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Nateglinide tablet and preparation method thereof

A technology for nateglinide and glinide tablets, applied to the field of nateglinide tablets and their preparation, can solve the problems of exhausted β-cell function, long action time, increased hypoglycemia, etc. The effect of complete dissolution and simple excipients

Inactive Publication Date: 2009-12-30
JIANGSU WANBANG BIOPHARMLS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patented product contains fewer parts than existing products that have been developed with other drugs like naftidrofurylurea (NFT) being able to quickly break down into smaller particles when taken by mouth without affecting its effectiveness over time. It also provides quicker release from liquid form during ingestion compared to traditional methods such as powders or liquids.

Problems solved by technology

The technical problem addressed in this patents relates to finding ways to improve the efficacy and safety of medications called nateglenatexone(NG), particularly when administering these medicine dosings frequently due to poor response rates associated with reduced responsiveness towards liver injury leading to increased risk of secondary failure.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 10,000 tablets of nateglinide tablets (specification 30mg) contain the following components:

[0045] Nateglinide 300g 36.3%

[0046] Starch 35g 4.2% Bulking agent

[0047] Microcrystalline Cellulose 100g 12.1% Filler

[0048] Silica 15g 1.8% glidant

[0049] Substituted hypromellose (L-HOLC 31 ) 25g 3.0% binder

[0050] Sodium Carboxymethyl Starch 350g 42.3% Disintegrant

[0051] in:

[0052] Add sodium carboxymethyl starch 130g 15.7%

[0053] Extra sodium carboxymethyl starch 220g 26.6%

[0054] Magnesium Stearate 2g 0.3% Lubricant

[0055] The preparation method comprises the following steps:

[0056] Step 1: Pass nateglinide through a 60-mesh sieve, and microcrystalline cellulose, starch, and sodium carboxymethyl starch through a 80-mesh sieve or a 60-mesh sieve for later use;

[0057] The second step: prepare the main drug and auxiliary materials according to the prescription quantity:

[0058] A. Preparation of the main drug: Weigh the prescribed amount...

Embodiment 2

[0062] 10,000 tablets of nateglinide (specification 60mg) contain the following components:

[0063] Nateglinide 600g 39.9%

[0064] Starch 80g 5.3% filler

[0065] Microcrystalline Cellulose 240g 16.0% Filler

[0066] Silica 40g 2.6% Glidant

[0067] Substituted hypromellose (L-HOLC 31 ) 60g 4.0% binder

[0068] Sodium Carboxymethyl Starch 480g 32.0% Disintegrant

[0069] in:

[0070] Add sodium carboxymethyl starch 180g 12.0%

[0071] Add sodium carboxymethyl starch 300g 20.0%

[0072] Magnesium Stearate 3g 0.2% Lubricant

[0073] The preparation method is the same as in Example 1.

Embodiment 3

[0075] 10,000 tablets of nateglinide (specification 120mg) contain the following components:

[0076] Nateglinide 1200g 50.6%

[0077] Starch 120g 5.1% filler

[0078] Microcrystalline Cellulose 320g 13.5% Filler

[0079] Silica 60g 2.5% glidant

[0080] Substituted hypromellose (L-HOLC 31 ) 100g 4.2% binder

[0081] Sodium Carboxymethyl Starch 570g 24.1% Disintegrant

[0082] in:

[0083] Add sodium carboxymethyl starch 220g 9.3%

[0084] Extra sodium carboxymethyl starch 350g 14.8%

[0085] Magnesium Stearate 6g 0.3% Lubricant

[0086] The preparation method is the same as in Example 1.

[0087] Three batches of samples were prepared according to the prescription process provided by the present invention. At a temperature of 25°C and a humidity of 60% + 10%, a long-term 12-month investigation has been completed. The inspection results: one side is smooth, the disintegration time limit, and content uniformity meet the requirements of the Pharmacopoeia. The dissoluti...

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Abstract

The invention relates to Nateglinide tablets and a preparation method thereof; in Nateglinide, 30-60% of filler is 3-15% of starch and 10-30% of microcrystalline cellulose, bonding agent is 1-10% of low substituted hydroxypropyl methylcellulose, disintegrant is 15-50% of sodium carboxymethyl starch, fluidizer is 0.1-5% of silica, and lubricant is 0.1-1% of magnesium stearate; the preparation method comprises the following steps: sieving raw materials for standby use; weighing Nateglinide with prescription amount, adding appropriate purified water, blending to prepare soft material, pelletizing and drying to prepare granules of main drug; evenly mixing microcrystalline cellulose, starch and part of sodium carboxymethyl starch, adding substituted hydroxypropyl methylcellulose by equivalently progressive method, evenly mixing to prepare soft material, pelletizing and drying; mixing granules of main drug with granules of accessories, adding residual sodium carboxymethyl starch, magnesium stearate and silica to be evenly mixed, pelletizing and tabletting. The invention has the characteristics of few components, available accessories, capability of fully disintegration in 3 minutes, above 95% of dissolution rate and suitability for long term storage.

Description

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Claims

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Application Information

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Owner JIANGSU WANBANG BIOPHARMLS
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