Pharmaceutical composition containing chondroitin sulphate and/or hyaluronidase and liposome for local application

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to medicine, namely to a pharmaceutical composition for local application. The composition contains chondroitin sulphate, hyaluronidase, glucosamine hydrochloride, liposome and pharmaceutically acceptable carriers and excipients in the amounts specified in the patent claim. The composition may additionally contain capsaicin.

EFFECT: pharmaceutical composition according to the invention is characterised by fast skin penetration of the ingredients.

3 cl, 4 ex

 

The present invention relates to medicine, namely to pharmaceutical compositions for topical application containing chondroitin sulfate and/or hyaluronidase and liposomes.

Recently, liposomes are most often used as carriers for various biologically active substances such as vitamins, antibiotics, fruit acids and other in medicine. In the range of liposomal drugs are ointments, creams and gels for the treatment of various diseases.

Chondroitin sulfate is a structural analogue of hyaluronic acid of natural origin and has contractualism, moisturizing, regenerating and anti-inflammatory action. Chondroitin sulfate stimulates the biosynthesis glucosamine, slowing degeneration in the cartilage tissue, promotes regeneration of the cartilage surfaces of the joints, increases mobility of joints and muscles, promotes skin hydration.

Liposomes can be single layer or multilayer, can have different sizes. Components of liposomal membranes can be charged lipids (PA, dipalmitoylphosphatidyl acid, phosphatidylserine, diacetilactis or its acetate, stearylamine, dimyristoylphosphatidylcholine-glycerol), sterols - cholesterol and its esters, isoprenoids, tocopherol, fatty acid, glycolipid is (gangliosides and cerebrosides), and also, under certain conditions, some proteins, diazotrophy alcohol (Abstract. Development of the basic biotechnological production processes and quality management system lipid cosmetic products http://www.fos.ru/biology/7369_1.html).

The known properties of liposomes, described in the article "LIPOSOMES" (LIEBERSON. LIPOSOMES - Sorovskie educational journal, No. 10, 1998, retrieved from the Internet 10.11.2011, <URL:http://www.pereplet.ru/nauka/Soros/pdf/9810_002.pdf) on page 5 indicates that the inclusion of drugs in liposomes can significantly improve their therapeutic efficacy (left column, second paragraph from the bottom). It also indicates that the problem of drug delivery to the desired location can be solved by topical application of liposomal drugs.

Known drug Lydasum is a drug containing hyaluronidase. Hyaluronidase found in the various tissues of the body, causes the breakdown of hyaluronic acid to glucosamine and glucuronic acid, and thereby reduces its viscosity, increases the permeability of the tissue and provides the movement of fluids in the interstitial spaces. Describes the use of lidz (in combination with anti-inflammatory drugs) in rheumatoid arthritis by electrophoresis: 64 UE lidz was dissolved in 30 ml of distilled water was added 4-5 drops of 0.1 molar hydrochloric KIS is the notes and was injected with a forked electrode (anode) on two of the joint. The drug is available in powder form in vials of 64 ITEMS.

Known gel Assawan™, which consists of: escin, "essential" phospholipids and heparin sodium salt and used phlebitis, thrombophlebitic and hemorrhoids (Mashkovsky PPM Medicines. - 15-ed., Rev., Corr. and extra - M.: New Wave, 2006. - s-462).

Known ointment handaxe™containing chondroitin sulfate and dimethyl sulfoxide, which is used in degenerative diseases of joints and spine (arthrosis, osteochondrosis), as well as bruises, contusions and sprains. Also known cream Artrozan containing chondroitin sulfate, plant extracts and vitamins, which is used with the aim of gradual resorption of excess deposits of calcium salts, reduce pain and restore joint mobility. The disadvantage of these tools is that they do not have a high absorbability.

Well-known cosmetic composition, which comprises chondroitin sulfate, hyaluronidase, liposomes (of unknown composition), for the implementation of transepidermal migration of chondroprotective, extracts of juniper, the Martini (EN 2004121471 A, 10.01.2006) for daily care of skin with the purpose of regeneration and hydration.

