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drug combination preparation

一种片剂、药学的技术，应用在制备该片剂领域，能够解决固有溶解度差、降低药物功效、低水溶性等问题，达到良好稳定性和溶解性、治疗或预防高血压、良好成片性和生产效率的效果

Active Publication Date: 2020-12-04
SHIN POONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Therefore, when the pharmaceutical composition comprising the active ingredient candesartan and other active ingredients is stored in a combination preparation for a long period of time, the increased impurity level caused by the decomposition of candesartan cilexetil and / or other active ingredients has a negative effect on The stability of the pharmaceutical composition has an adverse effect and also reduces the efficacy of the drug
[0015] In addition, as mentioned above, candesartan or candesartan cilexetil has low water solubility, and in addition, its intrinsic solubility may become more severe depending on the type and nature of other active ingredients or additives contained in the combination preparation Difference
If the dissolution of the active ingredient in the gastrointestinal tract or in the body becomes poor, it is difficult to increase or maintain the drug level in the blood for a desired period of time, and it is difficult to achieve the desired level of therapeutic or preventive effect of the disease

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1: the preparation of bilayer tablet

[0062] 6 g of hydroxypropylcellulose and 3 g of polyethylene glycol 15-hydroxystearate were dissolved in purified water and ethanol to prepare a binding solution (1). 16 g of candesartan cilexetil, 65 g of microcrystalline cellulose, and 10 g of pregelatinized starch were uniformly mixed in a high-speed mixer to prepare a mixture (1). The binding solution (1) is added to the mixture (1), granulated and then dried. Sieved granules (1) were obtained by sieving with a 20-mesh sieve in a semi-dry state and with a 30-mesh sieve in a dry state.

[0063] 79 g of silicified microcrystalline cellulose were added to the sieved granules (1 ) and mixed in a double cone mixer. Then, 1 g of magnesium stearate was added to obtain a lubricated mixture (1).

[0064] 5 g of hydroxypropylcellulose was dissolved in purified water and ethanol to prepare a binding solution (2). 13.87 g of amlodipine besylate, 71.13 g of microcrystalline c...

Embodiment 2

[0068] Embodiment 2: the preparation of bilayer tablet

[0069] 6 g of hydroxypropylcellulose and 3 g of polyethylene glycol 15-hydroxystearate were dissolved in purified water and ethanol to prepare a binding solution (1). 16 g of candesartan cilexetil, 65 g of microcrystalline cellulose, and 10 g of pregelatinized starch were uniformly mixed in a high-speed mixer to prepare a mixture (1). The binding solution (1) is added to the mixture (1), granulated and then dried. Sieved granules (1) were obtained by sieving with a 20-mesh sieve in a semi-dry state and with a 30-mesh sieve in a dry state.

[0070] 79 g of silicified microcrystalline cellulose were added to the sieved granules (1 ) and mixed in a double cone mixer. Then, 1 g of magnesium stearate was added to obtain a lubricated mixture (1).

[0071] 2.5 g of hydroxypropylcellulose was dissolved in purified water and ethanol to prepare a binding solution (2). 6.935 g of amlodipine besylate, 35.565 g of microcrystallin...

Embodiment 3

[0075] Embodiment 3: the preparation of bilayer tablet

[0076] 3 g of hydroxypropylcellulose and 1.5 g of polyethylene glycol 15-hydroxystearate were dissolved in purified water and ethanol to prepare a binding solution (1). 8 g of candesartan cilexetil, 32.5 g of microcrystalline cellulose, and 5 g of pregelatinized starch were uniformly mixed in a high-speed mixer to prepare mixture (1). The binding solution (1) is added to the mixture (1), granulated and then dried. Sieved granules (1) were obtained by sieving with a 20-mesh sieve in a semi-dry state and with a 30-mesh sieve in a dry state.

[0077] 39.5 g of silicified microcrystalline cellulose were added to the sieved granules (1 ) and mixed in a double cone mixer. Then, 0.5 g of magnesium stearate was added to obtain a lubricated mixture (1).

[0078] 2.5 g of hydroxypropylcellulose was dissolved in purified water and ethanol to prepare a binding solution (2). 6.935 g of amlodipine besylate, 35.565 g of microcrysta...

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Abstract

The present invention relates to a tablet comprising candesartan or candesartan cilexetil and amlodipine or a pharmaceutically acceptable salt thereof as active ingredients, which uses a specific solubilizer to significantly improve the activity Stability and solubility properties of ingredients. In addition, the invention relates to a process for the preparation of such tablets.

Description

technical field [0001] The present invention relates to a tablet comprising candesartan or candesartancilexetil and amlodipine or a pharmaceutically acceptable salt thereof as active ingredients, the tablet using a specific Solubilizers to significantly improve the stability and solubility of active ingredients. In addition, the invention relates to a process for the preparation of such tablets. Background technique [0002] According to several reports, the number of hypertensive patients worldwide will continue to increase and will reach approximately 1.5 billion by 2025. Hypertension is one of the most common diseases, occurring in about 30% or more of Korean adults over the age of 30. According to reports, various complications of hypertension occur, such as vascular sclerosis, atherosclerosis, coronary artery disease, heart failure, stroke, etc. [0003] To treat such high blood pressure, non-drug treatments such as weight loss, exercise therapy, dietary therapy such...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/41
CPCA61K9/204A61K31/4422A61K9/209A61K31/4184A61P43/00A61P9/10A61P9/12A61K2300/00A61K9/20A61K9/2013A61K31/4418
Inventor 柳济万朴雨逸姜璟焕金雨卿蔡阿凌金水原丁炫宇李宰永
Owner SHIN POONG PHARMA CO LTD
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