Veterinary Homeopathic medicines preprations

The homeopathic pharmacopoeias(Veterinary Homeopathic medicines preprations | Vetsuccess)

Veterinary Homeopathic medicines preprations
Veterinary Homeopathic medicines preprations | Vetsuccess

Introduction

Veterinary Homeopathic medicines preprations | Vetsuccess. Homeopathic medicines are prepared in accordance with the methods described in various official national homeopathic pharmacopoeias.

These have been adopted by the relevant regulatory authorities in the countries concerned. In the EU, the German and French pharmacopoeias are considered to be ‘official’. 

In the USA, the Homeopathic Pharmacopeia of the US (HPUS) is the standard. The British homeopathic pharmacopoeia (the latest edition of which appeared in 1999) is not considered to have this status in European law and for many years British manufacturers have relied on the German homeopathic pharmacopoeia (GHP, or HAB in the German abbreviation), with its various supplements, and the French and US pharmacopoeias, for most of their information, particularly with regard to the analysis of starting materials.

The European homeopathic pharmacopoeia that has been in preparation for many years will assume major importance as the number of monographs increases. It should be noted that some methods of preparing medicines differ between the various pharmacopoeias. 

There is currently no requirement for manufacturers to state on the label which pharmacopoeial standard their product conforms to. It might be prudent to enquire, especially if a supplier is changed.

Veterinary Homeopathic medicines preprations | Vetsuccess

The source materials -
The source materials used in homeopathic medicines can be classified as follows:

Plant material.
Approximately 70% of all homeopathic medicines are prepared from extracts of plant materials and, for this reason, many people confuse homeopathy with herbalism.

However, the manner of producing the two types of medicines is quite different. Herbal products are generally the result of an aqueous or alcoholic extraction alone,whereas homeopathy involves an additional dilution process. 

Either the whole plant may be used or only selected parts, as specified in the pharmacopoeia monographs. Medicines to treat allergies and made from materials such as grass and tree pollens, and moulds, are known as allergodes .

Zoological material. 
Examples of medicines derived from healthy zoological material are those derived from the bee and the cockroach.
Material from bacterial cultures and healthy animal secretions may also be used. They are generally known as sarcodes.
Examples include snake and spider venoms, musk oil (Moschus), and secretions of the cuttlefish (Sepia).

Musk is obtained from the African civet, a fox-like animal kept in battery accommodation mainly in Ethiopia.
Animal fur, hair and feathers may also be used to prepare allergodes, while pathological material yields nosodes and may include pus, bodily fluids and diseased tissue .

Auto-isopathics are similar to nosodes, but are prepared from an individual infected patient’s own products (e. g. blood, pustules, urine, warts, verrucae), or from milk from a cow or sheep suffering from mastitis.

Chemical material.
 Highly purified chemical material is rarely used in the preparation of medicines. Thus, calcium carbonate is obtained from the interspaces of oyster shells and sulphur is obtained from a naturally occurring geothermal source.
Chemical material and orthodox drugs may also be used to prepare homeopathic medicines known as tautodes.

In the USA, terminology differs from the above. The US homeopathic pharmacopoeia provides the following definitions:

Isodes, 
sometimes called detoxodes, are homeopathic dilutions of botanical, zoological or chemical substances, including drugs and excipients, that have been ingested or otherwise absorbed by the body and are believed to have produced a disease or disorder.

 
Nosodes are homeopathic attenuations of pathological organs or tissues; causative agents such as bacteria, fungi, ova, parasites, virus particles and yeast; disease products; excretions or secretions.

Sarcodes are homeopathic attenuations of wholesome organs, tissues or metabolic factors obtained from healthy specimens. 

Allersode is the term used to describe homeopathic dilutions of antigens, i.e. substances that, under suitable conditions, can induce the formation of antibodies. Antigens include toxins, ferments, precipitinogens, agglutinogens, opsonogens, lysogens, venins, agglutinins, complements, opsonins, amboceptors, precipitins and most native proteins.