From RU 2376011 C1-known remedy for the treatment of peripheral joints and allow the student with an active transdermal migration of several protective agents, such as chondroitin sulfate, glucosamine hydrochloride and acetylglucosamine. At the same time more effective transdermal transport is achieved through the use of liposomal concentrate containing phospholipids of soybean.

Pharmaceutical compositions containing chondroitin sulfate and/or hyaluronidase, and liposomes for topical use are not described.

Thus, the present invention is to create a pharmaceutical composition for topical application containing chondroitin sulfate and/or hyaluronidase and liposomes with rapid penetration through the skin.

According to the present invention proposed a pharmaceutical composition for topical application containing chondroitin sulfate and/or hyaluronidase and pharmaceutically acceptable carriers or excipients, characterized in that it further comprises liposomes. However, the rapid penetration through the skin is ensured not only by the liposomes, and hyaluronidase.

As liposomes can be used Dragosomes® (Symrise) representing bilayer liposomes with a diameter of 200 nm on the basis of cholesterol and lecithin, as well as Corneosphere® (Kobo) in the form of structured multilayer liposomes based on hydrogenated lecithin and modified amylopectin.

As the preferred waples is of the claimed invention proposed pharmaceutical composition, above, additionally containing glucosamine hydrochloride. Most preferred is a pharmaceutical composition, which has the following composition, wt.%:

chondroitin sulfateof 0.01 to 5.0
liposomesof 0.01 to 20.0
hyaluronidase0,01-1,0
glucosamine hydrochlorideof 0.01 to 10.0
emulsifier0.5 to 10.0
preservative0,05-1,0
water demineralized53,0-99,41

As one of the preferred embodiments of the claimed invention proposed pharmaceutical composition specified above, optionally containing capsaicin. Most preferred is a pharmaceutical composition, which has the following composition, wt.%:

chondroitin sulfateof 0.01 to 5.0
liposomesof 0.01 to 20.0
glucosamine hydro is lorid of 0.01 to 10.0
capsaicin0,01-1,0
hyaluronidase0,01-1,0
emulsifier0.5 to 10.0
preservative0,05-1,0
water demineralized52,0-99,4

The technical result of the present invention to provide a pharmaceutical composition based on chondroitin sulfate and/or hyaluronidase and liposomes, which has the ability to rapidly penetrate the skin and, accordingly, rapid absorption. Hyaluronidase increases tissue permeability and enhances the action of liposomes and chondroitin sulfate. Additional advantages are ease of application and ease of dispensing.

The pharmaceutical composition of the present invention are generally made by using common methods, using solid or liquid pharmaceutically acceptable carriers or excipients selected from emulsifiers, dispersing agents, preservatives, flavoring agents, pH regulators, polymeric carriers and other excipients, which are suitable for preparation of compositions for local application. The pharmacy is practical composition of the present invention can be prepared in the form of a gel, creams, ointments and the like.

The rapid penetration through the skin due to the binding of chondroitin sulfate with liposomes containing hydrogenated lecithins in combination with cholesterol.

In the first preferred embodiment of the composition based on chondroitin sulfate and/or hyaluronidase and liposomes additionally contains glucosamine hydrochloride, which reinforces the main effect of chondroitin sulfate and linking hyaluronidase with liposomes ensures the stability of the enzyme, in addition, hyaluronidase increases tissue permeability and improves penetration of the components of the composition.

In another preferred embodiment the composition is based on chondroitin sulfate and/or hyaluronidase and liposomes additionally contains capsaicin, which has more distracting distracting effect and helps to reduce pain, vasodilatation and improve the penetration of the components of the composition.

The present invention is illustrated by the following examples.

EXAMPLE 1

Pharmaceutical composition in the form of a cream based on chondroitin sulfate and/or hyaluronidase and liposomes has the following composition:

chondroitin sulfate5,0
carbomer1,0
emulsifier0,5
glucosamine hydrochloride2,00
liposomes2,00
hyaluronidase0,05
preservative0,2
water demineralized89,25

The above composition is prepared by the following method. In demineralized water by heating to 80°C mix: chondroitin sulfate, carbomer, emulsifier, glucosamine hydrochloride, then cooled to 30°C and add liposomes, hyaluronidase and preservative. The resulting homogenized cream and vacuum.

