Formulation for treatment of peripheral joints, spinal joints and/or extracellular matrix elements of connective tissue, method of manufacture and uses

A technology of exogenous matrix and preparation, applied in the field of pharmacy, can solve problems such as adverse effects, achieve large degradation, obvious therapeutic and anesthesia effects, and improve bioavailability

Inactive Publication Date: 2018-11-23
亚历山大·维莱诺维奇·阿萨福夫 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

It should also be noted that DMS, most commonly claimed as an ingredient promoting increased skin permeability, may have adverse effects, which lead to many contraindications

Method used

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  • Formulation for treatment of peripheral joints, spinal joints and/or extracellular matrix elements of connective tissue, method of manufacture and uses
  • Formulation for treatment of peripheral joints, spinal joints and/or extracellular matrix elements of connective tissue, method of manufacture and uses
  • Formulation for treatment of peripheral joints, spinal joints and/or extracellular matrix elements of connective tissue, method of manufacture and uses

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Embodiment 1. Preparation of Formulation A

[0124] The composition of Formulation A is as follows:

[0125]

[0126] To manufacture 100 kg of Formulation A, the following steps were taken.

[0127](i) Add high-purity water in an amount of 71.69 kg to the first mixing tank, followed by glycerol in an amount of 3.0 kg and butanediol in an amount of 2 kg; the mixture is heated to 70° C. under constant stirring at 60 to 70 rpm.

[0128] (ii) Then add cetyl alcohol in an amount of 2.3 kg, glyceryl stearate in an amount of 3.8 kg, caprylic / capric triglyceride in an amount of 5.0 kg, caprylic acid in an amount of 1.0 kg to the second mixing tank cetyl esters, dimethicone in an amount of 1.0 kg, steareth-2 in an amount of 1.0 kg and steareth-20 in an amount of 0.66 kg; at 60 to 70 rpm The mixture was heated to 70°C with continuous stirring.

[0129] (iii) Add the mixture of (ii) to the first mixing tank during 5 minutes with constant stirring at 60 to 70 rpm, then allow ...

Embodiment 2

[0130] Example 2. Structural studies of Formulation A

[0131] The above characteristics of the structures formed in the dispersion (hydrodynamic diameter of the structure / size and its number by hydrodynamic diameter / size)( figure 1 ).

[0132] exist figure 1 , an automatically generated report showing the dependence of the relative volume occupied by the particles in the test sample on the particle size. For example, 17.9% of the total volume of the test sample occupied by the particles corresponds to particles with a hydrodynamic diameter of 15 nm to 80 nm, and an average hydrodynamic diameter of 43.62 nm, while 82.1% of the total volume of the test sample is accounted for by the hydrodynamic diameter Particles from 0.5 μm to 5 μm were occupied, and the mean hydrodynamic diameter of this subset was 2005 nm.

Embodiment 3

[0133] Example 3. Study of Glucosamine Bioavailability Using Formulation A

[0134] For the purpose of obtaining objective information on the bioavailability of glucosamine after dermal application, studies in rats have been performed.

[0135] A study comparing the relative bioavailability and permeability of glucosamine with oral and intramuscular administration of an aqueous glucosamine sulfate solution and topical formulation A cream has been performed in Sprague-Dawley rats.

[0136] The results presented below were obtained by measuring plasma glucosamine concentrations in rats. The study of 5 groups of rats with 9 rats in each group was performed according to the main study protocol. One group applied Formulation A cream topically, while another group administered glucosamine solution orally, and the other three groups - by injection at different concentrations of glucosamine.

[0137] Based on the analysis of the pharmacokinetic profile of glucosamine in rat plasma, ...

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Abstract

The invention belongs to the field of pharmaceutics and relates to formulations for external use for the treatment of peripheral joints, spinal joints and / or extracellular matrix elements of connective tissue. The claimed formulation provides for superior (in comparison to existing analogs) transdermal delivery of pharmaceutically active ingredients, in particular, glucosamine sulfate or other glucosamine salts, and additional ingredients to affected joints. Also proposed is a method of producing said formulation and therapeutic use thereof. The efficacy of the proposed formulation is confirmed by clinical test results.

Description

technical field [0001] The present invention belongs to the field of pharmacy. More specifically, it relates to topical preparations for the treatment of diseases of peripheral joints, spinal joints and / or extracellular matrix elements of connective tissue. Background technique [0002] Glucosamine (2-amino-2-deoxy-D-glucose), and in particular glucosamine sulfate potassium chloride, are specific substrates and stimulators of endogenous glycosaminoglycan synthesis. It belongs to the class of amino sugars and is the universal precursor and building block of glycosaminoglycans and further proteoglycans, which in turn become the connective tissues of organisms (fascia, ligaments, tendons, cartilage, joints, joint capsules and intervertebral disc) extracellular matrix components. [0003] Glucosamine promotes restoration and prevents erosion of the cartilage surfaces of peripheral and spinal joints, including intervertebral discs. It also restores bone tissue eroded from bene...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/107A61K31/00A61K47/10A61K9/06A61K9/10
CPCA61K9/0014A61K9/06A61K9/10A61K9/1075A61K31/7008A61K33/14A61K47/10A61P19/02A61K2300/00A61K9/127A61K47/02A61K47/08A61K47/14A61K47/18A61K47/20A61K47/22A61K47/34A61K47/38A61K47/44A61K47/46
Inventor 亚历山大·维莱诺维奇·阿萨福夫利维奥·奥尔西尼格拉维纳
Owner 亚历山大·维莱诺维奇·阿萨福夫
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