A kind of preparation method of risperidone freeze-dried tablet and product thereof

A technology of risperidone and freeze-dried tablets, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problems of high plasma concentration and slow clearance of risperidone, Achieve the effect of simple preparation process and controllable quality

Active Publication Date: 2022-08-05
BEIJING MEDISAN TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Risperidone plasma concentrations are higher and clearance is slower in elderly patients and patients with renal insufficiency

Method used

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  • A kind of preparation method of risperidone freeze-dried tablet and product thereof
  • A kind of preparation method of risperidone freeze-dried tablet and product thereof
  • A kind of preparation method of risperidone freeze-dried tablet and product thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0032] Experimental Example 1 Preparation of risperidone freeze-dried tablets (10,000 tablets in batches as an example)

[0033] 1. Preparation of raw and auxiliary materials

[0034] The names and dosages of raw and auxiliary materials are shown in Table 1:

[0035] Table 1

[0036]

[0037]

[0038] 2. Preparation method

[0039] The preparation process is as follows:

[0040] (1) Pulverization: The raw materials are pulverized by a jet pulverizer, wherein the parameters of the pulverizer are air source pressure 0.4-0.6Mpa, pulverizing pressure 0.2-0.4Mpa, and feeding pressure 0.1-0.3Mpa.

[0041] (2) Weighing: Weigh the raw and auxiliary materials according to the prescription amount in Table 1 above.

[0042] (3) Sol: dissolve the gelatin in the recipe amount at 60°C with 500g of purified water, and then reduce the temperature to make the temperature be 30°C for later use as a light yellow transparent solution.

[0043] (4) Carbomer solution: 500g of water is pl...

experiment example 2

[0051] Experimental Example 2 Preparation of risperidone freeze-dried tablets (10,000 tablets in batches as an example)

[0052] 1. Preparation of raw and auxiliary materials

[0053] The names and dosages of raw and auxiliary materials are shown in Table 2:

[0054] Table 2

[0055] Raw material name mass volume percentage Risperidone 0.33％ gelatin 2.0％ Mannitol 1.0％ Glycine 1.0％ Dimethicone 0.001％ Sucralose 0.1％ red iron oxide 0.01％ peppermint 0.05％ Purified water to (g) 2850

[0056] 2. Preparation method

[0057] The preparation process is as follows:

[0058] (1) Pulverization: The raw materials are pulverized by a jet pulverizer, wherein the parameters of the pulverizer are air source pressure 0.4-0.6Mpa, pulverizing pressure 0.2-0.4Mpa, and feeding pressure 0.1-0.3Mpa.

[0059] (2) Weighing: Weigh the raw and auxiliary materials according to the prescription amount in Table 2 above.

[0060] (3) ...

experiment example 3

[0071] Experimental Example 3 Preparation of risperidone freeze-dried tablets (10,000 tablets in batch as an example)

[0072] 1. Preparation of raw and auxiliary materials

[0073] The names and dosages of raw and auxiliary materials are shown in Table 4:

[0074] Table 4

[0075]

[0076]

[0077] 2. Preparation method

[0078] The preparation process is as follows:

[0079] (1) Pulverization: The raw materials are pulverized by a jet pulverizer, wherein the parameters of the pulverizer are air source pressure 0.4-0.6Mpa, pulverizing pressure 0.2-0.4Mpa, and feeding pressure 0.1-0.3Mpa.

[0080] (2) Weighing: Weigh the raw and auxiliary materials according to the above-mentioned Table 4 recipe.

[0081] (3) Sol: dissolve the gelatin in the recipe amount at 60°C with 500g of purified water, and then reduce the temperature to make the temperature be 30°C for later use as a light yellow transparent solution.

[0082] (4) Dry powder mixing: place the raw material drug...

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Abstract

The invention discloses a preparation method of risperidone freeze-dried tablet and its product. The present invention utilizes jet milled risperidone to control its particle size D90 to be less than or equal to 30 μm. The risperidone raw material is mixed with the skeleton support agent, the flavoring agent, and the dry powder of the taste-masking agent. This mixing method can remove the electrostatic adsorption due to the small particle size of the main drug and the large specific surface area, and prevent the loss of content. Part of the recipe is added with water. Among them, continue to stir evenly, add the prepared binder solution, and make up the volume to the prescribed amount. Homogeneous mixing, degassing, filling, quick-freezing molding, freeze-drying, sealing, and packaging to form risperidone freeze-dried tablet products. The risperidone freeze-dried tablet prepared by the invention has controllable quality, can be taken directly without water, and has a disintegration time of less than 10s in vitro in 2 ml of water, and is suitable for patients with inconvenience in swallowing. The preparation process is simple, avoids the dust pollution problem of the orally disintegrating tablets obtained by traditional mixing and tableting, and can be continuously produced, and the prepared freeze-dried tablets have significantly less oxidized impurities than the traditionally disintegrating tablets.

Description

technical field [0001] The invention relates to a risperidone freeze-dried tablet and a preparation method thereof, belonging to the field of oral preparations. Background technique [0002] Risperidone is a selective monoaminergic antagonist with high affinity for 5HT2 receptors, D2 receptors, α1 and α2 receptors and H1 receptors. It also has an antagonistic effect on other receptors, but it is weaker. It has low to moderate affinity for 5HT1C, 5HT1D and 5HT1A, weak affinity for D1 and haloperidol-sensitive S receptors, and no affinity for M receptors or β1 and β2 receptors. The mechanism by which risperidone treats schizophrenia is unclear. It is believed that its therapeutic effect is the result of the combined effect of D2 receptor and 5HT2 receptor antagonism. The antagonism of receptors other than D2 and 5HT2 may be related to other effects of risperidone. [0003] Risperidone can be completely absorbed after oral administration, and reaches the peak plasma concent...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/42A61K47/36A61K47/26A61K47/18A61K47/44A61K47/02A61K31/519A61P25/18
CPCA61K9/2095A61K9/2063A61K9/205A61K9/2018A61K9/2013A61K9/2009A61K31/519A61P25/18
Inventor 刘荣王宏媛徐佳茗
Owner BEIJING MEDISAN TECH
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