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
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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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