Suppository

FIELD: medicine, pharmacology, pharmacy.

SUBSTANCE: invention proposes suppository containing 40% of drug, not above, and a base consisting of melt of a thickening agent, hydrophilic substance, lipophilic substance and complex with polyethylene glycol. Complex is prepared by mixing lipophilic or hydrophilic substances in polyethylene glycol of molecular mass 200-6000 Da. Proposed suppository provides rapid delivery of drug in blood.

EFFECT: improved and valuable medicinal and pharmaceutical properties of suppository.

19 cl, 3 tbl, 2 ex

 

The invention relates to medicine, in particular for the manufacture of suppositories, broad-spectrum, for suppositories rectal, urogenital or vaginal application.

Widely known suppositories for rectal or vaginal use with hydrophilic or lipophilic bases (EN 2185817, EN 2114609, EN 2115412, EN 2150268, EN 2104690, EN 2225213, EN 2097051, EN 2143261).

Closest to the invention are suppositories for rectal or vaginal application, containing the medicinal substance and the basis (EN 2102977).

The range of application of these suppositories are not wide enough.

The objective of the invention is the creation of suppositories medical application due to the use of universal bases, providing the bioavailability of fat and water-soluble substances simultaneously and allows you to enter in the basis of both water-and fat-soluble medicinal substances, solutions, and obtaining aggregately-resistant composition of suppositories that improves the quality of suppositories and their appearance.

This object is achieved in that suppositories containing the medicinal substance in an amount of not more than 40% of the total weight of the suppository in therapeutic dosage and the basis, according to the invention as a basis containing alloy or a mixture of the three components: lipoti is lnyh substances, hydrophilic substances and complex of lipophilic and/or hydrophilic substances, pre-mixed in polyethylenglycol with a molecular mass of 200-6000 D, taken in the following ratio, wt.%:

- hydrophilic substance 0,1-49,0

- complex of lipophilic and/or hydrophilic substances, pre-mixed in polyethylenglycol of 0.1 to 50.0

- lipophilic substances - other

As hydrophilic substances base according to the invention contains components selected from the group: medical gelatin, glycerin, sodium carbonate crystal, polyvinylpyrrolidone low or medium molecular, water-soluble cellulose derivatives, cyclodextrins, herbal extracts, alcohols, agar-agar, carragenin, propylene glycols with a molecular mass of 200-6000, pemulen, polysaccharides and their derivatives, honey, protein components, acrylic acid and its derivatives, peptides, dextrans in an effective amount.

As lipophilic substances base according to the invention contains components selected from the group of natural and synthetic oils, fats and their derivatives, fatty acids and their derivatives, lecithin in an effective amount.

The complex, which is the basis, according to the invention consists of the above-mentioned hydrophilic and/or lipophilic substances selected from the groups in the specified amount before artelino mixed in polyethylenglycol with a molecular mass of 200-6000 D.

As a thickener base according to the invention further comprises components selected from the group of natural resins, synthetic balms, wax, silica, chitosan, phytosterols and emulsifiers in quantities of 1 to 18 wt.%.

As a medicinal substance suppositories can contain:

- immune modulators selected from the group of: cytokines, metronidazole, Radostin in the amount of 0.001-0.5 g per 1 g suppository;

the cytokines selected from the group: alpha-, beta-, gamma-interferon in the number 500-1000000 ME, interleukin-2 in the amount of 1000-100000 ME, tumor necrosis factor alpha or beta in the number 1000-10000000 ME at 1 g suppository;

- antihistamines selected from the group: diasorin, mebhydrolin, antazoline, Bastin, loratadine, levocabastine, azelastine, astemizole, terfenadine, diphenhydramine, chloropyramine, cetirizine, promethazine in the amount of 0.0001-0.1 g per 1 g suppository;

- corticosteroid drugs selected from the group of hydrocortisone, fludrocortisone, flumetazon, atamazon, mometazon, perkantoran, triamcinolone, prednisone, prednisolone, dexamethasone in the amount of 0.001-0.02 g per 1 g suppository;

anti - inflammatory drugs are selected from the group: diclofenac sodium, indomethacin, ibuprofen, naproxen, salicylic acid, paracetamol, analgin, Riboxin, in the amount of 0.001-0.5 g H1 g suppository;

- antiseptic preparations, selected from the group of zinc salts, salts of silver, salt, iodine, dioxidine, boric alcohol, borowska liquid, hydrogen peroxide, Miramistin, boric acid, nonoxynol, boric acid in the amount of 0.001-0.5 g per 1 g suppository;

