Antibiotic compositions of modified release and process of production thereof

A composition and antibiotic technology, applied in the direction of drug combination, heterocyclic compound active ingredients, medical preparations containing active ingredients, etc., can solve the problems of prolonged time and insufficient dosing intervals, etc.

Inactive Publication Date: 2009-04-15
PANACEA BIOTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The time above the MIC was found to be significantly prolonged compared to the capsule formulation, but was not sufficient for a 12-hour dosing interval

Method used

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  • Antibiotic compositions of modified release and process of production thereof
  • Antibiotic compositions of modified release and process of production thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment -1

[0098] A. Preparation of pellets

[0099] No. Component Quantity / Tablet (mg)

[0100] T-1T-2T-3T-4

[0101] 1. Amoxicillin Trihydrate * 431.25488.75718.75862.50

[0102] 2. Polyoxyethylene 25.0028.3341.6750.00

[0103] 3. Polycarbophil 10.0011.3316.6720.00

[0104] 4. Lactose 15.0017.0025.0030.00

[0105] 5. Croscarmellose sodium 12.5014.1720.8325.00

[0106] 6. Purified water ** right amount right amount right amount

[0107] process:

[0108] i) Pass Amoxicillin Trihydrate, Polyoxyethylene, Lactose, Croscarmellose Sodium and Polycarbophil through a #30 sieve and mix.

[0109] ii) Granulating the mixture of step (i) with purified water.

[0110] iii) Pass wet mass from step (ii) through #8 sieve.

[0111] iv) The granules from step (iii) were semi-dried at a temperature of 50°C and passed through a #24 sieve and the pieces held on the sieve were broken.

[0112] v) Pass the granules of step (iv) through a #80 sieve and collect further.

[0113] vi) The undersized...

Embodiment -2

[0158] A. Preparation of pellets

[0159] No. Component Quantity / Tablet (mg)

[0160] 1. Amoxicillin trihydrate (equivalent to amoxicillin 750mg) 862.5

[0161] 2. Polyoxyethylene 50.0

[0162] 3. Polycarbophil 20.0

[0163] 4. Lactose 30.0

[0164] 5. Croscarmellose Sodium 25.0

[0165] 6. Purified water disappears during processing

[0166] process:

[0167] i) Pass Amoxicillin Trihydrate, Polyoxyethylene, Lactose, Croscarmellose Sodium and Polycarbophil through #30 sieve and mix.

[0168] ii) Granulating the mixture of step (i) with purified water.

[0169] iii) Pass wet mass from step (ii) through #8 sieve.

[0170] iv) The granules from step (iii) were semi-dried at a temperature of 50°C and passed through a #24 sieve and the pieces held on the sieve were broken.

[0171] v) Pass the granules of step (iv) through a #80 sieve and collect further.

[0172] vi) The undersized granules obtained in step (v) are ground and regranulated using purified water. Repeat th...

Embodiment -3

[0209] A. Preparation of pellets

[0210] No. Component Quantity / Tablet (mg)

[0211] 1. Amoxicillin trihydrate (equivalent to amoxicillin 750mg) 862.5

[0212] 2. Polycarbophil ( AA1) 20.0

[0213] 3. Mannitol 30.0

[0214] 4. Crospovidone 25.0

[0215] 5. Purified water disappears during processing

[0216] process:

[0217] i) Pass Amoxicillin Trihydrate, Mannitol, Crospovidone and Polycarbophil through #30 sieve and mix all these ingredients.

[0218] ii) Granulating the mixture of step (i) with purified water.

[0219] iii) Pass wet mass from step (ii) through #8 sieve.

[0220] iv) The granules from step (iii) were semi-dried at a temperature of 50°C and passed through a #24 sieve and the pieces held on the sieve were broken.

[0221] v) Pass the granules of step (iv) through a #80 sieve and collect further.

[0222] vi) Grind the granules obtained in step (v) and pass through #24 sieve.

[0223] B. Coating of granules

[0224] No. Ingredient Percentage (%)w / w...

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Abstract

Novel modified release pharmaceutical compositions wherein the composition comprises at least one antibiotic(s) preferably amoxicillin or its pharmaceutically acceptable salts, esters, polymorphs, isomers, prodrugs, solvates, hydrates, or derivatives thereof either alone or in combination with other antibiotic(s) as active ingredient, with at least one release modifying agent(s) for controlling the release of the beta lactam antibiotic optionally with one or more other pharmaceutically acceptable excipient(s) is provided, wherein the dosage form provides a release of not more than about 60 % of the antibiotic in about 30 minutes and not less than about 70 % of the antibiotic after 8 hours when subjected to in vitro dissolution study or when tested in vivo. Further, the compositions of the present invention which when tested in a group of healthy humans provide a mean peak plasma concentration (Cmax) after at least about 0.5 hour of administration of the dosage form. The present invention also provides process of preparing such dosage form and methods of using such dosage form.

Description

technical field [0001] The present invention relates to novel modified release pharmaceutical compositions, wherein the composition comprises at least one antibiotic, preferably amoxicillin, or pharmaceutically acceptable salts, esters, polymorphs, isomers, prodrugs, solvates thereof , hydrates or derivatives thereof, alone or in combination with other antibiotics as active ingredients, and at least one release regulator for controlling the release of β-lactam antibiotics, and optionally one or more other pharmaceutically acceptable excipient. wherein the dosage form provides a release of up to about 60% of the antibiotic within about 30 minutes and at least about 70% of the antibiotic after 8 hours when subjected to an in vitro dissolution study or when subjected to an in vivo test. Additionally, the compositions of the present invention provide mean peak plasma concentrations (C max ). The invention also provides methods of making such dosage forms and methods of using su...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K9/52A61K31/424A61P31/00A61K9/22
CPCA61K9/4891A61K9/2866A61K9/4866A61K9/5047A61K9/284A61K31/424A61K9/5026A61K31/43A61K9/286A61P11/00A61P31/00A61P31/04A61K9/20
Inventor 拉杰什·贾殷库尔·昌德·吉恩达尔穆尼什·塔瓦尔
Owner PANACEA BIOTEC
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