Method of obtaining composition with microdosaged agent

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention concerns method of obtaining composition, preferably ointment, including microdosaged and dispersible agent, involving the following production stages: - agent weighing inside input tank coated with Vaseline from inside; - agent capsulation by adding extra Vaseline; - adding input tank with Vaseline and agent to mixer containing excipient mix at 70°C to 90°C; - agent dispersion in mixer.

EFFECT: enhanced agent homogenisation degree in ointment excipients, prevented agent oxidation due to capsulation by Vaseline, limited exudation of paraffin oil included in excipient mix.

7 cl, 2 ex, 10 dwg

 

The present invention relates to a method for producing a pharmaceutical or cosmetic composition, preferably an ointment containing dispersible volume is decreased, the agent or active principle, which involves several stages of preparation:

1) a weighting agent or the applicable early inside the receiving tank, covered inside with vaseline;

2) encapsulation of the agent or the applicable start by adding additional quantities of vaseline;

3) the introduction of this receiving tank that contains the agent or the active principle and the vaseline in the mixer;

4) providing a dispersion agent or the applicable beginning in the mixer.

It is known that the manufacture of drugs with a low concentration of the active start due to problems of homogenization that acting early in the excipients. Indeed, the volume is decreased operating beginnings faced with problems of heterogeneity dispersion in the case when they are mixed with large amounts of excipients.

Such preparations usually require an intermediate phase dilution, which allows to obtain products with a low concentration of the active start.

An additional problem occurs when the active principle used belongs to a class of toxic substances. In addition, it is are manipulations are not only long, but also dangerous, which significantly increases the risk of unforeseen situations. This is also the problem of transportation and protection used toxic substances from light exposure and possible effects of oxidation.

The solution to this problem is provided in accordance with the invention using a new method of obtaining a composition containing the active principle, characterized in that the method comprises the following stages of preparation:

1) the weighting of the active substance within the receiving tank, covered inside with vaseline;

2) encapsulation or plugging of this active substance by adding additional quantities of vaseline;

3) introduction of a receiving tank containing the active principle and the vaseline in the mixer;

4) ensure that the dispersion of the beginning of the current in the mixer.

The implementation of these stages helps to ensure a gain in time and in quality of the final product when obtaining a homogeneous product.

Indeed, the continuous dispersion of the active substance from the receiving tank to the mixer is provided using the method in accordance with the invention, eliminates heterogeneous or non-uniform dispersion observed in the process of adding loads the relevant substances in the mixer chamber "in bulk", as is usually done in the past.

In addition, encapsulation of the applicable beginning in the shell of vaseline eliminates stage dilution of this existing start and to limit the risk of infection and unexpected situations during the handling of the active ingredient after weighing, in particular, in the course of its transportation into the mixer chamber.

Finally, the tightness provided when using the method in accordance with the invention, eliminates the problem of oxidation of this existing start and its decomposition due to exposure to light, thanks to the protection created by a capsule formed of vaseline.

Thus, the present invention provides, as a result of elimination of the intermediate stages of dilution, reducing the time of preparation of the corresponding composition.

Ointments are drugs for external use and are intended for direct application to the skin.

In the case when the active principle in the ointment is a solid, it poured as much as possible in a thin layer and propagate in the structure of this ointment using the principle of geometric dilution.

The principle of geometric dilution involves a series of stages of dilution. This dilution of nachine is consistent with the introduction of the active beginning in about the same number of excipient.

Then add the second amount of excipient approximately equal to the amount of the first mixture, and thereafter mixing.

This process of sequential dilution exercise until you have used all excipient, and get the desired concentration of the active beginning. Various products included in the composition of ointments usually are mixed with each other by fusion in a water bath, followed by stirring until cooling is complete the mixture.

This active principle is introduced into the composition at an appropriate stage.

It is this iterative process is essential in the manufacture of a homogeneous ointment.

