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A dosage form containing two or more active pharmaceutical ingredients in different physical forms

A technology of active pharmaceutical ingredients and physical forms, applied in the direction of organic active ingredients, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as interference testing

Inactive Publication Date: 2010-03-17
ALPHAPHARM PTY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In addition to interactions between ingredients, it has also been observed that one API or one or more excipients used may interfere with the testing of one or both APIs in the analytical test method
An example of this has been observed in high performance liquid chromatography (HPLC) analysis, where more than one API, API and excipients, or API elutes simultaneously with related substances from another API, thus making it impossible to perform each Accurate quantitative determination of separated substances

Method used

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  • A dosage form containing two or more active pharmaceutical ingredients in different physical forms
  • A dosage form containing two or more active pharmaceutical ingredients in different physical forms
  • A dosage form containing two or more active pharmaceutical ingredients in different physical forms

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Composition Weight / unit (mg)

[0084] Part A (powder)

[0085] Fluoxetine hydrochloride 27.95

[0086] Cornstarch 10.00

[0087] Pregelatinized corn starch 85.725

[0088] Magnesium stearate 1.325

[0089] Part B (small piece)

[0090] Olanzapine 6.00

[0091] Anhydrous lactose 47.15

[0092] Cornstarch 5.00

[0093] Pregelatinized Corn Starch 1.25

[0094] Crospovidone 2.00

[0095] Magnesium stearate 0.60

[0096] Total 187.00

[0097] The ingredients of Part A are suitably granulated and mixed as is known in the pharmaceutical formulation industry.

[0098] The ingredients of Part B are suitably granulated and mixed as is known in the pharmaceutical formulation industry. The resulting granules are compressed into tablets.

[0099] An appropriate amount of granules providing a sufficient amount of fluoxetine hydrochloride is filled into an appropriate size capsule and added to the olanzapine tablet.

[0100] There was no significant increase in known ...

Embodiment 2

[0102] Composition Weight / unit (mg)

[0103] Part A (Granules)

[0104] Metformin hydrochloride 502.51

[0105] RL / RS 50.00

[0106] Talc powder 11.89

[0107] water QS

[0108] Magnesium stearate 5.60

[0109] Part B (small piece)

[0110] Pioglitazone hydrochloride 15.00

[0111] Lactose 22.125

[0112] MCC 7.375

[0113] Crospovidone 9.00

[0114] Magnesium stearate 0.50

[0115] Total 620.00

[0116] The ingredients of Part A are suitably wet-granulated, dried, comminuted and blended as is known in the pharmaceutical formulation industry.

[0117] The ingredients of Part B are suitably mixed as is known in the pharmaceutical formulation industry. The resulting granules are compressed into tablets.

[0118] A suitable amount of granules providing a sufficient amount of Part A is filled into a suitable sized capsule, and an appropriate number of Part B tabletlets is added.

Embodiment 3

[0120] Composition Weight / unit (mg)

[0121] Part A (Granules)

[0122] Metformin hydrochloride 502.51

[0123] Povidone K30 20.00

[0124] Microcrystalline cellulose 105.00

[0125] water QS

[0126] Magnesium stearate 2.49

[0127] Part B (small piece)

[0128] Rosiglitazone maleate 5.30

[0129] Lactose 110.20

[0130] Hypromellose E3 4.50

[0131] MCC 16.50

[0132] Sodium starch glycolate 12.00

[0133] water QS

[0134] Magnesium stearate 1.50

[0135] Total 780.00

[0136] The ingredients of Part A are suitably wet-granulated, dried, comminuted and blended as is known in the pharmaceutical formulation industry.

[0137] The ingredients of Part B are suitably wet granulated, dried, comminuted and blended as is well known in the pharmaceutical formulation industry. The resulting granules are compressed into tablets.

[0138] A suitable amount of granules providing a sufficient amount of Part A is filled into a suitable sized capsule, and an appropriate ...

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PUM

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Abstract

A dosage form for administration of two or more active pharmaceutical ingredients to a subject, comprising a first pharmaceutical composition comprising a first active pharmaceutical ingredient and optionally one or more pharmaceutically acceptable excipients in a first physical form selected from the group consisting of powder, granule, pellet, bead or mini-tablet form, and at least a second pharmaceutical composition comprising a second active pharmaceutical ingredient and optionally one or more pharmaceutically acceptable excipients in a second physical form selected from the group consisting of granule, pellet, bead, mini-tablet or tablet form, wherein the composition is characterised in that said first and second physical forms are selected to be different to minimise interactions between said first and second pharmaceutical compositions and to allow separation of said first and second pharmaceutical compositions for analysis on the basis of size difference.

Description

technical field [0001] The present invention involves the formulation of two or more pharmaceutical compositions into a dosage form. Background technique [0002] Pharmaceutical formulations based on the simultaneous administration of two or more active pharmaceutical ingredients (APIs) are available. Various means have been used to achieve such multiple API administration, including separate dosage forms containing each API in a single package, multiple APIs in one dosage form, multiple layers of different APIs in a compressed tablet. [0003] The provision of packages such as blister tablets containing separate dosage forms of each API is not preferred because those administering the API, including the patient himself, may mix up the different drugs, resulting in an overdose of one API and the second API not taken at all . EP 1003503 discloses pharmaceutical compositions containing amlodipine and atorvastatin which can be formulated in a single conventional dosage form o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/16A61K9/52
CPCA61K9/4866A61K31/551A61K9/2072A61K31/135A61K9/2018A61K9/5084A61P25/18A61P25/24A61P43/00
Inventor 桑德拉·布兰德尔巴纳吉欧蒂斯·克拉米达斯布雷特·安东尼·穆尼托德·詹姆士·卢瑟福
Owner ALPHAPHARM PTY LTD
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