Antikainina composition for topical application comprising one or more antiparisitic drugs and one or more local anesthetics

 

(57) Abstract:

Pharmaceutical composition for topical application in the treatment of vaginitis includes the quality of medicines metronidazole and miconazole and local anesthetic lidocaine in form providing delayed (extended) release. The composition is made in the form of a cream or pessary. Miconazole can be used in salt form of miconazole nitrate. Local anesthetic lidocaine can be used in free base form or in salt form. Using a combination of metronidazole and miconazole with anesthetic lidocaine eliminates pain caused by vaginitis, while reducing or eliminating irritation in the form of burning and combustion. 10 C.p. f-crystals.

The present invention relates to new pharmaceutical compositions for combating vaginal infections.

Most often vaginitis occur due to the infection of the microorganism Candida albicans, Trichomonas vaginalis or Gardnerella sp, separately or together. For treatment of these conditions often apply imidazole derivatives or intorimidazole, as well as other medicines, including derivative of nitrofurfural about, and for local use. For example, metronidazole is often introduced through the mouth, however, mixed infections can not be satisfactorily cured this way, and compositions for topical application, in particular, pessaries containing two or more active ingredients that are more convenient for this purpose. Apply compositions for topical application containing a single ingredient.

In the past it was found that local application of active ingredients is sometimes accompanied by local irritation, but it is usually acceptable to patients. Currently, we have found that in some circumstances there is increased and unacceptable irritation in the form of burning and burning, especially if you use a combination of two or more active ingredients. More severe irritation can occur, for example, when using miconazole, especially in the presence of a second active ingredient, such as metronidazole. We also found that the pain caused by vaginitis, can be facilitated while reducing or eliminating this irritation by incorporating in the composition of the local anesthetic.

This is and vaginitis, which includes one or more antiparisitic drugs and one or more local anesthetics. This composition should include at least one drug with activity against Trichomonas vaginalis, preferably, metronidazole, and also preferably include one or more drugs active against Candida albicans and/or Gardnerella sp, because the use of metronidazole sometimes leads to the multiplication of the infecting fungal pathogens. As a drug active against Candida albicans, have the advantage fungicide active derivatives intorimidazole, such as butoconazole or, more preferably, miconazole. Ornidazole, ketoconazole, tioconazole and tinidazole are also suitable fungicide active agents. In cases where as a tool against trichomoniasis is metronidazole, it is also effective against Gardnerella sp. The present invention particularly relates to the use of metronidazole and miconazole, because a local anesthetic is very effective in increasing the acceptability of this combination of active ingredients.

A local anesthetic may be, NIN, ethylpropylamine, etidocaine, lidocaine (lignocaine), mepivacain, oxethazaine, prilocaine, ropivacaine, Tolkein or vadakan, or mixtures thereof, such as lidocaine and prilocaine. Can also be used local anesthetics type of esters of p-aminobenzoic acid, such as benzocaine. Local anesthetic can also be used in salt form.

Local anesthetic can be used in an amount of 0.1-10.0 wt.%, preferably, 1.0 to 7.0 percent. A local anesthetic is preferably lidocaine, which can be used in free base form (e.g., in the amount of 1.0 to 3.0 wt.%, preferably, about 1.5%) or in the form of a salt, such as hydrochloride, in quantity, for example, 1.5 to 4.0 wt.%, preferably, about 2%. Use of anesthetic in such low concentrations provides a good tolerability of the compositions.

This composition can be manufactured in the form of a cream containing antivalentine drug (means) in combination with one or more local anesthetics. You can use regular cream base, for example, containing an oily or waxy materials, such as liquid paraffin, white oil or cetyl alcohol, water and one or more powerhockey as benzalkonium chloride.

Preferably, the compositions give the form of pessaries, including the basis for pessaries containing antivalentine medicinal products (tools) and one or more local anesthetics.

