Pharmaceutical composition in form of capsule possessing antiviral, anti-inflammatory, antimicrobial and immunomodulatory action

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine and concerns a pharmaceutical composition in the form of a capsule either acid-resistant, or with an acid-resistant coating containing recombinant interferon specified from alpha, beta, gamma recombinant interferon; a stabiliser of the biological, physical and chemical properties specified in low-molecular polyvinylpyrrolidone, macrogol 400-12000, propylene glycol, hydroxypropyl methylcellulose; a stabiliser of microbial contamination resistance specified in dexamethasone, diflorazone, boric acid, phospholipids, cyclodextrins, calcium stearate, and/or magnesium stearate, a thickly-forming base specified in hydrophilic, lipophilic, hydrophilic-lipophilic bases.

EFFECT: invention provides a higher therapeutic effect and prolonged shelf life.

3 cl, 4 ex

 

The invention relates to medicine and the pharmaceutical industry and relates to a composition having antiviral, anti-inflammatory, antimicrobial and immunomodulatory action for the prevention and treatment of hepatitis, SARS, influenza, herpes, cancer.

Renowned pharmaceutical composition in the form of a capsule containing acetylcellulose, which in the presence of cytokines and specific additives is subjected to colloidal microgranulate with the formation of the final product of the fibrous structure with inclusions of cytokine and special additives. Well-known dietary Supplement as a cytokine may contain recombinant α-interferon. Moreover, the number of acetylcellulose is 30-80 wt.%. Known biologically active food Supplement can be a tablets, granules, capsules (patent RU №2129394, 27.04.1999, A23L 1/305, 1/29, AK 9/22, 38/21).

Closest to the technical essence and the achieved result is a pharmaceutical composition in the form of a capsule, which has antiviral and antimicrobial activity, which is a mixture for forming the contents of the capsules containing recombinant human interferon-α, swelling substance and targeted supplements. This composition contains a hydrophilic conglomerate recombinant human is on interferon-α, the adsorbed ethylene glycol 4000-6000, poliglyukin and the amendment, which is selected from the range: maltose, mannitol, glucose, fructose, with a particle size less than 250 microns, not greater than the average particle size of swelling and dispersing agents, swelling and dispersing agent selected from the range: cellulose, methylcellulose, acetylcellulose, sodium carboxymethyl cellulose, sodium croscarmellose, sodium starch glycolate, a mixture of sodium glycolate, starch and carboxymethyl cellulose, crosspovidone, cross-stitched carboximetilkrahmal, with a particle size of not more than 300 μm, and the target additive with a particle size less than 250 microns, not greater than the average particle size swelling and dispersing substances, with the following content of components in 1.0 g of composition:

Human recombinant interferon-α10000-3000000 ME
The glycol 4000-6000of 0.0001 to 0.5
Poliglyukin0,001-0,1
The amendmentof 0.01 to 0.8
Swelling and dispersing agent0,001-0,1
Target EXT the wka Rest

(patent RU №2292907 C1, AC 38/19, AK 9/20, 2007).

Known compositions do not provide the increased bioavailability of recombinant human interferon due to its stabilization at a discrete swelling and uniform dispersion of the composition in the aquatic environment.

The task of the invention to provide pharmaceutical compositions made in the form of capsules, for enhancing the bioavailability and stability of recombinant interferon containing recombinant interferon and stabilizer biological, physico-chemical properties and stabilizer resistance to microbial contamination, delivering the claimed drug in the gastrointestinal fluids, regulating drug release and hold him in the stomach for a long period.

The technical result to be obtained by the use of the invention is expressed in a high therapeutic effect of the claimed pharmaceutical composition with a long shelf life, which has antiviral, anti-inflammatory, antimicrobial and immunomodulatory action for the prevention and treatment of hepatitis, SARS, influenza, herpes, cancer, as well as helping to reduce recovery time in 2 times in comparison the prototype, due to the qualitative and quantitative selection of ingredients, including auxiliary.

