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Directly pressed starch and production method thereof

A production method and starch technology, which are used in pharmaceutical formulations, medical preparations with inactive ingredients, and pill delivery, etc., can solve the problems of large differences in the weight of preparations, unsuitable for main excipients, and poor powder fluidity. Solution time, excellent fluidity, good fluidity effect

Pending Publication Date: 2020-12-15
HUZHOU ZHANWANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] First, the fluidity of the powder is poor, the angle of repose is generally greater than 45 degrees, and the weight of the final preparation varies greatly;
[0004] Second, the hygroscopicity is too large, and the moisture-proof ability is poor;
[0005] Third, the adhesive force is very low, so it is not suitable as the main auxiliary material of the direct pressing process
[0008] However, the starch in this invention patent has the problem of poor performance after direct compression into tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] A kind of direct-pressed starch, starch material and binder solution are extruded in twin-screw extruder, and described starch material is cornstarch, and described binder solution is hypromellose E5 as binder The aqueous solution of the direct-pressed starch has a binder weight ratio of 4.9% (on a dry basis), the equilibrium weight loss of the direct-pressed starch is 6%, the angle of repose is 36°, and the straight-pressed starch has a diameter of 8mm, The hardness of the blank tablet weighing 200mg is 5.08kg / cm 2 , disintegration time 4min.

[0049] When the direct-compressed starch is directly compressed into a blank tablet with a diameter of 8 mm and 200 mg, the average tablet weight difference is 0.65%, and the friability is 0.61%.

[0050] When the solute weight ratio of the binder solution is 2%, the viscosity is 4-6mPa.s.

[0051] The particle size Dav of the direct-pressed starch is 60.7 μm, D 10 26.7 μm, D 50 50.6 μm, D 90 It is 110.7μm, and the bulk den...

Embodiment 2

[0064] A kind of direct-pressed starch, starch material is extruded in twin-screw extruder together with binder solution, and described starch material is cornstarch, and described binder solution is methyl cellulose as the aqueous solution of binder , the weight ratio of the binder in the direct-pressed starch is 6.5% (on a dry basis), the equilibrium moisture of the direct-pressed starch is 7%, the angle of repose is 34°, and the straight-pressed starch has a diameter of 8 mm and a weight of 200 mg. The hardness of the blank sheet is 5.91kg / cm 2 , disintegration time 5min.

[0065] When the direct-compressed starch is directly compressed into blank tablets with a diameter of 8 mm and 200 mg, the average tablet weight difference is 0.62%, and the friability is 0.18%.

[0066] When the solute weight ratio of the binder solution is 2%, the viscosity is 15 mPa.s.

[0067] The granule Dav of the direct-pressed starch is 62.2 μm, D 10 27.0 μm, D 50 52.6 μm, D 90 It is 113.7μm...

Embodiment 3

[0080] A kind of direct-pressing starch, starch material and binder solution are extruded in twin-screw extruder, and described starch material is wheat starch, and described binder solution is sodium carboxymethyl cellulose as binder The aqueous solution, the weight ratio of binder in the direct-pressed starch is 5.0% (on a dry basis), the equilibrium moisture of the direct-pressed starch is 8%, the angle of repose is 32°, and the direct-pressed starch has a diameter of 8mm, The hardness of the blank tablet weighing 200mg is 7.5kg / cm 2 , disintegration time 6min.

[0081] When the direct-compressed starch is directly compressed into a blank tablet with a diameter of 8 mm and 200 mg, the average tablet weight difference is 0.52%, and the friability is 0.18%.

[0082] When the solute weight ratio of the binder solution is 2%, the viscosity is 100 mPa.s.

[0083] The granule Dav of the direct-pressed starch is 80.3 μm, D 10 36.2 μm, D 50 70.0μm, D 90 It is 136.9μm, and the ...

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Abstract

The invention belongs to the technical field of synthesis of pharmaceutic adjuvants, and particularly relates to directly pressed starch and a production method thereof. According to the invention, astarch material and an adhesive solution are mixed and then subjected to extrusion molding, drying and crushing or direct spray drying, so that the effect of producing improved starch capable of beingdirectly pressed into sheets is achieved. The invention has the advantages that the production method is simple, effective, efficient and convenient, the produced starch is good in flowability, relatively small in hygroscopicity and sufficient in adhesive force, the performance is outstanding after the directly pressed sheets are prepared, and the starch is suitable for a powder direct pressing process when being used as a filling agent and a diluent.

Description

technical field [0001] The invention belongs to the technical field of synthesis of pharmaceutical excipients, in particular to a direct-pressed starch and a production method thereof. Background technique [0002] Starch is a multifunctional pharmaceutical excipient mainly used in oral solid dosage forms as a binder, diluent and disintegrant. Existing starch for pharmaceutical excipients has the following three problems: [0003] First, the fluidity of the powder is poor, the angle of repose is generally greater than 45 degrees, and the weight of the final preparation varies greatly; [0004] Second, the hygroscopicity is too large, and the moisture-proof ability is poor; [0005] Third, the adhesive force is very low, so it is not suitable as the main auxiliary material of the direct compression process. [0006] Therefore, in view of the above three problems, an improved starch that can be directly compressed into tablets with good powder flowability, low hygroscopicit...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K47/38
CPCA61K9/2059A61K9/2054A61K9/2095A61K47/36A61K47/38
Inventor 刘光海
Owner HUZHOU ZHANWANG PHARMA
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