Pregabalin composition suitable for powder tabletting and application thereof

A technology of pregabalin and composition, applied in the field of medicine, can solve the problems of affecting the disintegration time limit of the product, increase the cost of the product, etc., and achieve the effects of cool and slightly sweet taste, improved material compressibility, and soft and waxy taste.

Pending Publication Date: 2022-05-13
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most methods to improve the compressibility of pregabalin orally disintegrating tablets are by adding excipients with better compressibility or performing wet granulation. These methods will increase the cost of the product and affect the disintegration time limit of the product Situation etc.

Method used

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  • Pregabalin composition suitable for powder tabletting and application thereof
  • Pregabalin composition suitable for powder tabletting and application thereof
  • Pregabalin composition suitable for powder tabletting and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Product 1 Prescription Form:

[0054]

[0055] Product 2 Prescription Form:

[0056]

[0057]

[0058] Product 1 preparation process:

[0059] ① Pregabalin (D90 is 900 μm, crystal habit is long needle-shaped and square) is sized by a door-type granulator with a 0.8 mm sieve, and the granulation speed is 700 rpm. After sizing, the D90 of pregabalin is 500 μm , The crystal habit is square;

[0060] ②According to the dosage in the prescription table of product 1, mix microcrystalline cellulose, granulated pregabalin, mannitol, sucralose, sodium saccharin, crospovidone SH-SL10, and mint flavor in a square cone mixing bucket Mixing, mixing speed 10rpm, mixing time 20min;

[0061] ③ Pass the mixed granules obtained in the previous step through a 20-mesh vibrating sieve, and then add magnesium stearate to the granules after sieving and mix them with a square cone mixing bucket, the mixing speed is 10 rpm, and the mixing time is 20 minutes;

[0062] ④ Use the mixed...

Embodiment 2

[0094] Product 3 Prescription Form:

[0095]

[0096] Product 3 preparation process:

[0097] ① Pregabalin (D90 is 900 μm, crystal habit is long needle-shaped and square) is sized by a door-type granulator with a 0.8mm sieve, and the granulation speed is reduced from 700rpm to 300rpm, which is the lowest speed of the equipment. The D90 of pregabalin is 550 μm, and the crystal habit is square;

[0098] ②According to the dosage in the prescription table of product 3, mix microcrystalline cellulose, granulated pregabalin, mannitol, sucralose, sodium saccharin, crospovidone SH-SL10, and mint essence in a square cone mixing bucket. Mixing, mixing speed 10rpm, mixing time 20min;

[0099] ③ Pass the mixed granules obtained in the previous step through a 20-mesh vibrating sieve, and then add magnesium stearate to the granules after sieving and mix them with a square cone mixing bucket, the mixing speed is 10 rpm, and the mixing time is 20 minutes;

[0100] ④ Use the mixed granul...

Embodiment 3

[0107] Product 4 Prescription Form:

[0108]

[0109]

[0110] Product 4 preparation process:

[0111] ① Pregabalin (D90 is 900 μm, crystal habit is long needle-shaped and square) is sized by a door-type granulator, the 0.8mm sieve is changed to a 0.9mm sieve, and the sizing speed is 700rpm. After sizing, The D90 of pregabalin is 700 μm, and the crystal habit is long needle-shaped and square.

[0112] ②Mix the microcrystalline cellulose, granulated pregabalin, mannitol, sucralose, sodium saccharin, crospovidone SH-SL10, and mint essence in a square cone mixing barrel according to the dosage in the product 4 prescription table , mixing speed 10rpm, mixing time 20min;

[0113] ③ Pass the mixed granules obtained in the previous step through a 20-mesh vibrating sieve, and then add magnesium stearate to the granules after sieving and mix them with a square cone mixing bucket, the mixing speed is 10 rpm, and the mixing time is 20 minutes;

[0114] ④ Use the mixed granules o...

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Abstract

The invention discloses a pregabalin composition suitable for powder tabletting, the active component pregabalin of the pregabalin composition is pregabalin with a square crystal habit, the particle size range is D90: 350-600 [mu] m, and the dosage accounts for 20-50% of the total weight of the prescription. The pregabalin composition further comprises a filling agent, a disintegrating agent, a flavoring agent, essence and a lubricating agent. The invention provides another idea that the pregabalin bulk drug with a certain particle size range and a specific crystal habit form is prepared, and compared with the common pregabalin bulk drug, the compressibility of the prepared total mixed material is obviously improved, and the production cost is reduced.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a pregabalin composition suitable for powder compression. Background technique [0002] Internationally, the immediate-release oral solid preparations of pregabalin on the market are tablets, capsules, and orally disintegrating tablets. Compared with ordinary tablets and capsules, orally disintegrating tablets can quickly disintegrate in the oral cavity under the condition of no water or only a small amount of water, especially suitable for the elderly, children, and patients with difficulty swallowing. [0003] Pregabalin or (S)-(+)-3-aminomethyl-5-methyl-hexanoic acid can bind to the α-2-δ (α2δ) subunit of calcium channels and is involved in brain neuronal activity The regulation of related endogenous inhibitory neurotransmitter γ-aminobutyric acid (GABA) is related. As described in U.S. Patent 5,563,175, pregabalin has anti-seizure activity and is indicated for the treatm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/32A61K47/12A61K31/197A61P25/08A61P25/00A61P29/00
CPCA61K9/2095A61K9/0056A61K9/2054A61K9/2027A61K9/2013A61K31/197A61P25/08A61P25/00A61P29/00
Inventor 李俊遇梁文伟刘锋谭晓峰
Owner AC PHARMA CO LTD
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