A method of making pharmaceutical dosage forms and their predecessors and pharmaceutical dosage form

 

The invention relates to the pharmaceutical industry. Pharmaceutical form has matrix. The main characteristics of the matrix are determined by the extrusion process, and the matrix contains polysaccharide and/or its derivative, and/or complex and/or sugars and/or their derivatives as the main forming matrix. As well as the form contains at least one pharmaceutically effective substance. A method of manufacturing a matrix includes the extrusion process. The invention allows to obtain a dosage form with controlled release of the active substance, avoiding the use of biologically indestructible and toxic fillers. 2 C. and 17 C.p. f-crystals, 1 tab., 6 Il.

The present invention relates to the creation of a method of producing pharmaceutical dosage forms or their predecessors by using the extrusion process.

The present invention also relates to the creation of pharmaceutical dosage forms, which can be manufactured by means of extrusion.

Extrusion is a widely used process, in particular in the production of adhesives or plastics processing for modification of Polish is asih starch compositions such as pasta, so-called peanut flips (flips) or a variety of sweets. However, the conditions of production of all these products is chosen so that get expanded, so-called effervescent products.

In pharmaceutical extrusion technology used for treatment of paraffins, fatty alcohols, fats and various thermoplastics and example (duroplastics). For example, in patents EP-A2 0240904, EP-A2 0240906 and EP-A2 0358105 disclosed XPS (extruded) matrices of various polymer compounds. Processing of starch-containing mixtures with obtaining pharmaceutical products (capsules) using an injection molding described in the patent EP-B2 0118240. It should indicate that it is unknown how it will be used to change the polysaccharides during extrusion.

Methods of extrusion for the production of solid dispersions of the active substance in the polymer carrier is known from the patent EP-A 0580860. Among the starting materials, which can be used are listed starch and derivatives of starch, referred to in General terms. However disclosed in this patent, the method is not suitable for products containing starch as the main ingredient.

In the pharmaceutical techno is or capsules. Among these dosage forms are available dosage forms with controlled release, which contain a relatively high dose of the active substance and release it the active substance in a controlled fashion over an extended period of time. This means that the patient can take the medication less frequently. With medico-pharmacological point of view, the advantage of dosage forms with controlled release is fairly uniform concentration of active substance in the blood that allows you to gain a long-term beneficial effects with fewer side effects. When developing a formulation of dosage forms with controlled release of crucial form of so-called matrix (base). The matrix is a shaped body, for example, in the form of tablets or pills made of an inert reinforcing effects of drugs (activating) materials that produce active substances in the gastrointestinal tract in a controlled way. The release of the active substance is partly due to the diffusion and partly due to slow decomposition (resorption) of the matrix.

In f polietilen. In this context it should be noted that it is also known application methods of extrusion for the production of dosage forms with controlled release of synthetic raw materials.

The most important disadvantage produced to date by extrusion dosage forms is the use of such fillers as plastics, waxes and even fatty alcohols. These substances are not broken down biologically and is partially harmful. Among them you can specify the residual monomers from polymers, necessarily used hitherto for the production of dosage forms by methods of extrusion and allows for controlled and slow release of the active substance. Moreover, to date, no methods have been developed for extrusion, which allow the dosage form with the rapid release of the active substance.

In view of the above, there is a need to develop a method of extrusion for the production of dosage forms, which is adjustable, for example, select the desired delay release of the active substance, and also provides a more rapid release of the active substance, pricktease not decomposable biologically and somewhat toxic fillers.

These and other features of the invention will be more apparent from the subsequent detailed description, given as an example of non-restrictive.

In accordance with this invention features a method of making dosage forms or their precursors by means of extrusion, wherein the dosage form is a matrix that mainly contains content from the active substance, and this matrix is formed by means of extrusion and contains biologically erodible polysaccharide and/or its derivative, and/or complex, and/or any mixture of the above substances with other substances, and/or sugars and/or their derivatives, as forming a matrix, and at least one pharmaceutically effective substance.

