Pharmaceutical composition in form of solution for injection and method for production thereof

FIELD: chemistry.

SUBSTANCE: invention discloses a pharmaceutical composition in the form of a solution, having nootropic and neuromodulating activity, characterised by that it contains N-carbamoylmethyl-4-phenyl-2-pyrrolidone as an agent, hydroxyethyl starch as an auxiliary substance and water for injection. The invention also relates to a method of producing such a pharmaceutical composition, which includes adding hydroxyethyl starch to the water for injection which is preheated to 85-90°C and mixing until complete dissolution, adding N-carbamoylmethyl-4-phenyl-2-pyrrolidone powder and mixing at temperature of 75-85°C until complete dissolution, adding water for injection to obtain the end volume of the solution and mixing once more, holding the obtained solution for 35-40 minutes at temperature of 75-85°C, cooling to 20-30°C, sterilising by filtering through filters with pore diameter of 0.22 mcm and packing in ampoules, which are further sterilised for 8 minutes at temperature of 120°C.

EFFECT: composition is effective, safe and can be used for a long period of time.

2 cl, 3 ex

 

The invention relates to the field of medicine, pharmaceutical industry and relates to means possessing neuroprotective and neuromodulatory activity.

Nootropic drugs belong to the group of most frequently used drugs in borderline mental disorders and psychosomatic disorders along with anxiolytics and antidepressants. This group includes drugs that can have a direct activating effect on the processes of learning, improve memory and mental activity, as well as improve brain resistance to corrosive influences. Nootropic drugs (gr. noos - thought and tropos - direction) have a direct activating effect on metabolic processes in the Central nervous system, increase energy opportunities neurons exert a protective effect when functioning in conditions of hypoxia, stimulates mental activity, improve memory, ensure accelerated learning processes.

Fundamentals of nootropic concept was developed 1980's, when after a successful introduction in clinical practice of the first drug in this class - piracetam (2-oxo-1-pyrrolidone-ndimethylacetamide; Nootropil, firm, USB, Belgium, 1977) - began to appear other drugs pyrrolidone series. Currently, the collection pyrrolidineethanol includes more than 10 original drugs, of which the most famous piracetam, oksiratsetam, aniracetam, etirazetam and pramiracetam.

To nootropic drugs of new generation is the drug Fenotropil® or N-carbarnoyl-methyl-4-phenyl-2-pyrrolidone, which are registered and approved for commercial production by the Russian Ministry of health in 2003 in the form of tablets. Unlike other nootropics he has a wider range of pharmacological activity. N-carbarnoyl-methyl-4-phenyl-2-pyrrolidone improves cognitive function, learning and memory, has a stimulating, antihypoxic, anxiolytic, antiaggressive, anticonvulsant, analgesic, antidepressant, vegetal stabilizing, anorectic action, improves cerebral circulation, increases efficiency and resistance to extreme influences (Range of pharmacological effects of Fenotropil, V.I. Agapkina, FARMATEKA No. 13, 2005 ).

Tablets may not be used as a means of emergency medicine. Usually in these cases it is necessary to introduce solutions for injection. However, fenotropil is not easily soluble substance, the solubility of the substance of fenotropil 1.7%. Therefore, in the prior art, attempts were made to increase the solubility of the substance.

Known patents from RU 2414898 C1 (priority from 18.09.2009). The aim decided what I specified patent is the creation of a stable injectable dosage forms fenotropil with high bioavailability and method of reception. The goal is solved by means in the form of a solution for injection that contains fenotropil and solvent consisting of 2-hydroxypropyl-β-cyclodextrin and water for injection in the following ratio of components per 100 ml of solution:

Fenotropil2,0-4,0 g
2-hydroxypropyl-β-cyclodextrin12,0-24,0 g
Water for injectionto 100 ml

To obtain the dosage form in the reactor is placed, the calculated amount of water for injection, then the calculated amount of fenotropil and cyclodextrin are dissolved under stirring for 30 minutes. The solution is filtered through membrane filters Millipor with a pore diameter of preferably through a filter with a pore size not exceeding of 0.30 μm, most preferably through a filter with pore size 0.22 μm, poured into ampoules of neutral glass, sealed and subjected to sterilization at a temperature of 120°C for 15 minutes.

A disadvantage of the known compositions is that during storage of the composition reduces the amount of active ingredient and impurities are formed.

