Compounded Formulations of XXXX Show Significant Variability in Product Characteristics.

@entity1 @entity9104 @entity15626 @entity15627 @entity33935
UNASSIGNED: Background: Pharmacy compounded products are not regulated to the same standards as commercially available, approved products, increasing potential safety and efficacy risks to @entity1 . This report describes an in vitro study examining consistency of content and release profile of compounded @entity33935 fumarates. Methods: Samples of compounded @entity15626 (cDMF-A, cDMF-B, cFumaderm) from separate Austrian compounding pharmacies were analyzed for drug content, uniformity of dosage, impurity, and in vitro release. Results: The average @entity15626 ( @entity9104 ) content ranged from 102.5 to 96.7% of the 120   mg content listed on the product labels. While the @entity9104 capsule-to-capsule content of cDMF-A was somewhat uniform (~20% difference), there was greater variability amongst cDMF-B and cFumaderm capsules (>   30% difference). Impurity testing revealed 2 and 4 unknown components within cDMF-A and cDMF-B, respectively, with levels ranging from 0.05 to 0.81% of total drug content. In in vitro testing of cDMF-A,>10% (12   mg) of @entity9104 was released after 120   min in simulated gastric fluid and 17% (20   mg) released in simulated intestinal fluid after 60   min. While minimal amount of @entity9104 was released from cDMF-B in simulated gastric fluid, 50% (60   mg) of @entity9104 was released after 60   min in simulated intestinal fluid. Similarly for cFumaderm, a fraction (<   20   mg) of the 120   mg target dose was released after several hours in simulated intestinal fluid. The uniformity of release rates across capsules varied significantly. Conclusion: These results demonstrate that compounded @entity15627 are not equivalent to licensed products and may present unknown safety, efficacy, or quality risks.