To achieve the technical result of the pharmaceutical composition in the form of a capsule, which has antiviral, anti-inflammatory, antimicrobial and immunomodulatory effects containing recombinant interferon as a biologically active component and grease-forming base, characterized in that it contains the stabilizer of biological, physico-chemical properties, selected from the group of low-molecular polyvinylpyrrolidone, macrogol 400-12000, propylene glycol, hypromellose, contains the stabilizer of resistance to microbial contamination, selected from the group of: dexamethasone, diflorasone, boric acid, optionally the composition comprises phospholipids, cyclodextrins, calcium stearate and/or magnesium stearate, and as grease-forming the basis of the composition contains a base selected from the group of hydrophilic, lipophilic, hydrophilic-lipophilic base, in the following ratio of components, wt.%:

recombinant interferon, ME500-10000000
the stabilizer biological, physico-chemical properties0,0001-0,
the stabilizer resistance to microbial contaminationof 0.0001 to 0.1
phospholipids0,001-0,5
cyclodextrins0,001-0,5
calcium stearate0,001-0,1
and/or
magnesium stearate0,001-0,1
grease-forming baserest

The composition comprises recombinant interferon selected from the group: alpha-, beta-, gamma-interferon.

The capsule is made of acid or acid-resistant coating.

Spent an analysis of the prior art, including searching by the patent and scientific and technical information sources and identify sources that contain information about the equivalents of the claimed pharmaceutical compositions, has allowed to establish that the petitioners have not found a similar, characterized by signs, identical to all the essential features of the claimed composition.

The definition from the list of identified unique prototype allowed us to identify a set of essential for Rel is the solution to the apparent technical result of the distinctive features in the claimed composition, set forth in the claims.

Therefore, the claimed pharmaceutical composition meets the criterion of "novelty."

For verification of the compliance of the pharmaceutical composition, the applicants conducted an additional search of the known solutions to identify signs that match the distinctive features of the prototype of the characteristics of the claimed invention.

The search results showed that the composition of the claimed pharmaceutical composition does not follow for the expert in the obvious way from the prior art, certain applicants have identified no impact envisaged the essential features of the claimed invention transformations to achieve a technical result.

Therefore, the claimed invention meets the criterion of "inventive step".

The criteria of the invention "industrial applicability" is confirmed by the fact that the proposed pharmaceutical composition having antiviral, anti-inflammatory, antimicrobial and immunomodulatory effects, can be successfully used for the treatment and prevention of hepatitis, SARS, influenza, herpes, cancer. Due to the high stability of the pharmaceutical composition suitable for industrial production in the form of finished medicinal product and meets the requirements is contained in the Pharmacopoeia.

The invention is illustrated in the following examples.

Example 1

Mixed alpha-interferon, low-molecular polyvinylpyrrolidone, dexamethasone, phospholipids, cyclodextrins, calcium stearate, and as grease-forming bases - hydrophilic base. The composition used in the manufacture of capsules. The mass of the contents of one capsule average of 480 mg when the content of active ingredients and auxiliary substances. Capsule cover acid-resistant shell.

These components take the following ratio of components, wt.%:

Options
123
alpha-interferon ME50010000010000000
the low-molecular polyvinylpyrrolidone0,00010,0010,5
dexamethasone0,00010,0010,1
phospholipids0,0010,010,5
cyclodextrins0,0010,010,5
calcium stearate0,0010,010,1
hydrophilic basethe rest is up to 100

Example 2

Mixed beta-interferon, macrogol 400, diflorasone, phospholipids, cyclodextrins, magnesium stearate, and as grease-forming bases - lipophilic base. The composition used in the manufacture of capsules. Capsule cover acid-resistant shell. These components take the following ratio of components, wt.%:

Options
123
beta-interferon ME500100000 10000000
macrogol 4000,00010,0010,5
defloration0,00010,0010,1
phospholipids0,0010,010,5
cyclodextrins0,0010,010,5
calcium stearate0,0010,010,1
lipophilic basethe rest is up to 100

