Microbiologically stable pharmaceutical composition containing electrochemically activated saline and using it

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to a microbiologically stable pharmaceutical composition containing an active agent specified in prostaglandins, and a carrier. The carrier contains an aqueous electrochemically activated saline containing 1 to 500 mg/l of free chlorine and having an oxidation-reduction potential from +150 to +1350 mV. The active agent is present in a phase separated from the electrochemically activated saline; the electrochemically activated saline is a hypochlorite solution.

EFFECT: invention refers to using the pharmaceutical composition for treating and/or preventing dry eye syndrome and for cleansing contact lenses.

14 cl, 5 tbl, 2 ex

 

The invention relates to pharmaceutical compositions comprising an active ingredient and a carrier in which the carrier includes an aqueous electrochemically activated salt solution.

Annolyte® or Imecalyte® is a neutral electrochemically activated salt solution, which is a highly effective disinfectant. This activated solution can be obtained by electrolysis of sodium chloride. It can be applied in areas such as disinfection, for example, workstations, tables, floor, etc., for cold sterilization procedures, in agriculture for the removal of microorganisms for cleaning and washing, swimming pools and even for the prevention of athlete's. Device for the production of electrochemically activated neutral salt solutions is described in EP-A-1 728 768 incorporated herein by reference. The applicant, however, has no knowledge of the application of such solutions as carriers in pharmaceutical compositions.

WO 2004/031077 discloses a device for producing a biological solution by the electrolytic treatment of aqueous salt solutions. The contents of this document are incorporated herein by reference.

WO 2005/065388 discloses an aqueous solution with a redox potential and its use as a means of sanitizing�and or for treatment of wounds. The contents of this document are incorporated herein by reference.

The subject of this invention is the use of an aqueous electrochemically activated salt solutions, in particular solutions of salts of hypochlorite, as carriers in pharmaceutical compositions. The pharmaceutical compositions preferably include at least two separate phases where the first phase includes the active ingredient and the second phase includes the media.

In a first aspect the present invention relates to pharmaceutical compositions comprising an active ingredient and a carrier in which the carrier includes an aqueous electrochemically activated salt solution with a content of free chlorine between 1 and 500 mg/l and a positive redox potential of between +150 and +1350 mV. The active ingredient is preferably physically separated from the media, for example, the active ingredient is present in a phase separated from the electrochemically activated salt solution. However, if the active ingredient is sufficiently stable in the presence of electrochemically active salt, a pharmaceutical composition may also consist of one phase, e.g. an aqueous solution.

In another aspect this invention relates to the use of an aqueous electrochemically activated salt solution with a content of free x�ora between 1 and 500 mg/l and a positive redox potential of between +150 and +1350 mV as a carrier for the manufacture of pharmaceutical compositions.

Aqueous electrochemically activated solution has a content of free chlorine (determined using amperometric measurements (DFD) in accordance with US 4278507 incorporated herein by reference), providing sufficient activity, such as disinfecting or antimicrobial activity, without a negative impact on the stability of the composition. The chlorine content can be adjusted by diluting the electrochemically activated salt solutions in relation to, for example, 1 part (volume) saline solution to 1 - 250 parts (by volume) physiologically suitable carrier, such as water, buffer or saline solution. Preferably, the chlorine content is from 1 to 500 mg/l, particularly preferably from 10 to 400 mg/l, and most preferably from 100 to 350 mg/L.

The redox potential of the electrochemically activated salt solution is at least about +150 mV, preferably at least +200 mV, more preferably +300 mV, even more preferably at least +400 mV, even more preferably at least +500 mV and up to +1330 mV, preferably up to +1200 mV. In some embodiments the redox potential is between +650 mV to +950 mV, especially from +700 to +900 mV. Electrochemically activated salt solution of predpochtitel�but is a solution of alkali metal hypochlorite, for example, a solution of lithium hypochlorite, sodium or potassium. More preferably, the solution is a sodium hypochlorite solution.

Electrochemically activated salt solution generally has a pH of 2-8. In some embodiments the pH may be from 2-5, for example, from 2-4, 2-3 or 2-2,8. In other embodiments the pH may be from 5 to 8, in particular from 5.9 to 7.6 and more specifically, from 6.7 to 7.4.

The content of chlorate and/or the content of chlorite is preferably below the toxic level, for example below 10 mg/L. in addition, the solution is preferably free from detectable amounts of radicals such as Oh radicals, and ozone. In addition, the solution is preferably free from heavy metal ions, e.g., ions from Mo.

The active ingredient may be any medicament suitable for use in humans or in veterinary medicine, for example, selected from hydrophilic active ingredients or of lipophilic agents. In some embodiments it is preferable that the active ingredient has been selected from lipophilic or amphiphilic ingredients, i.e. ingredients, with the distribution coefficient of butanol-water at least 0.5, preferably at least 1. In other embodiments the active ingredient is a hydrophilic ingredient such as a polysaccharide. For example, the active agent can be selected from agents for the treatment of�I glaucoma, for example, prostaglandins, such as latanoprost, beta-blockers, such as timolol, agents to reduce elevated intraocular pressure such as dorzolamide, agents for the treatment of dry eye syndrome (ophthalmic lubricants, such as hydroxypropylmethyl cellulose (polymer) and hyaluronic acid, and other pharmaceutically active agents.