In accordance with a preferred embodiment of the present invention, release of the active substance pharmaceutical form is regulated by the addition of adjuvants and/or due to variations of the parameters of the extrusion process, such as temperature, geometry mouthpieces extrusion, and/or extrusion speed.

In accordance with another preferred Varian is whether partially amorphous.

Moreover, in accordance with the preferred embodiment of the present invention, the dosage form contains a matrix of starch or its derivatives, particularly amorphous or partially amorphous starch or its derivatives, such as polysaccharide.

In accordance with another preferred embodiment of the present invention proposes a method of production of the dosage form, which is insoluble in water and mainly razbujeny matrix.

In accordance with a particularly preferred embodiment of the present invention, the dosage form is a matrix controlled release of the active substance.

In accordance with another preferred embodiment of the present invention is proposed dosage form, the release of the active substance, which mainly corresponds Lapidus (lapidus) function, and mainly has the release of the active substance, which can be adjusted within 24 hours or more.

Another main objective of the present invention is a dosage form, which mainly can perform SWA solved by creating dosage forms, with the matrix, which mainly contains the active substance and the basic properties of which are determined by the extrusion process, and this matrix contains the polysaccharide and/or its derivative, and/or complex, and/or any mixture of the above substances with other substances, and/or sugars and/or derivatives thereof as a main component of the matrix, and at least one pharmaceutically effective substance.

Moreover, the present invention relates to the use of the claimed dosage forms as adjuvants in direct pelletizing, in the manufacture of granules for tableting and for filling capsules, as well as for additional processing using the technology of injection molding and/or for the production of monobloc pharmaceutical dosage forms.

During the extrusion process, i.e. when the use or application of heat, effort slicer and high blood pressure, get amorphous or partially amorphous matrix of crystalline or partially crystalline polysaccharides, in particular starch or its derivatives, or mixtures of these components. To ensure reproducible production process I conduct extrusion, such as the temperature, the geometry of the mouthpiece and the extrusion speed. For example, under appropriate conditions for extrusion can be plasticized or oaklawn natural starch, which allows to obtain homogeneous similar plastic figured body.

When carrying out the extrusion of starch heating is necessary only in the beginning of the process. In the further course of the process heat that is released due to the strong shear and friction, mainly given by cooling, and in the process the temperature mainly is maintained constant. Used in accordance with the present invention, the compositions include a mixture of polysaccharides and/or derivatives thereof, and predominantly a mixture of starch and/or starch derivatives, preferably use different types of starch. Moreover, the mixture contains at least one pharmaceutically effective substance, in an amount up to 50%, and mainly up to 30%, calculated on the total weight of the composition, and may optionally contain various other substances. In a thoroughly mixed dry composition add up to 15% water. When using an extruder with forced transport of enough smaller number of the NGOs are screened to remove lumps, to provide free transportation via a screw feeder. Start-up and cleaning of the extruder to produce, for example, using oat flour. When creating a matrix in accordance with the present invention, the temperature at the point of mouthpiece of the extruder should not exceed 100oWith at normal pressure, so as to temperatures above 100oWith the formation of non-porous matrix is hardly possible. The total energy input into the process in the form of efforts to cut, temperature, heat, or pressure, should be constant and sufficient to ensure vitrification. The optimum speed of the auger and the geometry of the mouthpieces can be adjusted depending on the composition of the mixtures containing media and water. At extrusion temperatures below 100oWith and at the appropriate speed auger receive transparent and completely amorphous product that is required in most cases. The degree of plasticization of the mixtures of the active substance with the polysaccharide predominantly mixtures of the active substance with starch is closely linked with the speed of the auger. If too low speed screw extrusion is not possible, then at too high a speed auger get torn with cotton medicament is in accordance with the present invention, which provide a modified release of the active substance. Used herein, the expression "controlled" means that the method in accordance with the present invention can be obtained from the dosage form as fast, and with the delayed release, namely, the so-called dosage forms with controlled release, with the allocation periods up to 24 hours or more. Besides the above mentioned process parameters important to control the release of active substance is also temperature processing. Dosage forms quick release can be obtained, for example, by extrusion temperature below gilotinirovaniya polysaccharides used in each case. Because among other things, the density matrix affects the release of a prisoner in her active substance, the appropriate dosage forms with controlled release can be obtained by partial or complete vitrification, that is due to the transition in amorphous state containing polysaccharide mixture under suitable conditions of the extrusion process. In contrast to previously described systems, such amorphous or partially amorphous matrix in the fit is small or its derivatives, or mixtures of these components, is mostly insoluble in water, but instead mainly razboieni. Pharmaceutically effective substance or substances may be present in the matrix in accordance with the present invention in solution, solid or in liquid form.

