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Sachet formulation for amine polymers

A preparation and powder technology, applied in the field of amine polymer sachet preparation

Active Publication Date: 2013-02-06
GENZYME CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] However, the above product is currently only available in tablet form and certain patients may be better suited for treatment with other dosage forms of this product

Method used

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  • Sachet formulation for amine polymers
  • Sachet formulation for amine polymers
  • Sachet formulation for amine polymers

Examples

Experimental program
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Embodiment 1

[0081] Example 1. Composition of the inventive powder formulation

[0082] Powder formulations were produced by standard pharmaceutical preparation techniques, as described in Remington's Pharmaceutical Sciences, 18th ed (1990), Mack Publishing Company, Easton, PA. The specific ingredients of the two exemplary powder formulations (Formulations A and B) invented are listed below in Table 1 displayed in .

[0083] Element Formulation A (wt%) Formulation B (wt%) Anhydrous sevelemer HCl 92.90 Anhydrous sevelemer carbonate 94.97 PGA 1.00 3.00 Orange Vanilla PR90 2.00 2.00 WG55 vanilla 0.50 0.50 lemon lime 0.11 0.12 NaCl 1.00 1.00 Sucralose 0.40 0.45 Iron oxide yellow 0.016 0.016

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Abstract

A powder formulation comprising a pharmaceutically acceptable anionic stabilizer and an aliphatic amine polymer or a pharmaceutically acceptable salt thereof mixed with the anionic stabilizer. The powder formulation is conveniently packaged in a container, such as a sachet. Also described are methods of treating a subject with hyperphosphatemia using the powder formulation.

Description

Background technique [0001] Aliphatic amine polymers are effective as phosphate binders and have been described in a number of cases (see US Pat. Nos. 5,496,545 and 5,667,775). For example, sevelamer hydrochloride, a cross-linked poly(allylamine) polymer, currently sold under the trademark RENAGEL Sold to remove phosphate from sick people. Aliphatic amine polymers have been described in the treatment of hypercholesterolemia (see US Patent Nos. 5624963 and 5679717 and PCT Publication Nos. WO98 / 29107 and WO99 / 22721). For example, colesevelam, an alkylated, cross-linked polymer (allylamine), currently traded under the trademark WELCHOL Sold to reduce serum cholesterol. [0002] However, the above product is currently only available in tablet form, and certain patients may be more suitable for treatment with other dosage forms of this product. Contents of the invention [0003] The present invention generally provides novel compositions and formulations of aliphatic amine...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/14A61K9/28A61K9/48A61K31/00A61K31/74A61K31/785
CPCA61K47/36A61K31/785A61K31/00A61K47/34A61K9/0056A61K9/0095A61K31/787A61P13/12A61P19/06A61P3/00A61P3/12A61P3/14A61P3/06A61P7/00A61K31/74A61K9/48A61K8/817A61K8/898A61K8/8105A61K9/0053A61K9/1652
Inventor H·R·布哈盖特J·M·戈德伯格
Owner GENZYME CORP