Single-dose pharmaceutical preparation of thyroid hormones t3 and/or t4

A technology for thyroid hormones and pharmaceutical preparations, applied to the pharmaceutical preparations of thyroid hormones T3 and T4, and the field of use in diseases, can solve the problems of increasing the amount of impurities, loss of alcohol solvents, inability to maintain chemical and physical stability, etc., and achieve no problem. The effect of easy contamination

Active Publication Date: 2014-08-13
ALTERGON SA (50)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been observed that although the container shows the characteristics of optimal compressibility ensuring that the solution is completely emptied, it is however not able to maintain the chemical and physical stability of the hydro-alcoholic solution of the hormones T3 / T4 it contains, Causes loss of alcohol solvent during storage and increases the amount of impurities present in it

Method used

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  • Single-dose pharmaceutical preparation of thyroid hormones t3 and/or t4
  • Single-dose pharmaceutical preparation of thyroid hormones t3 and/or t4
  • Single-dose pharmaceutical preparation of thyroid hormones t3 and/or t4

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Formulation and preparation of water-alcoholic solutions

[0083] The formulations are used to prepare doses of up to 200 μg of T4, up to 20 μg of T3, and combinations of the two active ingredients.

[0084] In a typical composition, excipients such as ethanol and glycerol, the concentration of the former may range between 5 and 30% w / v, the latter between 70 and 95% w / v, as required with Use with water.

[0085] A one liter aqueous-alcoholic solution containing 100 g / mL T4 was prepared as follows using the qualitative / quantitative compositions listed below:

[0086] 1) T40.105g

[0087] 2) Ethanol (96%) 243g

[0088] 3) Glycerin (85%) 861g

[0089] The T4 was dissolved in ethanol in a suitable dissolution apparatus under continuous stirring at ambient temperature. When a clear solution with no visible undissolved residue had been obtained, glycerol was added and a homogeneous, clear, colorless solution was obtained with gentle stirring at ambient temperature, th...

Embodiment 2

[0091] A solution prepared as described in Example 1, in a nominal volume of 1 mL characterized by different materials, was dispensed between four different one-component single-dose containers:

[0092] A) Squeezable single dose PVC076 container (equivalent to PVC with a thickness of 60 μm);

[0093] B) Squeezable single-dose COPO containers (EMAA copolymer resin-MFI9);

[0094] C) Squeezable single-dose 2 containers (EMAA ionomer resin - some Na&Zn salts and additives) - MFI5;

[0095] D) Squeezable single-dose LDPE containers (600 μm thick).

[0096] Melt flow index or melt index (MFI) is the flow index of a molten polymer.

[0097] Filling of single-use containers

[0098] The prototype was prepared on a laboratory scale using an automatic pipette (Gilson P-1000) to fill a disposable container with the aforementioned 1.1 mL glycerol-ethanol solution (prepared as described in Example 1), followed by The containers were sealed with a Pentaseal-lab benchtop sealer.

[...

Embodiment 3

[0104] Single-dose containers made of one-component LDPE plastic with a nominal volume of 1 mL contained in sealed sachets (PET / A1 / PE) were used. Characteristics of the sachet:

[0105] - Layered films with high gas and light barriers: polyester 12 μm, Al 9 μm, polyethylene 50 μm (values ​​to be considered ± 5-6%);

[0106] -Oxygen permeability: 0.1-0.2cc / m2 / day

[0107] -Water vapor permeability: 0.1-0.2g / m2 / day

[0108] The oxygen permeability is measured according to ASTM standard D-3985.

[0109] The water permeability is measured according to ASTM standard E-398.

[0110] Filling of single-use containers

[0111] The prototype was prepared on a laboratory scale using an automatic pipette (Gilson P-1000) to fill a disposable container with the aforementioned 1.1 mL glycerol-ethanol solution (prepared as described in Example 1), followed by The containers were sealed with a Pentaseal-lab benchtop sealer. Pack partial batches in airtight sachets of the type described a...

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Abstract

The present invention relates to a single-dose formulation for oral use of the thyroid hormones triiodothyronine or liothyronine (T3) and tetraiodothyronine or thyroxine (T4) in a water-alcohol solution. The formulation is physically and chemically stable, protected against accidental or microbiological contamination, in a container for pharmaceutical use which is squeezable and impermeable to the evaporation of the volatile substances it contains. The invention also relates to corresponding means for implementing the formulation.

Description

technical field [0001] The present invention relates to pharmaceutical preparations of thyroid hormones T3 and / or T4. In particular, the present invention relates to pharmaceutical formulations of the thyroid hormones T3 and T4 in aqueous-alcoholic solutions suitable for oral administration and characterized by high physical, chemical and microbiological stability. The invention also relates to the use of said pharmaceutical preparation in the treatment of disorders caused by deficiency of the hormones T3 and / or T4. Background technique [0002] The thyroid hormones triiodothyronine or liothyronine (T3) and tetraiodothyronine or thyroxine (T4) are secreted by the follicular cells of the thyroid in response to the pituitary gland hormone TSH, the products of which are in turn produced by the hypothalamus Hormone TH regulation. The secretion of thyroid hormones follows a circadian rhythm; the highest levels of T3 and T4 are reached at night and in the early hours of the morn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J7/00A61K9/00A61K47/10A61M15/00
CPCA61J1/00A61K47/10A61K31/198A61K31/197A61K9/0095A61K2300/00A61P5/14A61J3/07A61K9/48A61K38/19
Inventor 洛伦佐·贝洛里尼阿尔贝特·贝尔纳雷吉马尔科·皮佐蒂
Owner ALTERGON SA (50)
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