The basis for pessaries can be made of any conventional material for vaginal administration, such as glycerin/gelatin Glyco-gelatin, macrogol (glycols), natural, synthetic or semi-synthetic solid fats and fractionated palm oil. A particularly preferred material is a solid fat such as cocoa butter (theobroma oil), for example, a number of products based on cocoa butter, sold under the trade name Witepsol by the company Dynamit Nobel, Slough, England.

The basis for pessaries preferably contains a surfactant to ensure dispersion of the active substances and ensure long-term penetration of active substances into the folds of the mucous membrane.

Surfactant may be cationic, non-ionic, anionic or amorphous surfactant, however, the preferred non-ionic surfactants. Anionic surfactants include salts of sulfosalicylic sodium; salts of long-chain carboxylic acids, such as stearates.

Cationic surfactants include Quaternary ammonium or pyridinium compounds, such as benzalkonium chloride (a mixture of benzylacrylamide, an alkyl chain from C8to C18), bromide of tetradecyltrimethylammonium and chloride of cetylpyridinium.

Amorphous surfactants include lauryl-1-carboxylic and lecithins such as soybean lecithin.

Non-ionic surfactants include esters of glycol and of glycerol, such as glycerylmonostearate; macrosolve simple and complex esters such as cetomacrogol; sorbitane and montanovy esters, such as corbettreport; and polyoxyethylene derivatives of such esters sorbitan, for example, polyoxyethylene (20) sorbitan monooleate.

The specialist will easily determine required for pessary content of surface-active substances; this number will depend on the particular surfactant and the nature of the basis of the pessary; conveniently, when the amount is from 0.1 to 10 wt.%, preferably, from 1 to 5%.

Particularly preferred use of the compositions of the surfactant is preferably present in an amount of from 1 to 5 weight percent, for example, approximately 40 mg of the total weight of the pessary 2540 mg (including active ingredients).

May also advantageously be included in the composition of the broad-spectrum antibiotic, such as pivampicillin. To combat the inflammation and itching associated with vaginitis, may be the best inclusion in the composition of anti-inflammatory drugs, such as hydrocortisone. As another active ingredient may also advantageously be included in the composition of lactic acid. These compositions may also contain chlorophyll as a deodorant.

Usually, the amount of metronidazole is from 250 to 1500 mg of one pessary, more preferably from 400 to 1200 and preferably about 500 mg.

The pessary may contain from 50 to 600 mg of miconazole, preferably, from 50 to 450 mg and is usually 100 mg Miconazole may be in the form of a free base or salt, e.g. nitrate, especially in the basis of the pessary.

These compositions can be produced in the form of a medicinal product with fast or slow (extended) release, or preferably both, of the active ingredient (ingredient) and/or local anesthetic (anesthetics). To ensure the replacement of the Noah system delayed release can be achieved through the use of local anesthetic in two or more different forms, having different solubility, for example, hydrophobic and hydrophilic forms. For example, anesthetic, such as lidocaine, in free base form is practically insoluble in water, but soluble in lipids, while salt (e.g. hydrochloride anesthetic, such as lidocaine) has good solubility in water, but less soluble in lipids. Due to its hydrophilicity, salt is released from the base cream or pessary quickly, while the free base is liberated slowly due to its lipophilicity, providing, thus, a prolonged analgesic effect. The inclusion of salt and free base can therefore give different speed of release of the anesthetic, providing, thus, both immediate and prolonged effects.

Such compositions can, for example, contain 0.1 to 3.5 wt.% (preferably, about 2.0%) lidocaine model HC1 and 0.1-3.0 wt.% (preferably, about 1.5%) of lidocaine.

The total amount of lidocaine and its hydrochloride is preferably not more than 5 wt.%. The relative amount of free base and its salt may vary depending on the nature of the basis of the pessary or cream, in h is s may contain 20-80% anesthetic in the form of a free base and 80-20% - in salt form, of the total weight of these two forms.

