AU727171B2 - Process to produce solid homeopathic compositions - Google Patents

Description

WO 98/07411 PCT/GB97/02220 1 PROCESS TO PRODUCE SOLID HOMEOPATHIC COMPOSITIONS This invention relates to a process for the production of homeopathic medicines.

Homeopathic medicine is a system of healing which has been in existence since 1796. The word homeopathy comes from the Greek language and may be translated as "similar suffering". In other words an agent which can cause disease in a healthy person can be used to therapeutic advantage in a person who is sick and whose symptoms resemble those of the agent. Normally the agent is administered to a patient in minute amount and in very high dilution, in contrast to the practice in allopathic medicine in which the therapeutic agent is normally administered to a patient in much higher amount and at a much higher concentration.

The agent can be administered in the form of a solution, as an ointment or paste, as tablets, or in the form of pellets or globules of a carrier, such as lactose, which has been impregnated with a dilute solution of the agent.

Alternatively it is possible to triturate the agent with a solid carrier. A typical size for pellets is around 200 per gram, while globules typically come in a size of about 20 per gram. Tablets may be of any suitable size which are convenient for sucking for example about 0.2 g to about 1 g.

Two principal methods are used for dilution of a substance so as to lower its concentration in a given product, whether liquid or solid. In the first method, which was developed by the German physician and experimental pharmacologist Samuel Hahnemann (1755-1843), multiple flasks are used. The second method is one developed by Hahnemann's contemporary, Sim6on N. Korsakoff and involves use of a single flask.

The Hahnemannian process consists in effecting dilutions in separate flasks or bottles. To make a one hundred fold SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 dilution, 1% by volume of a starting solution (or mother tincture) of a convenient concentration, for example about 1 g per litre, is placed in a flask and mixed with 99% by volume of diluent. The resulting diluted mixture has a Hahnemannian Concentration which, for convenience, can be designated 1 CH. To make a further dilution, 1% by volume of this 1 CH solution is again mixed with 99% by volume of diluent. The resulting diluted solution can be designated 2 CH. These operations can be carried out N times to obtain a solution of the Nth CH.

The Korsakovian process is undertaken in a single bottle or flask. In this case 99% of a starting solution (or mother tincture) is drained or aspirated from the bottle or flask and the remaining 1% by volume is diluted by pouring in 99% by volume of the diluent. After mixing the resulting solution can, for convenience, be designated the first Korsakovian centesimal (or 1 cmK). Upon repeating the procedure with the 1 cmK solution a further diluted solution, i.e. the 2 cmK solution, is obtained. By carrying out the procedure N times the Nth cmK solution can be obtained.

Whilst dilutions of 1 in 100, i.e. centesimal dilutions, are common, another accepted method of dilution is the decimal method in which 1 part of the mother tincture is diluted to 1/10 of its original strength.

The number of operations that require to be carried out in order to reach a desired level of dilution can be summarised as shown in Table 1 below. The starting concentration is a convenient concentration, such as 1 g per litre.

SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 TABLE 1 Dilution Concentration Decimal Centesimal in 1/100 in 10-" Scale Scale 1/10 10/100 10- 1 1 D 1/100 1/100 10- 2 2 D 1 CH 1/1000 0.1/100 10- 3 3 D 1/10000 0.01/100 10 4 4 D 2 CH 1/100000 0.001/100 10- 5 5 D 1/1000000 0.0001/i00 10- 6 6 D 3 CH 10-8" 9 CH 10.60 30 CH In his writings Hahnemann recommended that utensils used for the preparation of a homeopathic medicinal preparation should be sterilised in boiling water. He also recommended that, in order to have a correct succussion effect in diluting a solution, the bottle should be large enough to be only two thirds filled up. In order to develop the dynamic pharmaceutical virtues of the preparations, the bottle should be submitted to a series of strong succussions. Typically this should involve pounding the bottle filled to 75% or with the solution on a thick book having a leather cover 100 times at the frequency of the heart's beat. Furthermore the prepared solutions should be stored and protected from the sun and the daylight in a well sealed bottle.