Known Patent RU No. 2327458, publ. 27.06.2008 concerns the solution of fenotropil for injection containing fenetre the sludge and solvent, which the solvent comprises a mixture of polyethylene glycol (PEG), ethyl alcohol and water for injection with the following content of components per ml solution:

Fenotropil0,02-0,6 g
The polyethylene glycol 200-6000,1-0,35 ml
Ethyl alcohol 95-96,5%0,1-0,35 ml
Water for injectionrest

The solution is prepared by dissolving fenotropil in ethyl alcohol, polyethylene glycol and adding water for injection, followed by sterilization by filtration, preferably through a filter with a pore size of 0.1 to 1.0 μm, most preferably through a filter with a pore size of 0.45 µm.

Although the source mentions the task of stabilization, the solution is also not sufficiently stable in storage since found the content of impurity - 2-pyrrolidone. That may slightly reduce the effectiveness of the tool.

In the international application WO 2013043085 A1 (nearest equivalent) described substance crystalline powder fenotropil and liquid forms. Tween 80 and cyclodextrins increase the solubility of Phenotropil in the water. Sterile 0.001 to 3%solutions of Phenotropil in the presence of cyclodextrin or Twin room (water for injection, Fenotropil, cyclodextrin (or solution Twin) is prepared by thorough mixing for 30 minutes, then filtered, poured into ampoules of neutral glass, sealed ampoules and subjected to sterilization for 15 minutes at a temperature of 120°C). Sterile solutions are stable when stored for at least 12 months.

Tween 80 is widely used in pharmaceutical practice as a solubilizer and emulsifier, including solutions for injection.

However, it is known that he, like other neionogennye surfactant has a denaturing effect. Therefore, it is undesirable long-term administration of surfactant in the body.

It is known that fenotropil not metabolized in the body and is excreted unchanged. The half-life is 3-5 hours.

In some cases, when injected large doses of the drug, the pharmacokinetic changes in General. Thus, there is a need for a safe drug that can permanently be entered in the patient's body.

The objective of the invention is to provide a safe effective drug prolonged action, possessing neuroprotective and neuromodulatory activity.

The problem is solved a new pharmaceutical composition in the form of solution for injection, with neuroprotective and neuromodulatory activity, characterized by the fact, which it includes as the active agent N-carbamoylmethyl-4-phenyl-2-pyrrolidone, as auxiliary substances gidroxiatilkrahmal 200/0 .5 and water for injection in the following ingredients, g / ml:

N-carbamoylmethyl-4-phenyl-2-pyrrolidone0,018-0,022
Gidroxiatilkrahmal 200/0 .50,027-of 0.066
Water for injectionrest

Brief description of the technological process.

Water for injection is heated to 85-90°C. Add gidroxiatilkrahmal and stirred until complete dissolution. Add the powder substance N-carbamoylmethyl-4-phenyl-2-pyrrolidone and stirred at a temperature of 75-85°C until complete dissolution. Typically (but not necessarily, depending on the type of mixer) mixing is carried out at a rotation speed of the stirrer at 400 rpm Add water for injection to obtain a final volume of solution of a given concentration and again mix. The resulting solution was incubated for 35 to 40 minutes at a temperature of 75-85°C and cooled to 20-30°C. the resulting solution is sterilized by the method of filtration through filters with a pore diameter of 0.22 μm and Packed in ampoules, which further sterilized for 8 minutes at a temperature of 120°C.

Effect: create a new PR is paratively form, which can long be entered into the patient through the improvement of excipients that have a major impact on the pharmacokinetics of the active agent and the reduced formation of undesirable impurities during storage.

In addition, the use in the solution of hydroxyethylamine (HES) 200/0 .5 (with an average molecular weight of about 200,000 Da and a degree of substitution of about 0.5) as complexone provided the required 1.8-to 2.2-percent concentration that provides the desired therapeutic effect and the possibility of long-term use of the drug. Although the present invention BSE is used as an auxiliary substance, its known properties (action aimed at the improvement of microcirculation in the stroke brain, when occlusive diseases of the peripheral arteries, in violation of blood supply to the organs of sight and hearing, and others) allow you to increase the effectiveness of the treatment.

The possibility of carrying out the invention can be demonstrated by the following examples:

Example 1

A method of obtaining a 2%-aqueous solution of N-carbamoylmethyl-4-phenyl-2-pyrrolidone.