The preparation of homeopathic medicines

STAGE ONE 

Preparation of starting materials..... 

Vegetable material 
Mother tinctures are liquid preparations resulting from the extraction of suitable vegetable source material, usually with alcohol/water mixtures.
They form the starting point for the production of most homeopathic medicines, although some are used orally (e.g. Crataegus) or topically (e.g. Arnica).
If a mother tincture is prescribed, the abbreviation Ø is often used. However, the letter Q is also sometimes used – care should be taken to distinguish between the mother tincture and an LM potency . The resulting extract solutions contain on average one part drug to three parts mother tincture, although this strength can vary depending on the species, type of extraction process and the particular pharmacopoeia being used.
The resultant solutions are strained to remove any extraneous pieces of debris.


Insoluble material 
Chemicals such as Aurum (gold), Graphites (graphite), Silicea (silica) and Sulphur are triturated with lactose in a pestle and mortar.
The resulting triturate may be compressed directly into trituration tablets or administered as a powder. More usually, however, trituration continues until the particle size has been reduced sufficiently to facilitate the preparation of a solution (‘source tincture’ ), usually achieved after three to six serial dilutions, depending on the scale being used. From this point the standard potentisation procedure described below can be followed.

Soluble chemicals 
In the case of soluble chemicals, solutions of known concentration in distilled water or alcohol can be initially prepared as the starting solution. This is called the ‘source tincture’ .

STAGE TWO 

Potentisation (also called dynamisation or attenuation)
With the exceptions noted above, most mother tinctures are serially diluted in a special process that increases the homeopathic strength (although the chemical concentration decreases), for which reason the process is known as potentisation.
 The solution resulting from admixture of the two liquids at each dilution is subjected to a vigorous shaking with impact, known as succussion. The number of times the vials should be shaken is not specified in the pharmacopoeia and may, depending on the manufacturer, be anything from 10 to 100 or more, but within each manufacturing process it remains constant.
Succussion is still carried out by hand in some pharmacies, but some large-scale manufacturers have mechanical shakers.
There are several different methods of dilution, of which the Hahnemannian method is the most widely used.

In the Hahnemannian centesimal method of potentisation, one drop of mother tincture is added to 99 drops of triple distilled alcohol and water diluent in a new, clean, screw-cap glass vial. After the initial process, successive serial dilutions are made, accompanied by succussion, using fresh glass vials at each stage until the solution reaches 3c, 6c, 12c, 30c, 200c and so on ; the number refers to the number of successive 1 in 100 dilutions and ‘c’ indicates the centesimal method. The suffix may also be expressed as ‘cH’ or may be omitted entirely, leaving just the number. 

In the decimal scale, one drop of mother tincture is added to nine drops of diluent. This is indicated in the UK by a number and the letter ‘x’ (e.g. 6x), although in other countries the scale may be indicated by ‘dh’ after the number (e.g. 6dh) or by ‘D’ before the number (e.g. D6). At the higher centesimal dilutions letters are sometimes used alone. Thus the 1000 dilution level is 1M or simply M, 10 000 is XM or 10M and 100 000 is CM (Table 2.2). These high potencies are usually made using the much quicker Korsakovian method (see below), but use the same notation.


Other potentisation methods
LM (or Q) potencies are triturated to the third centesimal level with lactose before being diluted according to a 1 in 50 000 scale (Figure 2.3). LM potencies are sometimes referred to as ‘Q’ potencies, which can often be confused with a mother tincture.
However, an LM will always have a numberto designate the potency level, e.g. LM1 or Q1, LM6 or Q6, whereas a mother tincture will simply use the letter alone.
Homeopaths often instruct patients to succuss liquid LM potencies before taking each dose. In the Korsakovian method, medicines are prepared by adding a measured volume of mother tincture to an appropriate volume of diluent and the resulting solution succussed thoroughly .
 Liquid is then removed from the vial by suction or inversion, leaving droplets of solution adhering to the container wall.
New solvent is then added, the vial agitated vigorously and the process repeated. Korsakovian potencies are usually denoted by a number showing the number of serial dilutions, followed by the letter ‘K’ (e.g. 30K).
This method and K potencies are rarely used in the UK, certainly at low potencies. However, as stated above, this method is often used in the case of very high potencies, which may not realistically be made by the Hahnemannian method. Thus, a 1000 potency may be referred to as 1M, M (as above) or even MK.

