Pharmaceutical composition for treating skin diseases

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to the pharmaceutical industry and represents a pharmaceutical composition for the external application for the treatment of skin diseases in the form of a cream, which includes as an active substance methylprednisolone aceponate in a therapeutically effective amount and a lipophilic base, characterised by the fact that as the lipophilic base it contains petrolatum, liquid paraffin and oil of castor oil plant seeds and additionally white bee wax, with the components of the composition being in a specified ratio in g/100 g of the composition.

EFFECT: invention provides the creation of the stable composition, improved pharmacological properties and absence of an irritating effect.

1 tbl

 

The invention relates to the field of medicine and pharmaceutics, more specifically, relates to compositions in the form of ointments for external use, and pogodno for the treatment of inflammatory skin diseases that are sensitive to therapy with topical corticosteroids, including atopic dermatitis, atopic eczema, children eczema; eczema, microbial eczema; professional eczema; dyshidrotic eczema; irritant contact dermatitis; allergic (contact) dermatitis.

The problem of atopic dermatitis (AD) and eczema is now a special scientific and social significance because of the wide spread and increasing numbers of patients with these dermatoses. Treatment of patients with allergic dermatoses, especially heavy, torpid forms, it is difficult to imagine without the use of external medicines, which include corticosteroid hormones [K. N. Suvorova, A. A. Antoniew, S. I. Dovzhansky, M. F. Pisarenko. Atopic dermatitis. Saratov: Saratov University Publishing house 1989; 168].

The basis of atopic dermatitis is an allergic inflammation of the skin. In its origin and maintenance plays the role of a variety of factors such as allergenic and non-allergenic properties. These include dry skin, increased sensitivity to stimuli, immunological disorders, Allez�logical reaction of immediate and delayed type, infection, etc. in spite of varied etiology and clinical symptoms, microscopic picture of skin inflammation in atopic dermatitis is almost independent of the combination of these "causal" factors. Thus, the use of anti-inflammatory agents external validity is the primary method of treatment of dermatitis, irrespective of the activity of its clinical manifestations and causes of [V. M. Walnut, V. A. Konstantinov, I. D. Maslov. The hormones in the external therapy of dermatoses. M. 1981].

Corticosteroids in the form of ointments have been used in the middle of the twentieth century and took its rightful place in the treatment of itching dermatoses. Over time, the pharmacologists to achieve higher efficiency of external funds changed the structure of corticosteroids. Thus, including the main connection (hydrocortisone) balance butyric acid caused the formation of hydrocortisone butyrate with more pronounced anti-inflammatory properties. Modification of the structure of molecules of steroids, through the introduction of Halogens (fluorine) more significantly increased anti-inflammatory activity of drugs. However it is known that fluorinated corticosteroid ointments most drugs cause side effects such as skin atrophy, telangiectasia, steroid acne, perioral dermatitis, ISU�trichos and others.

Efficacy of topical use corticosteroids for atopic dermatitis proved by long practice and by numerous controlled studies. An important moment in the development of the capacities of external therapy of atopic dermatitis in children was the appearance in Russia in the late 90-ies for corticosteroid topical use permitted in children 6 months of age - methylprednisolone aceponate (Advantan). The appearance of this drug marked the beginning of overcoming persistent corticosteroidal among pediatricians. All corticosteroids, each of which has its own characteristics and capabilities, have been used wider and more active. However, the possibility of choosing the form of the drug was limited, as only Elokim had three dosage forms (lotion, cream, ointment) to be applied depending on the activity and stage of allergic inflammation of the skin. However Elokim can only be used from the age of two, and the necessary choice of the dosage form outside glucocorticosteroid therapy for children from 6 months of age.

Traditional external funds intended for the treatment of children with atopic dermatitis in the acute stage, has not lost its significance even today. These include liquid forms of external antiseptics and drugs combined action (liquid� Castellani, Fukortsin, preparations containing salicylic acid and others). These funds are used exclusively in the acute phase as a disinfectant and disinfectant, especially in secondary infection and oozing of lesions [O. V. Zaitseva. External therapy of atopic dermatitis: a look at the problem from the perspective of a pediatrician. http://www.lvrach.ru/2005/03/4532280].