Pharmaceutical composition of the present invention is stabilized against microbial degradation. Thus, the composition is suitable for multipurpose usage. Composition for multi-purpose applications may not even contain conventional preservatives.

The composition is resistant to microbial degradation preferably within 6 months, more preferably at least 12 months even when stored at room temperature. Preferably, the antimicrobial activity of electrochemically activated salt solution can be determined by measuring c×t concentration (C) and contact time (t) of the product in accordance with the method described Schleupen, GWF, 1996. Preferably, the value of c×t is 1 mg/l×min or less, more preferably 0.5 mg/l×min or less to obtain a reduction factor of 106against microorganisms, such as Pseudomonas aeruginosa and Legionella pneumophila.

The composition may be intended� for any type of application, for example, for local or systemic use. For example, the composition is intended for ophthalmic, intranasal, custom, local, pulmonary, mucosal, oral or intraperitoneal application, for example, for use by injection. Preferred compositions are intended for ophthalmic applications, for example for the treatment of glaucoma or dry eye syndrome.

In one preferred embodiment of the invention the pharmaceutical composition comprises a single phase comprising as an active ingredient, and electrochemically activated salt. In this embodiment the active ingredient is sufficiently resistant to degradation in the presence of chemically active salt. Suitable examples of active ingredients are polymers selected from polysaccharides and polymers of polyvinylpyrrolidone. Polysaccharides, for example, may be selected from cellulose or derivatives of cellulose, or of glycosaminoglycans, such as heparin, heparan-sulfate and hyaluronic acid. More preferably, the composition may include an ophthalmic lubricant and a carrier, wherein the carrier includes an aqueous electrochemically activated salt solution with a content of free chlorine, as described above, i.e., from 1 to 500 mg/ml, and redox potential, as described above, i.e., from +150 to +130 mV. Ophthalmic lubricant may be a polymer, e.g. a polysaccharide or a polyvinyl, for example, cellulose or cellulose derivative such as methylcellulose, or glycosaminoglycans, such as hyaluronic acid. Pharmaceutical composition is preferably a homogeneous aqueous solution. In this embodiment it is preferable that the composition is not present other active agents and/or preservatives. The composition in accordance with this embodiment can be used for the treatment and/or prevention of dry eye syndrome.

In another embodiment, the composition preferably forms at least two separate stages, in which the active agent is present in the first phase and electrochemically activated salt solution is present in the second phase, separated from the first phase. The first phase can be a solid suspended phase and a liquid hydrophobic phase or a solid or liquid phase having a barrier in relation to the second phase which is an aqueous phase comprising a carrier. Thus, the composition may be an emulsion, e.g. microemulsion, or liposomal composition, or microcapsular composition or dispersion in which the active ingredient may be emulsified or dispersed in the presence of the optional carrier, n�example, lipophilic carrier and/or surfactants, in aqueous media. The active agent can thus be physically separated from the electrochemically activated salt solution.

Particularly preferred are micro-emulsions, as described in EP 07 008 347.1 incorporated herein by reference.

In addition to the active agent and the electrochemically activated salt solution, the composition may contain other known ingredients, such as buffers, adjuvants, auxiliary agents, fillers, diluents, etc.

The composition of the invention can be used in human or in veterinary medicine.

Another aspect of this invention relates to the use of electrochemically activated salt solution described above, for cleaning contact lenses, for example, glass or plastic contact lens. In this embodiment, the solution may not contain any active agent or may include an active agent such as a polymer, as described above.

Another aspect of this invention relates to the use of electrochemically activated salt solution described above for washing body cavities, for example, as a solution for intranasal, ophthalmic, or custom application. In this embodiment, the solution may not contain any active Angora�and or may include an active agent, for example, a polymer as described above.

Further, the present invention is described in more detail using the following examples.

Example 1. Preparation and characterization of microemulsion with electrochemically activated saline solution as a carrier

1.1. The composition of test formulations

Prepared following microemulsions comprising 0,0050% latanoprost as the active ingredient. All percentages are mass.

1.2. The stability of latanoprost in the microemulsions IMECALYTE®

The stability of latanoprost in the microemulsions comprising electrochemically

activated salt solution (IMECALYTE®) as a carrier was determined by HPLC. As a comparison, we analyzed the stability of latanoprost in solutions IMECALYTE®.

The amount of latanoprost (µg/ml) after storage at room temperature for specified time periods was as follows:

The results showed that latanoprost is protected from degradation caused IMECALYTE® in the formulation of microemulsions ME and ME2. In contrast, latanoprost was unstable in solutions IMECALYTE®. 0.5% IMECALYTE® significant degradation was observed after two weeks. A 10% solution IMECALYTE® latanoprost completely destroyed in a few minutes.

