Preparation containing lurasidone hydrochloride and preparation method thereof

A technology for lurasidone hydrochloride and preparations, which is applied in the field of preparations containing lurasidone hydrochloride and its preparation, and can solve problems such as difficulty in providing oral preparations

Active Publication Date: 2013-04-03
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For an active ingredient that is slightly water soluble like lurasidone hydrochloride, it is difficult to provide an oral formulation with the same dissolution profile

Method used

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  • Preparation containing lurasidone hydrochloride and preparation method thereof
  • Preparation containing lurasidone hydrochloride and preparation method thereof
  • Preparation containing lurasidone hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0052] Prescription:

[0053]

[0054] Preparation:

[0055] 1) Pass each raw and auxiliary material through a 40-mesh sieve for subsequent use.

[0056] 2) Weigh the prescribed amount of lurasidone hydrochloride and mannitol, and mix them evenly. Microsomal particles A were obtained by pulverization.

[0057] 3) Prepare 5% hypromellose solution to obtain solution B.

[0058] 4) Add microcrystalline cellulose and croscarmellose sodium to microsomal particle A and mix well to obtain mixture C.

[0059] 5) Add solution B to mixture C to make a soft material, granulate with 14 mesh, dry at 55°C until weight loss is 1-3% (wt / wt), granulate with 14 mesh, and obtain granule D.

[0060] 6) Add silicon dioxide and magnesium stearate to granule D, and mix well to obtain an intermediate.

[0061] 7) Intermediate detection.

[0062] 8) Press the tablet according to the test result of the intermediate.

[0063] 9) Prepare 12% Opadry and coat it.

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Abstract

The invention relates to an oral preparation and a preparation method thereof. The preparation contains lurasidone hydrochloride, a micronized particle of a dispersion supporter, microcrystalline cellulose and a water-soluble polymer adhesive. More specifically, the invention relates to the oral preparation and especially to a tablet. The preparation has a fast dissolution characteristic, and dissolution characteristics of an active component are identical; even though the content of the active component in the preparation changes in a certain range, the dissolution characteristics of the active component are still identical.

Description

technical field [0001] The present invention relates to an oral preparation and a preparation method thereof, the preparation contains micronized particles of lurasidone hydrochloride and a dispersion carrier, microcrystalline cellulose and a water-soluble polymer binder, more specifically, the present invention relates to an oral preparation, Especially tablets, the preparation has a faster dissolution profile and has the same active ingredient dissolution profile even when the content of the active ingredient varies within a certain range. Background technique [0002] Lurasidone hydrochloride ((3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl Methyl]cyclohexylmethyl]hexahydro-1H-4,7-methylisoindole-1,3-dione hydrochloride), that is, a compound represented by the following general formula (1): [0003] [0004] Lurasidone hydrochloride is known to have a therapeutic effect on psychosis, and it can be used as a therapeutic drug against schizophreni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61P25/18
Inventor 彭涛王悦
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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