- antibacterial drugs, selected from the group of broad-spectrum antibiotics, methylbenzethonium, benzylaniline, cetylpyridinium, alkyltrimethylammonium, chlorhexidine, iodopovidone, in an amount of 0.01 to 0.5 g per 1 g suppository;

- anti-viral agents are selected from the group of: acyclovir, essential oils, Kalanchoe juice, onion juice, garlic juice, lemon juice in an amount of 0.01 to 0.5 g per 1 g suppository;

- essential oils of fir needle oil, tea tree oil, eucalyptus oil, mint oil in the amount of 0.001 to 0.3 g per 1 g suppository;

- vitamins selected from the group: a, b, C, D, PP, B1, B6, yeast amount is 0.0002-0,025 g per 1 g suppository;

- trace elements selected from the group of zinc, chromium, selenium, and Nickel in an amount of 0.01-0.08 mg to 1 g suppository;

- sulfoxide in an amount of 0.01-0.3 g per 1 g suppository;

- lipoic acid in the amount of 0.001 to 0.2 g per 1 g suppository;

- aminocaproic acid in an amount of 0.01-0.3 g per 1 g suppository;

- microbial mass: Lactobacterin or one or more genera abioticheskikh bacteria, using the data from the group of bifidobacteria, streptococci or lactococcal in the amount of 105-109MK 1 suppository.

Offer suppositories create the most favorable conditions for rapid melting them in the body, ensure the rapid flow of drugs into the blood, improve the technological properties of the suppositories are recommended for medical applications: inflammation, including inflammatory processes of the rectum, prostatitis, hemorrhoids, treatment for anal fissures, various gynecological diseases.

Example. Proposed suppositories prepared as follows.

First serves basis. Get a set of substances by mixing the polyethylene glycol with molecular weight of 200-6000 D lipophilic and/or hydrophilic substances selected from the above groups. Then mix them with the hydrophilic and lipophilic components selected from the above groups, to obtain a melt or mixture. To thicken the mixture in it enter the components selected from the group of natural resins, synthetic balms, wax, silica, chitosan and phytosterols in the number of 1-18 wt.%.

Experiments were conducted for the preparation of bases for suppositories. The results are summarized in table 1-3.

Table 1
ComponentsNumber, wt.%
Hydrophilic substances0,10,51,05,010,015,025,030,035,049,0
The complex of the hydrophilic substances, pre-mixed in polyethylenglycol50,035,020,010,05,03,53,01,50,50,1
Thickeners18,016,015,014,0to 12.09,07,05,03,01,0
Lipophilic substances31,948,564,071.073,072,565,063,561,5to 49.9
Total:100100100100100100100100100100

Table 2
ComponentsNumber, wt.%
Hydro is safe substance 0,10,51,05,010,015,025,030,035,00,49
The complex of lipophilic substances, pre-mixed in polyethylenglycol50,035,020,010,05,03,53,01,50,80,1
Thickeners1,03,05.07,09,0to 12.014,015,016,018,0
Lipophilic substances48,961,574,078,076,069,558,053,551.832,9
Total:100100100100100100100100100100

The resulting mixture or melt basics mixed with the drug, taken in therapeutic doses, and placed in sterile form. Ready suppositories Packed. Packaging depends on the basis and form of suppository. Packaging depends on the basis and form of suppository.

As cartonnage substances suppositories can contain:

- immune modulators selected from the group of: cytokines, metronidazole, Radostin in the amount of 0.001-0.5 g per 1 g suppository;

the cytokines selected from the group: alpha-, beta-, gamma-interferon in the number 500-1000000 ME, interleukin-2 in the amount of 1000-100000 ME, tumor necrosis factor alpha or beta in the number 1000-10000000 ME at 1 g suppository;

- antihistamines selected from the group: diasorin, mebhydrolin, antazoline, Bastin, loratadine, levocabastine, azelastine, astemizole, terfenadine, diphenhydramine, chloropyramine, cetirizine, promethazine in the amount of 0.0001-0.1 g per 1 g suppository;

- corticosteroid drugs selected from the group of hydrocortisone, fludrocortisone, flumetazon, atamazon, mometazon, perkantoran, triamcinolone, prednisone, prednisolone, dexamethasone in the amount of 0.001-0.02 g per 1 g suppository;

anti - inflammatory drugs are selected from the group: diclofenac sodium, indomethacin, ibuprofen, naproxen, salicylic acid, paracetamol, analgin, Riboxin, in the amount of 0.001-0.5 g per 1 g suppository;

