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Pharmaceutical polymer composition for oral controlled-release delivery of terbutaline sulfate

A technology of terbutaline sulfate and controlled-release drugs, which is applied in the field of sodium bicarbonate, and can solve problems such as slowing down of outflow and delayed release

Inactive Publication Date: 2008-01-09
约旦制药公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The hydrogel barrier slows the efflux of the drug from the tablet, resulting in a delayed release

Method used

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  • Pharmaceutical polymer composition for oral controlled-release delivery of terbutaline sulfate
  • Pharmaceutical polymer composition for oral controlled-release delivery of terbutaline sulfate
  • Pharmaceutical polymer composition for oral controlled-release delivery of terbutaline sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Example 1: Study on Controlled Release Performance of Polymer Combination

[0088] Preparation of controlled-release tablets

[0089] The system contained 5 mg terbutaline sulfate and 15 mg release modifying excipient (acidic: tartaric acid, or basic: sodium bicarbonate, or neutral: Avicel PH101 ) and 60 mg release delaying polymer in each single matrix. The polymer mixture was CH:XG 1:1 (w / w). The ratio of drug / excipient to polymer mixture was 1:3 (see Table 1). Tablets of 7 mm diameter were prepared by direct compression. The ingredients for each tablet were geometrically mixed using a porcelain mortar and pestle for about 10 minutes prior to pressing. Biplanar tablets were prepared by compressing the powder mixture with a hydraulic press applying a pressure of about 443 MPa for 15 seconds.

[0090] In Vitro Dissolution Test

[0091] USP Apparatus 1 (basket) was used. During the test the containers were placed in a water bath adjusted to maintain a temperat...

Embodiment 2

[0104] Example 2: Sieve out polymer mixture (P) (chitosan / xanthan gum 1:1) and carbon Suitable D / E:P ratio of sodium bicarbonate excipient (E)

[0105] The system contained 5 mg terbutaline sulphate and 15 mg release modifying excipient (sodium bicarbonate) and release delaying polymer mixture. The polymer mixture is CH:XG in a 1:1 ratio. The drug / excipient to polymer mixture (D / E:P) ratios were 1:5, 1:6 and 1:8, as shown in Table 4. Tablets of 7 mm diameter were prepared by direct compression. The ingredients for each tablet were geometrically mixed using a porcelain mortar and pestle for about 10 minutes prior to pressing. Biplanar tablets were prepared by compressing the powder mixture with a hydraulic press applying a pressure of about 443 MPa for 15 seconds. The in vitro dissolution conditions and analysis methods are similar to those mentioned in Example 1.

[0106] Table 4 : Overview of the formulation used in the development of a controlled-release product of...

Embodiment 3

[0114] Example 3: Powders with a D / E:P ratio of 1:5 were directly compressed by using a single-punch tablet press small-scale experiment

[0115] The system contains 5 mg Terbutaline Sulfate and 15 mg release modifying excipient (sodium bicarbonate) and release delaying polymer blend in each tablet. The polymer mixture was CH:XG in a 1:1 ratio. The drug / excipient to polymer mixture (D / E:P) ratio was 1:5 (see Table 6). The ingredients for each tablet were geometrically mixed for about 10 minutes prior to compression. Biplanar tablets of 7 mm diameter were prepared by direct compression method using a single-punch tablet press. The batch size was 500 g and the batch number was called S1. The proposed generic designations for Lot S1 tablets are "Talin" and "Talin Extended Release Tablets" and "Talin XR". Five tablets were randomly selected from Bricanyl Durules and Talin XR for physical characterization (see Tables 7 and 8, respectively). The in vitro dissolution conditi...

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PUM

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Abstract

The present invention is directed to a controlled-release pharmaceutical composition providing a sustained delivery of the basic drug Terbutaline sulfate, said composition comprising at least Terbutaline sulfate or a derivative thereof as an active agent, and further comprising an inactive matrix, said matrix comprising a hydrophilic polysaccharide polymer mixture, said mixture comprising chitosan or a derivative thereof, and further comprising xanthan gum or a derivative thereof, wherein the ratio of xanthan gum and chitosan within said mixture is in the range from about 1:10 to about 10:1, and said composition optionally comprising sodium bicarbonate.

Description

[0001] The present invention relates to a controlled release pharmaceutical composition providing sustained delivery of the basic drug terbutaline sulfate, the composition comprising a hydrophilic polysaccharide polymer mixture of chitosan and xanthan gum and further comprising sodium bicarbonate. Background of the invention [0002] Polymers that hydrate in an aqueous medium and form a gel structure are called hydrophilic polymers, such as chitosan and xanthan gum. These polymers are chemically cationic (like chitosan) or anionic (like xanthan gum). Binary mixtures of these polymers will result in the formation of a gel layer on the tablet surface, allowing for a slow release of the active substance from the tablet. As a result, prolonged drug release is achieved. [0003] When the solid dosage form is exposed to an acidic medium, as found, for example, in the stomach, the hydratable polymer swells to form a gel. Sodium bicarbonate acts as a buffer to maintain the tablet mi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/22
CPCA61K9/2013A61K9/205A61K31/137A61K9/2009A61P21/00A61P43/00A61K9/20
Inventor M·阿尔-雷马伊A·巴德旺
Owner 约旦制药公司
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