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A pharmaceutical container for the quantitative release of a single dose of t3 and t4 thyroid hormone solution for oral administration

A thyroid hormone, single-dose technology, used in pharmaceutical formulations, drug combinations, drug delivery, etc., can solve problems such as not being recommended, thyroid hormones not known, etc.

Inactive Publication Date: 2011-12-28
ALTERGON
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, this may not be acceptable for reasons of dosing precision in the discussion of thyroid hormones
No bottle of this type is known nor suggested for the administration of thyroid hormones

Method used

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  • A pharmaceutical container for the quantitative release of a single dose of t3 and t4 thyroid hormone solution for oral administration

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0039] Preparation of Glycerol-Ethanol Solution of Levothyroxine Sodium (T4)

[0040] Composition and quantity for the preparation of 25 L:

[0041] Levothyroxine Sodium (T4): 2.625g

[0042] Glycerol (85%): 21.525kg

[0043] Ethanol (96%): 6.100kg

[0044]In a 10 L stainless steel vessel fitted with a paddle stirrer and lid, add 90% ethanol (5.49 L) and add T4 with stirring; stir slowly while maintaining nitrogen flow until complete dissolution. Glycerol (21.525 kg) was poured into a 25 L turbo emulsifier (Olsa-Italy) and an ethanol solution containing the T4 solution was added. Rinse the 10 L stainless steel vessel with the remaining ethanol (0.61 L) and pour it into a 25 L turbo emulsifier. Stirring was continued at low speed for 15 minutes under a nitrogen environment and protected from light.

example 3

[0060] Preparation of 1.0 ml (1.3 ml fill) nominal, neutral LDPE / EVA single-dose plastic containers with screw caps containing levothyroxine sodium (T4) in glycerol-ethanol solution.

[0061] a) Fabrication of single-use containers

[0062] Composition of materials, amounts and relative percentages used for preparation:

[0063] Low-density polyethylene (LDPE): 25.0kg, 50%

[0064] Ethylene-vinyl acetate copolymer (EVA): 25.0kg, 50%

[0065] The product contains 5 single-dose strips of 1.0 ml with screw caps.

[0066] 5 single-dose strips and 5 cap strips were produced by injection molding using two different molds and then assembled with semi-automatic equipment.

[0067] The characterization of the injection molded products is carried out by determining the Young's modulus: the UNI-EN-ISO 527-1 reference standard is used to determine the sample size and the pulling is carried out using a pulling speed of 5 mm / min.

[0068] 50LDPE / 50EVA mixture

63.5MPa

...

example 4

[0077] Preparation of 1.0 ml (1.3 ml fill) nominal, neutral LDPE / EVA single-dose plastic containers with screw caps containing levothyroxine sodium (T4) in glycerol-ethanol solution.

[0078] a) Fabrication of single-use containers

[0079] Composition of materials, amounts and relative percentages used for preparation:

[0080] Low-density polyethylene (LDPE): 12.5kg, 25%

[0081] Ethylene-vinyl acetate copolymer (EVA): 37.5kg, 75%

[0082] The product contains 5 single-dose strips of 1.0 ml with screw caps.

[0083] 5 single-dose strips and 5 cap strips were produced by injection molding using two different molds and then assembled with semi-automatic equipment.

[0084] The characterization of the injection molded products is carried out by determining the Young's modulus: the UNI-EN-ISO 527-1 reference standard is used to determine the sample size and the pulling is carried out using a pulling speed of 5 mm / min.

[0085] 25LDPE / 75EVA mixture

42.2 MPa

...

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Abstract

The present invention relates to a pharmaceutical container for the quantitative release of a single dose of T3 and T4 thyroid hormone solutions for oral administration, characterized in that the container is made of plastic with a Young's modulus of 10 to 80 MPa material.

Description

technical field [0001] The present invention relates to a method of administering a thyroid hormone-based pharmaceutical formulation, and related devices for realizing said method. Background technique [0002] Hormones produced by thyroid cells are released into the blood and act on the body's metabolism by: increasing oxygen consumption and heating products with increased body temperature, stimulating protein synthesis and achieving a more positive nitrogen balance, increasing sugar Mass regeneration and glycogenolysis, and generally stimulates the synthesis, mobilization and catabolism of cholesterol and lipids. Thyroid hormones increase the rate of cellular oxidative processes and regulate the metabolism of most tissues. In general, it has prominent anabolic effects at low doses and catabolic effects at high doses. This biphasic action is evident in the metabolism of glycogen, proteins and lipids. [0003] In the case of physiological deficiency, it is necessary to in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/07A61K9/48A61K38/29
CPCH01H1/225H01H71/1009H01H2071/1036H01H2001/223A61P5/14
Inventor 乔治奥·佐佩蒂安东尼奥·丰塔纳
Owner ALTERGON
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