EXAMPLE 2

Farmacevticheskaja composition in the form of a cream based on chondroitin sulfate and/or hyaluronidase and capsaicin has the following composition:

/tr>
chondroitin sulfate5,0
carbomer1,0
emulsifier0,5
glucosamine hydrochloride2,00
liposomes2,00
hyaluronidase0,05
capsaicin0,01
preservative0,2
water demineralized89,24

The above composition is prepared as in EXAMPLE 1, characterized in that it additionally uses capsaicin, which is added during the cooling of the cream in a random order. The resulting homogenized cream and vacuum.

EXAMPLE 3

Evaluation of stability of hyaluronidase in compositions for local application

Since the main drawback of enzymes is their instability during long-term storage of finished dosage forms based on them within the expiration date was the comparative assessment of the conservation activity of hyaluronidase during storage in solution and in the form of a composition for topical use (for example cream).

The hyaluronidase activity was determined by the following method. 2 tubes were made in 0.5 ml of water was added in the first 0.1 ml, and the second 0.2 ml of substrate hyaluronic acid. In each tube was made of 0.1 ml of 1%solution of bovine serum albumin (BSA, M=67000 Yes) firm "Serva" (With The A) and added 0.2 ml of 15%aqueous solution of acetic acid. For a working dose took the minimum number of substrate, forming a clearly defined mutiney clot adding acetic acid.

The results are shown in the following table.

The analyzed sampleMain ingredientsThe storage stability
123
Cream No. 1According to Example 1The activity of hyaluronidase 90% within 1 year of observation
Cream No. 2According to Example 2The activity of hyaluronidase 92% within 1 year of observation
The solution of the native enzyme-The activity of hyaluronidase 40% for 1 day

As can be seen from the table, the introduction of the enzyme hyaluronidase in compositions for topical application allows to obtain a stable pharmaceutical composition for local application. Despite the fact that with the introduction of this enzyme in the composition of these songs is a minor loss of enzyme activity, etc is further stored for 1 year hyaluronidase does not change its activity.

EXAMPLE 4

Study of the pharmaceutical composition with chondroitin sulfate and liposomes on the ability of rapid penetration into the skin.

For this purpose, we compared the ability of rapid skin penetration composition according to the present invention on the basis of chondroitin sulfate and a control composition containing chondroitin sulfate without liposomes. The tests were carried out on rabbits. The above composition was applied on the inner surface of the rabbit ear. Absorption was determined by the amount of chondroitin sulfate, remaining on the skin of the rabbit after 10 minutes after application of the compositions, expressed in percentage of the initial amount of chondroitin sulfate in the composition.

Results: the control composition is 50% of the remaining chondroitin sulfate; the composition of the present invention is 10% of the remaining chondroitin sulfate.

Thus, the pharmaceutical composition according to this invention has the ability to rapidly penetrate the skin, providing a more rapid manifestation of therapeutic effect of the active substances of the composition.

1. Pharmaceutical composition for topical application, haraktrizuyutsya the fact that it contains chondroitin sulfate, hyaluronidase, glucosamine hydrochloride, liposomes and a pharmaceutically acceptable carriers and excipients in the following autosizecomponents, wt.%:

chondroitin sulfateof 0.01 to 5.0
liposomesof 0.01 to 20.0
hyaluronidase0,01-1,0
glucosamine hydrochlorideof 0.01 to 10.0
emulsifier0.5 to 10.0
preservative0,05-1,0
water demineralized53,0-99,41

2. The pharmaceutical composition according to claim 1, characterized in that it further comprises capsaicin.

3. The pharmaceutical composition according to claim 2, characterized in that it has the following composition, wt.%:

chondroitin sulfate0,01-50
liposomesof 0.01 to 20.0
hyaluronidase0,01-1,0
glucosamine hydrochlorideof 0.01 to 10.0
capsaicin0,01-1,0
emulsifier 0.5 to 10.0
preservative0,05-1,0
water demineralized52,0-99,4



 

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