Deferasirox granules and preparation method thereof

A technology of deferasirox and granules, applied in the field of pharmaceutical preparations, can solve the problems of time-consuming and inconvenient use, limited widespread use, poor compliance and the like, and achieves the effects of convenient administration, easy dose division, and fast absorption

Inactive Publication Date: 2014-04-23
无锡万全医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In the past many years, the only iron-expelling agent available in China was deferoxamine. Because it cannot be absorbed orally and has a short half-life, it must be infused subcutaneously, 5-7 days a week, and each infusion lasts 8-12 hours , it is time-consuming and inconvenient to use, and there are many adverse reactions, resulting in poor long-term medication compliance of patients, which also limits their wide use

Method used

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  • Deferasirox granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 (prescription quantity is 1000 bags)

[0029] Raw material dosage (g)

[0030] Deerasirox 125

[0031] Lactose 590

[0032] Microcrystalline Cellulose 590

[0033] 10% PVP K30 aqueous solution 75

[0034] Crospovidone 75

[0035] Sodium Lauryl Sulfate 3

[0036] Aspartame 42

[0037] Preparation process: Weigh the prescribed amount of deferasirox, lactose, microcrystalline cellulose, crospovidone, sodium lauryl sulfate and aspartame, pass through a 80-100 mesh sieve and mix thoroughly. Add an appropriate amount of 10% PVP K30 aqueous solution and stir well to make a soft material. Extrude the soft material through a 24-mesh sieve to make wet granules, and dry at 60°C for 2 hours. The dried granules are passed through a 18-mesh sieve for granulation, quality inspection, and packaging (1.5g / bag) after passing the test.

Embodiment 2

[0038] Embodiment 2 (prescription quantity is 1000 bags)

[0039] Raw material dosage (g)

[0040] Deerasirox 125

[0041] Lactose 787

[0042] Microcrystalline cellulose 393

[0043] 10% PVP K30 aqueous solution 75

[0044] Crospovidone 75

[0045] Sodium Lauryl Sulfate 3

[0046] Aspartame 42

[0047] Preparation process: Weigh the prescribed amount of deferasirox, lactose, microcrystalline cellulose, crospovidone, sodium lauryl sulfate and aspartame, pass through a 80-100 mesh sieve and mix thoroughly. Add an appropriate amount of 10% PVP K30 aqueous solution and stir well to make a soft material. Extrude the soft material through a 24-mesh sieve to make wet granules, and dry at 60°C for 2 hours. The dried granules are passed through a 18-mesh sieve for granulation, quality inspection, and packaging (1.5g / bag) after passing the test.

Embodiment 3

[0048] Embodiment 3 (prescription quantity is 1000 bags)

[0049] Raw material dosage (g)

[0050] Deerasirox 125

[0051] Lactose 885

[0052] Microcrystalline Cellulose 295

[0053] 10% PVP K30 aqueous solution 75

[0054] Crospovidone 75

[0055] Sodium Lauryl Sulfate 3

[0056] Aspartame 42

[0057]Preparation process: Weigh the prescribed amount of deferasirox, lactose, microcrystalline cellulose, crospovidone, sodium lauryl sulfate and aspartame, pass through a 80-100 mesh sieve and mix thoroughly. Add an appropriate amount of 10% PVP K30 aqueous solution and stir well to make a soft material. Extrude the soft material through a 24-mesh sieve to make wet granules, and dry at 60°C for 2 hours. The dried granules are passed through a 18-mesh sieve for granulation, quality inspection, and packaging (1.5g / bag) after passing the test.

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Abstract

The invention provides deferasirox granules and a preparation method thereof, and belongs to the field of medicinal preparations. The deferasirox granules comprise a main component and auxiliary components, wherein deferasirox serves as a main component; the auxiliary components include a filling agent, a disintegrating agent, an adhesive, a surface active agent, a corrigent, etc. The deferasirox granules can be quickly dissolved in water to form uniform suspension, taste is great, and the deferasirox granules are convenient to carry, accurate in quantifying, easy to divide in dose, and high in bioavailability, etc.; the deferasirox granules can improve patient compliance and are particularly suitable for children.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a medicine for treating chronic iron overload diseases, in particular to a deferasirox granule and a preparation method thereof. Background technique [0002] Deferasirox is an orally active chelating agent that interacts with iron (Fe 3+ ) are highly selective. Developed by Novartis, it was first launched in the United States in 2005 under the trade name Exjade. It is mainly used for the treatment of chronic iron overload disease caused by blood transfusion at the age of 2 and above; the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia (NTDT) at the age of 10 and above. [0003] Patients with thalassemia require massive blood transfusions, and long-term blood transfusions may lead to iron overload. Chronic siderosis can cause damage to organs such as the heart, liver, and endocrine glands, and may be life-threatening in severe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4196A61K47/38A61K47/26A61P7/06A61P7/00
Inventor 张芳刁媛媛郭夏
Owner 无锡万全医药技术有限公司
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