General description of the invention

The present invention relates to a method for producing a composition, preferably an ointment containing volume is decreased active principle. This method differs in that it includes the following stages of preparation:

1) weighing the beginning of the current inside the receiving tank, covered inside with vaseline;

2) encapsulation of this active substance by adding additional quantities of vaseline;

3) introduction of a receiving tank containing the active principle and the vaseline in the mixer;

4) the dispersion of the current start in the mixer.

According to a variant of the homogeneous liquid composition, containing volume is decreased, the active substance, as follows.

During stage 1 the receiving tank must first be weighted (see figa) before its bottom part is processed by applying a layer of pharmaceutical vaseline (see figv).

This will need to be re-weighting, which allows to determine the added weight of vaseline. Then, in this receiving tank enter the effective start, as is schematically shown in figs. Then weighed again receiving tank to determine the exact amount added to the beginning of the current.

During stage 2 form a tube of pharmaceutical vaseline (see fig.1D), allowing to cover it with vaseline entered the active principle. This complex stage should be designed in such a way as to prevent the formation of air pockets, which could damage the formation of the so-called "cocoon" of pharmaceutical vaseline.

To complete the preparation of this receiving tank must be closed on both sides by means of two rigid tubes (see file).

In this closed, thus receiving tank active substance encapsulated using pharmaceutical vaseline, can be transported to an area reserved for it places the molding, being protected from exposure to light and oxidation phenomena.

For the implementation of the subsequent stage 3 shallow hard tube receiving tank must be removed, and the biggest hard tube of the tank should be replaced by another special perforated tube (see figure 3 and 4).

Thus, after performing these manipulations receiving tank can be introduced into the chamber (see Fig.6) mixer, with this camera and it contains excipients is heated sufficiently so that the mixture of excipients, which it is, was in a liquid state.

During stage 4 pharmaceutical vaseline in the solid state, which seal the active principle in the receiving tank, is melted in contact with the heated mixture of excipients. Thus, the vaseline will be dispersed and distributed in a homogeneous way other excipients contained in the mixer chamber, causing along with the dissolution of the current start.

This homogeneous distribution is possible with the assistance of various factors, primarily using the corresponding temperature of the excipients contained in said chamber, having a value in the range from 70°to 90°that helps to ensure melting of pharmaceutical vaseline, soda is amagosa in the receiving tank, containing the active principle. This homogeneous distribution then also it is possible with the help of face lattices of a receiving tank, which help to disperse the active substance only in a continuous manner and in small quantities. These screens prevent the formation of large masses of semi-solid petrolatum, which could carry away a significant portion of this current began that would ultimately lead to his poor distribution and, consequently, to poor homogenization of the final product.

In this case, the expression "volume is decreased active principle" should be understood in the sense that the concentration of this beginning of the current has a value in the range from 1 to 10 ppm, and preferably is from 1 to 5 ppm.

In accordance with a preferred embodiment of the method according to the invention used in the implementation of this method is the active principle is a calcitriol (calcitriol), and is preferred to use, in particular, calcitriol with the final concentration selected among concentrations at the level of 3 ppm, 6 ppm and 9 ppm, in particular focusing on the level of 3 ppm.

Using the method in accordance with the invention, of course, it is possible to prepare compositions having inhis composition of many different active substances, one or more of which are volume is decreased.

Under the weigh-in this case it is necessary to understand the action of weighing containers or, more generally, the method of determining the weight or mass of the product.

The preferred way to eliminate any danger of contamination of toxic active substance mentioned stage weighing must be carried out under a fume hood with vertical laminar flow of air or in an isolation chamber.

The preferred way to eliminate unacceptable inaccuracies this stage weighing should be carried out with the use of scales with a precision of 1/100 mg

In this case, the term "receiving tank" should be understood as any volume, vessel, tank, allowing the introduction of the current beginning. In the example considered here the implementation of the present invention that the receiving tank has the shape of a truncated cone.

The preferred way in order to facilitate dispersion, use a tank type of a truncated cone, which, due to its shape, will have the feature of ease of movement and speed of the fluid. The speed of this movement will be more moderate in the wide part of the tank that allows you to provide the best dispersion acting the beginning.

