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Modified release pharmaceutical composition and a process of making the same

A composition and drug technology, applied in the field of description, can solve problems such as poor solubility, and achieve the effect of prolonging the preventive concentration or the therapeutic concentration

Inactive Publication Date: 2009-11-25
PANACEA BIOTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, formulating drugs with pH-dependent solubility such as weakly basic drugs into modified release dosage forms poses many problems
Although these drugs have relatively good solubility at gastric pH, they have relatively poor solubility at intestinal pH

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment -1

[0058] No. Ingredient mg / tablet

[0059] 1. Mycophenolate Mofetil 1011.28

[0060] 2. Lactose anhydrous 74.25

[0061] 3. Polyethyl acrylate ( L30D55) 67.50

[0062] 4. Copovidone 04.59

[0063] 5. Pectin 60.75

[0064] 6. Hydroxypropyl methylcellulose ( K100M CR) 87.75

[0065] 7. Calcium sulfate 30.38

[0066] 8. Magnesium Stearate 13.50

[0067] coating composition

[0068] 9. White dispersion (in water) appropriate amount

[0069] process:

[0070] i) Mycophenolate mofetil and lactose anhydrous were sieved through a #40 sieve and granulated with an aqueous polyethyl acrylate dispersion containing copovidone and dried.

[0071] ii) Mix together pectin and calcium sulfate, then add hydroxypropyl methylcellulose and mix well.

[0072] iii) Mixing the granules from step (i) above with the blend from step (ii).

[0073] iv) The blend of step (iii) above was lubricated with magnesium stearate and compressed into tablets.

[0074...

Embodiment -2

[0076] No. Ingredient mg / tablet

[0077] 1. Quetiapine (as quetiapine fumarate) 400.00

[0078] 2. Hydroxyethyl cellulose phthalate 75.00

[0079] 3. Calcium hydrogen phosphate 49.05

[0080] 4. Microcrystalline cellulose 37.50

[0081] 5. Xanthan Gum 37.50

[0082] 6. Sodium alginate 60.00

[0083] 7. Calcium chloride 18.75

[0084] 8. Magnesium Stearate 7.50

[0085] process:

[0086] i) Mix together quetiapine (as fumarate), microcrystalline cellulose and dibasic calcium phosphate.

[0087] ii) Pass the blend of step (i) through a #40 sieve.

[0088] iii) The blend of step (ii) is granulated by using a solution of hydroxyethyl cellulose phthalate in acetone:ethanol (1:1).

[0089] iv) Sieve the granules of step (iii) through a sieve.

[0090] v) Sieve xanthan gum and calcium chloride separately through a #40 sieve, and then mix thoroughly with the granules of step (iv).

[0091] vi) Sieve the sodium alginate through a #40 sieve and mix well with the blend of step...

Embodiment -3

[0094] No. Ingredient mg / tablet

[0095] 1. Mycophenolate mofetil (mycophenolate mofetil) 750.00

[0096] 2. Polyethyl acrylate 120.00

[0097] 3. Lactose anhydrous 144.00

[0098] 4. Pectin 60.00

[0099] 5. Hydroxypropyl methylcellulose 84.00

[0100] 6. Calcium sulfate dihydrate 30.00

[0101] 7. Magnesium Stearate 12.00

[0102] coating composition

[0103] 8. Yellow dispersion (in water) appropriate amount

[0104] process:

[0105] i) Mix together mycophenolate mofetil and lactose.

[0106] ii) Pass the blend of step (i) through a #40 sieve.

[0107] iii) Granulate the blend of step (ii) with polyethyl acrylate.

[0108] iv) The granules of step (iii) are dried and sieved.

[0109] v) Separately sieve the pectin and calcium sulfate dihydrate through a #40 sieve, then mix well, then mix the blend with the granules of step (iv).

[0110] vi) Sieve the hydroxypropyl methylcellulose through a #40 sieve and mix with the blend of step (v).

[0111] vii) Th...

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PUM

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Abstract

The present invention refers to a modified release pharmaceutical composition comprising an in-situ gelling agent (=0,5 % w / w) and a gellation facilitating agent (e.g. calcium sulfate) in an amount of 2-17,5 % w / w. Additionally, the composition contains a release rate controlling polymer such as an acrylate and optionally a pH independent rate controlling polymer such as HPMC. A preferred active agent is mycophenolate mofetil. A process of making the above described composition is also disclosed.

Description

technical field [0001] The present invention relates to a novel modified release pharmaceutical composition comprising at least one pharmaceutically active agent with pH-dependent solubility, at least one release rate controlling polymer mainly controlling the release of the active agent in an acidic environment, and controlling the active agent in acidic and Both the release rate modulating system for release in an alkaline environment, and optionally one or more other pharmaceutically acceptable excipients. The present invention also describes methods of making such compositions and methods of using such compositions. The modified release compositions of the present invention can be used to provide prophylactically or therapeutically effective levels of an active agent over an extended period of time. Background technique [0002] Many medical conditions are best treated by administering a drug that modulates its mode of action over an extended period of time. Modified r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/32A61K47/36A61K47/42
CPCA61K9/2077A61P25/18A61P37/06A61K9/20A61K47/42A61K47/32A61K47/36
Inventor 拉杰什·贾殷库尔·昌德·吉恩达尔桑贾伊·博尔德哈内
Owner PANACEA BIOTEC
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