Salt of lidocaine, such as the hydrochloride, can be included in the basis of the pessary (for example, a material based on cocoa butter) in the form of a suspension, or, preferably, dissolved in the substrate using surface-active substances (in particular, nonionic active agents, such as mentioned above). The free base can be dissolved directly in the basis of the pessary.

Similar technology can be used to enable the agent to the composition in cream form. So, the salt form can be mixed with the ingredients of the aqueous phase of the cream, and the free base with ingredients of the oil phase. Then these two phases can be mixed together for the thick, creamy emulsion that contains these two forms of anesthetic in different phases. Because of the possibility to change the lipophilic oil phase, the rate of release of lidocaine from this phase can be selected in such a way as to provide a slow but continuous release of lidocaine from the oil phase. On the contrary, the hydrophilicity and the pH of the aqueous phase can be changed to vary the rate of release of lidocaine from the aqueous phase. This way you can find oshirowanen the release of lidocaine from the cream containing the emulsion of the two phases.

To ensure both quick and slow release can also be used in other ways. For example, the composition can include a base cream or pessary containing one or more active ingredients and one or more local anesthetics for quick release and porous particles dispersed therein, for slow release of one or more local anesthetics and, preferably also, one or more active ingredients over an extended period of time, for example, within 24 hours. This anesthetic (anaesthetics) may, therefore, be included in the composition as a cream or pessary, described in WO 95/07071.

The use of anesthetics with different solubility, may also be acceptable compositions comprising porous particles described above, for example, by including lidocaine hydrochloride in porous particles and its free base in a continuous phase, or Vice versa.

The porous particles may contain two or more active ingredients and anesthetics, and the composition may contain a mixture of porous particles, each of which contain different active ingredients and ane WO 89/10132, US-A-4 873 091 and 469085 and EP-A-306236, incorporated herein as references.

In such porous particles total pore volume is preferably from 0.1 to 2.0 ml/g, more preferably from 0.3 to 1.0 ml/g, the Diameter of these particles is usually from 1 to 1000 μm, preferably from 5 to 100 μm, more preferably from 10 to 50 μm. The surface area of these particles is usually from 1 to 500 m2/g, preferably from 20 to 200 m2/,

These porous particles can be prepared from a variety of materials. For this purpose is the multitude of synthetic organic polymers as well as natural substances such as cellulose and gelatin. The choice of material will depend in part on the desired nature of the slow release of the active drug, i.e., diffusion, compression, dissolution or melting.

Where refers to the diffusion of the active drug, the porous particles can be relatively hard. This has the advantage that most remote from the middle of the particle pores do not collapse and, therefore, do not block the diffusion of drug from the interior of the pores. Such rigidity can be adjusted by the level of the transverse jet at least 10%, often in the range from 20 to 80%, for example, from 25 to 60%.

The polymers which can be produced particles include polyolefins, including polyethylene, polystyrene, politicamente etc.; polyacrylate esters, for example, esters of polyacrylic or polymethacrylic acids and optional alkoxysilanes C1-10of alkyl, cycloalkyl, aryl or aralkyl; polyvinyl esters, such as polyvinyl acetate or polivinilhlorod; polyvinyl ketones, for example, polyvinylacetate, and polyvinyl esters, for example, polivinilbutilovy ether.

Porous particles in the cream can release the active drug by diffusion, pressure, dissolution or melting. One preferred implementation is that the particles are elasticise compressible, so that after the first application of the cream, during which the drug is in contact with the infected area, gentle pressure, for example, when grinding causes rapid release of the active drug, which leads to the formation of a layer of drug over a layer of cream.

Elasticise compressible particles may be manufacturing the rubber, chloroprene rubbers, Starovoitova (rubber?). Especially useful are the ethylene-propylene-diene trampoliner, in which the diene components can be diolefine straight chain, cyclic diene and biciclistii diene. Examples of such dienes include 1,4-hexadiene, Dicyclopentadiene, ethylidenenorbornene. You can also use silicone rubbers.

