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Topiroxostat dispersible tablets and preparation method of topiroxostat dispersible tablets

A technology of topinostat and dispersible tablets, which is applied in the field of pharmaceutical preparations, can solve problems such as unstable quality and low dissolution rate, and achieve the effects of good drug efficacy, high bioavailability, and fast absorption by the human body

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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Because topirestat is a drug that is almost insoluble in water, the absorption of the drug mainly depends on the dissolution rate of the drug, and the existing topinastat preparations have defects such as unstable quality and low dissolution rate.

Method used

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  • Topiroxostat dispersible tablets and preparation method of topiroxostat dispersible tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Prescription (specification: 20mg):

[0030] Topicastat 20.0 g

[0031] Microcrystalline cellulose 60.0 g

[0032] Lactose 20.0 g

[0033] Crospovidone 40.0 g

[0034] Sodium hydroxide 2.0 g

[0035] Meglumine 6.0 g

[0036] Povidone K30 2.0 g

[0037] Magnesium stearate 2.0 g

[0038] Micronized silica gel 2.0 g

[0039] A total of 1000 pieces were made

[0040] Preparation:

[0041] ① Treatment of raw and auxiliary materials: Dissolve sodium hydroxide and meglumine in 9 g of purified water, add 25 g of ethanol, and then add the prescribed amount of topinostat, and stir until completely dissolved; pass the rest of the auxiliary materials through a standard sieve above 60 mesh for later use.

[0042] ② Weigh the diluent, adhesive and 30g crospovidone according to the prescription and mix evenly, add the above liquid to make a soft material

[0043] ③ Wet granulation: take the above-mentioned soft material and pass it through a 24-mesh sieve to...

Embodiment 2

[0049] Prescription (specification: 40mg):

[0050] Topicastat 40.0 g

[0051] Microcrystalline Cellulose 100.0 g

[0052] Lactose 40.0 g

[0053] Sodium starch glycolate 80.0 g

[0054] Sodium hydroxide 4.0 g

[0055] Meglumine 15.0 g

[0056] Hypromellose 5.0 g

[0057] Magnesium stearate 4.0 g

[0058] Micronized silica gel 4.0 g

[0059]A total of 1000 pieces were made

[0060] Preparation:

[0061] ① Treatment of raw and auxiliary materials: Dissolve sodium hydroxide and meglumine in 20 g of purified water, add 50 g of ethanol, and then add the prescribed amount of topicastat, and stir until completely dissolved; pass the rest of the auxiliary materials through a standard sieve of 60 mesh or above for later use.

[0062] ② Weigh the diluent, binder and 70g sodium starch glycolate according to the prescription and mix evenly, add the above liquid to make a soft material

[0063] ③ Wet granulation: take the above-mentioned soft material and pass it through a 2...

Embodiment 3

[0069] Prescription (specification: 60mg):

[0070] Topicastat 60.0 g

[0071] Microcrystalline Cellulose 120.0 g

[0072] Mannitol 120.0 g

[0073] Crospovidone 120.0 g

[0074] Sodium hydroxide 6.0 g

[0075] Meglumine 20.0 g

[0076] Hypromellose 6.0 g

[0077] Magnesium stearate 4.0 g

[0078] Micronized silica gel 6.0 g

[0079] A total of 1000 pieces were made

[0080] Preparation:

[0081] ① Treatment of raw and auxiliary materials: Dissolve sodium hydroxide and meglumine in 30g of purified water, add 80g of ethanol, and then add the prescribed amount of topicastat, and stir until completely dissolved; pass the rest of the auxiliary materials through a standard sieve of 60 mesh or above for later use.

[0082] ② Weigh the diluent, adhesive and 100g crospovidone according to the prescription and mix evenly, add the above liquid to make a soft material

[0083] ③ Wet granulation: take the above-mentioned soft material and pass it through a 24-me...

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Abstract

The invention provides topiroxostat dispersible tablets and a preparation method of the topiroxostat dispersible tablets. The topiroxostat dispersible tablets are prepared from an active ingredient topiroxostat and medicinal auxiliary materials: filler, a disintegrating agent, a lubricant, a flow aid, a solubilizer and an acid-base regulator. The dissolution rate of the topiroxostat dispersible tablets prepared by the invention reaches over 90% and the topiroxostat dispersible tablets are high in bioavailability and stable and reliable in quality and have an extreme market development prospect.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a topicastat dispersible tablet and a preparation method thereof. The invention also provides a topicastat dispersible tablet with high quality, safety and stability. Background technique [0002] The occurrence of gout is due to the excessive production of uric acid in the body and the decline in the ability of the kidneys to clear it. The accumulation of uric acid in the body leads to the deposition of urate crystals in the joints and various organs. With the continuous improvement of people's living standards, changes in dietary structure and living habits (increase in nucleoprotein-rich foods), the extension of average life expectancy, and the improvement of human understanding and diagnosis of gout, no matter in European and American countries or in Asia In all countries, the prevalence of gout is increasing year by year. At present, the number of patients w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4439A61P19/06
Inventor 不公告发明人
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