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Enteric solid oral dosage form of bisphosphonate containing a chelating agent

A bisphosphonate and oral preparation technology, applied in the field of oral dosage forms, can solve the problems of abnormal deposition of calcium and phosphate, poor patient compliance, complicated patients, etc., to reduce upper gastrointestinal irritation, increase compliance, EFFECTS OF SIMPLIFIED TREATMENT APPROACHES

Active Publication Date: 2011-10-26
APTALIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 2. Conditions that cause or lead to abnormal deposition of calcium and phosphate in the body
These dosing instructions can be complicated and inconvenient for the patient, which can lead to poor patient compliance

Method used

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  • Enteric solid oral dosage form of bisphosphonate containing a chelating agent
  • Enteric solid oral dosage form of bisphosphonate containing a chelating agent
  • Enteric solid oral dosage form of bisphosphonate containing a chelating agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I

[0132] Enteric-coated tablets containing risedronate and EDTA

[0133] Preparation of tablets comprising risedronate and ethylenediamine by preparing a coating composition together with compressed tablets comprising risedronate and ethylenediaminetetraacetic acid and then applying the coating composition to the tablets Enteric-coated tablets of tetraacetic acid.

[0134] An enteric coating composition in the form of a coating is prepared, each tablet comprising the following excipients:

[0135] A. Enteric coating suspension

[0136]

[0137] Enteric coatings were prepared as follows:

[0138] Pigment suspensions were prepared by adding polysorbate 80, ground iron oxide and talc to about two-thirds of purified water while stirring. The suspension was stirred for at least two hours. Add the 30% simethicone emulsion and the remaining water to the pigment suspension and stir for at least 45 minutes. Combine Eudragit L 30D-55 solution and triethyl citrate and stir for at l...

Embodiment II

[0147] Enteric-coated tablet containing risedronate and EDTA

[0148] Enteric-coated tablets containing risedronate sodium were prepared using a method similar to that described in Example I as follows.

[0149] A coating composition in the form of a coating is prepared, each tablet comprising the following excipients:

[0150] Element:

[0151] Acryl-EZE (manufactured by Colorcon, Inc., West Point, Pa.) dry solid 200mg

[0152] Purified water 950mg

[0153] A coating weight of 40% weight gain was obtained for the tablets by conventional pan coating methods, the tablets contained 150 mg risedronate and 75 mg EDTA, resulting in a final oval tablet weight of 500 mg. The composition of each tablet is as follows:

[0154]

[0155] *This amount is calculated based on anhydrous risedronic acid monosodium salt.

Embodiment III

[0157] Enteric-coated tablet containing risedronate and EDTA

[0158] Preparation of tablets comprising risedronate and ethylenediamine by preparing a coating composition together with compressed tablets comprising risedronate and edetate and then applying said coating composition to said tablets Enteric-coated tablets of tetraacetic acid.

[0159] An enteric coating composition in the form of a coating is prepared, each tablet comprising the following excipients:

[0160] A. Enteric coating suspension

[0161]

[0162]

[0163] Enteric coatings were prepared as follows:

[0164] Pigment suspensions were prepared by adding polysorbate 80, ground iron oxide and talc to about two-thirds of purified water while stirring. The suspension was stirred for at least two hours. Add the 30% simethicone emulsion and the remaining water to the pigment suspension and stir for at least 45 minutes. Combine Eudragit L 30D-55 solution and triethyl citrate and stir for at least 45 min...

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Abstract

Oral dosage forms of a bisphosphonate comprised of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent, and, means for effecting delayed release of the bisphosphonate and the chelating agent in the lower gastrointestinal tract provide delivery of the pharmaceutical composition to the lower gastrointestinal tract of the mammal subject and pharmaceutically effective absorption of the bisphosphonate with or without food or beverages. The present invention substantially alleviates the interaction between bisphosphonates and food or beverages,which interaction results in the bisphosphonate active ingredient not being available for absorption. The resulting oral dosage form may thus be taken with or without food. Further, the present invention effects delivery of the bisphosphonate and the chelating agent to the lower GI tract, substantially alleviating the upper GI irritation associated with bisphosphonate therapies. These benefits simplify previously complex treatment regimens and can lead to increased patient compliance with bisphosphonate therapies.

Description

[0001] The patent application for this invention is a divisional application of the patent application for invention with the international application number PCT / US 2005 / 012537, the international application date being April 14, 2005, and the application number 200580016087.0 entering the Chinese national phase. field of invention [0002] The present invention relates to an oral dosage form of a bisphosphonate consisting of a safe and effective amount of a pharmaceutical composition comprising a bisphosphonate, a chelating agent for administering the bisphosphonate active ingredient with food or drink, a A method for affecting the delayed release of bisphosphonates and chelating agents in the lower gastrointestinal tract, and one or more pharmaceutically acceptable excipients. The oral dosage forms of the present invention provide delivery of the pharmaceutical composition into the lower gastrointestinal tract of a mammalian subject and provide drug-effective absorption of th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/675A61K47/16A61P3/14A61P5/20A61P19/08A61P19/10A61K9/20A61K9/28
CPCA61K9/2009A61K9/2013A61K9/2086A61K9/2846A61P19/00A61P19/02A61P19/08A61P19/10A61P3/14A61P35/00A61P35/04A61P5/18A61P5/20A61P5/22A61K9/20
Inventor R·J·当塞罗D·E·小布吉奥
Owner APTALIS PHARMA
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