Otilonium bromide capsule

A composition and drug technology, applied in the directions of capsule delivery, medical preparations of inactive ingredients, digestive system, etc., can solve the problems such as the inability to rapidly relieve symptoms, the inability to take effect quickly, and the slow onset of tablet effect, and achieve easy control. The effect of moisture, saving drying time and reducing pollution

Inactive Publication Date: 2007-10-17
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the tablet has a slow onset of action, and it usually takes 45 minutes to dissolve in vitro to reach more than 8

Method used

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  • Otilonium bromide capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Composition and preparation method of 40mg otilonium bromide capsule

[0027] Mix 40g of otilonium bromide hydrochloride, 65g of lactose, 43g of starch, and 20g of crospovidone evenly, add 10% starch slurry to make soft material, granulate with 24 mesh, and dry at 60°C until the moisture is less than 3%. Whole grains, add 2g of magnesium stearate, mix well, fill capsules, and get final product.

[0028] Inspection indicators

[0029] The results showed that using the ratio of lactose and starch and using 10% starch slurry as a binder not only made granulation difficult, but also had poor granule fluidity and low granule yield. It also showed that due to irregular granules and poor fluidity, As a result, when filling capsules, the loading capacity varies greatly. Therefore, no dissolution studies were performed for this formulation.

Embodiment 2

[0031] Composition and preparation method of 40mg otilonium bromide capsule

[0032] Mix 40g of otilonium bromide hydrochloride, 65g of microcrystalline cellulose, 43g of pregelatinized starch, and 12g of crospovidone evenly, add 2% soft material made of hydroxypropylmethylcellulose, granulate with 24 mesh, and heat at 60°C Blow drying until the water content is less than 3%, granulate into 30 meshes, add 2g of magnesium stearate, mix evenly, and fill capsules to obtain.

[0033] Inspection indicators

[0034] The results show that the ratio of microcrystalline cellulose and pregelatinized starch is adopted, and 2% hydroxypropyl methylcellulose is used as a binder, which is not only difficult to granulate, the fluidity of granules is not good, and the yield of granules is low, but also It shows that due to the irregular particles and poor fluidity, when filling the capsules, the filling volume varies greatly. Therefore, no dissolution studies were performed for this...

Embodiment 3

[0036] Composition and preparation method of 40mg otilonium bromide capsule

[0037] Mix 5g of otilonium bromide, 20g of lactose, 100g of microcrystalline cellulose, and 10g of crospovidone evenly, add an appropriate amount of 5% crospovidone ethanol solution to make a soft material, granulate with 30 mesh, and blast at 60°C Dry until the water content is less than 3%, granulate, add 2g of magnesium stearate, mix well, and fill the capsules to obtain the product.

[0038] Inspection indicators

[0039] The results show that the soft material is prepared by using the ratio of lactose and microcrystalline cellulose, and using 5% cross-linked povidone ethanol solution. Although the granulation is easy, the shape of the dry granules is irregular, and the hardness is large, the fluidity is improved, and the granules are collected. Efficiency also improves further, and loading difference is in the controllable scope, and dissolution rate reaches 84%, but not very ideal.

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Abstract

The present invention discloses a medical composition comprising effective amount of otilonium Br for treating irritable bowel syndrome or stomach convulsion. Said composition will disperse into small granules within five minutes in water and the in vitro dissolve-out will be above 90%, which will hence dispel the convulsion rapidly. The preferred composition is of capsule type.

Description

technical field [0001] The invention belongs to the field of western medicine preparations, and relates to a pharmaceutical composition containing a therapeutically effective amount of otilonium bromide for treating irritable bowel syndrome or stomach cramps. The composition can quickly disperse into fine particles within 5 minutes after being exposed to water, and its dissolution in vitro can reach more than 90% within 5 minutes, so as to rapidly exert an antispasmodic effect. Most preferably in the form of capsules. Background technique [0002] Otilonium bromide can exert a strong antispasmodic effect on the smooth muscle of the distal digestive tract, thereby reducing irritable bowel or spasmodic pain in the distal digestive tract. [0003] U.S. Patent No. 4,978,772 describes the role of otilonium bromide as an auxiliary drug in medical endoscopy. In this patent, otilonium bromide forms a dry powder mixture with oily substances and surfactants, and water is added befor...

Claims

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Application Information

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IPC IPC(8): A61K31/245A61K47/30A61K47/06A61K9/48A61P1/06
Inventor 张明
Owner BEIJING D VENTUREPHARM TECH DEV
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