Soft pharmaceutical formulation of anti-arthritis for rectal application containing diclofenac and glucosamine hydrochloride

FIELD: pharmaceutical industry, in particular agent for prophylaxis and treatment of rheumatoid arthritis and osteoarthritis.

SUBSTANCE: disclosed are suppository having mass of 2-2.5 g containing (g): diclofenac 0.0225-0.0525; glucosamine hydrochloride 0.175-0.525; lecithin 0.057-0.063; and balance: solid fat.

EFFECT: agent for prophylaxis and treatment of arthritis, degenerative joint and backbone diseases with increased anti-inflammatory action and reduced ulcerogenic action.

1 tbl, 3 ex

 

The invention relates to medicine, on the production of therapeutic and prophylactic drugs used to treat rheumatoid arthritis, osteoarthritis.

Offer suppositories containing diclofenac and glucosamine hydrochloride relate to medicine, can be used as a therapeutic and preventive tools in degenerative diseases of joints and spine, arthritis of various etiologies.

Known dosage forms analogues of the claimed invention, the essential features. Rectal candles "Declouet" (U.S. Pat. Of the Russian Federation No. 96118892/14), containing in g / candle weight of 1.15-1.40 g: diclofenac 0,045-to 0.055 g, dry basis suppory or witepsol - rest.

Rectal candles, manufactured by CiBA-YEJYJ (Germany), containing as active substance diclofenac and fat basis, in the following ratio of components, 1 candle weighing 1.5 to 2.5,: diclofenac of 0.025-0.1 g; the basis of fat - the rest.

Diclofenac (ortofen, voltaren) is an inhibitor of prostaglandines, inhibits the activity of several enzymes involved in the inflammatory process, including lysosomal hydrolases.

Action - anti-inflammatory, analgesic and antipyretic. The disadvantage is that the action is directed only to the inhibition and reduction in palielinamo process and does not provide for the recovery of the cartilage in the affected joint.

The closest to the pharmacological action of the present invention is rectal candles "Declouet" (U.S. Pat. No. 96118892/14), containing in g / candle weight of 1.15-1.40 g: diclofenac 0,045-to 0.055 g, dry basis suppory or witepsol - the rest, as well as pills glucosamine hydrochloride, 0.3 g (U.S. Pat. No. 2133597). The disadvantage with suppositories diclofenac is that they only provide anti-inflammatory effect, and, among the complications caused by taking NSAIDs, including diclofenac, the main place is occupied by erosive-ulcerative lesions of the mucous membrane of the gastrointestinal tract (Levitsky, EL NSAIDs aspects the pharmacodynamics and pharmacokinetics / AL Levitsky // Pharmacy. - 1998. No. 23(144). - P.3).

At the same time, tablets glucosamine hydrochloride are the most famous medication showing chondroprotective action on cartilage repair of the damaged joint, and has little influence on the processes of inflammation. However, we know that glucosamine is able to suppress the activity of proteolytic enzymes and affect the education of the factors stimulating the regeneration of the gastric mucosa. (Zupanets I.A., Bezdetko NV, Reckman IE, Semenov A.N. Prospects for the use of amino sugars in ulcerative lesions of the stomach // Gastroenterology. 1991. VIP. P.50-54.)

Technical C is the summer residence of the present invention is to create a new combination of a medicinal product with enhanced anti-inflammatory activity and reduced ulcerogenic action. This goal is achieved by the fact that there are suppositories, containing in its composition diclofenac and glucosamine hydrochloride. Thus due to the synergistic effect provides higher anti-inflammatory activity at the dose of diclofenac and observed a significant reduction in ulcerogenic action of diclofenac.

Distinctive features is the combination of diclofenac and glucosamine hydrochloride in one soft dosage form, which leads to more convenient to use and more effective action of the drug. Introduction to suppozitornyj the basis of lecithin allows you to enter a medicinal substance in suppository type of solution that increases the kinetic and sedimentation stability of the system in the manufacture of suppositories, and as a consequence allows to increase the accuracy of dosing and other technological characteristics of the proposed suppositories. The introduction of lecithin also helps to increase the completeness of the release of drugs.

Anti-inflammatory activity of the combination of glucosamine and diclofenac was studied on rats male line "Wistar" (m=200,0±10.0 g). In each group there were 6 animals. Randomly formed 4 groups of laboratory animals, in which simulated pathological process is S. The first group of animals was the control and received no treatment. The second group of animals was administered suppositories in which diclofenac was contained in a dose of 12.5 mg/kg of the Third group was administered suppositories containing diclofenac at a dose of 6.3 mg/kg of the Fourth group was administered the drug comparison - rectal suppositories 0.05 g "Declouet" (at a dose of 12.5 mg/kg in terms of diclofenac).

The objects of study were introduced rectally in a fixed time of day (10-1100) therapeutically, i.e. after modeling pathology, in the form of warmed up to 37°suppozitornoj weight within 7 days. The amount of glucosamine hydrochloride with the introduction of diclofenac in doses of 12.5 mg/kg or 6.3 mg/kg was identical and was 125 mg/kg To evaluate the impact of research objects in the process of inflammation used the method of "cotton granuloma (Manual on experimental (preclinical) study of new pharmacological substances. - M., 2000. - 398 S.) (table 1).