Veterinary Homeopathic medicines preprations | Vetsuccess

Mechanisms of potentisation 

One of the fundamental tenets of homeopathy is the concept of potentisation, and yet it continues to be one of the major stumbling blocks to its widespread acceptance, with many sceptics claiming that it is just a myth.


1. It is not known how Hahnemann came upon the procedure of potentisation, but it probably arose from his knowledge of chemistry and alchemy.
Geometric and dynamic models have been constructed to try and explain how medicines can be therapeutically active at such extreme dilutions.

2 There is some evidence to indicate that the structure of solvent molecules may be electrochemically changed by succussion, enabling them to acquire an ability to ‘memorise’ an imprint of the original medicine.
It is acknowledged that this concept is difficult for many highly trained personnel with scientific backgrounds to accept. The simplest suggestion is that succussion may merely facilitate a complete mixing.


STAGE THREE 

Presentation Dose 

forms Solid dose forms

In orthodox medicine, tablets and capsules are made in different forms to control the speed at which the active ingredient is delivered.
This is not necessary in homeopathy, so the choice of ‘carrier’ is governed by convenience rather than therapeutic efficiency. 

Tablets
are about 100 mg in weight and are similar to the classic, biconvex, plain white product used widely in conventional medicine.
They are manufactured commercially from lactose and appropriate excipients. On an industrial scale, blank lactose tablets, or indeed any of the solid dosage forms, can be surface inoculated by spraying on the medicine in an alcoholic tincture or as a syrup in a revolving pan, rather like the old method of sugar coating.
The exact amount of medicine to be applied to ensure an even covering is validated using dyes. On a small scale in the pharmacy, the solid dose forms may be placed in glass vials and medicated by placing drops of liquid potency in strong alcohol on the surface, the number of drops used depending on the amount of solid dose form being medicated.
The container is agitated in a manner similar to succussion, to disperse the medicine throughout the dose form.

Individual powders
are made from lactose impregnated with medicating liquid potency and are useful where small numbers of doses are required.

Pills
and granules are small spheres, usually sucrose, which resemble cake decorations.
The former are approximately 3–4 mm in diameter, while the latter are very tiny, approximately 0.9 mm in diameter and often referred to as ‘poppy seeds’.

Crystals
are sucrose, and have the appearance of granulated sugar.

Soft tablets are loosely compressed lactose tablets that melt in the mouth.


Liquid dose forms 


Mother tinctures -may be given orally (e.g. Crataegus, Valerian), usually in water. They are often applied topically.


Liquid potencies are serial dilutions made from mother tinctures but in a lower concentration of alcohol (typically 20–30%) than that used to medicate solid dose forms (typically 95%).
They are usually given in water but the drops may be placed directly on the tongue, or on a sugar cube.

Injections There are a number of injectables on the market, of which the most widely prescribed in the UK are variants of Mistletoe used in the management of cancer, e.g. Adnoba (Abvoba Heilmittel Gmbh, Pforzheim, Germany) and Iscador (Weleda).

Topical dose forms 

Mother tinctures may be applied topically, either singly (e.g. Arnica for bruising, Thuja for warts or Tamus for chilblains) or in mixtures (e. g. Hypericum and Calendula – widely known as ‘Hypercal’).

Ointments, creams, gels, lotions, liniments (generic and patent) and oils contain between 5 and 10% of mother tincture, or in a few cases where no mother tincture exists liquid potency (e. g. Graphites,Sulphur), incorporated in a suitable vehicle. Available topical preparations include Arnica (bruising), Calendula and Hypericum (superficial wounds), Rhus tox/Ruta (sprains and strains), Tamus (chilblains), and Thuja (warts and verrucae).

