January 7, 2018

Твёрдые формы дозы

from left: tablets, soft  tablets, pills, crystals and granules
слева направо: таблетки, мягкие таблетки, пилюли (горошины), кристаллы, гранулы

There is presently no standard for solid dose forms in the BHomP, so size and ingredients are likely to vary from one manufacturer to another.

Crystals. Solid preparations composed of sucrose, resembling granulated sugar and intended for oral or sublingual use. Coated (‘medicated’) with a 95% alcohol preparation of one or more homeopathic potencies and usually administered by measuring approximately 10–20 crystals per dose. Usuallydispensed in clear or amber glass vials with screw cap or in a single dose sachet, similar to homeopathic powders.

Granules. These are also called ‘non-pareils’, ‘globules’ and ‘globuli’, causing some confusion with pills (see below). Very small solid spherical preparations composed of sucrose, and intended for oral or sublingual use. Coated (‘medicated’) with a 95% alcohol preparation of one or more homeo- pathic potencies and usually administered by measuring approximately 10–20 granules per dose. Usually dispensed in clear or amber glass vials with screw cap or in a single dose sachet, similar to homeopathic powders. Size and composition vary by manufacturer, but sucrose granules of approximately 0.8–1.0 mm diameter have been common in the UK although a much finer product is now also used (see Fig. 4.6).

Pills. These are also called ‘pillules’, ‘granules’ or ‘globules’ in some non- English-speaking countries, causing some confusion with granules (see above). Pills are solid spherical dose unit preparations composed of sucrose, lactose or a compound of the two intended for oral or sublingual use. Coated (‘medicated’) with a 95% alcohol preparation of one or more homeopathic potencies. Pillules are often found to be non-uniform in their size and shape, particularly if the manufacturers have obtained their stocks from food man- ufacturers rather than from specialist producers. In many cases the pills are built up by adding successive aliquots of liquid sucrose in a revolving drum, and it is rather difficult to control the dimensions of the finished product using this method. Continental European and South American suppliers offer pillules in different sizes and their product tends to be more uniform (weighing on average 0.0435 g) but naturally more expensive. Pillules of approximately 3–4 mm diameter are most common in the UK. Dispensed in clear or amber glass vials with screw cap.

Powders – individual. Made from lactose impregnated with liquid potency, individual powders are especially useful for combined medicated and placebo treatments or where one remedy must follow another in sequence. The powders can be individually numbered in the correct sequence and the patient instructed to take the powders in order. The powders, wrapped and usually packed in multiples of 10, are generally medicated from outside the powder paper, by dropping liquid potency on the long edge of the bundle. The alcoholic solution passes through the powder paper to medicate the lactose powder inside. The powders dry by evaporation of the alcohol. It is important to use a liquid potency made up in a high concentration of alcohol (usually 90%) to facilitate the medication process. Some authorities recommend strengths as high as 96% alcohol (Aubin et al., 1980). If a low concentration is used some of the lactose dis- solves in the water content of the vehicle, giving a damp mass that clumps together.

A solid preparation composed of lactose and intended for oral (directly or dissolved in water) or sublingual use. Approximately 100 mg of powder is coated (‘medicated’) with a 95% alcohol preparation of one or more homeopathic potencies and enclosed in a paper sachet to form a single dose unit. Individual powders are shown in Figure 4.7.

Powder – bulk. Bulk powders have a pure lactose base and are impreg- nated with liquid potency. Their use has largely fallen out of currency.

Tablets. A solid dose unit preparation, typically white and biconvex in nature, about the same in appearance as a 75 mg dispersible aspirin tablet, and composed of lactose or a compound of lactose/sucrose intended for oral or sublingual use. Usually prepared by compression of a uniform volume of the excipients and then coated (‘medicated’) with a 95% alcohol prepara- tion of one or more homeopathic potencies. An alternative method of prepa- ration exists in large scale manufacture whereby homeopathic granules are medicated and then compressed to form the tablet in a method similar to allopathic manufacture. Size and composition vary by manufacturer, but lactose tablets of approximately 100 mg weight are most common in the UK. Dispensed in clear or amber glass vials with screw cap.

Soft tablet. A solid dosage form prepared by loose compression of lactose, intended to dissolve readily when administered by the oral or sublingual route. Coated (‘medicated’) with a 95% alcohol preparation of one or more homeopathic potencies. Dispensed in clear or amber glass vials with screw cap.

Trituration tablet. A solid dose form containing largely insoluble reme- dies (e.g. Sulphir, Graphites at low potencies) and compressed directly with excipients into a tablet. Few examples of trituration tablets exist but histor- ically they were used widely.