Method for transdermal transfer of active substances with use of peg-12 dimethicone niosomes

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and cosmetology and can be used for the effective transdermal delivery of the wide range of active substances (AS). What is declared is a method for the transdermal delivery of the active substances as a part of PEG-12 dimethicone niosomes characterised by the fact that the AS are included into the niosomes in the concentration of 10% by homogenising gel containing 10% niosomes in the homogeniser APV.

EFFECT: invention provides the higher transdermal effect of the interstitial delivery of the AS as a part of the niosomes.

3 tbl, 2 dwg

 

The invention relates to medicine and cosmetology and can be used for delivery of active substances in the tissues of the body through the skin without mechanical damage and destruction of the integrity of the lipid layer of the epidermis.

The inclusion of active substances in neosome based on PEG-12 Dimethicone with treatment in AR the homogenizer provides effective prolonged dosage transdermal delivery of active substances into cells of tissues, disrupting their integrity.

Nozomi consist of a shell of water-insoluble double layer nonionic emulsifier PEG-12 Dimethicone, on structure similar to the structure of elementary biological membranes and the prisoner inside the capsule and / or the wall depending on the lipophilicity of the active substance. Dimethicone copolyol, forming Nozomi, are Hypo-allergenic compounds of oxygen, hydrogen, silicon and carbon. The presence of covalent bonds Si-Ow hydrophobic part of the molecule polydimethylsiloxanes basis of emulsifier, which has high elasticity and reactivity, can be directed to deliver in the tissue of a wide range of active substances: antibiotics, vitamins, plant and animal extracts, low molecular weight peptides using reactive sites and purposefully them is to puskat of vesicles.

A known method of delivery of biologically active substances using siloxane emulsifiers (U.S. patent - US Patent 5364633. Silicone vesicles and entrapment, 15/11/1994), the essence of which consists in the inclusion of water-soluble biologically active substances in vesicles formed from siloxane surfactants, pre-dissolving substance and its involvement in the vesicles adding siloxane surfactants, easy mixing, further remove excess water and BAS.

The disadvantage is the poor reproducibility of the vesicles, accompanied by the formation of micelles (defective vesicles with small internal volume), and, as a consequence, the lack of inclusion of active substances in vesicles. This is accompanied by an increase in consumption siloxane emulsifier that can cause possible skin irritation and appreciation of the target product.

As the closest analogue may serve as a technical solution disclosed in the patent of the Russian Federation 2383328, where for the transfer of active substances through the skin and uses transdermal carriers - Nozomi representing complexes of amphiphilic molecules PEG 12 Dimethicone surrounding the active components. Paving their way through the epidermal barrier, vector pulling BAS. As BAS gel used extract stem cells placed the s pigs, hyaluronic acid, avocado oil, concentrate Actiflow laboratory SILAB (France) containing polysaccharides and vitamin PP. The content of the NRENs based on PEG 12 Dimethicone in the composition of the gel is 10-30 wt.%.

The disadvantage of the prototype is a low percentage of active substances because of their high molecular weight, a large scatter of values of the NRENs from 10 to 10000 nm, which makes it impossible to overcome the skin barrier for large molecules complicates the standardization of the final product, resulting in reduced therapeutic efficacy and additional costs.

The aim of the invention is to increase the transdermal effect of interstitial delivery of active substances in the composition of the NRENs. This goal is achieved by application of APV homogenizer, allowing to obtain low molecular weight components.

In relation to the prototype, the claimed invention is that derived from PEG-12 Dimethicone neosome have a high transdermal effect due to the use of APV homogenizer (APV Lab Series Homogenizers). This increases the percentage of inclusion of active substances (as) and standardizes the size of the NREN, which ultimately improves the efficiency of transdermal interstitial delivery.

The invention

Nozomi obtained from PEG-12 Dimethicone enabled in the internal volume of the active substances with APV homogenizer, represents complete multilamellar patterns standard size from 20 to 100 nm (Fig.1), including a high percentage of immobilized AU, stable during storage.

Stability of silicon particles against agglomeration largely depends on the electrostatic stability, due to the value of Zeta-potential of more than +30 mV or below -30 mV. Values of Zeta potentials of the samples of the NRENs that are defined on a Zetasizer nano ZS, amounted to range from 49,4 to 54.6 mV mV (Fig.2). The proposed method has good reproducibility and a high percentage of inclusion of active substances in neosome based on PEG-12 Dimethicone.

The implementation of the invention

As AC to encapsulate in neosome based on PEG-12 Dimethicone it is possible to use various pharmacological substances, extracts of plant and animal origin. In the examples shown the ability to achieve a technical result, when the encapsulation in various compositions of dihydroquercetin, oak bark extract, placental cells of animal origin, ascorbic acid, tocopherol acetate.

For implementing the method it is proposed to use a gel containing Nozomi for the treatment and prevention of periodontal disease. Mnogonapravlennostj action gel allows you not only to remove vasyapavlova periodontal disease, but to fight the causes of this disease. Nozomi obtained from PEG-12 Dimethicone enabled in the internal volume of dihydroquercetin, oak bark extract and extract of placental cells of animal origin using APV homogenizer, represents complete multilamellar patterns standard size from 20 to 100 nm. The use of silicon nanocontainers - NREN, allows the delivery of active substances into the deeper layers of the periodontium, and not work locally on the surface of the damaged mucosa of the oral cavity.

