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

 

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

 

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

 

Impregnated homeopathic pellets are excipient variants impregnated with one or more liquid homeopathic preparations.

In contrast, the excipient pellets for coated homeopathic pellets are covered with a sucrose syrup in which the homeopathic preparations are contained (dissolved). Independently, other triturations (for example, mineral-effective substances with lactose powdered) can also be incorporated.

Both groups are intended for sublingual or oral use. Even though the water activity of both product groups is likely to be very low (low water content, high sugar content), the Ph.Eur. provides for a microbiological purity test for globules. The acceptance criteria are identical for the excipient pellets as well as for the two 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

 

Therefore, to comply with the Ph.Eur. requirements, globules also need a microbiological test. As a microbiological laboratory specialized in the testing of pharmaceuticals, the BAV Institute would be pleased to support you.