Porous particles that dissolve primarily in aqueous body fluids, can be made of a water-soluble gels, including gelatin, agarose, etc., and certain polymetylmetacrylate, such as Tudragit (Rohm, Darmstadt) that dissolve when the pH of the vagina.

Porous particles, which melt can be produced from fats and waxes of the type used in suppositories and melts at body temperature, but it is a solid at room temperature, and gelatin.

Porous materials for use in the compositions of the present invention can be manufactured in any convenient way. So, the possible polymerization of one or more suitable monomers in the presence of dispersed porogen: by the end of the polymerization porogen you can delete aprimi ingredient or anesthetics can then be absorbed in a porous material, if desired, after removal of air from the pores. The active ingredient or anesthetic may, however, itself be used as porogen: this material may be dispersed to the state of small drops in the monomer with which it is immiscible, so that after polymerization, the active drug effectively fills the pores in the polymer material. In General, however, it is preferable first to produce a porous material to thoroughly remove all traces of monomer, catalysts and agents that create cross links, before the introduction of the active ingredient or anesthetic.

In the patents listed above, described a number of possible ways of making a porous material, in particular, porous particles.

In General, the porous particles can be conveniently made by the polymerization of an emulsion or suspension in the system liquid-liquid. So, for example, a solution comprising selected is not miscible with water monomer, any required agent that creates a cross-linking catalyst, if required, and porogen, which is mixed with this solution, but is not miscible with water. This solution is then suspended in an aqueous solution, which may contain one or Vom increasing the temperature or by irradiation. Porogen then removed from the solidified particles, for example, by evaporation or by extraction into a solvent, which is practically inert to the polymer.

Examples of such proginov include C5-12alkanes, C5-8cycloalkanes and aromatic solvents such as benzene, toluene, etc., the Particles are usually thoroughly washed to remove contaminants, using solvents, so that the final solvent can be removed by evaporation.

In General, the particle diameter can be controlled by the intensity of mixing in the manufacture of the initial emulsion. The diameter of pores and the pore volume is controlled by the number of porogen and the formation of cross-links.

Monomers for the manufacture of particles can be any monomer suitable for polymers described above. For monoolefins suitable agents that produce cross-linking, include relatively unsaturated polyethylene monomers.

The dosage of active drug (funds) and anesthetics contained in the porous particles will vary depending on the specific drugs and their half-life. In General, appropriate what the group is preferably from 1:1 to 5:1, for example, from 2:1 to 4:1.

Porous particles can be distributed in the composition evenly or, in the case of pessaries, can concentrate in one or more areas, for example, in the Central part.

In General, the size of the porous particles preferably is such that they cannot penetrate into the lymphatic ducts. On the other hand, large particles can be felt as sand, which may cause discomfort. In General, the preferred size range for porous particles is 10-100 μm.

Slow release of the active ingredient (ingredients) and anesthetic (anaesthetics) may also be provided through the use of systems Polytrap and Hydrosponge (trademark of Advanced Polymer Systems, Inc. ). You can also use porous polymer granules with a cationic surface charge, such as, for example, described in EP-A-0369741 and WO 93/07862.

On the slow release of the active ingredient (ingredients) and anesthetic (anesthetics) can also be affected by incorporating in the composition of liposomes encapsulating these materials. Liposomes are vesicles formed by phospholipid membranes and methods for their manufacture are described, for example, in US-A-4937078, 4485054 and 4761288, VCCI) dissolved or dispersed in the fat-containing organic solvent. Especially useful phospholipids, such as phosphatidylcholine, lysophosphatidylcholine, phosphatidylserine, phosphatidylethanolamine and phosphatidylinositol. These phospholipids can be modified, for example, cholesterol, stearylamine and Tocopherols. The solvent is then evaporated, usually under reduced pressure, to obtain a thin lipid film containing the active ingredient (the ingredients) and anesthetic (anesthetics). This tape then hydronaut with stirring, using an aqueous phase containing any desired electrolyte, and receive lipid vesicles containing the active ingredient (the ingredients) and anesthetic (anesthetics). Similarly the active ingredient (the ingredients) and anesthetic (anesthetics) can be included in liposphere, as described in US-A-5227165. These liposphere have an average diameter of 0.35-250 μm and a core containing the active ingredient (the ingredients) and anesthetic (anesthetics), dispersed in an inert hydrophobic carrier, and phospholipid surface layer. These liposphere can be produced by obtaining a liquid core material, adding phospholipids to the core material, adding an aqueous solution to the mixture and stirring to obtain a suspension of lipofen.