In the conventional method of preparing homeopathic medicines in solid form the final dilution step is typically achieved by spraying a measured amount of an appropriately diluted solution, for example, a 30 CH solution, onto a mass of granules of a carrier of known weight contained in a rotating flask. In this way the granules become randomly SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 4 impregnated with the solution. Typically the quantity of solution corresponds to at most about 2 or 3 w/w of the weight of the granules. The end result may be that some of the granules become saturated with the solution, while others remain totally dry. Although some improvement can be obtained by changing the direction of rotation of the flask during spraying, for example, after about approximately one third of the spraying operation has been completed and again after about two thirds of the solution has been sprayed on the mass of granules, the end result is still unsatisfactory in that it cannot be assured that every granule shall be uniformly impregnated with the solution.

It would accordingly be desirable to provide a process for the production of solid forms of homeopathic medicines in which the product is reliably impregnated with the final diluted solution. It would further be desirable to provide a process for preparing solid forms of homeopathic medicinal preparations which can enable the reliable production, preferably on an industrial scale, of solid homeopathic medicinal preparations with reproducible effects. It would further be desirable to provide a homeopathic medicinal product in a solid form which, it can be ensured, will reach the patient in optimal condition and with its efficacy undiminished.

It is accordingly an object of the present invention to provide a process for the production of solid forms of homeopathic medicines in which the product is reliably impregnated with the final diluted solution. It is a further object of the present invention to provide a process for preparing solid forms of homeopathic medicinal preparations which can enable the reliable production, preferably on an industrial scale, of solid homeopathic medicinal preparations with reproducible effects. It is yet a further object of the SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97102220 invention to provide a homeopathic medicinal product in a solid form which, it can be ensured, will reach the patient in optimal condition and with its efficacy undiminished.

According to the present invention there is provided a process for preparing a homeopathic medicinal composition in solid form which comprises: providing an initial solution containing a predetermined starting concentration of a selected compound having homeopathic efficacy; diluting the initial solution using at least one dilution step by addition of diluent so as to produce following the or each dilution step a diluted solution having a higher dilution than that of the solution being diluted; and dosing a compacted mass of particles of a solid carrier with a predetermined amount of the resulting diluted solution so as to produce a solid homeopathic medicinal composition in compacted solid form.

Preferably the compacted mass of particles of a solid carrier is a tablet or globule comprising the solid carrier.

A suitable weight for the tablets is about 0.15 g each.

Globules can, for example, weigh about 0.05 g each.

The process may further include the step of packaging the resulting solid homeopathic medicinal preparation in a container adapted to protect the solid homeopathic medicinal composition from f3 radiation, including emitted radiation in the tritium energy range, until required for consumption by a patient.

In a particularly preferred process according to the invention the compacted mass of particles of the solid carrier is placed in a packaging container prior to effecting the dosing step.

The dilution step may comprise succussion of the diluted SUBSTITUTE SHEET (RULE.26) WO 98/07411 PCT/GB97/02220 6 solution during or after each dilution stage.

Preferably the dilution step, any succussion step, and :he dosing step, as well as packaging are carried cut within an environment shielded from B- radiation, including emitted 2- radiation in the tritium energy range.

The compound having homeopathic efficacy may be any agent conventionally used in homeopathic medicine.

In the process of the invention, in the or each dilution step, the diluent generally comprises a solvent, such as water, ethyl alcohol, or a mixture thereof. The diluent preferably comprises water in all dilution steps except the last one; however, in the last dilution step to produce the diluted solution for use in the dosing step the diluent preferably comprises ethyl alcohol.

In one form of the process the dilution step is repeated a plurality of times prior to the dosing step (c) which constitutes a final dilution step. In the dosing step there is preferably used a diluted solution which has been prepared using a final dilution step wherein the diluent is ethyl alcohol.

A typical solid carrier material comprises a carbohydrate, such as a saccharose, for example lactose, sucrose, threalose, threose, or the like. A mixture of saccharoses can be used. The solid carrier material is preferably formed into tablets weighing, for example, from about 0.2 g up to about 1 g or more, e.g. up to about 2 g.

Shielding is effected so as to shield from g- radiation, including emitted radiation in the tritium energy range.

In other words the shielding should be effective to prevent penetration of p-particles. In order to provide the necessary shielding during the dilution step, any succussion step, the dosing step and packaging, these operations can be SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 7 carried out inside a Faraday cage. Normally such shielding will also be effective to prevent penetration by a particles; it is, however, impractical to attempt to provide shielding against rays. The shielding step is preferably carried so as to shield from P- radiation having energy in the range of up to about 19 keV. In particular, the shielding step can be carried out so as to shield from 3- radiation energy in the range of from about 1 keV to about 19 keV.

