Acomplia Rimonabant
ACOMPLIA is presented as film-coated tablets containing 20mg rimonabant INN. The product is
packaged in PVC-aluminium blisters and in HPDE bottles closed with a child-resistant tamper-proof
polypropylene screw cap.
Rimonabant is a fine powder, white to practically white. Two different polymorphic forms (1 and 2) have
been identified during development. Form 1 has been used from the beginning of the pharmaceutical
development to the end of Phase 3 clinical studies. Form 2, identified after the start of Phase 3 studies,
was selected for product development. The two forms have very similar physico-chemical characteristics.
As rimonabant is practically insoluble in water, the drug substance has been micronized to increase
particle surface area and thus, facilitate dissolution, and to ensure blend homogeneity during drug product
manufacture.
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