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Stabilization of solid thyroid drug formulations

A technology for pharmaceutical dosage forms and thyroxine, which is applied in the directions of drug combination, pill delivery, pharmaceutical formulation, etc., can solve problems such as difficulty in preparation, and achieve the effects of reducing hydrolysis and degradation reactions and improving stability.

Inactive Publication Date: 2004-11-03
SIGMAPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, thyroid hormones can react with a variety of pharmaceutically available excipients, so it is difficult to prepare pharmaceutical preparations containing thyroid hormones that can maintain a sufficiently long shelf life under conventional storage conditions

Method used

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  • Stabilization of solid thyroid drug formulations
  • Stabilization of solid thyroid drug formulations

Examples

Experimental program
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Effect test

Embodiment

[0048] The pharmaceutical preparations of the present invention were prepared and tested as follows. A powder formulation containing the composition listed in Example 1 in Table 1 was prepared by pretreatment of the drug with oil ("drug-oil-pretreatment" method). Accordingly, the drug is suspended in the oil and homogenized to obtain a drug / oil suspension. The drug / oil suspension is then added to carrier powders including microcrystalline cellulose and hydroxypropylmethylcellulose. The resulting wet liquid / powder mixture is mixed with fine silica particles to create a free-flowing, easily compressible liquid-solid system. Then, the disintegrant sodium starch glycolate and the lubricant magnesium stearate are added into the liquid-solid system, and the final product powder is obtained after mixing.

[0049] Powder formulations containing the compositions listed in Examples 2-7 in Table 1a were prepared by pretreatment of the excipient with oil ("vehicle-oil-pretreatment" meth...

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PUM

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Abstract

Pharmaceutical formulations and dosage forms are provided having improved stability to moisture-induced degradation when compared with conventional dosage forms, especially tablets. The invention features low compression forms of thyroid drugs together with excipients, preferably in encapsulated forms. In other embodiments, relatively non-volatile oils can be admixed with the drug and / or the excipients to stabilize the formulation toward moisture-induced degradation. Hydrophobic powders are also optionally added to the formulations.

Description

field of invention [0001] The present invention relates to stable formulations of pharmaceuticals and methods of preparing these formulations. In particular, the present invention relates to stable formulations of deliquescent thyroid drugs and methods of preparing these formulations. Background of the invention [0002] It is known in the art of pharmacy that many drugs and drug classes exhibit little or moderate stability during storage. For example, many solid pharmaceutical formulations are unstable and chemically transform important active substances in the drug into other compounds after a relatively short period of time. Although these compounds are usually relatively harmless, sometimes degradation products may contain components of antagonist drugs or increase the incidence of adverse side effects. In any case, the reduction of the effective active ingredient in the formulations is clearly detrimental and these formulations are less reliable for therapeutic use. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/198
CPCA61K9/2054A61K9/4866A61K9/485A61K9/4858A61K31/198A61K9/2009A61K9/4816A61P5/14
Inventor 斯皮里东·斯皮雷亚斯
Owner SIGMAPHARM