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Exemestane chewable tablet and preparation method for same

A technology for exemestane and chewable tablets, which is applied in pharmaceutical formulas, medical preparations containing active ingredients, drug delivery, etc., to achieve the effects of good drug compliance, simple production process, and high bioavailability

Inactive Publication Date: 2014-07-30
赵辉
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Exemestane’s current clinical dosage forms mainly include tablets and capsules, which need to be swallowed by patients with water, which is inconvenient for children, the elderly and patients who cannot swallow solid medicines

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1 Preparation of Exemestane Chewable Tablets

[0042] 1.1 Formulation

[0043] Exemestane 25g

[0044] Lactose 675g

[0045] Cyclamate 90g

[0046] Aspartame 20g

[0047] Magnesium Stearate 40g

[0048] Powder essence 100g

[0049] Ethanol 40g

[0050] food coloring 10g

[0051] Made into 1000 pieces

[0052] 1.2 prepare the exemestane chewable tablet of above-mentioned prescription, carry out according to the following steps:

[0053]1.2.1 The raw and auxiliary materials are passed through a 100-mesh sieve;

[0054] 1.2.2 Mix exemestane, lactose, cyclamate, aspartame and grape pigment evenly, add ethanol to make a soft material, pass through a 20-mesh sieve to granulate, dry under vacuum at 50°C, and then pass through a 20-mesh sieve . Sieve for granulation.

[0055] 1.2.3 Add magnesium stearate and fresh creamer, mix well.

[0056] 1.2.4 Tablets.

Embodiment 2

[0057] Example 2 Preparation of Exemestane Chewable Tablets

[0058] 2.1 Formulation

[0059] Exemestane 5g

[0060] Lactose 695g

[0061] Cyclamate 90g

[0062] Aspartame 20g

[0063] Magnesium Stearate 40g

[0064] Powder essence 100g

[0065] Ethanol 40g

[0066] food coloring 10g

[0067] Made into 1000 pieces

[0068] 2.2 To prepare the exemestane chewable tablets of the above prescription, follow the steps below:

[0069] 2.2.1 The raw and auxiliary materials are passed through a 100-mesh sieve;

[0070] 2.2.2 Mix exemestane, dextrin, cyclamate, glycyrrhizin and mastia pigment evenly, add 5% ethyl cellulose ethanol solution to make soft material, granulate through 20 mesh sieve, and granulate at 40 ℃ Dry under vacuum conditions, and then pass through a 20-mesh sieve for sizing.

[0071] 2.2.3 Add micronized silica gel and green apple essence, and mix well.

[0072] 2.2.4 Tabletting.

Embodiment 3

[0073] Example 3 Preparation of Exemestane Chewable Tablets

[0074] 3.1 Formulation

[0075] Exemestane 50g

[0076] Mannitol 600g

[0077] Erythritol 50g

[0078] Cyclamate 50g

[0079] Stearic acid 10g

[0080] Sweet Orange Flavor 100g

[0081] 5% polyvinylpyrrolidone ethanol solution 100g

[0082] Mastiff Yellow Pigment 40g

[0083] A total of 1000 pieces were made

[0084] 3.2 To prepare the exemestane chewable tablets of the above prescription, follow the steps below:

[0085] 3.2.l The raw and auxiliary materials are passed through a 100-mesh sieve:

[0086] 3.2.2 Mix exemestane, mannitol, erythritol, and cyclamate evenly, add 5% polyvinylpyrrolidone ethanol solution to make a soft material, pass through a 20-mesh sieve to granulate, dry under vacuum at 55°C, and then Pass through a 20-mesh sieve for sizing.

[0087] 3.2.3 Add stearic acid and sweet orange essence, and mix well.

[0088] 3.2.4 Compress the tablet and coat it, and add the yellow pigment of ja...

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Abstract

The invention relates to the technical field of medicine preparations, and in particular relates to an exemestane-containing chewable tablet and a preparation method for the same. The exemestane chewable tablet is composed of main medicine exemestane, filler, a flavouring agent, a flow aid, a deodorant and an adhesive, capable of being used for patients difficult to swallow common tablets, and good in medicine compliance; the exemestane chewable tablet can be dissolved in saliva after being chewed in mouth, the medicine can be absorbed by mucous membranes in oral cavity or esophagus, and the bioavailability is high; the exemestane chewable tablet is sweet in flavour and good in taste, eliminates pungent smell, and is fragrant; the exemestane chewable tablet is convenient to take and carry; and the exemestane chewable tablet is prepared by a direct compression method, good in medicine stability, simple in production process, and low in cost.

Description

field of invention [0001] The invention relates to a pharmaceutical composition containing exemestane, more specifically, the invention relates to a chewable exemestane tablet. The present invention also relates to a preparation method of the exemestane chewable tablet. Background of the invention [0002] Breast cancer is one of the most common malignant tumors among women in the world. The incidence rate is increasing year by year. In today's elderly population, women over 65 years old, about 26% suffer from breast cancer, and about 1 / 3 of the tumor growth requires high estrogen levels to maintain, that is, estrogen dependence Characteristics. Estrogen-dependent breast cancer occurs more frequently in postmenopausal women. Antiestrogens are commonly used in patients with estrogen-dependent breast cancer. Tamoxifen has been used as the first-line treatment drug, but the effect of tamoxifen is better when it is first used, and long-term use is prone to drug resistance, le...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/36A61K31/5685A61P35/00
Inventor 赵辉赵冠淇苏天慧胡晓川
Owner 赵辉