- antiseptic preparations, selected from the group of zinc salts, salts of silver, salt, iodine, dioxidine, boric alcohol, borowska liquid, hydrogen peroxide, Miramistin, boric acid, nonoxynol, boric acid in the amount of 0.001-0.5 g per 1 g suppository;

- antibacterial drugs, SEL is installed from the group of broad-spectrum antibiotics, methylbenzothiazole, benzylaniline, cetylpyridinium, alkyltrimethylammonium, chlorhexidine, iodopovidone, in an amount of 0.01 to 0.5 g per 1 g suppository;

- anti-viral agents are selected from the group of: acyclovir, essential oils, Kalanchoe juice, onion juice, garlic juice, lemon juice in an amount of 0.01 to 0.5 g per 1 g suppository;

- essential oils of fir needle oil, tea tree oil, eucalyptus oil, mint oil in the amount of 0.001 to 0.3 g per 1 g suppository;

- vitamins selected from the group: a, b, C, D, PP, B1, In6the yeast in the number is 0.0002-0,025 g per 1 g suppository;

- trace elements selected from the group of zinc, chromium, selenium, and Nickel in an amount of 0.01-0.08 mg to 1 g suppository;

- sulfoxide in an amount of 0.01-0.3 g per 1 g suppository;

- lipoic acid in the amount of 0.001 to 0.2 g per 1 g suppository;

- aminocaproic acid in an amount of 0.01-0.3 g per 1 g suppository;

- microbial mass: Lactobacterin or one or more genera abioticheskikh bacteria selected from the group: bifidobacteria, streptococci or lactococcal in the amount of 105-109MK 1 suppository.

To illustrate the present invention such examples:

I. Paracetamol0.5 g
and basis:
Solid is th fat 45 wt.%
Complex
solid fat and PEG 20035 wt.%
Gelatin medical5 wt.%
Chitosan15 wt.%

(upon receipt of a complex solid fat with PEG were mixed in a volume ratio 1:2).

II. Dioxidine0.02 g
and basis:
Glycerin17 wt.%
Complex
of glycerol and PEG 600043 wt.%
Cocoa butter32 wt.%
Wax8 wt.%

(upon receipt of the complex was mixed with glycerol PEG in a volume ratio 1:1).

III. Indometacin0.1 g
Vitamin Dis 0.0002
and basis:
Agar-agar15 wt.%
complex
Agar-agar and PEG 150045 wt.%
Olive oil30 wt.%
Silicon dioxide10 wt.%

Here is also to illustrate the quantitative examples the ratios of the components of the framework and physico-chemical properties of these bases JV (tables 3 and 4).

100
Table 3
The quantitative ratio of the components of the framework for SP
ComponentsNumber, wt.%
Hydrophilic substances0,10,51,05,010,015,025,030,035,00,49
The complex of lipophilic substances, pre-mixed in polyethylenglycol50,035,020,010,05,03,53,01,50,80,1
Thickeners1,03,05,07,09,0to 12.014,015,016,018,0
Lipophilic substances:48,961,574,078,076,069,558,053,551,832,9
No. basics12345678910
Total:100100100100100100100100100

33
Table 4
Physico-chemical properties of individual variants of the above bases suppositories
no songsAverage weight (g)Tplvl.(°)Tsaturd.(°)The full deformation, min
12,01±0,131255,02
21,99±0,1362718,50
32,04±0,135286,47
42,02±0,136262,70
52,00±0,135323,15
62,02±0,1372918,50
71,99±0,1362617,20
81,97±0,131267,00
92,00±0,127of 5.06
102,02±0,133264,39

Below is evidence of the rapid melting of the JV in the body and, consequently, the release and absorption in the blood of the examples JV with paracetamolum (at a dose of 0.5 g) and dioksidin (0.02 g).

Used a model two-factor analysis of variance with repeated experiments. The optimization parameters were chosen concentration released paracetamol and dioksidina for 50 and 60 minutes respectively. The release of substances studied by the method of equilibrium dialysis through a semipermeable membrane. Dialysis medium was phosphate-borate buffer solution with a pH of 7.8, which corresponds to the pH value of the mucous membrane of the rectum. The concentration of paracetamol and dioksidina samples dialysate was determined by extraction titration. When the experiment JV was melted on a water bath.

When the analysis of variance revealed approximation to the optimization settings (50 and 60 min): 83% dose of paracetamol and 92% of the dose dioksidina.

