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Faropenem Sodium Gastric Floating Sustained Release Preparation and Preparation Method

A technology of faropenem sodium and sustained-release preparations, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, antibacterial drugs, etc., can solve the problems of destroying normal intestinal flora, intestinal adverse reactions, etc. Part entry, weight reduction, good effect

Active Publication Date: 2017-11-24
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] 1. Provide a new dosage form of faropenem sodium preparation, i.e. balloon-type faropenem sodium gastric floating sustained-release preparation, which overcomes the existing dosage form of faropenem sodium preparation because a large amount of unabsorbed drugs enter the lower intestinal tract, causing damage to normal intestinal bacteria group, leading to the shortcomings of intestinal adverse reactions such as diarrhea, abdominal pain, and soft stools;

Method used

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  • Faropenem Sodium Gastric Floating Sustained Release Preparation and Preparation Method
  • Faropenem Sodium Gastric Floating Sustained Release Preparation and Preparation Method
  • Faropenem Sodium Gastric Floating Sustained Release Preparation and Preparation Method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Embodiment 1: the investigation of drug-containing layer composition

[0054] 1. Prescription (1000 capsules)

[0055] Waterproof air bag prescription:

[0056] Capsule No. 2

1000

Ethylcellulose N-100

3.0g

stearic acid

5.0g

95% ethanol solution

100ml

[0057] Isolation gown layer prescription:

[0058] Hypromellose E5

50g

lactose

100g

Mannitol

100g

95% ethanol solution

400ml

water

600ml

[0059] Drug-containing layer prescription:

[0060] Faropenem Sodium

123.5g*

polyethylene glycol 4000

48g

Absolute ethanol

1600ml

[0061] *: Calculated as 100g by faropenem

[0062] Second, the preparation process:

[0063] 1. Preparation of waterproof air bag: put the No. 2 capsule into the coating pan, spray the prepared waterproof coating solution (made by dispersing stearic acid and ethyl cellulose in 95% ethanol) at a tablet bed tempe...

Embodiment 2

[0071] Embodiment 2: the investigation of drug-containing layer composition

[0072] 1. Prescription (1000 capsules)

[0073] Waterproof air bag prescription: with embodiment 1

[0074] Isolation gown layer prescription: with embodiment 1

[0075] Drug-containing layer prescription:

[0076] Faropenem Sodium

123.5g

talcum powder

3g

Povidone K30

48g

Absolute ethanol

1600ml

[0077] Second, the preparation process:

[0078] 1. Preparation of waterproof airbag: same as Example 1;

[0079] 2. Prepare the isolation gown layer: the same as in Example 1;

[0080] 3. Preparation of the drug-containing layer: Dissolve the raw material drug of faropenem sodium in absolute ethanol, add povidone K30 to dissolve, add talcum powder and mix well to prepare the coating liquid of the drug-containing layer. Under the condition of avoiding light, use a conventional film Coating method The drug-containing layer is wrapped outside the waterproof a...

Embodiment 3

[0084] Embodiment 3: the investigation of drug-containing layer composition

[0085] 1. Prescription (1000 capsules)

[0086] Waterproof air bag prescription: with embodiment 1

[0087] Isolation gown layer prescription: with embodiment 1

[0088] Drug-containing layer prescription:

[0089] Faropenem Sodium

123.5g

Hypromellose-SL

48g

Absolute ethanol

1600ml

[0090] Second, the preparation process:

[0091] 1. Preparation of waterproof airbag: same as Example 1;

[0092] 2. Prepare the isolation gown layer: the same as in Example 1;

[0093] 3. Preparation of the drug-containing layer: Dissolve the raw drug of faropenem sodium in absolute ethanol, add hydroxypropyl cellulose-SL to dissolve, add talcum powder and mix to prepare the coating solution of the drug-containing layer. The film coating method wraps the drug-containing layer outside the waterproof air bag wrapped with the isolation coat layer.

[0094] Three, impurity assay m...

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Abstract

The invention provides a faropenem sodium gastric floating sustained-release preparation. The preparation has a hollow waterproof airbag, can stay in the stomach for a long time, and continuously releases drugs. The waterproof airbag of the airbag type faropenem sodium gastric floating sustained-release preparation is prepared through wrapping a common gastric-solubility hard capsule shell by a waterproof layer composed of stearic acid and ethyl cellulose, an isolation coat is composed of hydroxypropyl methylcellulose, lactose and mannitol, a drug-containing coat is composed of faropenem sodium and hydroxypropylcellulose-SL, and a sustained release coat is composed of ethyl cellulose N-100 and the hydroxypropylcellulose-SL. Compared with other excipients, the above excipient adopted in the drug-containing layer and the sustained release layer in the invention can avoid the decomposition of the faropenem sodium and guarantee the stabilities of the drugs in the preparation.

Description

technical field [0001] The invention relates to a novel gastric floating sustained-release preparation of faropenem sodium and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Faropenem sodium is a carbapenem antibiotic developed by Japan Suntory Company. It has broad-spectrum antibacterial activity and is highly stable to β-lactamase. It was first launched in Japan in 1997 under the product name Farom. The dosage forms currently listed abroad include ordinary tablets and dry suspensions for children. Domestic marketed dosage forms include ordinary tablets, granules, capsules, etc. [0003] After oral administration, the drug is mainly absorbed in the upper part of the small intestine, and the time for the drug to pass through this section is only about 2 hours, that is, the absorption time of the drug is only about 2 hours, the absorption window is narrow, and the bioavailability is low (20%). A large number of una...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/431A61K47/38A61K47/12A61P31/04
Inventor 姜庆伟刘全志杨文斌狄媛吕玉珠张强
Owner 北京天衡药物研究院有限公司
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