Another method of providing a slow release of the active ingredient (ingredients) and anesthetic (anesthetics) is the use of hollow pessaries containing these materials. Hollow pessaries can be manufactured by molding the material of the pessary around the Central pin, the introduction of active materials in the formed cavity and then filling the remaining space with the basis of the pessary.

Pessaries should be placed in packaging to ensure complete treatment, in which some of pessaries contain a local anesthetic, for initial application (for example, during the first three days), and some of them do not contain, for use when the symptoms begin to subside. The following examples are only for illustration purposes:

Example 1

The pessary

Metronidazole - 500.0 mg

Miconazole nitrate - 100.0 mg

Lidocaine (1,5%) - 37.5 mg

Lidocaine hydrochloride (2,0%) - 50.0 mg

Witepsol W35 - 1762,5 mg

Cetomacrogol - 50.0 mg

All 2500,0 mg pessary

Alternatively, the composition may contain a 2.0% lidocaine and 1.5% lidocaine hydrochloride.

Example 2

Cream, %

Liquid paraffin - 23,75

White petrolatum - 8,0

Cetyl alcohol - 7,0

Span 60 - 3,0

Miconazole nitrate - 2,0

Metronidazole - 10,0

Lidocaine - 1,5

Lidocaine hydrochloride - 2,0

Monopotassium phosphate potassium - 0,5

1% aqueous benzalkonium chloride - 10,0

Twin 60 - 5,0

70% aqueous sorbitol - 5,0

Water - 22,25

Just 100,0

Alternatively, the composition may contain a 2.0% lidocaine and 1.5% lidocaine hydrochloride.

An oil phase comprising liquid paraffin, white petrolatum, cetyl alcohol, lidocaine and Span 60, mixed at 60oC. the Aqueous phase comprising the remaining components are mixed well at 60oWith, and both phases are combined and mixed.

Example 3

One pessary contains:

Metronidazole - 500.0 mg

Miconazole nitrate - 100.0 mg

Lidocaine is 75.0 mg (3%)

Lidocaine model HC1 - 25.0 mg (1%)

Witepsol W35 - 1750,0 mg

Cetomacrogol - 50.0 mg

All 2500,0 mg

Prigotovlenoy alcohol - 7,0

Span 60 - 3,0

Miconazole nitrate - 2,0

Metronidazole - 10,0

Lidocaine - 3,0

Lidocaine model HC1 - 1,0

Monopotassium phosphate potassium - 0,5

1% aqueous benzalkonium chloride - 10,0

Twin 60 - 5,0

70% aqueous sorbitol - 5,0

Water is a 21.75

Just 100,0

Preparation as in example 2.

Example 5

The pessary

Metronidazole - 500.0 mg

Miconazole - 100.0 mg

Lidocaine - 25.0 mg (1%)

Microsponges* lidocaine (load 40%) - 250.0 mg (4%)

Witepsol W35 - 1575,0 mg

Cetomacrogol - 50.0 mg

All 2500,0 mg

* All placed inside a polystyrene-divinylbenzene porous granules.

Preparation as in example 1.