Example 3

Mixed gamma-interferon, macrogol 12000, boric acid, phospholipids, cyclodextrins, calcium stearate and magnesium stearate, as well as grease-forming bases - hydrophilic-lipophilic base. The composition used in the manufacture of capsules. Capsule cover acid-resistant shell. These components take the following ratio of components, wt.%:

Options
123
gamma-interferon ME50010000010000000
macrogol 12000,00010,0010,5
boric acid0,00010,0010,1
phospholipids0,0010,010,5
cyclodextrins0,0010,010,5
calcium stearate and magnesium stearate0,0010,010,1
hydrophilic-lipophilic basethe rest is up to 100

Example 4

Mixed alpha - and beta-interferon, propylene glycol, boric acid, FOSFA the lipids, the cyclodextrin, calcium stearate, and as grease-forming bases - hydrophilic base. The composition used in the manufacture of acid-resistant capsules. These components take the following ratio of components, wt.%:

Options
123
alpha - and beta-interferon ME50010000010000000
propylene glycol0,00010,0010,5
boric acid0,00010,0010,1
phospholipids0,0010,010,5
cyclodextrins0,0010,010,5
calcium stearate0,001 0,010,1
hydrophilic basethe rest is up to 100

As a result of the studies were first obtained the conglomerates of the components of the above pharmaceutical compositions with hydrophilic, lipophilic and hydrophilic-lipophilic bases, the combination of which capsules when used provides increased bioavailability of recombinant interferon due to its stabilization and conservation antiviral, anti-inflammatory, antimicrobial and immunomodulatory activity. Check the stability of the composition was carried out after 12 months and 24 months. The contents of each of the capsules were checked for compliance with the requirements of the Pharmacopoeia GF X1, issue 1, 2. Tested to 10 capsules of each formulation of the compositions. All values correspond to the claimed composition. Capsules and their contents kept the original color and compliance GF X1, 2), p.143.

Test methods of composition in experimental studies confirm the above about therapeutic effect. Experimental studies conducted with the use of influenza infection in outbred mice weighing 18-22 g On the basis of the obtained experimental data it was established that antiviral dei is a journey of the test samples for the duration of the incubation period confirms the conclusion of high influenza activity of the investigated compositions.

Thus, the proposed pharmaceutical composition provides for the use of high therapeutic effect with a pronounced antiviral, anti-inflammatory, antimicrobial and immunomodulatory activity for the prevention and treatment of hepatitis, SARS, influenza, herpes, cancer, helping to reduce recovery time.

1. Pharmaceutical composition in the form of a capsule, which has antiviral, anti-inflammatory, antimicrobial and immunomodulatory effects containing recombinant interferon as a biologically active component and grease-forming base, characterized in that the composition comprises a stabilizer biological, physico-chemical properties, selected from the group of low-molecular polyvinylpyrrolidone, macrogol 400-12000, propylene glycol, hypromellose, contains the stabilizer of resistance to microbial contamination, selected from the group of: dexamethasone, diflorasone, boric acid, optionally the composition comprises phospholipids, cyclodextrins, calcium stearate and/or magnesium stearate, and as grease-forming base composition comprises the basis selected from the group of hydrophilic, lipophilic, hydrophilic-lipophilic basis in the following ratio, wt.%:

recombinant interferon, ME500-10000000
the stabilizer biological, physico-chemical propertiesof 0.0001 to 0.5
the stabilizer resistance to microbial contaminationof 0.0001 to 0.1
phospholipids0,001-0,5
cyclodextrins0,001-0,5
calcium stearate and/or0,001-0,1
magnesium stearate0,001-0,1
grease-forming baserest

2. The composition according to claim 1, characterized in that it contains recombinant interferon selected from the group: alpha-, beta-, gamma-interferon.

3. The composition according to claim 1, characterized in that the capsule is made of acid or acid-resistant coating.



 

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