On the remote control set temperature range water for injection in the reactor 85-90°C. Served in the reactor water in the amount of 120 HP, weighed On electronic scales with accuracy of 0.001 g hydroc italtractor in the amount of 9 kg The sample is transferred into the reactor and stirred for 10 minutes to dissolve when the rotation speed of the stirrer at 400 rpm Completeness of dissolution checked visually: the solution should be transparent. The capacity of the rinse water 5 l twice and added to the General solution in the reactor. Add the powder substance N-carbamoylmethyl-4-phenyl-2-pyrrolidone in an amount of 3 kg and stirred for 20 minutes at a temperature of 80°C until complete dissolution when the rotation speed of the stirrer at 400 rpm Completeness of dissolution checked visually: the solution should be transparent. The capacity of the rinse water 5 l twice and added to the General solution in the reactor. Add water for injection to obtain 150 l of a solution and again stirred for 5 minutes while operating the stirrer at a speed of 400 Rev/min the resulting solution was incubated for 40 minutes at a temperature of 75-80°C and cooled to water temperature 20-30°C. the resulting solution was sterilized by filtration method in a stream of nitrogen through a Durapore filters type CVGL with a pore diameter of 0.22 μm. The solution is supplied from the reactor in a stream of sterile nitrogen under a pressure of 0.7-1.0 MPa. Sterile solution is Packed in ampoules of neutral glass in a stream of sterile air cleanliness class And 5 ml. Ampoules sealed and sterilized for 8 minutes at a temperature of 120°±1 ° C.

The resulting solution contains

N-carbamoylmethyl-4-phenyl-2-pyrrolidone0.02 g
Gidroxiatilkrahmal0.06 g
Water for injectionto 1 ml

The values of the pharmacokinetic parameters showed no significant deviations in the study during long-term use.

Example 2

The study of identity and content of impurities during storage. The samples were stored under standard conditions defined regulatory requirements within 12 months.

UV-spectrophotometry. UV absorption spectra of the test solution and the standard solution sample fenotropil prepared to quantify, in the region from 230 to 350 nm have maxima and minima at the same wavelengths. The measurements were carried out relative to the reference solution.

Impurities was determined by thin layer chromatography on plates "TLC Silica gel 60 F254".

Standard sample: fenotropil (Federal state unitary enterprise "special design "Technology", Russia).

The solution for spraying. 0,016 g o tolidine placed in a volumetric flask with a capacity of 50 ml, add 3 ml of acetic acid ice, shake the flask to dissolve the sample, add 30 ml of water and 0.1 g of potassium iodide, mix, annual the Yat solution volume to the mark with water and mix.

Assessment of impurities in the drug solution of the standard sample fenotropil conduct at the time of manifestation solution of o tolidine.

The impurity content of less than 0.2%. Not found the content of 2-pyrrolidone.

Example 3

Definition of pharmacological activity.

Antiamnesic effects of Fenotropil studied in rats using the method of the conditioned reflex of passive avoidance (passive avoidance reaction) using electroshock [Belousov SHE, Mukhina M.A., Fenotropil - nootropic drug of the new generation. Good clinical practice No. 3, 2005]. The solution fenotropil at a dose of 12.5 mg/kg was fully restored memory. At higher doses the effect was stronger and was much higher than piracetam (control 300 mg/ml).

Antihypoxic effect of Phenotropil studied in mice in hypobaric and normobaric models of hypoxia. The protective effect of the drugs was assessed by the life expectancy of animals. Fenotropil significantly increased the lifespan of mice in the chamber already at a dose of 50 mg/kg

1. Pharmaceutical composition in the form of solution for injection, with neuroprotective and neuromodulatory activity, characterized in that it comprises as active principle N-carbamoylmethyl-4-phenyl-2-pyrrolidone, as auxiliary substances gidroxiatilkrahmal 200/0 .5 and module injection in the following ingredients, g per ml solution:

N-carbamoylmethyl-4-phenyl-2-pyrrolidone0,018-0,022
Gidroxiatilkrahmal 200/0 .50,027-of 0.066
Water for injectionrest

2. A method of obtaining a pharmaceutical composition according to claim 1, characterized in that in water for injection, pre-heated to 85-90°C, add gidroxiatilkrahmal and stirred until dissolved, add the powder substance N-carbamoylmethyl-4-phenyl-2-pyrrolidone and stirred at a temperature of 75-85°C until dissolved, add water for injection to obtain a final volume of solution and again mixed, the resulting solution was incubated for 35 to 40 minutes at a temperature of 75-85°C, cooled to 20-30°C, sterile filtration method through filters with a pore diameter of 0.22 μm and Packed in ampoules, which further sterilized for 8 minutes at a temperature of 120°C.



 

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