The container in which dosing of the tablet or other comDacted mass of the carrier is carried out and in which the homeopathic medicinal composition may be eventually distributed to practitioners or customers is desirably substantially impervious to 3 radiation, including emitted Pradiation in the tritium energy range. Such a container may be made from a paramagnetic metal. Alternatively it may comprise a composite container comprising an inert inner container and an outer shield substantially impervious to fradiation, including emitted f- radiation in the tritium energy range. Suitable metals from which to form the storage container are, for example, aluminium, nickel or copper.

The dilution step preferably includes a succussion step. Succussion can be imparted manually; in this case the succussion should preferably be carried using a gloved hand so as not to supply heat to the flask or other container during succussion. Alternatively the flask or other container can be succussed mechanically. It is desirable to avoid stirring the solution during succussion in such a way as to produce a vortex. A suitable succussion regimen involves shaking the flask or other container mechanically at a frequency in the range of from about 0.1 Hz to about 60 Hz with an amplitude of about 40 mm for a period of about seconds. Whilst succussion is desirable, it should not be so vigorous as to impart energy to the solution of more than SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 8 about 85000 kJ/mole.

In another aspect the invention provides a homeopathic medicinal preparation which has been prepared according to the process of the invention.

The invention further provides a storage container which is adapted to shield its contents from the effects of p' radiation, including emitted P- radiation in the tritium energy range, containing a charge of a solid homeopathic medicinal preparation containing an agent having homeopathic efficacy, which preparation has been prepared by a process which comprises: providing an initial solution containing a predetermined starting concentration of a selected compound having homeopathic efficacy; diluting the initial solution using at least one dilution step by addition of diluent so as to produce following the or each dilution step a diluted solution having a higher dilution than that of the solution being diluted; and dosing a compacted mass of particles of a solid carrier with a predetermined amount of the resulting diluted solution so as to produce a solid homeopathic medicinal composition in compacted solid form.

Conveniently the storage container is adapted to contain a unit dosage of the homeopathic medicinal composition, for example one or more tablets or from three up to twenty one, in multiples of three, globules. This means that, when the patient opens the container in readiness for taking the unit dosage, there is no risk of any subsequent dosage being exposed to the effects of radiation such as would occur if the container contained more than one unit dosage of the homeopathic medicinal composition and were opened by the patient. There is also no risk of the contents of the SUBSTITUTE SHEET (RULE 2B) WO 98/07411 PCT/GB97/02220 9 container, in this case, being influenced by the contents of another container with a homeopathic preparation of another strength or containing a different homeopathic agent. Such a container can be a screw capped container, a container with a childproof cap, a container with a slide-off cap, a sealed ampoule with a frangible tip, or a bag made of a metallised plastics material. The container may be provided with a tamperproof seal of conventional design so as to indicate to the patient that the homeopathic medicinal preparation contained therein has remained shielded from P- radiation, including emitted p- radiation in the tritium energy range, since packaging was effected.

In the dilution step the conventional dilution methods of Hahnemann or of Korsakoff can be used in which the initial solution, which is of any convenient strength, is diluted by a factor of one hundred or ten at each dilution stage.

Alternatively the initial solution can be diluted by a method (which we have termed the GCL method) which involves dilution in a first dilution step by a factor of 100 and mixing by succussion. In such a succussion step the flask should be shaken a number of times in the same direction, e.g.

horizontally or vertically, in order to introduce into the diluted solution energy in the range of, for example, from about 10- 3 to about 200 J/g. This solution can be termed a 1 G solution. Then the succussed diluted solution resulting from such a first dilution step is diluted by discarding one fifth of its volume and replacing the discarded volume with further diluent and again succussing the resulting solution.

This resulting solution can be termed a 2 G solution. The concentrations in the resulting solution are set out in Table 2 below.

SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCTGB97/02220 TABLE 2 Dilution Concentration GCL in 1/100 in 10-n Scale 1/100 1/100 10- 2 1 G 8/1000 0.8/100 8 x 10- 2 G 64/10000 0.64/100 64 x 10- 4 3 G 512/100000 0.512/100 512 x 10- 5 4 G 4096/1000000 0.4096/100 4096 x 10- 5 G A molar solution of a substance contains, according to accepted molecular theory, 6.023 x 1023 molecules (i.e.

