Coated Homoeopathic Pillules

Ph Eur

DEFINITION

Solid preparations prepared from sucrose Pillules for homoeopathic preparations (2153) (category 5), by coating with a syrup made from homoeopathic preparations either potentised or mixed with sucrose syrup. Triturations can be incorporated separately. Coated homoeopathic pillules possess a suitable mechanical strength to resist handling without crumbling or breaking. They are intended for sublingual or oral use. Coated homoeopathic pillules may also be called ‘globuli velati’.

PRODUCTION

In the manufacture, packaging, storage and distribution of coated homoeopathic pillules, suitable measures are taken to ensure their microbiological quality; recommendations on this aspect are provided in general chapter 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use.

For coating, use homoeopathic stocks (in case of a mother tincture or a glycerol macerate) and/or decimal dilutions thereof or decimal triturations and a syrup made from 64 parts of sucrose and 36 parts of purified water. The homoeopathic preparations used are prepared according to the general monograph Methods of preparation of homoeopathic stocks and potentisation (2371).

To prepare 100 parts of coated homoeopathic pillules, the pillules are coated with the syrup using one of the following procedures, depending upon the type of homoeopathic preparation used.

Aqueous dilutions

Mix 1 part of an aqueous preparation with 9 parts of the syrup and potentise by succussion; evenly apply the mixture to (100 -x) parts of pillules (where x is the mass of sucrose in the syrup). The potency of the coated homoeopathic pillules corresponds to the potency of the liquid preparation used for coating.

Triturations

Mix 10 parts of a trituration with 20 parts of the syrup; evenly apply the mixture to (100 -x-y) parts of pillules (where x is the mass of sucrose in the syrup and y is the mass of lactose monohydrate in the incorporated trituration). The potency of the coated homoeopathic pillules corresponds to the potency of the trituration used.

Mixtures

Unless otherwise justified and authorised, prepare a mixture obtained from 10 parts of a liquid preparation (obtained from aqueous preparations, triturations or aqueous dilutions of glycerol macerates) and 90 parts of the syrup, adding sufficient purified water to evenly apply the mixture to (100 -x-y) parts of pillules (where x is the mass of sucrose in the syrup and y is the mass of lactose monohydrate in the incorporated triturations). The potency/potencies of the coated homoeopathic pillules correspond to the potency/potencies of the individual preparations used in the mixture.

TESTS

Uniformity of mass.

Carry out the test using 20 coated homoeopathic pillules to constitute 1 unit. Weigh individually 20 units taken at random and determine the individual and average masses. Not more than 2 of the individual masses deviate from the average mass by more than 10 per cent and none deviate by more than 20 per cent.

Microbial contamination.

Unless otherwise justified, authorised and labelled, coated homoeopathic pillules are intended for sublingual administration and the following acceptance criteria apply.

TAMC: acceptance criterion 10² CFU/g (2.6.12).

TYMC: acceptance criterion 10¹ CFU/g (2.6.12).

Absence of Staphylococcus aureus (2.6.13).

Absence of Pseudomonas aeruginosa (2.6.13).

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