To objectively assess the periodontal condition of patients KGKG before treatment has allowed the study of the performance index: ACA, PI, CPITN, IG. The average value of the index PI (0.96±0.12) was characterized by the presence of inflammation in the gums. Figure ACA (18.52±2.04) reflected the predominant localization of inflammatory process in gingival nosochkah and marginal part of the gums. The CPITN index (0.98±0.17) testified about the need for therapeutic measures, in compliance with the rules of hygiene for the care of mouth and local drug therapy. The average value of IG (1.84±0.39) characterized the General hygienic condition of the oral cavity of patients as satisfactory.

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Table 1
Values of periodontal indices before and after application of dental tools
Subgroup 1Dental toolsPeriodontal indexes
ACA %PICPITNIG (points)
before the treatment
holds 18.52±2,040,96±0,120,98±0,171,84±0,19
directly after the treatment
0.05% of R-R chlorhexidine4,87±0,26*0,37±0,05*0,23±0,06*1,24±0,06*
25% tincture11,73±1,21*0,55±0,16*0,26±0,45*1,31±0,18*
3noamany gel with speakers made by mechanical shaking2,48±0,42* 0,14±0,03*0,15±0,02*1,16±0,05*
4noamany gel with speakers made at AR homogenization0,46±0,07*0,04±0,01*0,06±0,01*1,04±0,03*
*P≤0.05 compared with the data before the treatment.

Index evaluation of periodontal directly after the treatment with investigational drugs showed that reliable advantage possessed noamany gel with speakers made at AR homogenization, the use of which not only quickly eliminate the signs of inflammation, but also improved the hygienic condition of the periodontium.

Most high therapeutic activity was observed in gel with 10% content of the NREN, having in its composition dihydroquercetin 1% and oak bark extract 0,5%.

Examples of the transfer of hydrophilic and lipophilic speakers using the nios-based PEG-12 Dimethicone serve as a 5% solution of ascorbic acid and 5% oil solution of tocopherol acetate. These components may be used as antioxidants for the prevention of damaging effects on the body and treatment of complications in combined treatment of cancer patients.

1.1. Phase And prigotovlyu is carried out at room temperature by mechanical mixing of the components in the mixer.

The manufacturing phase B is produced by adding 2% PEG-12 Dimethicone to 5% solution of ascorbic acid in a separate container. The process was performed at room temperature and intensive mechanical shaking on the shaker for 5 minutes. Phase B containing 5% by NRENs, contribute to the phase a under stirring. In order to stabilize the concentration of hydrogen ions (pH) to 6.6-7.0 and the formation of gel structure making phase, resulting gel process AR the homogenizer APV Lab Series Homogenizers - 1000 (Phase D).

1.2. Is similar to example 1, except that the nios payable at 10%.

1.3. Is similar to example 1, except that the NRENs to be paid in the amount of 15%.

Phase preparation and formulation of the gel with ascorbic acid are presented in table 2.

№ p/pTable 2
Phase preparation and formulation of the gel with ascorbic acid
Ingredient nameContent in % (by weight)
Phase And
1Distilled water100
2 Preservative0,05
3Gelling2,5
4Perfume0,15
5Hyaluronic acid0,1
Phase B
6Nozomi containing ascorbic acid5,10,15

Phase G
7Triethanolamine2,0
Phase D
8The treatment gel on AR the homogenizer

2. Method transdermal transport of lipophilic active substances under item 1, characterized in that they are pre-mixed in a separate container with PEG-12 Dimethicone.

For example, lipophilic deliver the active substance in the sample, we used 5% oil solution of tocopherol acetate.

2.1. Phase And is prepared at room t is mperature by mechanical mixing of the components in the mixer.

The manufacturing phase In different pre-mix 2% PEG-12 Dimethicone with 5% oil solution of tocopherol acetate in a separate container and then adding distilled water. The process was performed at room temperature and intensive mechanical shaking on the shaker for 5 minutes. The phase containing 5% emulsion by NRENs, enrolled in the phase a under stirring. In order to stabilize the concentration of hydrogen ions (pH) to 6.6-7.0 and the formation of gel structure making phase, resulting gel emuleret on AR the homogenizer APV Lab Series Homogenizers - 1000 (Phase D).

2.2. Is similar to example 1, except that the emulsion of the NRENs based on PEG-12 Dimethicone is payable at 10%.

2.3. Is similar to example 1, except that the NRENs based on PEG-12 Dimethicone paid in the amount of 15%.

Phase preparation and formulation of the gel with the oil solution of tocopherol acetate are presented in table 3.

Table 3
Phase preparation and formulation of the gel with tocopherol acetate
№ p/pPhase preparation and formulation of the gel with tocopherol acetate

Ingredient nameContent in % (by weight)
Phase And
1Distilled water100
2Preservative0,05
3Gelling2,5
4Perfume0,15
5Hyaluronic acid0,1
Phase
7Nozomi containing the lipid fraction (5% oil solution of tocopherol acetate)5,10,15
Phase G
8Triethanolamine2,0
Fasad
9The treatment gel on AR the homogenizer

In the course of studies on the formation of gels with retained is eaten by NRENs 5, 10 and 15% of the experimentally established that the highest stability have compositions with 10% content of the NRENs based on PEG-12 Dimethicone (the State Pharmacopoeia of the USSR, XI edition, Issue 2).

The highest percentage of water-soluble compounds: 60-82% and fat-soluble compounds in Nozomi: 78-91%, was determined titrimetrically (the State Pharmacopoeia of the USSR, eleventh edition. Issue 2) was observed when the concentration of the active compounds 10% after exposure to APV homogenizer.

Method of transdermal delivery of active substances (as) in the composition of the NRENs obtained from PEG-12 Dimethicone, characterized by the fact that speakers are included in neosome at a concentration of 10% by homogenization on the AR the homogenizer gel containing 10% by NRENs



 

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