutes of exposure to intestinal fluid. The sodium cromoglycate may be presented as enteric-coated tablets or individually enteric-coated pellets or microgranules packaged with disintegrant in a ratio of at least 1.2:1 disintegrant:sodium cromoglycate (w:w). Optionally, the patients are first selected to have a total serum IgE level of at least 150 iu / ml.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 09 / 831,681, filed on May 10, 2001, and entitled “TREATMENT OF ALLERGIC CONDITIONS”, which itself is a National Stage application submitted under 35 U.S.C. §363 of PCT Application No. PCT / GB99 / 03731, having a filing date of Nov. 9, 1999, which PCT application claims priority to Great Britain Patent Application Serial No. GB 9824604.4, the contents of which are herein incorporated in their entirety.FIELD OF THE INVENTION [0002] The present invention relates to the treatment of allergic conditions, in particular allergic conditions which relate to the nature of the food or drink consumed by the patient. BACKGROUND OF THE INVENTION [0003] Allergy to ingested substances can manifest itself in a wide range of symptoms affecting any organ in the body. Commonly it affects particularly the gastrointestinal tract, the skin, the lung, the nose and the central nervous system. Al...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/353A61K9/24A61K9/16C07D311/22A61K9/20A61K9/48A61K9/50A61K31/352A61K45/00A61K47/14A61K47/38A61P1/00A61P1/06A61P1/08A61P9/00A61P11/00A61P11/06A61P17/00A61P25/06A61P27/16A61P37/00A61P37/08
CPCA61K9/1641A61K9/1652A61K31/352A61K9/5015A61K9/5042A61K9/2077A61P1/00A61P1/06A61P1/08A61P11/00A61P11/06A61P17/00A61P25/06A61P27/16A61P37/00A61P37/08A61P9/00
Inventor WIGMORE, ALEXANDER JAMES
Owner THORNTON & ROSS
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