Avogadro's number of olecules) of that substance per litre.

Hence conventional scientific wisdom would suggest that, even if one were to commence with an initial solution of molar strength, a 10-60 molar solution (or a 30 CH solution) of a substance contains statistically less than 1 molecule per litre of that substance. Nonetheless there is evidence to suggest that a beneficial homeopathic effect can be observed in a patient, in a suitable case, who has been treated with a 30 CH solution of a given homeopathic agent.

The applicants postulate that, in contrast to the usually accepted theory which suggests that mass is uniformly distributed in the space-time continuum, in fact mass is nonuniformly spread in the space-time continuum and so nonexisting in the cone of the future of a point. Within this theoretical framework it can be calculated mathematically and verified experimentally by use of so-called contonian statistics that, in the cone of the future where a particle disappears, a non-trivial physical field appears; this can be termed the remanent wave. A remanent wave is always created when a particle disappears and leaves what can be termed a "white hole". It is further postulated that, at any SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 11 Hahnemannian dilution, remanent waves and so-called hyperprotons are created which take over and reorganise the structure of the diluent.

For further information regarding the mathematical calculations involved in contonian statistics reference may be made to interpretation physico-math6matirue de 1'effet pharmacologique des hautes dilutions: onde remanente apparences contoniennes (conton) by H. Berliocchi R. R.

Conte, Cahiers de Biothdrapie, No. 126, pages 73 to '1994).

In the process according to the invention at least one tablet or globule or other compacted mass of solid carrier can be placed in a container and impregnated with a suitable amount of the diluted solution. In the case of globules, it may be desirable to place three globules in the container; if tablets are used, then a single tablet can be placed in the container. Next a suitable amount, for example, a drop, of the diluted solution can be allowed to fall on to each globule or tablet. Then a further set of globules, e.g. a further three globules, or a further tablet, can be placed in the container, preferably on top of the first treated set of globules or tablet, and dosing repeated. This procedure can be repeated as many times as desired until the container contains the desired quantity of globules or tablets.

In a'particularly preferred process according to the invention, the tablets are each a snug fit in the cross section of the open container. If globules are used, then the container is preferably sized so that a predetermined number of aligned globules are a snug fit in the cross section of the open container.

The container is desirably elongate and of substantially rectangular cross section. The tablets or globules are sized so as to fit snugly in the container as described above.

SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 12 In order that the invention may be clearly understood and readily carried into effect, a preferred process according to the invention will now be described, by way of example only, with reference to the accompanying drawings, wherein:- Figure 1 is a diagram illustrating a conventional method of impregnating granules or globules; Figure 2 is a cross section of a container containing three globules; and Figure 3 is a diagram illustrating a dosing step of a process for preparing solid homeopathic medicinal compositions according to the invention.

Referring to Figure 1 of the drawings, in a conventional process for the production of a solid homeopathic medicinal composition, a mass 1 of, for example, from about 10 g to about 20 kg, for example about 4 kg of granules or globules of a solid carrier, such as a carbohydrate, is placed in a flask 2 which is rotated about its axis 3 as indicated by arrow 4. Whilst so rotating the flask 2 and its contents, i.e. the mass i, a diluted solution 5 of appropriate strength of a compound having homeopathic efficacy, for example a CH solution, is sprayed into the flask 2 from a container 6 through an atomiser 7. The resulting spray 8 of atomised droplets of the solution 5 is directed into the interior of flask 2. After approximately one third of the solution 5 has been sprayed into flask 2, the direction of rotation of flask 2 is reversed and spraying is continued. After about two thirds of the final volume of solution has been sprayed into flask 2, the direction of rotation is again reversed.

In a typical procedure the weight of solution 5 sprayed into flask 2 corresponds to about 2.5% w/w based upon the weight of the globules or granules i.

Figure 2 illustrates a container 9 which contains three SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB9702220 13 globules 10. Container may be elongated so as to contain, for example, seven rows of globules each weighing typically 0.05 g each. If the dosage is appropriately controlled, then it can be arranged that the patient can consume one globule three times a day; if the container 9 contains seven rows each of three globules, then the patient will have a supply of globules 10 sufficient to last him or her for a total of a week.