One of the important parameters characterizing the state of the skin barrier is the liquid content in the stratum corneum. Unlike the tissue of internal organs, containing 70-80% of water in the stratum corneum water content and slightly 10-30% depending on the ambient humidity. Thus water in the stratum corneum is unequally distributed, and its concentration increases with depth, 10% liquid associated with lipids, 20% have a physical-chemical bond with the keratin. Fluid content provides ductility and stretch ability of the Horny layer, and they are in directly proportional dependence. Normal stratum corneum retains a sufficient amount of water to maintain their functions, even at relatively low humidity and high evaporation coefficient. If the damage of the stratum corneum is excessive transepidermal water loss (TEWL) and decreases the concentration of natural moisturizing factor of the skin. �any violation of the sequestration of fluid in the stratum corneum, due to exogenous toxins or endogenous factors, leads to the development of the pathological process. The skin becomes less plastic, wrinkled and sagging.

The presence of different bases for corticosteroids significantly expands the possibilities of their application, allowing for differentiated therapy, depending on the area of skin lesions, extent, severity and stage of the inflammatory process. The right choice of various dosage forms of the drug, in addition, improves the safety and effectiveness of outdoor glucocorticosteroid therapy that is important, primarily in pediatric practice. So, for example, creams are usually well tolerated. Thanks to its composition, the cream penetrates deeply into the skin, holding in the upper layer of the epidermis that can be used in acute inflammatory processes. Gels and lotions that often contain alcohol or water based, are well tolerated by patients, but they have a drying effect, which is undesirable in the presence of high dryness. Fat-free basis of the lotion helps it to easy distribution on the skin surface without gluing and drying hair. The lotion leaves no visible traces on the skin and applies a cooling effect. This makes a convenient dosage form for the treatment of dermatitis with localization�th on the scalp. At the same time, preparations corticosteroids in the form of ointments possess more potent anti-inflammatory activity than their counterparts in the form of a cream of the same concentration [Atopic dermatitis. New approaches to prevention and topical therapy (Y. V. Sergeev - ed): health for all, 2003].

Methylprednisolone aceponate - dehalogenation synthetic steroid. Methylprednisolone aceponate has anti-inflammatory, antiallergic, antiexudative and antipruritic activity, according to the severity of it is superior to prednisolone, hydrocortisone, dexamethasone, and a number of other modern glucocorticoids applied locally. In contrast, the drug has little systemic glucocorticoid and mineralocorticoid effect, little effect when multiple applications on the thickness and turgor of the skin. These properties of methylprednisolone aceponate connected with the peculiarities of the chemical structure and metabolism. So, methylprednisolone aceponate being vysokopitatelny substance that quickly and easily penetrates through the stratum corneum of the skin into the dermis, where under the influence of enzymes - esterase becomes methylprednisolone 17-propionate is a very active metabolite, whose connection with steroid receptors is higher than that of hydrocortisone 6 times. This metabolite is entering the bloodstream fast is associated with transport Belko� (transcortin) and inactivated in the liver, therefore, its existence in free form in the blood, and therefore systemic side effect is minimal. These properties of methylprednisolone aceponate as a "prodrug" allow to apply it 1 time a day, and also explain the almost complete lack of influence on the level of endogenous cortisol in the blood plasma of patients, good overall tolerability [N. In. Kungurov, P. Cohan, J. V. Kinksthe, Y. G. Mirin, S. V. Vedernikov. About optimization of treatment of patients with atopic dermatitis children and adults. Journal of dermatology and venereology. 2004; 3: 23-29].

The literature describes various dosage forms of methylprednisolone aceponate.

In the patent of the Russian Federation 2223750 described dosage form of methylprednisolone aceponate for outdoor use. However, it is not enough stable.

Known composition of methylprednisolone aceponate for external application according to the patent 2437679 contains an organic acid as a stabilizer and aprotic dispersant, in particular a lipophilic ingredient, as the carrier. However, the presence of organic acids is not always acceptable because of possible adverse effects on inflamed skin.

The objective of this invention is to create a stable pharmaceutical composition of methylprednisolone aceponate topical use for the treatment of inflammatory skin diseases�tions of the skin, which can also be used in Pediatrics, for very dry skin and chronic skin diseases, that is, in cases where it is very important the absence of auxiliary ingredients with a high irritant, and at the same time a new composition should possess improved pharmacological properties.

To solve this problem is proposed pharmaceutical composition for topical application as an ointment, comprising as active ingredient methylprednisolone aceponate in a therapeutically effective amount and a lipophilic base, characterized in that it contains as lipophilic bases petrolatum, liquid paraffin and oil of castor seeds ordinary and additionally white beeswax. Preferably, the ingredients are contained in the following ratio, g/100 g of composition:

Methylprednisolone aceponate 0,03-0,18

Lipophilic basis 69,9-95,0

Beeswax white 4,9-30,0

Introduction to the composition of white beeswax allows to obtain the desired consistency and viscosity of an ointment necessary for ease of application, ensures the stability of the present composition, and simultaneously improves the pharmacological properties of the composition, since the white beeswax is antiseptic and antibacterial agent, and has a regenerating effect, �are particularly important in the application of the composition in pediatric patients for the treatment of chronic skin lesions and the treatment of very dry skin that is particularly prone to infection.

