SYSTEM FOR TRANSFORMATION OF SOLID ORAL DOSAGE FORMS (SODFS) INTO GEL FORM

The present invention relates to a system for transformation of SODFs into gel form of the type specified in the preamble to the first claim. In particular, the system for converting solid oral dosage pharmaceutical forms (SODFs) such as tablets or capsules into gel form is applied in pharmaceutical and similar fields.

The dysphagia is a dysfunction of the digestive system that results in difficulty during the swallowing process. Such pathological condition often occurs as a consequence of other obstructive or motor disorders and particularly affects hospital patients or, in any case, patients who have to take medication on a regular basis.

As is well known, most medications are marketed in solid form, e.g. in the form of tablets or capsules. Therefore, people with dysphagia are not able to take these drugs orally. In particular, healthcare professionals are regularly confronted with the problem of handling and administering specific active ingredients that are only commercially available in solid tablets or capsules, especially if the patients are of paediatric or geriatric age. In routine clinical practice, to administer solid drugs to patients with swallowing difficulties, healthcare professionals have to crush tablets or open capsules. This practice can be dangerous as there is a risk of administering a lower or higher dose of drug than needed, making it ineffective or even toxic. Furthermore, the operation of the crushing tablets and/or opening capsules, if not carried out with the utmost care, may alter the efficacy of the active ingredient, make it unstable or reduce its palatability.

In addition, the powders released during the handling of tablets and/or solid capsules may be inhaled by the healthcare worker causing side effects. If the operation is not carried out with due precautions, these powders may contaminate the working environment and the instruments used to handle them. In this situation, a drug could be contaminated with foreign dusts that could alter its efficacy.

The powder and/or fragments thus obtained are mixed with food or drink that can easily be administered to the patients in question. Semi-solid and/or gel preparations are known to be particularly used for this purpose. For example, Nestle's Resource® gelled water developed specifically for people who have difficulty swallowing liquid substances is commercially known. Pulverised solid medications can thus be added to such gelled water in order to facilitate its administration to patients with dysphagia.

The known technique described includes some major drawbacks.

In particular, the handling of solid drugs and their reduction to powder, if not properly carried out, can lead to contamination of the drug itself and the surrounding environment.

Furthermore, the operation of reducing solid drugs to powder may result in less or more active ingredient being administered than necessary.

In this situation, the technical task underlying the present invention is to devise dispersion a system for transformation of SODFs into gel form capable of substantially obviating at least part of the aforementioned drawbacks.

In the context of said technical task, it is an important aim of the invention to obtain a system for transforming SODFs into gel form that is effective, safe and controllable. Another important purpose of the invention is to achieve a system for transformation of SODFs into gel form that allows for an easy and convenient formulation to be ingested by dysphagic patients.

The specified technical task and purposes are achieved by a system for transformation of SODFs into gel form as claimed in the appended claim 1 .

Preferred technical solutions are highlighted in the dependent claims. The features and advantages of the invention are hereinafter clarified by the detailed description of preferred embodiments of the invention, with reference to the appended drawings, in which: the Fig. 1 shows a simplified schematic of a first embodiment of a system for converting solid tablets into gel form according to the invention; and the Fig. 2 shows a simplified schematic of an alternative embodiment of a system for converting solid tablets into gel form according to the invention.

In the present document, the measurements, values, shapes and geometric references (such as perpendicularity and parallelism), when associated with words like “about” or other similar terms such as “approximately” or “substantially”, are to be considered as except for measurement errors or inaccuracies due to production and/or manufacturing errors, and, above all, except for a slight divergence from the value, measurements, shape, or geometric reference with which it is associated. For instance, these terms, if associated with a value, preferably indicate a divergence of not more than 10% of the value.

Moreover, when used, terms such as “first”, “second”, “higher”, “lower”, “main” and “secondary” do not necessarily identify an order, a priority of relationship or a relative position, but can simply be used to clearly distinguish between their different components. Unless otherwise specified, as results in the following discussions, terms such as “treatment”, “computing”, “determination”, “calculation”, or similar, refer to the action and/or processes of a computer or similar electronic calculation device that manipulates and/or transforms data represented as physical, such as electronic quantities of registers of a computer system and/or memories in, other data similarly represented as physical quantities within computer systems, registers or other storage, transmission or information displaying devices.

The measurements and data reported in this text are to be considered, unless otherwise indicated, as performed in the International Standard Atmosphere ICAO (ISO 2533:1975).

With reference to the Figures, the system for transformation of SODFs into gel form according to the invention is globally referred to as 1.

With the term solid tablets or SODFs (Solid Oral Dosage Forms), as used by the branch engineer, it is meant that solid tablets or capsules or similar elements.

The system 1 is preferably used in the pharmaceutical industry. In particular, system 1 is configured to reformulate solid pharmaceutical forms containing water-soluble active ingredients. In detail, the system 1 allows the reformulation of active ingredients which are commercially available only in solid form and which are therefore difficult to take by patients suffering from swallowing difficulties or dysphagia, thus requiring manipulation for administration in patients suffering from swallowing difficulties The solid pharmaceutical forms suitable for reformulation by the system 1 are preferably tablets, capsules or similar.

