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swallowable n-acetylcysteine ​​tablets

An acetylcysteine ​​and tablet technology, which is applied in the directions of pill delivery, medical preparations containing active ingredients, and drug combinations, can solve the problems of worsening quality of life, increased mortality, increased direct and indirect costs, etc. Improve the production process and eliminate the effect of sulfur odor

Active Publication Date: 2019-01-04
ZAMBON SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Indeed, COPD is often characterized by episodes in which symptoms become acute again, during which there is an amplification of inflammatory and oxidative processes, which often leads to hospitalization, especially in patients with multiple serious diseases, resulting in Is a significant increase in mortality (49% at 2 years, similar to lung cancer), leading to worse quality of life and increased direct and indirect costs

Method used

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  • swallowable n-acetylcysteine ​​tablets
  • swallowable n-acetylcysteine ​​tablets
  • swallowable n-acetylcysteine ​​tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Example 1 - Preparation of Granules

[0078] NAC was dry granulated using a roller compactor. Inside the machine, two separate stages of the process are carried out, the powder first passes through two counterclockwise rotating drums, which exert a force on the powder, converting it into flakes, and then the flakes pass through a small A grinder that shoots standardized granules from a sieve.

Embodiment 2

[0079] Example 2 - Preparation of Tablets

[0080] The granules produced according to Example 1 were mixed with hydroxypropylcellulose, microcrystalline cellulose, crospovidone and colloidal silicon dioxide for 9 minutes, followed by mixing with Mg stearate for a further 1 minute. The resulting blend was compressed using a rotary tablet press applying a compression force of 20 KN and a pre-compression of approximately 3 KN.

[0081] The resulting tablet had a hardness of 7.0 KP, a disintegration time of 2 minutes and a friability of 0.2% by weight.

[0082] Each tablet having the composition shown in Table 2 was prepared as taught in Examples 1 and 2.

[0083] Table 2

[0084] Element

Embodiment 3

[0085] Example 3 - Smell test 1

[0086] In order to check whether there is a sulfur smell when opening the pack containing 6 tablets prepared by dry granulation of the active ingredient of the present invention having the composition shown in Table 2, a test was carried out in which Mode Appropriately select 30 individuals, excluding smokers, allergic individuals, asthmatics and pregnant women.

[0087] Individuals required to select:

[0088] 1. Free from any cold or any pathological condition, which may impair his ability to smell;

[0089] 2. Do not chew gum or eat at least 30 minutes before the start of the test;

[0090] 3. Do not eat spicy food during meals before the test;

[0091] 4. Do not wear perfume, cologne or in any case use aftershave water or fragrance on the day of the test;

[0092] 5. Use a fragrance-free deodorant on the day of the test;

[0093] 6. Avoid using fragranced cosmetics and personal hygiene products on the day of the test;

[0094] 7. Was...

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Abstract

The present invention relates to swallowable tablets comprising at least 80% by weight of N-acetylcysteine ​​(NAC) and at least one pharmaceutically acceptable excipient, in particular tablets in which there is no sulfur odor, which It is characterized in that the tablet is made using granules prepared by a process of dry granulation of the active ingredient alone, wherein the granules are mixed with the excipients before compression.

Description

technical field [0001] The present invention relates to swallowable tablets having a high content of N-acetylcysteine ​​(NAC), in particular tablets free of sulfur odour. Background technique [0002] NAC is known to be a substance with a mucolytic effect, which reduces the viscosity of mucus and breaks disulfide bonds in glycoproteins. [0003] NAC is usually administered topically or orally in the form of aerosols, syrups, granules or tablets. [0004] NAC is an acidic molecule characterized by an unpleasant taste and a sulfurous odor, an odor that becomes stronger during the manufacturing phase of NAC-containing pharmaceuticals and storage in primary containers. [0005] After oral administration, NAC is rapidly and completely absorbed from the gastrointestinal tract in men (De Caro, L., Ghizzi, A., Costa, R. et al. Pharmacokinetics and bioavailability of oral acetylcysteine ​​inhealthy volunteers. Arzneim. Forsch. 1989;39:382-385). [0006] The specific tropism of thi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K9/16A61K31/198
CPCA61K9/2009A61K9/2027A61K9/2054A61K9/2095A61K31/198A61K9/1688A61P11/00A61P11/08A61P11/12
Inventor A·德拉扎里A·莫雷托
Owner ZAMBON SPA
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