The survey shows that the investigated suppositories containing diclofenac and glucosamine hydrochloride, have a limiting influence on the process of exudation, and in the process of proliferation, i.e. have a more pronounced anti-inflammatory effect than drug "Declouet".

The use of suppositories containing glucosamine hydrochloride diclofenac dose of 6.3 mg/kg, not inferior in intensity and antiexudative antiproliferative activity of the medicinal drug "Declouet" and even surpasses it.

In examining the impact of foreign exchange administration of suppositories "Declouet" on the state of the mucous membrane of the large intestine with its irritating effect on the mucous: observed swelling, hyperemia, petechial haemorrhages. Introduction in suppositories with diclofenac glucosamine hydrochloride limits povrezhdayushchee action investigated NSAIDs on the mucous membrane of the large intestine. The use of suppositories containing diclofenac at a dose 2 times less does not cause significant damage to the mucous membranes of the large intestine - the mucous membranes was comparable to the state of the mucosa of the control group animals.

This object is achieved in that there are suppositories diclofenac with glucosamine hydrochloride following composition, in one suppository weighing 2.0 to 2.5 g: diclofenac 0,0225-0,0525 g; glucosamine hydrochloride 0,175-0,525 g; lecithin 0,057-0,063 g; tallow - rest.

Example 1 for specific performance

Diclofenac0,025
Glucosamine hydrochloride0,4
Lecithin0,05
Solid confectionery fat
based on plasticized
of hydrogenated fat (VFS 42-1117-86)- to 2.00 g

It melted at a temperature of 40-45°solid fat (1,525 g), while the agitator add 0.05 g of lecithin and mix until smooth. Then in the resulting basis in small portions with stirring, add shredded 0.025 g of diclofenac, and then 0.4 g of glucosamine hydrochloride and stirred until dissolution. The intensity of mixing shall be such as to prevent foaming, all substances should be completely dissolved. The resulting mass is poured in the form of a film of polyvinyl chloride.

Example 2 specific performance

Diclofenac0,035
Glucosamine hydrochloride0,35
Lecithin0,055
Solid confectionery fat
based on plasticized
of hydrogenated fat (VFS 42-1117-86)to 2.25 g

It melted at a temperature of 40-45°solid fat (1.56 g), while the agitator add to 0.055 g of lecithin and mix until smooth. Then by the scientists based in small portions with stirring, add shredded 0.035 g of diclofenac, and then 0.35 g of glucosamine hydrochloride and stirred until dissolution. The intensity of mixing shall be such as to prevent foaming, all substances should be completely dissolved. The resulting mass is poured in the form of a film of polyvinyl chloride.

Example No. 3 of specific performance

Diclofenac0,05
Glucosamine hydrochloride0,5
Lecithin0,06
Solid confectionery fat
based on plasticized
of hydrogenated fat (VFS 42-1117-86)- to 2.50 g

It melted at a temperature of 40-45°solid fat (1.89 g), while the stirrer is added 0.06 g of lecithin and mix until smooth. Then in the resulting basis in small portions with stirring, add shredded 0.05 g of diclofenac, and then 0.5 g of glucosamine hydrochloride and stirred until dissolution. The intensity of mixing shall be such as to prevent foaming, all substances should be completely dissolved. The resulting mass is poured in the form of a film of polyvinyl chloride.

Rectal suppositories are in the shape of a cylinder with a pointed end with Maxi the material with a diameter of 1.5 cm, color from white to slightly yellowish, due to the color of the solid fat and lecithin.

Suppositories are a homogeneous mass, the same shape and have the hardness, providing ease of use. Deviations in the weight of the suppository does not exceed ±5%.

The melting temperature does not exceed 37°C.

The full deformation suppositories does not exceed 15 minutes

Analysis of scientific-technical and patent documents showed that the proposed suppositories with diclofenac and glucosamine hydrochloride are new and meet the criterion of "inventive step".

204,6±4,18*
Table 1

The number of the resulting exudate, granulation tissue and the strength of the scar after implantation of a cotton ball
The condition of the experimentThe exudation mgGranulation tissue mgThe strength of the scar, cu
Group # 1538,0±6,16523,0±6,16283,0±16,5
Group # 2163,5±10,12*x148,5±10,12*x402,5±28,6*x
Group # 3169,1±14,41*x154,2±14,41*474,0±35,2*x
Group # 4189,6±4,18*323,0±18,7
Indicated statistically significant changes (p<0,05) in comparison:

*- with control group of animals;

x- a group of animals who were injected suppositories "Declouet".

Rectal suppositories containing diclofenac and base, with anti-inflammatory action, characterized in that it further contains glucosamine hydrochloride, tallow and soy lecithin in the following ratio of components, g:

on 1 suppository weighing 2.0 to 2.5 g:

Diclofenac0,0225-0,0525
Glucosamine hydrochloride0,175-0,525
Lecithin0,057-0,063
TallowRest



 

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