Study of the release and other drugs showed similar satisfactory results, which suggests that the proposed framework does not preclude the optimal dynamics of release of the drug from the JV and post what came of it in the environment of the body, including in the blood.

Proposed suppositories tested on pilot scale equipment. The results of the experiments showed that the resulting suppositories have improved appearance, have elevated aggregately-resistant properties, quickly melted in the body, contributing to rapid flow of drugs into the blood.

Offer suppositories passed clinical trials.

The effectiveness of the treatment the patients were evaluated by clinical data. The results showed that the proposed suppositories are effective for a wide range of diseases and allow us to expand the Arsenal of suppositories.

In addition, suppositories with the proposed universal basis, having the above properties, have a virtually unlimited shelf life.

1. Suppositories containing the medicinal substance and a base, characterized in that contain the medicinal substance is not more than 40% of the total weight of the suppository, and as the basis they contain alloy thickener and these three components, as hydrophilic substances, lipophilic substances and complex with polyethylene glycol, previously obtained by mixing the polyethylene glycol molecular weight 200-6000 D lipophilic or hydrophilic substances, and these three components are taken in the following is a rate, wt.%:

hydrophilic substances0.1 to 49,0
complex with polyethylene glycolof 0.1 to 50.0
lipophilic substancesrest

2. Suppositories according to claim 1, characterized in that the hydrophilic substances framework contains components selected from the group: medical gelatin, glycerin, stearic acid, sodium carbonate crystal, polyvinylpyrrolidone low or medium molecular, water-soluble cellulose derivatives, cyclodextrins, herbal extracts, alcohols, agar-agar, carragenin, lecithin, propylene glycols with a molecular mass of 200-6000 D, pemulen, polysaccharides and their derivatives, propolis or propolis extract, honey, protein components, acrylic acid and its derivatives, peptides, dextrans in an effective amount.

3. Suppositories according to claim 1, characterized in that as lipophilic substances framework contains components selected from the group of natural and synthetic oils and fats and their derivatives and fatty acid in an effective amount.

4. Suppositories according to claim 1, characterized in that as a thickener base contains components selected from the group of natural resins, synthetic balms, wax, silica, chitosan, amongat the market and phytosterols in the number of 1-18 wt.%.

5. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain immune modulators selected from the group of: cytokines, metronidazole, Radostin in the amount of 0.001-0.5 g per 1 g suppository.

6. Suppositories according to claim 6, characterized in that, as a medicinal substance they contain cytokines selected from the group: alpha-, beta-, gamma-interferon in the number 500-1000000 ME, interleukin-2 in the amount of 1000-100000 ME, tumor necrosis factor alpha or beta in the number 1000-10000000 ME at 1 g suppository.

7. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain antihistamines selected from the group: diasorin, mebhydrolin, antazoline, Bastin, loratadine, levocabastine, azelastine, astemizole, terfenadine, diphenhydramine, chloropyramine, cetirizine, promethazine in the amount of 0.0001-0.1 g per 1 g suppository.

8. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain corticosteroid drugs selected from the group of hydrocortisone, fludrocortisone, flumetazon, atamazon, mometazon, perkantoran, triamcinolone, prednisone, prednisolone, dexamethasone in the amount of 0.001-0.02 g per 1 g suppository.

9. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain anti-inflammatory drugs, in the abusive group: diclofenac sodium, indomethacin, ibuprofen, naproxen, salicylic acid, paracetamol, analgin, Riboxin, in the amount of 0.001-0.5 g per 1 g suppository.

10. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain antiseptic preparations, selected from the group of zinc salts, salts of silver, salt, iodine, dioxidine, boric alcohol, borowska liquid, hydrogen peroxide, Miramistin, boric acid, nonoxynol, boric acid in the amount of 0.001-0.5 g per 1 g suppository.

11. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain antibacterial agents selected from the group of broad-spectrum antibiotics, methylbenzethonium, benzylaniline, cetylpyridinium, alkyltrimethylammonium, chlorhexidine, iodopovidone, in an amount of 0.01 to 0.5 g per 1 g suppository.

12. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain anti-viral agents are selected from the group of: acyclovir, essential oils, Kalanchoe juice, onion juice, garlic juice, lemon juice in an amount of 0.01 to 0.5 g per 1 g suppository.

13. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain essential oils, selected from the group of fir oil, tea tree oil, eucalyptus oil, mint oil in the amount of 0.001 to 0.3 g per 1 g of suppository.

14. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain vitamins selected from the group: a, b, C, D, PP,1In6the yeast in the number is 0.0002-0,025 g per 1 g suppository.

15. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain trace elements, selected from the group of zinc, chromium, selenium, and Nickel in an amount of 0.01-0.08 mg to 1 g suppository.

16. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain dimethyl sulfoxide in an amount of 0.01-0.3 g per 1 g suppository.

17. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain lipoic acid in the amount of 0.001 to 0.2 g per 1 g suppository.

18. Suppositories according to claim 1, characterized in that they contain aminocaproic acid in an amount of 0.01-0.3 g per 1 g suppository.

19. Suppositories according to claim 1, characterized in that, as a medicinal substance they contain microbial mass: Lactobacterin or one or more genera abioticheskikh bacteria selected from the group: bifidobacteria, streptococci or lactococcal in the amount of 105-109MK 1 suppository.



 

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4 cl, 5 ex

FIELD: medicine, proctology, pharmaceutics.

SUBSTANCE: the present innovation deals with obtaining medicinal forms as suppositories applied for treating proctological diseases. Medicinal preparation as suppositories containing active substance, anesthetic, purified water and foundation could additionally contain antiseptic and local irritating substance, as an active substance - glucocorticoid at the following ratio of components, weight%: glucocorticoid 0.0277-0.0368, anesthetic 1.8-2.2, antiseptic 2.8-3.52, local irritating substance 0.288-0.352, purified water 1.8-2.2, foundation - the rest. As glucocorticoid that inhibits the release of inflammation mediators and causes pronounced antiphlogistic and antiallergic action one should apply, for example, hydrocortisone or synaflane. As anesthetic one should apply, for example, anesthesin, lidocaine or trimecaine. As antiseptic being of astringent, drying off and analgesic actions one should apply, for example, dermatol or xeroform. As local irritating substance being of reflector, venotonic, analgesic and antiphlogistic and, also, antimicrobial actions one should apply, for example, racemic menthol or essential oils.

EFFECT: higher therapeutic efficiency.

5 cl, 3 ex, 4 tbl

FIELD: pharmaceutical industry.

SUBSTANCE: new urogenital drug contains 50-250 g antibacterially efficient antibiotic erythromycin, 50-250 g antifungally efficient antibiotic nistatin, antiprotozoal preparation metronidazole, and 1.5-3.5 g (to complete weight of suppository) A type solid fat as filler. Drug can be used to treat mixed urogenital infections.

EFFECT: reduced treatment time, lowered recurrence of diseases, lack of adverse effects, and lowered cost.

FIELD: medicine, chemical-pharmaceutical industry.

SUBSTANCE: invention relates to the development of new homeopathic suppository that can be used for treatment of prostatitis, hemorrhoid, uterus cervix erosion, endometritis. Invention proposes two variants. By the first variant agent represents suppository comprising the following components, g: propolis, 0.1; sea-buckthorn, 0.2; chestnut homeopathic essences, 0.1; Ginkgo biloba homeopathic essences, 0.1; aloe homeopathic essences, 0.1; milfoil, 0.1; wax, 0.1 and a base. The second variant represents suppository comprising the following components, g: sea-buckthorn, 0.2; propolis, 0.1; rue homeopathic essences, 0.05; Hypericum (Saint-John's-wort), 0.05; Symphytum (comfrey), 0.05; Tambukan curative muddy extract, 0.2; lanolin, 0.15; wax, 0.1, and a base. Proposed suppository elicits an anti-inflammatory regenerating effect and without toxic effect.

EFFECT: valuable medicinal properties of suppository.

15 cl, 4 ex

FIELD: medicine, gynecology, contraceptives, pharmaceutical chemistry.

SUBSTANCE: invention proposes vaginal suppository comprising benzalconium chloride, benzoic acid, purified water and the preparation vitespol taken in the definite content of components. Invention provides the reliable inhibition of fungal microflora being especially against fungus Candida albicans and the absence of irritation and symptoms in vagina drying. Invention can be used as an individual agent for prophylaxis of undesirable pregnancy.

EFFECT: valuable properties of suppository.

5 tbl

FIELD: veterinary pharmacology, veterinary science.

SUBSTANCE: the suggested method deals with mixing formalin with components followed by heating with subsequent cooling at the following ratio of components including: 0.8%-formalin 5 ml, analgin 1 g, Veratrum tincture 1.0 ml, glycerol 5 ml, citric acid 0.2 g, gelatin 3 g.

EFFECT: enhanced curative result, more convenient medicinal form.

1 ex, 2 tbl

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