Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Enalapril maleate oral solution and preparation method thereof

A technology of oral solution and enalapril, which is applied in the field of oral solution powder composition containing enalapril and its salts, can solve problems such as instability of enalapril maleate oral solution, achieve accurate dosage, Convenience to take and increase compliance

Inactive Publication Date: 2014-09-24
AVENTIS PHARMA HAINAN
View PDF6 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the oral liquid has a good taste, is convenient to take, has an accurate dosage, and has a quick onset of action, which increases the patient's compliance, is especially suitable for children and the elderly, and solves the problem of unstable enalapril maleate oral solution at the same time

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Enalapril maleate oral solution and preparation method thereof
  • Enalapril maleate oral solution and preparation method thereof
  • Enalapril maleate oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1: Stability Evaluation

[0020] Enalapril maleate powder formula: mix enalapril maleate with lactose, sucrose or xylitol, and prepare 10% (w / w) enalapril maleate by granulation Lithium powder was used to investigate the stability under different conditions. The prescription is shown in Table 1.

[0021] compound prescription 1 prescription 2 prescription 3 Enalapril Maleate (mg) 150 150 150 Xylitol (mg) 1350 Lactose (mg) 1350 Sucrose (mg) 1350

[0022] Enalapril maleate was slowly dissolved in 12% sodium bicarbonate solution. Place the stabilizer (lactose, sucrose or xylitol) in a mixer and slowly spray the enalapril maleate solution into the stabilizer for about 20 minutes with low agitation. Dry the wetted material in an oven at 60°C for at least 4 hours. The dried granules were passed through a 40 mesh screen. The particles were collected, an appropriate amount was sealed in a PET bottle, and the ...

Embodiment 2

[0029] Example 2: Evaluation of Mixing Uniformity

[0030] Enalapril maleate powder composition was prepared by dry mixing method to investigate the effect of mixing time on drug content uniformity. The formula is shown in Table 4.

[0031] compound prescription 4 prescription 5 Enalapril Maleate (mg) 150 150 Xylitol (mg) 900 890 Colloidal silica (mg) 10

[0032] Increase in proportion as prescribed in Table 4 (150mg enalapril maleate, 900mg xylitol / vial) or (150mg enalapril maleate, 890mg xylitol, 10mg colloidal silica / vial) Weigh each component, directly mix and sieve, take 3 point samples from different positions, and measure the content uniformity after mixing. The results are shown in Table 5:

[0033] Table 5 Results of the effect of colloidal silica on the mixing uniformity of enalapril maleate powder

[0034]

[0035] Although colloidal silica has been reported to reduce the stability of enalapril (Resend et al., Stability ...

Embodiment 3

[0036] Example 3: Stability Evaluation

[0037] The samples prepared according to recipe 5 in Example 2 were placed under the conditions of 25°C / RH60% and 40°C / RH75%. Samples were taken at different time points, and the content of enalapril maleate and related substances were determined by HPLC / UV. The results are shown in Table 6.

[0038] Table 6 Stability evaluation results of enalapril maleate powder

[0039]

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses a stable enalapril maleate powder composition which is taken orally, and specifically relates to a stable enalapril maleate oral solution composition. The enalapril maleate composition disclosed by the invention can be used for treating hypertension, cardiac failure, ventricular dysfunction and the like. The composition disclosed by the invention is superior to enalapril, can be better absorbed by body, is good in mouthfeel, is suitable for the children and the old, and remarkably increases medication compliance of a patient.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, relates to an oral preparation for treating essential hypertension, in particular, relates to an oral solution powder composition comprising enalapril and a salt thereof, and the obtained oral solution has good taste, Can be used by the elderly. Background technique [0002] Hypertension is the most common disease with the highest morbidity in the world. It is a major public health problem worldwide, and the prevalence is increasing year by year. According to the forecast of the World Health Organization, by 2020, non-communicable diseases will account for 79% of the causes of death in my country, of which cardiovascular diseases will take the first place. Hypertension is one of the important causes of heart disease, stroke, renal failure, premature death and life dysfunction. Prevention and treatment of hypertension is the key to prevention and treatment of cardiovascular disease. ...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/05A61K47/26A61K47/04A61P9/12
Inventor 浦洁宋雪梅郭夏
Owner AVENTIS PHARMA HAINAN
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com