In the European Pharmacopoeia (Ph. Eur.), the monograph 2153 defines excipient-free pellets for homeopathic preparations as solid preparations made from sucrose, lactose, or other suitable excipients. 

These excipient-free pellets form the basis for the well-known globules. The Ph. Eur. distinguishes between two different types of globules:

• Impregnated homeopathic pellets (Globules – Granula homoeopathica imbuta) Ph. Eur. Monograph 2079
• Coated homeopathic pellets (Globuli velati – Granula homoeopathica velata) Ph. Eur. Monograph 2786

The impregnated homeopathic pellets are the excipient-free variant, which are impregnated with one or more liquid homeopathic preparations.

In contrast, the excipient-free pellets in coated homeopathic globules are coated with a sucrose syrup in which the homeopathic preparations are contained (dissolved). Independently, other triturations (for example, mineral active substances triturated with milk sugar) can also be incorporated.

Both groups are common in that they are intended for sublingual or oral use. Even though the water activity of the two product groups is likely to be very low (low water content, high sugar content), the Ph. Eur. requires a microbiological quality control for globules. The acceptance criteria are identical for the excipient-free pellets and both variants of globules.

The following acceptance criteria are required in the respective monographs:

• Total aerobic microbial count (according to Ph. Eur. 2.6.12): 102 CFU/g
• Total yeast and mold count: (according to Ph. Eur. 2.6.12): 101 CFU/g
• Pseudomonas aeruginosa (according to Ph. Eur. 2.6.13): Absent
• Staphylococcus aureus (according to Ph. Eur. 2.6.13): Absent

 

In order to comply with the Ph. Eur. requirements, globules also require microbiological testing. As a microbiological laboratory specializing in the testing of pharmaceuticals, the BAV Institute can gladly assist you with this.