As lipophilic component framework is preferable to use a combined lipophilic ingredient. Preferably a combination of ingredients that provides a buttery consistency of the drug, an ingredient that softens the skin and is an ingredient for the input of the active substance in the form of suspensions

As an ingredient, which provides a buttery consistency of the drug preferably, the use of vaseline.

As the lipophilic component, which is intended for input of the active substance preferably, the use of liquid paraffin (paraffin oil).

As the lipophilic component, which absorbs well and softens the skin preferably using oil of castor seeds ordinary. Preferably used as the lipophilic ingredient petrolatum, liquid paraffin and oil seeds ordinary castor in the following ratio

Vaseline 40,0-48,0;

Liquid paraffin (mineral oil) 30,0-38,0

The ordinary castor seed oil (castor oil) 2,0-5,0

A selected combination of additives allows the penetration of active ingredients through the epidermis and provides them d�actvie on the border of epidermis and dermis. Also it provides a sufficient duration of action of methylprednisolone aceponate.

Pharmaceutical composition is a soft dosage form is preferably in the form of ointments. Selected qualitative and quantitative composition represented by the composition was found experimentally and is optimal.

The present composition can be used in all skin diseases amenable to local treatment with corticosteroids, including in chronic current medicine. The ointment is recommended to use topically, causing a thin layer to the affected area and gently rubbing. Perhaps the use of the drug under occlusive dressing.

When topically applied ointment has anti-inflammatory, antiallergic, antipruritic and antiexudative action, quickly penetrates the stratum corneum of the skin into the dermis. Ointment form, containing at its core, the greatest amount of lipophilic components. It is recommended for treating dry skin rash, the presence of infiltration (compaction) in the skin. The use of ointments "beneath the blindfold" increases the depth of penetration of the active substance. The imposition of the ointment on the affected area leading to complete cessation of skin perspiration, which causes a local temperature rise of the skin, loosening her superficial�x layers and a slight expansion of the vessels of the skin. Thanks to that introduced in ointments medicinal substances are absorbed into the skin. The main indication for the use of ointments is the presence of infiltration of the skin in the absence of acute or subacute inflammatory phenomena.

A comprehensive therapeutic program for the treatment of diseases of the skin involves the use of moisturizers. Introduction to the composition of white beeswax also prevents excessive transepidermal water loss. It blocks the passage of fluid through the stratum corneum, resulting in transepidermal water loss decreases and the water content in the stratum corneum is increased accordingly.

Thus, the proposed pharmaceutical composition intended for cutaneous application in diseases of the skin, including chronic in adults and children for which effective local use of corticosteroids.

According to the proposed method of obtaining a mixture of white beeswax and a part of the lipophilic ingredient by heating to a temperature of 65-75°C and mixing until uniform, and then adding the active substance in the form of a suspension in the remaining part of the lipophilic ingredient, then the mass is homogenized until uniform and cooled.

THE TYPICAL EXAMPLE. Prepare a mixture of white beeswax and lip�philic ingredient heating the lipophilic ingredient (petrolatum, part of liquid paraffin and oil of castor seeds ordinary) with white beeswax to a temperature of 65-75°C. Then the mass is stirred until uniform, then the basis of the active substance is administered in the form of a suspension in liquid paraffin at a temperature of 55-65°C. Then the mass is homogenized until uniform and cooled.

The resulting composition on the basis of methylprednisolone aceponate meets the regulatory requirements for microbiological purity.

Specific examples of the invention presented in the Table.

The resulting compositions meet the requirements of the pharmaceutical agent and have a shelf life of more than 2 years.

Pharmaceutical composition for external use in the treatment of diseases of the skin as an ointment, comprising as active ingredient methylprednisolone aceponate in a therapeutically effective amount and a lipophilic base, characterized in that it contains as lipophilic bases petrolatum, liquid paraffin and oil of castor seeds ordinary and additionally white beeswax with the following ratio of ingredients, g/100 g of composition:
Methylprednisolone aceponate - 0,03-0,18
Lipophilic base - 69,9-95,0
Beeswax white - 4,9-30,0



 

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