In this case, the expression "metal tank" preferred, you should understand the tank, made of stainless steel.

In accordance with a preferred embodiment of the proposed method receiving tank, designed to provide optimal dispersion of the current beginning of calcitriol for the preparation of the drug Silkis, is composed of the following parts (see figure 2):

1 - metal tank in the shape of a truncated cone (see figure 3), made of stainless steel, which is internally coated with vaseline in the preparation of the desired composition;

2 - two solid tubes and one large perforated tube (see figure 2 and 4)made of white Teflon. These plugs with clamping bayonet type can snap into place on the tank.

3 - the shape of a large perforated tube (see figure 4) and lattice made on the small end of the inlet tank (see figure 3), allow the diffusion of the melted vaseline in the case when the vaseline will enter into contact with hot excipients, preventing the formation of lumps.

Fixing this receiving tank on the rod, fixed height (in accordance with the configuration of the mixer)by using a socket connection, as this schematics is shown in figure 5. In this embodiment, the receiving tank, fixed height, so that it can be rotated to ensure uniform distribution of the current start in the camera (see Fig.6).

The term "hard tube" should be understood as a tube made of Teflon or stainless steel.

The term "vaseline" should be understood as any fatty substance of petroleum origin, which is included in the composition of ointments. The invention applies in particular to the vaseline that meet the definition of European and American Pharmacopoeia, i.e. respectively the documents Pharmeuropa" and "USP", and having a viscosity in the range of 550,000 130,000 to SP.

The preferred way in this case, use vaseline, allowing the maximum extent possible to ensure the limitation of exudation of paraffin oil.

The preferred way to provide the possibility of forming a sealed system, this operation must be carried out in vacuum, which allows to obtain a sealed system whose properties can be retained for a longer period of time.

Under the expression "mixture of excipients" in this case shall mean any mixture containing two or more excipient, for example a mixture of vaseline and paraffin, and, in particular, the mixture, which is composed of from 50% to 60% of the pharmaceutical vaseline and from 40% to 50% paraffin.

The term "heat" in this case should be understood as any method of production of heat to increase the temperature used excipients such a way that these excipients were passed in liquid form.

The preferred way in order to be able to better homogenization, it is important to observe certain temperature and a certain time this homogenization. For example, in accordance with the preferred method of implementation of the invention, the temperature has a value in the range from 70°to 90°and time of homogenization is from 2 hours to 7 hours, in particular from 3 hours 30 minutes to 5 hours and 30 minutes.

The list is presented in Appendix figures

Figa - weighting of the receiving tank.

Figv application and weighing layer pharmaceutical vaseline.

Figs - introduction and weighing of calcitriol.

Fig.1D - forming tube of vaseline.

File - closing inlet tank by means of two rigid tubes.

Figure 2 is a top view of various parts of the inlet tank.

Figure 3 - receiving tank having the form of a truncated cone (side view).

4 is a perforated tube with a device for fixing a bayonet type (top view).

Figure 5 - socket connection of the inlet tank to the terminal (top view).

6 is a receiving tank, fixed in the camera (top view).

Example 1A: Implement weighting of calcitriol in the receiving tank.

First of all, you must prepare the vessel and the tube with vaseline, which will be used for the implementation stage weighing substances calcitriol.

Weighing of the vessel and the tube with vaseline as follows:

- establish the said vessel and its cover on the scale with a measuring range of 8 kg;

- tazrout scales;

- squeeze about 50 g of petroleum jelly and insert it into the vessel;

- close the vessel and set the scales to zero;

- place the tube with vaseline on the scales;

- tazrout scales;

- taken about 50 g of petroleum jelly and insert it into the tube;

- clog the tube by bending.

After the implementation of this phase of training vaseline receiving tank in the shape of a truncated cone is prepared together with vaseline as follows.

