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A pharmaceutical delivery system for deliverying active component dispersed in dispersion medium

A technology of active substance and dispersion medium, applied in the field of oral drug delivery system, which can solve the problem of narrow absorption window of active substance

Inactive Publication Date: 2008-05-28
EGALET LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Many active substances have a narrow absorption window in the gastrointestinal tract

Method used

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  • A pharmaceutical delivery system for deliverying active component dispersed in dispersion medium
  • A pharmaceutical delivery system for deliverying active component dispersed in dispersion medium
  • A pharmaceutical delivery system for deliverying active component dispersed in dispersion medium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0133] Composition according to the invention containing 50000 units of calcitonin oil dosage units

[0134] A three-layer coating composition having the shape shown in Figure 1 and containing calcitonin as active substance was prepared as follows:

[0135]

[0136] The outer plug was prepared as described in EP 0493 513 B1 with the following components:

[0137] %(w / w)

[0138] PEO 200000 60

[0139] Citric acid 5

[0140] PEG 2000ms 5

[0141] cornstarch 30

[0142] The inner plug containing calcitonin has the following composition:

[0143] %(w / w)mg

[0144] Mixed fatty acid glycerides 63 630

[0145] Corn oil 27 270

[0146] Calcitonin 10 100

[0147] While keeping the temperature below 40°C, heat the oily ingredients in a water bath until melted, then pour the melt into a mortar and cool to about 27°C with constant stirring. Add calcitonin to the melt and stir until homogeneous to obtain the inner matrix composition.

[0148] F...

Embodiment 2

[0166] Composition according to the invention containing 15,000 units of calcitonin

[0167] This composition was prepared as described above in Example 1, but with a different composition for the inner plug:

[0168] Material % (w / w) mg

[0169] Mixed fatty acid glycerides 66.8 2004

[0170] Coconut oil 28.8 864

[0171] Calcitonin 4.4 132

[0172] The composition was subjected to a dissolution test using a dissolution apparatus 2.

[0173] After about 5 hours in the artificial intestinal fluid, calcitonin began to be released (at the end of the release, the solution changed from a clear colorless solution to a cloudy solution) and ended within 1 / 2 hour.

[0174] The dosage unit has a burst release.

[0175] The composition is also tested by DSC under the following conditions:

[0176] 1) Keep at 10.00°C for 2.0min

[0177] Data Points: 120

[0178] 2) Heating from 10.00°C to 50.00°C at a rate of 15.00°C / min

[0179] Data Points: 266

[0180] Figure 7 shows the DSC ...

Embodiment 3

[0182] Composition according to the invention containing 20 mg hydrocortisone as active substance

[0183] This composition was prepared as described above in Example 1, but with a different composition for the inner plug:

[0184] Material % (w / w) mg

[0185] Mixed fatty acid glycerides 44.8 672

[0186] Corn oil 19.2 288

[0187] Hydrocortisone succinate 36 540

[0188] While keeping the temperature below 40°C, heat the oily ingredients in a water bath until melted, then pour the melt into a mortar and cool to about 27°C with constant stirring. Add hydrocortisone succinate to the melt and stir until homogeneous.

[0189] The composition was subjected to a dissolution test for 15 hours using a dissolution apparatus 1, and a dissolution curve was obtained at 273 nm with a UV detector under the conditions of 37° C. and 50 rpm.

[0190] The results are shown in Figure 8. Release of hydrocortisone succinate started after 5.5 h and ended after 1 / 2 h. The dosage unit has a b...

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Abstract

A solid pharmaceutical composition in the form of a single dosage unit for oral use, the composition comprising a first and a second fraction, the first fraction comprises a therapeutically and / or prophylactically active substance dispersed in a dispersion medium that is sufficiently fluid at body temperature and the second fraction comprises a matrix comprising a substantially water soluble and / or crystalline polymer or a mixture of substantially water soluble and / or crystalline polymers, the first fraction being included in the composition in such a manner that at least a part of the second fraction is firstly exposed to the gastrointestinal fluids upon administration before the first fraction becomes exposed. The system is designed to release the active substance after a predetermined period of time after administration, and the release of the active substance at that point in time is relatively fast.

Description

[0001] preface [0002] The present invention relates to orally administered drug delivery systems comprising diagnostic, therapeutic and / or prophylactic active substances. The system is designed to release the active substance after a predetermined period of time following administration, the release of the active substance being relatively rapid at this point in time. Background of the invention [0003] Many active substances have a narrow absorption window in the gastrointestinal tract. Also, for example, in the case of certain conditions or diseases such as arthrosclerosis, many patients suffer from morning stiffness and thus require appropriate drug treatment at that time. In this case it would be advantageous to administer a pharmaceutical composition which releases the active substance in the morning, but already before going to bed. [0004] Therefore, there is a need to develop a pharmaceutical composition designed to release the active substance after a certain la...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K38/23A61K31/57
CPCA61K38/23A61K9/2086A61K31/57
Inventor 丹尼尔·巴沙洛姆莉莲·斯洛特
Owner EGALET LTD