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Orally disintegrating tablet containing lasofoxifene tartrate and preparation method thereof

A technology of lasofoxifene tartrate and orally disintegrating tablets, which is applied in the field of orally disintegrating lasofoxifene tartrate tablets and its preparation, can solve the problem of the lack of lasofoxifene tartrate orally disintegrating tablets related literature and patent reports and other issues, to achieve good promotion prospects, no need for repeated investment, simple and convenient preparation process

Inactive Publication Date: 2014-04-30
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Through literature search, there are no relevant literature and patent reports on lasofoxifene tartrate orally disintegrating tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prescription:

[0035] lasofoxifene tartrate 2.5g lactose 45g microcrystalline cellulose 30g Polyvinylpyrrolidone 8 Sucralose 1g Low-substituted hydroxypropyl cellulose 12 silica 0.5 Magnesium stearate 1 made into: 1000 pieces

[0036] Preparation:

[0037] Prepared by wet granulation process using conventional tablet equipment: pass lasofoxifene tartrate and lactose through an 80-mesh sieve (3 times) and mix well, add microcrystalline cellulose, polyvinylpyrrolidone, and sucralose, and pass through 80 mesh again Sieve (3 times) to mix evenly, granulate with purified water, dry at 60°C, pass the dry granules through a 30-mesh sieve for granulation, add low-substituted hydroxypropyl cellulose, silicon dioxide and magnesium stearate, mix evenly and press into tablets , to obtain orally disintegrating tablets.

[0038] Static disintegration time limit detection: The static disintegration time limit of lasofo...

Embodiment 2

[0042] Prescription:

[0043] lasofoxifene tartrate 1g lactose 41.5g precrossified starch 25g Sodium carboxymethyl cellulose 12 Low-substituted hydroxypropyl cellulose 8 aspartame 1g Low-substituted hydroxypropyl cellulose 10 Sodium aluminosilicate hydrate 0.5 Magnesium stearate 1 made into: 1000 pieces

[0044] Preparation:

[0045]Prepared by wet granulation process using conventional tablet equipment: pass lasofoxifene tartrate and lactose through an 80-mesh sieve (3 times) and mix well, add precrossified starch, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose Sodium glutamate and aspartame, passed through 80-mesh sieve (3 times) to mix evenly, granulated with 30% alcohol water, dried at 50°C, dried granules passed through 30-mesh sieve for granulation, added low-substituted hydroxypropyl cellulose , hydrated sodium aluminosilicate and magnesium stearate, mixed uniformly and press...

Embodiment 3

[0050] Prescription:

[0051] lasofoxifene tartrate 0.5g lactose 66.5g microcrystalline cellulose 20g stevia 1g silica 0.5 Magnesium stearate 0.5 Low-substituted hydroxypropyl cellulose 10 silica 0.5 Sodium dodecyl sulfate 0.5 made into: 1000 pieces

[0052] Preparation:

[0053] Prepared by dry granulation process using conventional tablet equipment: pass lasofoxifene tartrate and lactose through an 80-mesh sieve (3 times) and mix well, add microcrystalline cellulose, stevia, silicon dioxide and magnesium stearate, Go through the 80-mesh sieve (3 times) to mix evenly, dry granulate, the hardness is 40-50N, control the granules in the range of 30-80 mesh to account for 70-90%, add low-substituted hydroxypropyl cellulose and silicon dioxide after granulation After mixing with sodium lauryl sulfate, it is uniformly pressed into tablets to obtain orally disintegrating tablets.

[0054] Static disintegration t...

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PUM

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Abstract

The invention belongs to the field of medicinal preparations, and relates to a lasofoxifene tartrate orally disintegrating tablet for treating postmenopausal osteoporosis and a preparation method thereof. Proper medical auxiliaries are selected according to physicochemical properties of lasofoxifene tartrate, and the orally disintegrating tablet comprises a filling agent, a disintegrating agent, a flavoring agent, a lubricant, a glidant and the like. The medicine can be prepared by granulating and tabletting by a wet method, directly tabletting, or granulating and tabletting by a dry method. The invention aims to provide the lasofoxifene tartrate orally disintegrating tablet with simple preparation process, convenience in administration, quick response to indications, exact curative effect and high bioavailability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a medicine convenient for taking and a preparation method thereof, in particular to an orally disintegrating tablet of lasofoxifene tartrate for preventing and treating postmenopausal osteoporosis and a preparation method thereof. Background technique [0002] Osteoporosis is a worldwide health problem that attracts more and more attention. Osteoporosis refers to the reduction of bone mass per unit volume and the change of normal bone structure, which leads to the reduction of bone toughness and stiffness. Clinically, low back pain, kyphosis, and fractures can be induced by minor trauma. Metabolic bone disease threatening the health of the elderly. At present, my country has entered an aging society, and the prevention and treatment of geriatric diseases, especially osteoporosis, has become an important research topic. Osteoporosis occurs more rapidly in women and progr...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/40A61P19/10
Inventor 王程程刁媛媛傅雪猛郭夏
Owner BEIJING VENTUREPHARM BIOTECH
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