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Medicament compound containing levorotatory ammonia chlorine horizon and atorvastatin and preparing method thereof

A technology of levamlodipine and atorvastatin, which is applied in the field of pharmaceutical compositions and preparations containing levamlodipine and atorvastatin, can solve the problems of poor patient compliance, complicated process, fragile tablets, etc., and achieve High bioavailability, simple preparation process, and less intestinal residue

Active Publication Date: 2008-06-18
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mannitol dissolves completely in the mouth and tastes good, but the tablet needs to be heated to remove the camphor after pressing, the process is complicated and it is difficult to ensure that the camphor is completely sublimated and removed
[0016] In addition, the commercially available orally disintegrating tablets also have the following three problems: 1. Fragile, special packaging and transportation
Because the pressure of orally disintegrating tablets is smaller than that of ordinary tablets, the hardness of the tablets is also smaller than that of ordinary tablets, and the tablets are easily broken. It is required to use special packaging materials for manual packaging, and it also brings difficulties to transportation.
2. The disintegration time limit exceeds the standard
Because orally disintegrating tablets are easy to fragment, many manufacturers use the method of increasing the pressure of tablet compression to solve the problem of tablet fragmentation, but this method of pressurization leads to the time limit of tablet disintegration exceeding the standard, and the disintegration exceeds 1 minute
3. Since the disintegrating agent selected for orally disintegrating tablets is an insoluble substance, the disintegration tastes like gravel, the taste is poor, and the patient's compliance is poor
4. Due to the use of special preparation methods such as freeze-drying tablet technology and solid solution technology, the production cost is increased

Method used

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  • Medicament compound containing levorotatory ammonia chlorine horizon and atorvastatin and preparing method thereof
  • Medicament compound containing levorotatory ammonia chlorine horizon and atorvastatin and preparing method thereof

Examples

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preparation example Construction

[0065] The method for preparing the oral immediate-release preparation of the present invention is known in the prior art, and a person of ordinary skill in the art can select a suitable method and process from the prior art to prepare the present invention according to the description of the present invention. oral immediate-release formulations. It has been reported to prepare orally disintegrating tablets by freeze-drying (DilipJG. Ann Arbor, Mich. Fast dissolving solid dosage from comprising a porous network of matrix material [P]. US5,558,880 1996). In a preferred example of the present invention, the preparation method comprises directly mixing levamlodipine and its pharmaceutically acceptable salts and atorvastatin and its pharmaceutically acceptable salts and pharmaceutically acceptable salts of the present invention. acceptable carrier (such as fillers and / or adsorbents, disintegrants, wetting agents and / or binders, lubricants and / or glidants, flavoring agents, etc.),...

Embodiment 1

[0076] As shown in Table 1, atorvastatin (purchased from Beijing Maijin Pharmaceutical Technology Co., Ltd.) and levamlodipine (purchased from Ningbo Red Eagle Pharmaceutical Co., Ltd.) of the stated weight were mixed, and then sequentially Add microcrystalline cellulose, low-substituted hydroxypropyl cellulose, mannitol, and croscarmellose starch sodium of the weight described in Table 1 and mix evenly, and directly compress tablets (8 punching tablet machines, manufacturer RIMEK, model: MiniPRESS- 11SF), 400 oral immediate release formulations. The resulting tablets were tested and the results obtained are listed in Table 1 below.

Embodiment 2-7

[0078] Oral immediate-release formulations were prepared as described in Example 1, except that the components and amounts used were shown in Table 1 below. The resulting tablets were tested and the results obtained are listed in Table 1 below.

[0079] Table 1

[0080] implement

[0081] It can be seen from the above table that the obtained oral immediate-release preparation has good mouthfeel, short disintegration time, high hardness, and does not require special packaging, thereby achieving the purpose of the present invention.

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Abstract

The invention provides an oral solid rapidly disintegrating dosage form, comprising 4 to 32 weight parts of atorvastatin and acceptable salt in pharmacy, 0.1 to 10 weight parts of l-amlodipine and acceptable salt in pharmacy, 20 to 93 weight parts of filler and / or adsorbent, 0.1 to 10 weight parts of disintegrant, 0.5 to 3 weight parts of wetting agent and / or adhesive, 0.5 to 2 weight parts of lubricant and / or flow agent and 0.1 to 1 weight parts of corrective. The oral solid rapidly disintegrating dosage form has the advantages of rapid disintegration, instant dissolution, taking effect fast, full absorption and high bioavailability.

Description

technical field [0001] The present invention relates to a composition comprising levamlodipine or a pharmaceutically acceptable salt thereof and atorvastatin (atorvastatin) or a pharmaceutically acceptable salt thereof, and treating patients with angina pectoris, atherosclerosis with this composition Patients with cirrhosis, comorbid hypertension and hyperlipidemia and methods of treating patients with cardiac risk conditions, including humans. Background technique [0002] Coronary artery disease (CAD) is the leading cause of rising mortality in the developed world. Often, patients with CAD have several comorbid conditions, including hypertension, diabetes mellitus, and dyslipidemia, which increase the risk of adverse outcomes and complicate treatment. [0003] Amlodipine includes levamlodipine and dexamlodipine. Amlodipine and its pharmaceutically acceptable salts are long-acting calcium channel antagonists, which are very effective for treating hypertension and angina p...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K47/44A61K47/42A61K47/38A61K47/36A61K47/34A61K9/20A61P9/10A61P9/12A61P3/06A61K31/40A61K47/10
Inventor 郑启兰高原陈彬华夏凌云
Owner SHANGHAI SINE PHARMA LAB
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