1.3. Antimicrobial act�emergency supply

We analyzed the activity of microemulsions containing latanoprost against the growth of microorganisms Staphylococcus aureus and Pseudomonas aeruginosa. The initial concentration of S. aureus amounted 2,82×105/ml for ME and ME2, and 1.7×106/ml for M3 and ME. The initial concentration of P. aeruginosa was 2.15×106/ml for ME and ME2, and of 3.18×105/ml for M3 and of 3.18×106/ml for ME.

After 14 days it was observed viable microorganisms S. aureus and P. aeruginosa (concentration<10/ml) in ME, M3 and ME. In ME2 after 28 days was found organisms S. aureus. However, in ME the growth of P. aeruginosa was significantly inhibited.

The results of example 1 showed that the active ingredient, such as latanoprost, was protected from degradation in the microemulsions based on IMECALYTE®. In addition, these microemulsions exhibit significant antibacterial properties.

Example 2. Preparation and characterization of formulations of hyaluronic acid-based IMECALYTE®

Were prepared following the formulations of hyaluronic acid. All percentages are by mass percent.

Analyzed, does IMECALYTE® significant influence on the properties of the formulations, such as the droplet. The contact angle of drops separated control on the paper surface was measured immediately after production of formulations HS1 and HS2 and after XP�tion for three months at room temperature. For comparison, a formulation of hyaluronic acid corresponding to HS2 (but without IMECALYTE®).

The following results were obtained:

In addition, we determined the spreading of the separated drops of different formulations of hyaluronic acid immediately after production (t=0) and after storage for three months at room temperature (t=3 months).

The above results showed that IMECALYTE® has no significant effect on characteristics of separation drops formulations of hyaluronic acid. The quality of separation and the formation of drops of solutions based on IMECALYTE® was very good.

In addition, it was determined the antimicrobial activity of formulations of hyaluronic acid-based IMECALYTE®. As a test organisms used S. aureus (initial concentration 7,27×105ml) and P. aeruginosa (initial concentration of 1.29×106/ml). With the solution HS1 concentration of viable P. aeruginosa was below 102/ml after 6 hours. With S. aureus was not detectable viable organisms after 14 days. With recipes HS2 viable microorganisms P. aeruginosa was not determined 7 days later. Viable microorganisms S. aureus was not detectable after 14 days.

The above results showed that formulations of hyaluronic acid-based IMECALYTE� are stable and possess antimicrobial activity.

1. Microbiologically stable pharmaceutical composition comprising an active agent selected from prostaglandins, and a carrier, wherein the carrier includes an aqueous electrochemically activated salt solution with a content of free chlorine between 1 and 500 mg/l and a redox potential of between +150 and +1350 mV, and the active agent is present in a phase separated from the electrochemically activated salt solution, and electrochemically activated salt solution is a solution of hypochlorite.

2. A composition according to claim 1, in which the chlorine content is from 10 to 400 mg/l, in particular from 100 to 350 mg/L.

3. A composition according to claim 1, in which the redox potential is from +650 to +950 mV, in particular from +700 to +900 mV.

4. A composition according to claim 1, in which the electrochemically activated salt solution is a solution of sodium hypochlorite.

5. A composition according to claim 1 in which the hypochlorite solution has a pH from 2 to 8.

6. A composition according to claim 1, intended for ophthalmic, intranasal, custom, local, mucosal or oral application.

7. A composition according to claim 1, in which the active agent is present in the suspended solid phase, a liquid hydrophobic phase or a solid or liquid phase, with the barrier relative to the electrochemically activated salt solution.

8. A composition according to claim 1, yavlyayuschayasya or dispersion.

9. The use of an aqueous electrochemically activated salt solution with a content of free chlorine between 1 and 500 mg/l and a redox potential of between +150 and +1350 mV as a carrier for the manufacture of pharmaceutical compositions according to claim 1, wherein the electrochemically activated salt solution is a solution of hypochlorite.

10. The use of electrochemically activated salt solution with a content of free chlorine between 1 and 500 mg/l and a redox potential of between +150 and +1350 mV for cleaning contact lenses, and electrochemically activated salt solution is a solution of hypochlorite.

11. Microbiologically stable pharmaceutical composition comprising ophthalmic lubricant selected from polyvinylpyrrolidone, cellulose, hydroxypropylmethylcellulose or hyaluronic acid, and a carrier, wherein the carrier includes an aqueous electrochemically activated salt solution with a content of free chlorine between 1 and 500 mg/l and a redox potential of between +150 and +1350 mV, and the electrochemically activated salt solution is a solution of hypochlorite.

12. A composition according to claim 11, which represents an aqueous solution.

13. A composition according to claim 11, containing additional active agents and/or preservatives.

14. Use of the composition according to claim 11 for the treatment and/or prophylaxis of syndrome dry�about the eyes.



 

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