Pharmaceutical composition comprising 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof in the form of personalised supply units and corresponding manufacturing method
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A technology of dihydroxybenzene sulfonic acid and supply unit, which is applied in the directions of drug combination, anhydride/acid/halide active ingredient, pill delivery, etc., can solve the problem of not being able to ensure immediate effect and the like
Pending Publication Date: 2019-09-27
BELAC INVEST SL
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[0018] The use of prolonged release formulations is mentioned in different patent documents, however, there is a risk of not ensuring the immediate effect required of this pharmacological agent, which is important for reducing fibrinogen in human blood and for prophylaxis and treatment by high levels of Diseases caused by fibrinogen are of particular importance
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Embodiment 1
[0150] The programmed release drug preparation process will be divided into the following two steps.
[0151] Step 1: Fabricate the Immediate Release Layer
[0152] a) 74.07% w / w calcium dobesilate, 20.74% w / w microcrystalline cellulose and 2.07% w / w sodium starch glycolate were sieved through a #20 sieve. All percentages are based on the total weight of the immediate release step.
[0153] b) Mixing the substances obtained in a) within a time interval of 1 minute to 30 minutes.
[0154] c) Sieve 1.33% w / w magnesium stearate and 1.78% w / w talc through a #30 sieve. All percentages are based on the total weight of the immediate release step.
[0155] d) Mixing the substances obtained in b) and c) within a time interval of 1 minute to 15 minutes.
[0156]
[0157] Step 2: Fabricate the Extended Release Layer
[0158] a) 53.76% w / w calcium dobesilate was micronized. All percentages are based on the total weight of the extended release step.
[0159] b) Dissolve 0.81%...
Embodiment 2
[0173] Step 1: Fabricate the Immediate Release Layer
[0174]
[0175] Step 2: Fabricate the Extended Release Layer
[0176]
[0177] * evaporates during the process
[0178] Both stages are compressed in the elongated punch. The ratio between the immediate release layer and the extended release layer was 31:69.
Embodiment 3
[0180] Step 1: Fabricate the Immediate Release Layer
[0181]
[0182] Step 2: Fabricate the Extended Release Layer
[0183]
[0184] * evaporates during the process
[0185] Both stages are compressed in the elongated punch. The ratio between the immediate release layer and the extended release layer is 34:66.
[0186] Figure 5 Release profiles of bilayer tablets are shown.
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Abstract
The invention relates to a pharmaceutical composition comprising 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof in the form of personalised supply units and a corresponding manufacturing method. The pharmaceutical composition comprising 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof in the form of personalised supply units, in which part of the 2,5-dihydroxybenzenesulfonic acid is in the form of an immediate-release composition additionally comprising between 8% and 28% microcrystalline cellulose, and the other part of which is in the form of a prolonged-release composition additionally comprising between 10% and 45% hydroxypropylmethylcellulose and between 6.1% and 20% hydroxypropylcellulose. The proportion between the two parts is between 24:76 and 40:60. This allows administration of the composition to the patient once every 24 hours. The composition can be used to treat primary varicose states, chronic venous insufficiency, phlebitis, thrombophlebitis, post-thrombotic syndrome, leg ulcers, pregnancy-related varicose veins. as a coadjuvant for varicectomy, sclerotherapy or as a coadjuvant in the treatment of diabetic retinopathy.
Description
technical field [0001] The present invention relates to a pharmaceutical composition for oral administration with programmed dual release, i.e. immediate release and extended release, comprising 2,5-dihydroxybenzenesulfonic acid and / or a pharmaceutically acceptable salt thereof , which is used to reduce fibrinogen in human blood, and to prevent and treat diseases caused by high levels of fibrinogen. One part of 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof is in the form of an immediate release composition and the other part of 2,5-dihydroxybenzenesulfonic acid or a pharmaceutically acceptable salt thereof is an extended release composition form. [0002] The invention also relates to a method of manufacture for the composition according to the invention. Background technique [0003] 2,5-Dihydroxybenzenesulfonic acid and / or its salts (dobesylate, eg calcium dobesilate) are capillary function modulators described in patent ES 335945 . Cal...
Claims
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