SILYMARIN FOOD SUPPLEMENTS - ORAL SOLID DOSAGE FORMS

Several tablet formulations containing silymarin were developed, in order to meet the requirements of different markets. Milk thistle - Silybum marianum (L.) Gaertn - standardized extracts have proven their positive effect on liver functionality plus other health benefits. Lactose is a widely used excipient for the production of oral solid dosage forms. One important inconvenient of lactose is related to the lactose intolerant potential customers. Cellulose, isomalt and dicalcium phosphate have been selected as alternative possible tablet binders and diluents. Laboratory and pilot batches were studied for each excipient. The pharmacotechnical properties and silybin content of the tablets were measured and recorded in accordance to the European Pharmacopoeia. All pilot batches had results in the desired range of values in order to permit large scale compacting and blistering of the tablets. Currently the formulations containing isomalt and dicalcium phosphate that made the subject of this study are being produced on industrial scale.