Formula of directly tableted olopatadine hydrochloride tablet

A technology of olopatadine hydrochloride and tablets, which is applied in the field of medicine and can solve the problems of limited physical and chemical properties of active ingredients, easy adsorption, and dissolution resistance

Pending Publication Date: 2020-03-17
HAINAN ZHONGJI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, direct compression is often limited by the physicochemical properties of the active ingredient
[0004] Because olopatadine hydrochloride is slightly soluble in water, and the raw material of olopatadine hydrochloride often has static electricity, it is easy to adsorb on water-insoluble excipients to hinder dissolution. Therefore, the formulation of olopatadine hydrochloride tablets for direct compression was developed , need to solve the technical problem of dissolution
In addition, olopatadine hydrochloride is prone to degradation under light and oxidation conditions, which also poses challenges to the stability of tablet formulations

Method used

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  • Formula of directly tableted olopatadine hydrochloride tablet
  • Formula of directly tableted olopatadine hydrochloride tablet
  • Formula of directly tableted olopatadine hydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: the olopatadine hydrochloride tablet formula of direct compression

[0023] In this example, olopatadine hydrochloride with an average particle size of 43 μm is used. Table 1 lists the formulation information of the tablet and the batch size of 1000 tablets.

[0024] Table 1

[0025] Element effect weight percentage (%) Batch (g) Olopatadine Hydrochloride active ingredient 3.0 5.0 microcrystalline cellulose Thinner 7.7 12.9 lactose Thinner 77.3 129.0 Low-substituted hydroxypropyl cellulose disintegrant 5.0 8.4 Sodium carboxymethyl starch disintegrant 5.0 8.4 Magnesium stearate lubricant 2.0 3.3

[0026] The active ingredient, the diluent and the disintegrating agent are mixed, the mixture is sieved, the sieved materials are mixed, a lubricant is added for total blending, and the total blended materials are pressed into tablets.

Embodiment 2

[0027] Embodiment 2: the olopatadine hydrochloride tablet formula of direct compression

[0028] In this example, olopatadine hydrochloride with an average particle size of 9 μm is used. Table 2 lists the formulation information of the tablet and the batch size of 1000 tablets.

[0029] Table 2

[0030] Element effect weight percentage (%) Batch (g) Olopatadine Hydrochloride active ingredient 4.0 5.0 microcrystalline cellulose Thinner 18.0 22.5 lactose Thinner 72.0 90.0 Croscarmellose Sodium disintegrant 5.0 6.3 Magnesium stearate lubricant 1.0 1.2

[0031] Tablets were prepared according to the method of Example 1.

Embodiment 3

[0032] Embodiment 3: the olopatadine hydrochloride tablet formula of direct compression

[0033] In this example, olopatadine hydrochloride with an average particle size of 50 μm is used. Table 3 lists the formulation information of the tablet and the batch size of 1000 tablets.

[0034] table 3

[0035] Element effect weight percentage (%) Batch (g) Olopatadine Hydrochloride active ingredient 3.5 5.0 microcrystalline cellulose Thinner 42.3 60.4 lactose Thinner 42.2 60.4 Crospovidone disintegrant 5.0 7.2 Low-substituted hydroxypropyl cellulose disintegrant 3.0 4.3 Magnesium stearate lubricant 1.0 1.4 Sodium stearyl fumarate lubricant 3.0 4.3

[0036] Tablets were prepared according to the method of Example 1.

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Abstract

The invention provides a formula of directly tableted olopatadine hydrochloride tablet which has the advantages of rapid dissolution and good stability.

Description

technical field [0001] The invention relates to a formula of olopatadine hydrochloride tablet directly compressed, and belongs to the technical field of medicine. Background technique [0002] Olopatadine hydrochloride is a histamine H 1 Receptor antagonists for histamine H 1 The receptor has selective antagonistic effect, and inhibits the generation and dissociation of chemical transmitters (leukotrienes, thromboxane, PAF, etc.), and has inhibitory effect on the dissociation of neurotransmitter tachykinin. Olopatadine Hydrochloride Tablets are clinically used for the treatment of allergic rhinitis, urticaria, itchy skin diseases (eczema, dermatitis, prurigo, pruritus, psoriasis vulgaris, erythema multiforme exudates), clinically Olopatadine tablets require rapid dissolution to ensure efficacy. [0003] Tablet preparation methods usually include wet granulation, dry granulation and direct compression. Direct compression is considered to be a relatively simple preparation ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/335A61K47/38A61K47/36A61K47/26A61K47/10A61K47/32A61K47/12A61P11/02A61P37/08A61P17/00A61P17/04A61P17/06
CPCA61K31/335A61K9/2054A61K9/2018A61K9/2013A61K9/2027A61K9/2095A61K9/2059A61P11/02A61P37/08A61P17/00A61P17/04A61P17/06
Inventor 不公告发明人
Owner HAINAN ZHONGJI MEDICAL TECH
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