Examples of starches that can be used in the method of manufacturing in accordance with the present invention, it is possible to specify tapioca starch, wheat starch, potato starch, starch 1500(specially pre-relatively corn starch, which can be purchased at the company use), Waxylis(wax corn starch, which can be purchased on the company Roquette), Eurylon 7(AMILO grain starch company Roquette), corn starch and acetyloxy starch.

In addition, by the method of extrusion in accordance with the present invention it is possible to obtain a dosage form, which have a modified release of the active substance by the addition of adjuvants. To accelerate the release of active substance in the matrix can be formed pores, for example, for scheria, lactose, surfactants such as sodium lauryl sulfate, silicon dioxide (colloidal dispersed and/or in the form of a xerogel), hydrophilic or amphiphilic fluids, polyglycols such as glycerine, polyethylene glycol, surfactants such as ether polyoxyethylene fatty acids, gases, such as nitrogen and carbon dioxide.

The reduction in the release of the active substance due to the inhibition of diffusion can be carried out, for example, by adding the following adjuvants: - lipophilic or amphiphilic adjuvants natural, synthetic or partially synthetic origin, such as fats, fatty acids and waxes, in solid or liquid state, is a saturated or unsaturated hydrocarbon - soap for lubricant-coolant emulsion, such as magnesium stearate.

Moreover, the reduction in the release of the active substance can be carried out due to the formation of stoichiometric or not stoichiometric complexes, such as complex of iodine with starch and complex miltefosin-amylase.

Moreover, the release of a prisoner in matricarioides due to the use of mixtures of different starches and/or their derivatives. Other factors that can also affect the release of the active substance, are the external surface of the shaped body of the dosage form and the size of its particles or distribution of the active substance inside the particles.

Studying the process (process) release of the active substance indicates that the release of the active substance mainly controlled by diffusion and follows the so-called rule of worry, which is reflected in the following examples. The process of release of the active substance does not change even after storage of the dosage forms over time over several months.

Obtained in accordance with the present invention the dosage form can be used in the manufacture of granules for tableting and for filling capsules, can be used as adjuvants in direct pelletizing, and can also be used for additional processing using the technology of injection molding and/or for the production of monobloc pharmaceutical dosage forms, when the extrudate is formed by means of a suitable location in the mouthpiece for the extrusion - as in the case of the production of soap. Som creates an extrudate, which lecluyse only on the surface and contains a mixture of active ingredient with the carrier in the same condition. To provide desirable pharmaceutical properties of dosage forms can be used all known adjuvants, which are used in the manufacture of solid dosage forms.

Drying dosage forms may occur simply due to the generated friction heat, so that the operation of the final drying is not necessary. In the production extruder, which is mainly extruder, double screw, and preferably an extruder, double screw with the forced transportation, can be continuously carried out all the operations process, such as dosing, wetting, mixing and molding. Thus, the method in accordance with the present invention allows to combine in one unit of the equipment, the processes of mixing, granulating and drying, which do not require the supply of additional energy.

