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Idelalisib effervescent tablet and preparation method thereof

A technology of idelaris and effervescent tablets, which is applied in pharmaceutical formulas, medical preparations of non-active ingredients, pill delivery, etc. It can solve problems such as poor compliance, long disintegration time of ordinary tablets, and poor absorption

Inactive Publication Date: 2016-11-09
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The disintegration time of the ordinary tablet of idelaris is long, the absorption is poor, the bioavailability is low, the proportion of excipients is large, children and elderly patients with dysphagia are inconvenient to take, and the compliance is poor, which affects the treatment of idelaris. role play

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment l

[0029] Aderaris 150g (15% by weight)

[0030] Sucrose 550g

[0031] Tartaric acid 60g

[0032] Sodium bicarbonate 60g

[0033] Disodium Glycyrrhizinate 60g

[0034] Orange Flavor 33g

[0035] Scarlet Red 32g

[0036] Talc powder 55g

[0037] A total of 1000 pieces were made

[0038] Preparation method: mix 200-mesh idelaris powder and 200-mesh lactose powder in equal increments; mix the remaining excipients fillers, organic acids, inorganic bases, flavoring agents, taste-masking agents, coloring agents and lubricants Mix evenly in equal increments and pass through a 200-mesh sieve; add it to the mixed powder of Idelalis and lactose, mix evenly in equal increments, and then directly compress into tablets.

Embodiment 2

[0040] Aderaris 100g (10% by weight)

[0041] Lactose 510g

[0042] Citric acid 75 g

[0043] Sodium carbonate 75g

[0044] Aspartame 7.5g

[0045] Glycyrrhizin 10 g

[0046] Peach Flavor 72.5g

[0047] Orange 75g

[0048] Micronized silica gel 75g

[0049] A total of 1000 pieces were made

[0050] Preparation method: with embodiment 1.

Embodiment 3

[0052] Aderaris 40g (4% by weight)

[0053] Sucrose 515g

[0054] Tartaric acid 85g

[0055] Sodium bicarbonate 85g

[0056] Disodium Glycyrrhizinate 60 g

[0057] Orange Flavor 75g

[0058] Scarlet Red 75g

[0059] Talc powder 65g

[0060] A total of 1000 pieces were made

[0061] Preparation method: with embodiment 1.

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PUM

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Abstract

The invention relates to an idelalisib effervescent tablet for treating recurrent follicular B-cell non-hodgkin lymphoma (FL) and recurrent small lymphotic lymphoma (SLL), and a preparation method of the idelalisib effervescent tablet. The invention aims at providing a novel preparation, namely, the idelalisib effervescent tablet which is rapid in disintegration, rapid in absorption, high in bioavailability, convenient to take, little in intestinal tract residue and small in side effects for vast patients and medical workers. According to the idelalisib effervescent tablet, idelalisib is taken as a raw material, auxiliary materials with certain varieties and ratios are added, and the idelalisib effervescent tablet is prepared by adopting the technical means provided by the invention; the idelalisib effervescent tablet is sweet in taste, has fragrance, is rapid in taking effect, and is high in bioavailability, and the medication compliance of the patients can be easily improved.

Description

technical field [0001] The present invention relates to a convenient medicine and its preparation method, in particular to a drug for treating recurrent follicular B-cell non-Hodgkin's lymphoma (FL) and recurrent small lymphocytic lymphoma (SLL). Laris effervescent tablet and preparation method thereof. Background technique [0002] Idelalisib is the first marketed oral, selective phosphoinositide 3-kinase delta (PI3K-delta, P110-delta) inhibitor. P110-delta is involved in changing the immune environment of B lymphocytes, and plays a key role in the activation, proliferation, survival and migration (trafficking) of such tumor cells. [0003] The accelerated approval of Idelalisib is based on a single-arm, multi-center, open-label positive phase II clinical results. The clinical trial enrolled 123 patients with relapsed "indolent" non-Hodgkin's lymphoma (iNHL) and small lymphocytic lymphoma (SLL). Patients received 150 mg of Idelaris twice a day. The primary endpoint was t...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K31/52A61K47/26A61K47/12A61K47/02A61K47/28A61K47/46A61K47/22A61K47/18A61K47/04A61P35/02
CPCA61K9/0007A61K9/2009A61K9/2013A61K9/2018A61K9/2068A61K31/52
Inventor 王雪峰韩亮
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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