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Highly stable formulations of thyroid hormone in soft capsules

A technology of thyroid hormones and soft capsules, which is applied in capsule delivery, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as reduced therapeutic effects

Pending Publication Date: 2020-11-13
ALTERGON
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It should be added that thyroxine and triiodothyronine are effective at very low doses, so moderate reductions in titers can even lead to significant reductions in therapeutic efficacy

Method used

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  • Highly stable formulations of thyroid hormone in soft capsules
  • Highly stable formulations of thyroid hormone in soft capsules
  • Highly stable formulations of thyroid hormone in soft capsules

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Embodiment Construction

[0013] The expression "high amylose" as used herein means containing about: relative to the total weight of starch, at least 50% by weight, preferably 50-85% by weight, more preferably 65-75% by weight, such as about 70% by weight of amylose, Wherein the term "about" means a variation of ±3%. A preferred class of high amylose starches for the purposes of the present invention is commercially available under the trademark Such as Hylon VII. The applicant has unexpectedly found high amylose to maintain the stability of thyroid hormones in liquid or semi-liquid phase, especially in soft gelatin capsule fillings; this ingredient is rarely used in pharmaceutical technology (cf., e.g., WO2004 / 043140 , showing its use as a binder for slow-release drug particles (cf.); high amylose starches are significantly different from standard starches that contain less than 30% amylose (the rest is amylopectin); for example, amylose starch The content is as follows: wheat (25%), barley (19-22...

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Abstract

New soft capsules are described having within them a fill comprising thyroid hormones (thyroxine T4 or triiodothyronine T3) and a high amylose-starch, optionally associated with vegetable hydrocolloids and / or glycerol. Compared to traditional capsules, these capsules have a strong and unexpected increase in the stability of T4 or T3 during storage.

Description

technical field [0001] The present invention relates to the field of pharmaceutical compositions in soft capsules which contain active ingredients of hormonal nature and are storage stable. Background technique [0002] Soft capsules are a form of medicine that are widely used for active ingredients that need to be formulated in a liquid or semi-liquid state but are poorly soluble in water. The use of this drug form is ideal for very low unit doses of the active ingredient: in this case, a solution form formulation is preferred over a solid formulation because it allows for a more even distribution of the active ingredient in the liquid carrier , which has the advantage of better measurement accuracy. Furthermore, the formulation of the active ingredient in a liquid carrier facilitates the dispersion and absorption of the drug after the capsule wall has been degraded by bodily fluids. Soft capsules can also be used for water-soluble active ingredients, in which case additi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/36A61K9/48A61K31/195A61P5/14
CPCA61K9/4866A61K9/4858A61K31/195A61P5/14A61K9/0053A61K9/4883A61K47/36A61K31/198A61K2300/00A61K9/4825A61K9/485
Inventor 西蒙尼·卡鲁西毛里齐奥·马尔乔里马尔科·蓬蒂贾蒂齐亚诺·福萨蒂
Owner ALTERGON