Hydrodynamically balancing oral drug delivery system

A drug and pharmaceutical technology, applied in the field of oral drug delivery system, can solve the problems of difficult drug release rate, unfavorable users, unsatisfactory oral controlled release drug delivery system, etc.

Inactive Publication Date: 2002-10-23
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is known to be difficult to use such systems where the desired release rate is tuned by etching the polymer
[0012] These oral controlled release drug delivery systems are not entirely satisfactory for the above reasons, and the complex devices and systems disclosed in the prior art which are difficult to manufacture on an industrial scale, or the components used therein are unfavorable to the user

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] This example illustrates the invention in the form of pellets in which Eudragit NE 30D with hydrogenated vegetable oil is used as the delayed release polymer in the matrix. The active ingredient is diltiazem hydrochloride. The pharmaceutical composition is shown in Table 1.

[0068] components

w / w%

diltiazem hydrochloride

20.40

Hydrogenated Cottonseed Oil (Lubritab)

16.48

Starch (Maize)

22.09

Dried glucose syrup (Glucidex 40 * )

16.48

Pregelatinized Starch (Starch 1500)

1.32

Microcrystalline Cellulose (Avicel PH 101)

9.88

ammonium bicarbonate

2.75

calcium carbonate

4.95

Eudragit NE 30D

5.65 (solid)

[0069] *Dextrose equivalent - 40%

[0070] Diltiazem hydrochloride, hydrogenated cottonseed oil, starch, dry dextrose syrup, pregelatinized starch, microcrystalline cellulose, ammonium bicarbonate and calcium carbonate wer...

Embodiment 2

[0075] This example shows the invention in matrix capsule form with propranolol hydrochloride as active agent. Table 3 gives the pharmaceutical compositions.

[0076] components

%weight

propranolol hydrochloride

20.00

Hydrogenated Cottonseed Oil (Lubritab)

22.86

Starch (Maize)

14.28

Dried glucose syrup (Glucidex 40 * )

28.58

ammonium bicarbonate

7.14

calcium carbonate

7.14

[0077] *Dextrose equivalent - 40%

[0078] Propranolol hydrochloride, starch, hydrogenated vegetable oil, dextrose dry syrup, ammonium bicarbonate and calcium carbonate were sieved together (British Standard Sieve (BSS) No. 44; 355 μm) and mixed. The mixture was manually filled into size 2 gelatin capsules. The average capsule fill weight of the composition was 320 mg. The filled capsules were kept in an oven at 110°C for 2.5 minutes. Then cool to room temperature.

[0079] The buoyancy pro...

Embodiment 3

[0082] This example shows a single unit pellet (6-8 mm in diameter) which can be used as a single unit dosage form, the active ingredient being diltiazem hydrochloride. The pharmaceutical composition is shown in Table 5.

[0083] components

w / w%

diltiazem hydrochloride

22.37

Hydrogenated Cottonseed Oil (Lubritab)

10.28

Starch (Maize)

30.30

Dried glucose syrup (Glucidex 40 * )

12.12

Pregelatinized Starch (Starch 1500)

6.04

Microcrystalline Cellulose (EMCOCEL 50M)

9.62

ammonium bicarbonate

3.87

calcium carbonate

5.40

[0084] *Dextrose equivalent - 40%

[0085] Diltiazem hydrochloride, hydrogenated cottonseed oil, starch, dextrose dry syrup, pregelatinized starch, microcrystalline cellulose, ammonium bicarbonate and calcium carbonate were passed through a 355 micron sieve (British Standard Sieve (BSS) No. 44) and mix. The mixture was gra...

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Abstract

The present invention relates to an oral gastric retention drug delivery system comprising a highly porous matrix comprising at least one drug, a sugar, a gas generating component and optionally pharmaceutically acceptable adjuvant components. The pharmaceutical composition is either in the form of pills (multiparticulate or single unit dosage form), beads, granules or capsules, which are retained in the stomach and selectively released in the stomach and upper small intestine over a prolonged period of time.

Description

field of invention [0001] The present invention relates to an oral gastric retention drug delivery system comprising a highly porous matrix comprising at least one drug, a sugar, a gas generating component and optionally pharmaceutically acceptable auxiliary components. Pharmaceutical compositions in the form of pills (multiparticulate or single unit dosage forms), beads, granules or capsules are held in the stomach while selectively releasing drug in the stomach and upper small intestine over a prolonged period of time. Background of the invention [0002] An oral drug delivery system encounters a wide range of variable conditions such as pH, agitation intensity, and composition of GI fluids as it passes through the GI tract. Additionally, the presence of food in the digestive tract can affect dosage form performance. Therefore, in order to optimize an oral controlled-release system, the physicochemical and physiological environment of the gastrointestinal tract needs to b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/16A61K9/20A61K9/30A61K9/46A61K9/48A61K47/02A61K47/04A61K47/12A61K47/18A61K47/20A61K47/26A61K47/30A61K47/32A61K47/36A61K47/38A61K47/42A61K47/44A61K47/46
CPCA61K9/0007A61K9/0065
Inventor N·塔尔瓦尔J·N·斯塔尼福思M·J·托比恩
Owner RANBAXY LAB LTD
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