In accordance with the present invention reduces the number of possible incompatibilities (nesmeshivaemost), as the dosage form contains, for example, only one filler, and mostly krahm the m invention the matrix additionally prevents the possibility of inadvertent separation of the mixture.

The following examples show that the degree of slow release of the active substance is best regulated by the selection of a process or process parameters, type of polysaccharide or add additional adjuvants. The examples serve only as an illustration of the process and are not restrictive part of certain options or applications, and possible additional options that are not beyond the scope of the invention.

Examples In the following examples, which were carried out using a method in accordance with the present invention were used in a variety of polysaccharides with the addition of caffeine as a model of the active substance. Experiments with carrying out the extrusion was carried out in a single screw Brabender extruder 811201. This extruder has three segments, the temperature of which can be set independently from each other, and the area power connection, screw zone and the mouthpiece of the extruder. Transporting auger that was used without compression, has a length of 22 cm, diameter 19 mm, a core diameter of 16 mm and pitch of 15 mm Were used mouthpieces of different diameter from 2.5 to 7 mm

The lot size when conducting expert hydrated using 15% water, then the obtained pre-mixture was sifted to remove lumps.

Found that for the success of the method in accordance with the present invention can be selected temperatures around 65oIn the power zone of the extruder, approximately 80oIn the area of the screw and about 98oWith the mouthpiece.

Check transition of crystalline or partially crystalline structures of polysaccharides in amorphous or partially amorphous structure can be performed using various methods.

The transition of crystalline or semi-crystalline starch in the amorphous state can be detected using differential scanning colorimetry (DSC). Under suitable conditions, the extrusion of the starch is fully vitrified, that is transformed into an amorphous state. For example, the test was performed with tapioca starch as a polysaccharide and caffeine as the active ingredient. In Fig.1A shows thermogram of the pre-mixture, which contains 90% of tapioca starch and 10% caffeine with the addition of water, and this thermogram has a typical endothermic peaks in the range of about 65oC.

After extrusion in accordance with the present invention were not what about the starch was completely Steklova, that means its conversion into an amorphous state (see Fig.1b).

The transition from a crystalline or semi-crystalline state to the amorphous state can also be detected using x-ray diffraction. In the next test was used to sample that contains 80% potato starch and 20% of the caffeine. Picture of x-ray diffraction pre-mix potato starch with caffeine shown in Fig.2 where you can see the signals of the crystalline part of the starch in the range of about 20oC. After the implementation of the method in accordance with the present invention, the picture of x-ray diffraction from the extrudate does not have any signals, indicating the presence of crystalline parts of starch.

In this context, it should again be emphasized that the degree of destructuring in the vitrified state is decisive for the kinetics of excretion of the active substance. Check the release of the active substance held in the model blade mixer in accordance with USP, in liquids formed of 0.1 N chloride-hydrogen acid (which is an artificial gastric juice with pH 1) and phosphate buffer with a pH of 7.2 (art is scrudato, and there is just swelling. When carrying out the following experiments to determine the quantitative yield of the active substance was used a sample that contains a commercially available starch Eurylon 7(AMILO grain starch company Roquette) and 30% of caffeine. In Fig.3 shows a diagram of the quantitative release of the active substance. For comparison, shows a net release of caffeine from the capsule, which occurs without delay.

You can see that the introduction of caffeine in a matrix of polysaccharide leads to significant delays in the release, which in this case is approximately from 15 minutes to 8-10 hours for a full dose of 25 mg.

Chart released amount of the active substance relative to the square root of time in accordance with the rule of worry is almost linear, which suggests that the release of active ingredient is controlled by diffusion (see Fig.4).

As mentioned here previously, the rate of release of the active substance can also be adjusted by choosing the polysaccharide or mixture of polysaccharides. In the following example, prior smenk release of the active substance. Changing the type of starch, together with a smaller dose of the active substance, leads to a significant slowdown in the release of the active substance. In Fig.5 shows a diagram, which shows that prepared by the method in accordance with the present invention, the extrudate provide release of the active substance over time in excess of 24 hours.