Example 6

The pessary

Metronidazole - 100.0 mg

Miconazole nitrate - 20.0 mg

Lidocaine - 35,0 mg (1%)

Microsponges* metronidazole (load 40%) - 1250,0 mg (500 mg active)

Microsponges* miconazole (load 40%) - 250.0 mg (100 mg active)

Microsponges* lidocaine (load 40%) - 350,0 mg

Cetomacrogol - 70.0 mg

Witepsol W35 - 1425,0 mg

All 3500,0 mg

* All placed inside a polystyrene-divinylbenzene porous granules.

Preparation as in example 1.

Example 7

The pessary

Metronidazole - 500.0 mg

Miconazol Is R>
PEG 400 - 140,0 mg

Monateric 951A - 42,0 mg

All 2500,0 mg

Preparation as in example 1.

Monateric is a surfactant, which can be purchased at the company's Mona Industries Ltd., Paterson, New Jersey, USA

Example 8

Cream, %

Liquid paraffin - 20,75

White petrolatum - 8,0

Cetyl alcohol - 7,0

Span 60 - 3,0

Miconazole nitrate - 2,0

Metronidazole - 10,0

Lidocaine model HC1 - 1,0

Microsponges* lidocaine (load 40%) - 10.0 mg (4% active)

Monopotassium phosphate potassium - 0,5

1% aqueous benzalkonium chloride - 10,0

Twin 60 - 5,0

70% aqueous sorbitol - 5,0

Water - 17,75

Just 100,0

* All placed inside a polystyrene-divinylbenzene porous granules.

An oil phase comprising liquid paraffin, white petrolatum, cetyl alcohol, lidocaine and Span 60, mixed at 60oC. the Aqueous phase that includes all the remaining ingredients except the porous pellet, mix well at 60oWith, and both phases are combined and mixed. Then add porous granules and dispersed them into the cream.

Example 9

The pessary

Metronidazole - 500.0 mg

Miconazole nitrate - 100.0 mg

Lidocaine - 50.0 mg (3%)

Witepsol W35 - 1800,0 mg

Cetomacrogol - 50.0 mg

All 2500,0 m is lidocaine and 1812,5 mg Witepsol.

Example 10

Cream, %

Liquid paraffin - 24,75

White petrolatum - 8,0

Cetyl alcohol - 7,0

Span 60 - 3,0

Miconazole nitrate - 2,0

Metronidazole - 10,0

Lidocaine - 4,0

Monopotassium phosphate potassium - 0,5

1% aqueous benzalkonium chloride - 10,0

Twin 60 - 5,0

70% aqueous sorbitol - 5,0

Water - 20,75

Just 100,0

Preparation as in example 2.

Alternatively, the composition may contain a 1.5% or 2% lidocaine at the corresponding increase of the quantity of liquid paraffin.

1. Pharmaceutical composition in the form of a cream or pessary for local application in the treatment of vaginitis, including drugs metronidazole and miconazole and local anesthetic lidocaine in form providing delayed (extended) release.

2. The composition according to p. 1, characterized in that it is formulated to provide fast or slow (extended) release, or both, of the medicines and slow or fast and slow release of the local anesthetic.

3. The composition according to p. 1, characterized in that the rapid and slow release of the local anesthetic provides the I p. 1, characterized in that it includes a base cream or pessary containing these medicines and specified local anesthetic, for quick release, and porous particles dispersed therein, for slow release of the specified local anesthetic.

5. Composition according to any one of paragraphs. 2-4, characterized in that it includes porous particles for sustained release of one or both of the medicines.

6. Composition according to any one of the preceding paragraphs, characterized in that these drugs are metronidazole and miconazole nitrate.

7. Composition according to any one of the preceding paragraphs, characterized in that it comprises a surfactant.

8. Composition according to any one of the preceding paragraphs, characterized in that it is in the form of a pessary.

9. The composition according to p. 1, characterized in that it further includes at least one antibiotic, anti-inflammatory agent or deodorant.

10. The composition according to p. 1, characterized in that it includes the basis for a pessary containing product on the basis of cocoa butter.

11. The composition according to p. 3, characterized in that it mahonia is present in the oil phase.

 

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