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Solid rapidly-released blonanserin tablet for oral medication and preparation method thereof
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A technology of blonanserin and solids, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems such as the ineffective improvement of the dissolution effect, and achieve improved bioavailability, Improved dissolution effect and simple preparation process
Inactive Publication Date: 2017-08-22
SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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Problems solved by technology
Although it is beneficial to improve the stability of the pharmaceutical composition, it does not significantly improve the dissolution effect
Method used
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Embodiment 1
[0032] The composition of this embodiment is as follows:
[0038] The preparation method of this embodiment is as follows:
[0039] 1) Sieve each component by a 40-mesh sieve;
[0040] 2) Mix blonanserin and N-[8-(2-hydroxybenzoyl)amino]octanoic acid monosodium with a mortar;
[0041] 3) Dissolving povidone in water, using the resulting solution to granulate the mixture of blonanserin and N-[8-(2-hydroxybenzoyl)amino]octanoic acid monosodium;
[0042] 4) drying the granules at a temperature not exceeding 40°C to a moisture content of ≤3%;
[0043] 5) the obtained dry granules are sieved through a 40 mesh screen;
[0044] 6) Finally, the obtained granules are mixed with other suitable auxiliary materials, and the final mixture is compressed into tablets, the specification of blonanserin is 4 mg...
Embodiment 2
[0046] The composition of this embodiment is as follows:
[0052] The preparation method of this embodiment is as follows:
[0053] 1) Sieve each component by a 40-mesh sieve;
[0054] 2) Mix blonanserin and N-[8-(2-hydroxybenzoyl)amino]octanoic acid monosodium with a mortar;
[0055] 3) Dissolving povidone in water, using the resulting solution to granulate the mixture of blonanserin and N-[8-(2-hydroxybenzoyl)amino]octanoic acid monosodium;
[0056] 4) drying the granules at a temperature not exceeding 40°C to a moisture content of ≤3%;
[0057] 5) the obtained dry granules are sieved through a 40 mesh screen;
[0058] 6) Finally, the obtained granules are mixed with other suitable auxiliary materials, and the final mixture is compressed into tablets, the specification of blonanserin is 4 mg, wh...
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Abstract
The invention discloses a solid rapidly-released blonanserin tablet for oral medication. The tablet comprises blonanserin, monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate, polyvinylpyrrolidone and adjuvants, wherein a mass ratio of blonanserin to monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate is 1: 25-35, and polyvinylpyrrolidone accounts for 0.5 to 2% of the total weight of blonanserin and monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate. According to the invention, the adjuvants in the blonanserin tablet are simple in composition, the dissolving-out effect and bioavailability of blonanserin are effectively improved, and the blonanserin tablet has good uniformity as a small-size product.
Description
technical field [0001] The invention belongs to the field of blonanserin pharmaceutical preparations, in particular to a solid fast-release blonanserin tablet for oral administration and a preparation method thereof. Background technique [0002] Bronanserin was developed by Sumitomo Co., Ltd. of Japan, and was first listed in Japan in 2008. It is a new generation of atypical anti-schizophrenia drugs, which belong to serotonin and dopamine antagonists. It is more selective for the two receptors than other antipsychotic drugs, and has fewer side effects in the extrapyramidal system. The role of schizophrenia can alleviate cognitive impairment. [0003] Blonanserin (English name: Blonanserin), namely 2-(4-ethyl-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-six Hydroaromatic octa[b]pyridine, the molecular formula is C23H30FN3, the molecular weight is 367.5, and its structural formula is: [0004] [0005] The physical and chemical properties of blonanserin are soluble in...
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