It is shown in Fig. 6 chart based on the rule of Lapidus suggests that the release of active ingredient is controlled by diffusion.

As mentioned here previously, the duration and character of the course (the course) to fully release the active substance can be adjusted. For a very long time release of the active substance, or up to 24 hours in this example, would be beneficial for the development of the new principle of delayed release, as thus receive the "reserves" to obtain water-soluble active substances of very good quality. It is possible to selectively influence the release of the active substance, which has already been described many times, using polysaccharides or their respective derivatives and compounds, as well as through the introduction of appropriate and with the present invention can be also obtained faster excretion of the active substance. The following table shows an example of the change of process parameters, which leads to incomplete transition, which creates the possibility of regulation time release of the active substance in a wide range.

From the table we can see that for identical types of starch, solely due to changes in process parameters can be obtained as relatively short periods of release of the active substance, and the periods of release in the range of controlled release dosage forms.

Claims

1. The method of manufacturing of pharmaceutical dosage forms or their precursors by means of extrusion, wherein the dosage form is a matrix, which mainly comprises the active ingredient and the matrix contains polysaccharide and/or its derivative, and/or complex and/or sugars and/or their derivatives as the primary forming a matrix, and at least one pharmaceutically effective substance, the matrix created by co-extrusion with active ingredient and provide release of the active substance.

2. The method according to p. 1, hotelcategory the release of the active substance and/or by changing the parameters of the extrusion process, in particular the temperature, the geometry of the mouthpieces and/or the speed of extrusion.

3. The method according to p. 1 or 2, characterized in that the receive amorphous or partially amorphous matrix.

4. The method according to one of paragraphs.1-3, characterized in that the polysaccharide is starch or its derivative.

5. The method according to one of paragraphs.1-4, characterized in that the gain matrix is not soluble in water.

6. The method according to one of paragraphs.1-5, characterized in that the gain matrix controlled release of the active substance.

7. The method according to one of paragraphs.1-6, characterized in that the release of the active substance pharmaceutical form follows basically the function of worry.

8. The method according to one of paragraphs.1-7, characterized in that the release of the active substance pharmaceutical form may be regulated within 24 h or more.

9. The method according to one of paragraphs.1-8, characterized in that at least one pharmaceutically effective substance is present in the matrix in dissolved, particulate or liquid form.

10. Pharmaceutical dosage form, characterized in that it has a matrix, which mainly comprises the active ingredient and the matrix contains polysaccharide and/or its derivative, and/or the one pharmaceutically effective substance, the matrix created by co-extrusion with active ingredient and provide release of the active substance.

11. Dosage form under item 10, characterized in that the release of the active substance govern by introducing additives that regulate the release of active substance, and/or by changing the parameters of the extrusion process, in particular, temperature, geometry of mouthpieces and/or the speed of extrusion.

12. Dosage form under item 10 or 11, characterized in that the matrix is amorphous or partially amorphous.

13. Pharmaceutical form according to one of paragraphs.10-12, characterized in that the polysaccharide is starch or its derivative.

14. Pharmaceutical form according to one of paragraphs.10-13, characterized in that the matrix is not soluble in water.

15. Pharmaceutical form according to one of paragraphs.10-14, characterized in that the matrix is a matrix controlled release of the active substance.

16. Pharmaceutical form according to one of paragraphs.10-15, characterized in that the release of the active substance mainly follows the function of worry.

17. Pharmaceutical form according to one of paragraphs.10-16, characterized in that the release of the active substance may be at least one pharmaceutically effective substance is present in the matrix in dissolved, solid or liquid form.

19. Dosage form according to any one of paragraphs.10-18, intended for the production of granules for tableting and for filling capsules, as well as for additional processing using the technology of injection molding, as adjuvants in direct pelletizing and/or for the production of monobloc pharmaceutical dosage forms.

 

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