Eye drops have caused manufacturers licensing difficulties and at the time of writing are restricted to prescription on a named patient basis in the UK. Argent nit, Calendula, Cineraria and particularly Euphrasia eye drops are all extremely useful and are likely to prove very popular should they become more widely available.

The containers 

There has been much discussion as to whether plastic or glass containers are appropriate for solid dose forms.
The traditionalists still favour neutral glass containers, suggesting that there is a possibility of chemicals leaching into the plastic.
Little work has been done to investigate whether the fears of those eschewing plastic have a firm foundation. T
here have also been suggestions that the glass may play some part in ‘holding’ the potency. Again, these have not been substantiated.
Liquids are packed in glass dropper bottles. The major suppliers use amber screw cap bottles with a plug in the neck, with a channel that facilitates the delivery of one measured drop (0.05 ml).
Silicone rubber teat droppers are rarely used as again there is some concern over leaching.

Legal classification of homeopathic medicines 

Manufactured homeopathic medicines are subject to careful scrutiny to ensure that they are of the highest quality and safety.
In the UK they have been treated as medicines since the inception of the NHS in 1948 and are available on medical prescription just as orthodox medicines are.
As a result, they are subject to rules governing their manufacture and supply.

Human use

In Europe, there are three routes by which homeopathic medicines can be registered:
1. Products with limited claims of efficacy based on bibliographic evidence, and injections, may be registered under UK national rules.
2. Products that are 4x and above may be registered on the basis of quality and safety only (i.e. making no claims of efficacy) under an abbreviated European scheme.
3. Full registration with substantiated claims of efficacy as for orthodox medicines supported by clinical trials. No homeopathic medicine has been registered under this classification.

In the USA, homeopathic medicines are subject to the Food, Drug, and Cosmetic Act of 1938 and regulations issued by the Food and Drug Administration (FDA).
3 Pre-market approval is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS).4 While homeopathic drugs are also subject to the FDA’s non-prescription drug review, the FDA has not yet used this authority.
However, manufacturing, labelling, marketing and sales of homeopathic medicines are subject to FDA compliance rules.
These rules, with the exception of provisions for expiration dating, tablet imprinting and finished product testing, are functionally identical to the rules for their allopathic counterparts.
Good manufacturing practice standards for homeopathic and allopathic drugs are the same. Subject to the relevant FDA regulations, homeopathic medicine indications may be given on the label and there are no limitations on where homeopathic medicines can be sold

Veterinary use 

The normal UK category is Authorised Veterinary Medicine – General Sales List (AVM-GSL).
If a registered homeopathic veterinary product exists then it must be supplied even if it is requested generically.
A vet may use medicines ‘off-label’ under the ‘prescribing cascade’, subject to a strict hierarchy. These provisions apply to both orthodox and homeopathic practice.

If there is no licensed veterinary medicine available for a particular condition or for use in a particular species, similar veterinary products may be used.
If there are no suitable veterinary products, a human medicine may be prescribed.
If no suitable human product is available, a pharmacist or a vet may prepare the required medicine extemporaneously provided that they have the necessary expertise.

The position with respect to the over-the-counter (OTC) supply of homeopathic veterinary products was under review at the time of writing, pending clarification of the European position.
Under a grandfather clause in the 2006 Veterinary Regulations, products that were on the market in the UK prior to 1996 may be registered with the Veterinary Medicines Directorate (VMD) and placed on the market without further action.
Nosodes and sarcodes do not qualify for grandfather rights

Also Read-

References
1. Isbell W, Kayne S B (1997). Potentization – just a myth? Br Homeopath J 86: 156–160.
2. Schulte J (1999). Effects of potentisation in aqueous solutions. Br Homeopath J 88: 155–160.
3. Borneman J P, Field R L (2006).
Regulation of homeopathic products. Am J Health-Syst Pharm 63: 86–91.
4. Food, Drug, and Cosmetic Act of 1938, Pub. L. 103–417, 52 Sta. 1041 (1938), as amended and codified in 21 U. S. C. §321(g)(1) (1938).

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