To prepare the globules according to the process of the invention a drop of appropriate dilution is dropped on to each globule 9 in a first row and then a further row of globules 10 is inserted into the container 9 and the procedure repeated.

Figure 3 shows a container 11 with two tablets 12 and 13 therein. Tablet 12 is inserted first and then dosed by allowing a drop of an appropriately diluted solution, for example, a 30 CH solution of aconitum to fall from a needle 14 on to tablet 12. Then tablet 13 is placed on top of tablet 12 and the procedure is repeated. A further tablet or tablets (not shown) can be placed on top of tablet 13 and the dosing procedure again repeated. When the desired number of tablets has been so treated, a closure member (not shown) can be put on the container to continue the packaging procedure.

As will be appreciated by those skilled in the art, the process can be readily automated with containers being moved in an array on a conveyor belt in turn through a tablet inserting station at which a first tablet 12 is inserted into each container 11, then through a first dosing station at which a multiple needle dispensing device doses an appropriate amount of a diluted solution on to the tablets 12, then through a second tablet insertion station for addition of tablets 12 and through a further dosing station, and so on, as necessary, and eventually through a package SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 14 closure station at which a closure is placed on the container 11 or in which container 11 is other wise sealed.

Multiple dosing apparatus suitable for use in the practice of the invention is well known, for example, in the field of medical diagnosis and in microbiology for dispensing small quantities of liquid into multiple wells of a multiple well plate or can readily be adapted therefrom.

SUBSTITTE SHEET (RULE 26)

Claims (12)

1. 2. A process according to claim 1, in which the compacted mass of particles of a solid carrier is a tablet or globule comprising the solid carrier.
2. 3. A process according to claim 2, in which the tablet weighs about 0.15 g.
3. 4. A process according to claim 2, in which the globules weigh about 0.05 g each. A process according to any one of claims 1 to 4, which further includes the step of packaging the resulting solid homeopathic medicinal preparation in a container adapted to protect the solid homeopathic medicinal composition from radiation, including emitted radiation in the tritium energy range, until required for consumption by a patient.
4. 6. A process according to any one of claims 1 to 5, in which the compacted mass of particles of the solid carrier is placed in a packaging container prior to effecting the dosing step.
5. 7. A process according to any one of claims 1 to 6, in SUBSTmTUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 16 which the dilution step comprises succussion of the diluted solution during or after each dilution stage.
6. 8. A process according to any one of claims 1 to 7, in which the dilution step, any succussion step, and the dosing step, as well as packaging are carried out within an environment shielded from radiati6n, including emitted 3- radiation in the tritium energy range.
7. 9. A process according to any one of claims 1 to 8, in which the solid carrier material comprises a carbohydrate.
8. 10. A process according to claim 9, in which the carrier material comprises lactose, sucrose, threalose, or threose.
9. 11. A process according to any one of claims 1 to 10, in which the container in which dosing of the tablet or other compacted mass of the carrier is carried out and in which the homeopathic medicinal composition is eventually distributed to practitioners or customers is substantially impervious to 9 radiation, including emitted f3 radiation in the tritium energy range.
10. 12. A process according to claim 11, in which the container is made from a metal selected from aluminium, nickel or copper.
11. 13. A solid homeopathic medicinal preparation which has been prepared by a process according to any one of claims 1 to 12.
12. 14. A storage container which is adapted to shield its contents from the effects of radiation, including emitted radiation in the tritium energy range, containing a charge of a solid homeopathic medicinal preparation containing an agent having homeopathic efficacy, which preparation has been prepared by a process which comprises: providing an initial solution containing a predetermined starting concentration of a selected compound having homeopathic efficacy; diluting the initial solution using at least one SUBSTITUTE SHEET (RULE 26) WO 98/07411 PCT/GB97/02220 17 dilution step by addition of diluent so as to produce following the or each dilution step a diluted solution having a higher dilution than that of the solution being diluted; and dosing a compacted mass of particles of a solid carrier with a predetermined amount of the resulting diluted solution so as to produce a solid homeopathic medicinal composition in compacted solid form. A storage container according to claim 14, which contains a unit dosage of the solid homeopathic medicinal composition. SUBSTITUTE SHEET (RULE 26)