Acotiamide hydrochloride dispersible tablet and preparation method thereof

A technology of acotiamide hydrochloride and dispersible tablets, applied in the direction of dispersion liquid delivery, pill delivery, digestive system, etc., can solve the problems of difficult treatment for patients, influence on drug absorption, low dissolution rate, etc., and achieve good drug safety and human body Good absorption and convenient use

Inactive Publication Date: 2017-06-23
PEKING UNIV FOUNDER GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The most important problem that acotiamide hydrochloride exists is that because it itself is slightly soluble in water, the dissolution rate is very low after being made into tablets, and as a drug for the treatment of functional dyspepsia, after the patient takes it, the drug needs to be released in the body. Rapid release can meet the symptomatic requirements of clinical patients
Ordinary tablets have the disadvantage of slow disintegration speed, which affects the absorption of drugs; in addition, ordinary tablets have a large volume, or often need to use multiple tablets (grains) at a time, and need to be washed with water, which is inconvenient to take, especially for the elderly. , young and patients with swallowing dysfunction have certain difficulties in treatment

Method used

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  • Acotiamide hydrochloride dispersible tablet and preparation method thereof
  • Acotiamide hydrochloride dispersible tablet and preparation method thereof
  • Acotiamide hydrochloride dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Prescription (Specification: 100mg)

[0033]

[0034] Preparation:

[0035] (1) Treatment of raw and auxiliary materials: the Dv90 of the co-micronized active ingredient acotiamide hydrochloride and mannitol is 21.4 μm, and the rest of the auxiliary materials are sieved through an 80-mesh sieve for later use;

[0036] (2) making soft material: after taking the co-micronized product of recipe quantity, microcrystalline cellulose, 2% carboxymethyl starch sodium and mixing evenly, make soft material with water;

[0037] (3) Granulation: get above-mentioned soft material and granulate with 18 mesh screens;

[0038] (4) Drying: dry the wet granules, control the temperature of the material at 50±5°C, and make the moisture of the granules reach about 2%;

[0039] (5) Grain sizing: the dried granules are sieved with a 24-mesh sieve;

[0040] (6) Total blending: the granulated granules are added to the converted magnesium stearate and 1% sodium carboxymethyl starch and mix...

Embodiment 2

[0043] Prescription (Specification: 150mg)

[0044]

[0045] Preparation:

[0046] (1) Treatment of raw and auxiliary materials: the Dv90 of the co-micronized active ingredient acotiamide hydrochloride and mannitol is 18.6 μm, and the rest of the auxiliary materials are passed through an 80-mesh sieve for later use;

[0047] (2) making soft material: after taking the co-micronized product of recipe quantity, microcrystalline cellulose, 2% carboxymethyl starch sodium and mixing evenly, make soft material with water;

[0048] (3) Granulation: get above-mentioned soft material and granulate with 18 mesh screens;

[0049] (4) Drying: dry the wet granules, control the temperature of the material at 50±5°C, and make the moisture of the granules reach about 2%;

[0050] (5) Grain sizing: the dried granules are sieved with a 24-mesh sieve;

[0051] (6) Total blending: the granules after the granulation are added into the converted magnesium stearate and 0.67% sodium carboxymethy...

Embodiment 3

[0054] Prescription (Specification: 200mg)

[0055]

[0056]

[0057] Preparation:

[0058] (1) Treatment of raw and auxiliary materials: the Dv90 of the co-micronized active ingredient acotiamide hydrochloride and mannitol is 10.3 μm, and the rest of the auxiliary materials are passed through an 80-mesh sieve for later use;

[0059] (2) making soft material: after taking the co-micronized product of recipe quantity, microcrystalline cellulose, 2.22% carboxymethyl starch sodium and mixing evenly, make soft material with water;

[0060] (3) Granulation: get above-mentioned soft material and granulate with 18 mesh screens;

[0061](4) Drying: dry the wet granules, control the temperature of the material at 50±5°C, and make the moisture of the granules reach about 2%;

[0062] (5) Grain sizing: the dried granules are sieved with a 24-mesh sieve;

[0063] (6) Total blending: the granulated granules are added into the converted magnesium stearate and 1.11% sodium carboxyme...

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Abstract

The invention provides an acotiamide hydrochloride dispersible tablet and a preparation method of the acotiamide hydrochloride dispersible tablet. The dispersible tablet is composed of the active ingredient, namely, acotiamide hydrochloride, as well as the pharmaceutical adjuvants including a filler, a disintegrating agent and a lubricating agent. The prepared acotiamide hydrochloride dispersible tablet can completely disintegrate rapidly, so that the time for reaching the peak is shortened, the dissolution rate achieves 90% or above, the taking is convenient, the efficiency release is rapid, and the bioavailability is high; the preparation process is simple, the control is easy, the operation is convenient, and the preparation method is suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to acotiamide hydrochloride dispersible tablets and a preparation method thereof. Background technique [0002] Functional dyspepsia is one of the most common clinical diseases, and its main symptoms are epigastric discomfort, postprandial fullness, early satiety, and loss of appetite. Most patients with functional dyspepsia have gastrointestinal motility disorders, so promotility drugs are often used to improve symptoms in these patients. There are great differences in the definition of functional dyspepsia, which makes it difficult to statistically analyze the epidemiology, so there is a lack of accurate and uniform reports in China. There are reports in China: the incidence rate in the population is 20-30%, accounting for about 50% of digestive outpatient clinics; foreign reports, the incidence rate in the population is 19-78%. Everyone has had functional dyspepsia symptoms...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/426A61K47/38A61P1/14
CPCA61K9/2059A61K9/0095A61K31/426
Inventor 易崇勤王海超冀蕾
Owner PEKING UNIV FOUNDER GRP CO LTD
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