First of all it is necessary to set the receiving tank in the shape of a truncated cone, made of stainless steel and equipped with a solid bottom tube and solid top tube, on the scale platform, then these scales tazrout before filling inlet tank vaseline with a putty knife. This receiving tank in the shape of a truncated cone must be filled by two-thirds and should be the Central part of filling this tank vaseline recess, in which will be introduced calcitriol. It should be noted a lot of vaseline, added before the introduction mentioned receiving tank in the shape of a truncated cone with vaseline in the insulating chamber.

Ampoule calcitriol pre-entered in the above-mentioned insulator so that it acquired the same temperature as the tank at the time of weighing.

Then weighted to determine the difference in weight resulting from the introduction of calcitriol in the receiving tank in the shape of a truncated cone. This stage is the introduction of calcitriol is carried out by gradual deterioration in such a way as to prevent dispersion of the powder.

After this stage weighing the beginning of the current block mentioned recess, containing calcitriol using vaseline, contained in the above-mentioned tube.

Formed thus receiving tank in the shape of a truncated cone then overlap the two solid tubes with fixation systems bayonet type, after which the tank can be transported to the place of his subsequent processing while ensuring reliable protection from any danger of toxic contamination.

Example 1b: preparation Silkis 3 ppm

1A) Camera manufacturing fill pharmaceutical vaseline so that et is t vaseline represented in the final product share component 56,2487% in the composition. This vaseline pre-melted at a temperature that ensures its transition into a liquid state, and then heated in nitrogen atmosphere and with stirring to provide temperature conditions, allowing you to support this vaseline in the liquid and homogeneous state.

1b) Parallel to the melting device is filled with liquid wax so that the wax was represented in the final product share of $ 43,75% in the composition. Then heat the wax in a nitrogen atmosphere and with stirring to a temperature equivalent to the temperature used vaseline on the stage 1A).

1C) during this first stage also prepare in isolating the cell active principle. To do this, weigh calcitriol placed in a cocoon of vaseline, in nitrogen atmosphere and lighting nonactinic light so that calcitriol was represented in the final product share component 0,0003% in the composition.

2) After the preparation of these three components primarily hot wax is injected into the chamber containing the vaseline.

3) Then in the mixture of excipients add D.L. alpha-tocopherol in a concentration to obtain the final composition of its contents at the level of 0.001%.

4) After that, the mixture of the three excipients subjected to degassing and you is Erivani in nitrogen atmosphere.

5) followed by a phase of homogenization, which is stirring in vacuum.

6) After this period homogenization in lighting nonactinic light exercise introduction conical inlet tank containing calcitriol, in a chamber containing a mixture of three of the excipients.

7) After this stage, the degassing and re-making inertia in nitrogen atmosphere and in vacuum.

8) Then this system for some time required for homogenization, is kept in a vacuum.

9) After this last phase, homogenizing the resulting composition is allowed to cool in vacuum in order to eliminate any possibility of air entering into this mixture.

10) the Last stage will be a primary operation of bringing to the condition in the liquid state in a nitrogen atmosphere with slow stirring and under lighting nonactinic light.

1. A method of obtaining a composition containing volume is decreased active principle, and the method is characterized by the following stages of preparation: weighing the beginning of the current inside the receiving tank, covered inside with vaseline; encapsulation of the current start by adding additional quantities of vaseline; the introduction of a receiving tank containing the active principle and VA is Elin, in a mixer containing a mixture of excipients, at a temperature of excipients from 70 to 90°; spreading the beginning of the current in the mixer.

2. The method according to claim 1, characterized in that in order to avoid the risk of toxic contamination the current early stage of the weighing carried out under a fume hood with vertical laminar flow or in an isolation chamber.

3. The method according to claim 1, characterized in that the volume, allowing the introduction of the current starters, is a tank that has the shape of a truncated cone.

4. The method according to claim 1, characterized in that the vaseline has a viscosity factor of around 13000 of 550,000 to SP.

5. The method according to claim 1, characterized in that the active principle is a calcitriol.

6. The method according to claim 5, characterized in that the active principle is a calcitriol with the final concentration of 3 million-1.

7. The method according to claim 5 or 6, characterized in that the mixture of excipients comprises 50-60% of the pharmaceutical vaseline and 40-50% of paraffin.



 

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