The system 1 includes, in brief, a machine 2. In detail, the machine 2 comprises at least a first housing 3 and a second housing 4.

The first housing 3 is substantially a tank for holding preserved water and solid pharmaceutical forms containing water-soluble active ingredients. Advantageously, the first housing 3 contains precisely preserved water and the solid pharmaceutical forms containing water-soluble active ingredients. By the term water-soluble, it is meant that the active ingredients contained in such solid pharmaceutical forms are capable of dissolving completely in contact with an adequate amount of water. Thus, the preserved water in which the solid pharmaceutical forms are dispersed is an aqueous solution of the active ingredient.

In detail, in a first embodiment, the system 1 comprises a first cartridge 30 configured to be inserted into or extracted from the first housing 3. The first cartridge 30 preferably contains preserved water. It further includes at least one slot 31 suitable for allowing the insertion of solid pharmaceutical forms containing water-soluble active ingredients. Essentially, therefore, the first cartridge 30 is a bicomponent cartridge functioning as a disposable dispersion chamber.

In an alternative embodiment, the system 1 may comprise a third housing 3a and a fourth housing 3b. Also third and fourth housings 3a, 3b are essentially tanks within which cartridges may be inserted or extracted. Thus, the system 1 may include a third cartridge 32 and a fourth cartridge 33. If present, third and fourth cartridges 32, 33 are configured to be inserted or extracted within the third and fourth housings 3a, 3b respectively.

The third cartridge 32 preferably comprises water, while the fourth cartridge 33 preferably comprises solid pharmaceutical forms containing water-soluble active ingredients and may be provided with its own slot for inserting said solid forms into the fourth cartridge 33.

Furthermore, third and fourth housings 3a, 3b are in fluid passage connection or connected with the first housing 3.

Preferably, in this embodiment, the first housing 3 is suitable for receiving water and solid forms arriving from the third and fourth housings 3a, 3b in which third and fourth cartridges 32, 33 are positioned.

Accordingly, third and fourth cartridges 32, 33 each include their own component introduced into the respective third and fourth housings 3a, 3b capable of being poured into the first housing 3 which substantially acts as a dispersion chamber.

The second housing 4 is substantially a tank capable of containing a gelling polymer. Advantageously, the second housing 4 contains precisely a gelling polymer and water. In detail, the gelling polymer is preferably a semi-synthetic polymer of cellulose. Said polymer preferably comprises hydroxypropyl methyl cellulose. More preferably, the gelling polymer comprises only hydroxypropyl methyl cellulose.

In detail, in the first embodiment, the system 1 comprises a second cartridge 40 configured to be inserted into or extracted from the second housing 4. The second cartridge 40 preferably contains the gelling polymer and water.

Essentially, therefore, the second cartridge 40 is a bicomponent cartridge functioning as a disposable dispersion chamber.

In the alternative embodiment, the system 1 may comprise a fifth housing 4a and a sixth housing 4b. Also fifth and sixth housings 4a, 4b are essentially tanks within which cartridges can be inserted or extracted. Thus, the system 1 may include a fifth cartridge 42 and a sixth cartridge 43. If present, fifth and sixth cartridges 42, 43 are configured to be inserted or extracted within the fifth and sixth housings 4a, 4b respectively.

The fifth cartridge 42 preferably comprises water, and the sixth cartridge 43 preferably comprises gelling polymer forms.

Furthermore, fifth and sixth housings 4a, 4b are in fluid passage connection or connected with the second housing 4.

Preferably, in this embodiment, the second housing 4 is suitable for receiving water and incoming polymer from the fifth and sixth housings 4a, 4b in which fifth and sixth cartridges 42, 43 are positioned.

Accordingly, fifth and sixth cartridges 42, 43 each include their own component introduced into the respective fifth and sixth housings 4a, 4b capable of being poured into the second housing 4 acting substantially as a dispersion chamber.

The machine 2 further preferably comprises a mixing unit 5 and a packaging unit 6. The mixing unit 5 is preferably a tank defining a main axis 5a. The mixing unit 5 is in fluid passage connection with the first housing 3 and the second housing 4. By fluid passage connection it is meant that substances contained in the first housing 3 and the second housing 4 can flow into the mixing unit 5. Such fluid passage connection is preferably, and not necessarily, realised by pipes. Within the mixing unit 5, mixing therefore takes place between the homogeneous mixture coming from the first housing 3 and the gelling polymer coming from the second housing 4 so as to obtain a semi solid preparation. Therefore, the mixing unit 5 is configured to mix the substances coming from the first housing 3 and the second housing 4 respectively so as to obtain a semi-solid preparation. Said semi-solid preparation preferably comprises hydroxypropyl methyl cellulose in a proportion of preferably between 1% and 6% by weight with respect to the total weight of the semi-solid preparation. The composition of the semi-solid preparation is described in detail in patent EP-B-3513782, incorporated herein by reference, from page 14 line 8 to page 28 line 13.

The mixing unit 5 comprising an agitation mean 50. The stirring means 50 is preferably arranged along the main axis 5a. In particular, it is in the form of a rod. Furthermore, it comprises at least one blade arranged, in use, transversely to the main axis 5a. The agitation means 50 may comprise a plurality of blades, each disposed, in use, transverse to the main axis 5a. The stirring means 50 is advantageously connected to an energy source capable of providing the electrical energy required for its movement. In detail, the agitation means 50 is put into rotation around the main axis 5a. It is also preferably magnetically agitated.

The packing unit 6 is in fluid passage connection with the agitation unit 5. In particular, the agitation unit 5 and the packing unit 6 are preferably connected via a conduit which allows the semi-solid preparation to pass from one unit to the other. The packaging unit 6 is configured to package the semi-solid preparation. In detail, the packaging unit 6 comprises, for example, a dispenser 9. The dispenser 9 is configured to package the semi-solid preparation in single-dose packs. Such single-dose confections may be, for example, heat-sealed sachets.

Therefore, the dispenser 9 may comprise a dispensing spout and a conveying apparatus capable of bringing the opened sachets below the spout and conveying them, after filling, to a heat-sealing apparatus capable of closing the filled sachet and heat-sealing it.

Means of this kind are, in any case, familiar to the branch technician.

The system 1 advantageously comprises a control unit 11. The control unit 11 is substantially configured to control the operation of the components of the machine 2. It may include a computer processor and may also include connection means configured to allow access to the control unit 11 also remotely, for example Wi-Fi, Bluetooth™. Furthermore, the control unit 11 may implement loT, Blockchain, or other logics.

The system 1 further comprises a plurality of dosing means 7. The dosing means 7 are operatively connected to the control unit 11 . The control unit 11 includes instructions organised in at least one algorithm. Part of these instructions are given to the dosing means 7 to control the amount of preserved water to be fed into the mixing unit 5, the amount of gelling polymer to be fed into the mixing unit 5 and the amount of semi-solid preparation suitable to be packed into the packing unit 6. The dosing means 7 may comprise, for example, pneumatic valves.

Thus, the dosing means 7 may substantially comprise at least between first housing 3 and mixing unit 5, between second housing 4 and mixing unit 5, and between mixing unit 5 and packing unit 6.

The machine 2 further comprises a heating apparatus 8. The heating apparatus 8 is, if present, operatively connected to the control unit 11 and the mixing unit 5. The heating apparatus 8 is capable of heating the substances contained in the mixing unit 5, during mixing, according to the instructions given by the control unit 11. In detail, the heating apparatus 8 may comprise, for example, one or more heating elements. Furthermore, the heating apparatus 8 maintains the mixing unit 5 at a temperature preferably between 60°C and 80°C. Indeed, such a temperature range allows for efficient mixing of the preserved water mixture and the gelling polymer.

The packaging unit 6 comprises a cooling apparatus 10. The cooling apparatus 10 is operatively connected to the control unit 11. It is suitable for bringing and maintaining the semi-solid preparation at a temperature of between 20°C and 30°C. The cooling apparatus 10 may be, for example, a water coil.

In addition, the system 1 comprises sensor means 12. The sensor means 12 are operatively connected to the control unit 11 . The sensor means 12 include at least a first sensor 12a suitable for detecting the temperature of the mixing unit 5 and at least a second sensor 12b suitable for detecting the temperature of the packing unit 6. The temperature sensors 12a, 12b may be, for example, thermocouples. In particular, the control unit 11 is configured to receive such temperatures and to execute instructions based on such temperatures. For example, the instructions may consist in commanding the heating unit 8 and/or cooling unit 10 respectively to increase or decrease the temperatures detected by the sensor means 12a, 12b. Thus, the sensor means 12 enable feedback control of at least part of the system 1.

The operation of the system 1 described above in structural terms is as follows.

The first cartridge 30 is inserted into the first housing 3 and the second cartridge 40 is inserted into the second housing 4. Subsequently, a suitable quantity of solid pharmaceutical forms is introduced into the first cartridge 30 via the slot 31. In the first cartridge 30, disintegration of the solid pharmaceutical forms and dissolution of the active ingredient takes place. The dosing means 7, carrying out the instructions given by the control unit 11 , feed predetermined amounts of gelling polymer and aqueous mixture into the mixing unit 5. The mixing unit 5 mixes the two substances so as to obtain a semi-solid preparation. The semi-solid preparation flows into the packing unit 6. In the packaging unit 6, via the dispenser 9, the semi-solid preparation is packaged in single-dose confections. The invention comprises a new process of producing a semi-solid pharmaceutical preparation by means of the previously described machine 2.

The system 1 according to the invention achieves important advantages.

Indeed, the system 1 makes it possible to transform solid pharmaceutical forms into a semi-solid preparation in an automated and therefore safe and controllable manner. Furthermore, the semi-solid preparation obtained is packaged directly in single-dose packages that are particularly convenient to handle.

The invention is susceptible to variations within the scope of the inventive concept as defined by the claims.

Within this scope, all details are substitutable by equivalent elements and the materials, shapes and dimensions can be any.