translation agency

NLM AIDSLINE
A long wait for Ritonavir capsules.
Cadman J
October 30, 1999
GMHC Treat Issues. 1998 Oct;12(10):10-2. Unique Identifier : AIDSLINE

Abbott Laboratories encountered a serious manufacturing problem with its Ritonavir (Norvir) capsules, and officials have since announced that the capsule form will not be back on the market. The company is working on a new formula that is not prone to crystallization, as was the case with the original capsule. Before the problem occurred, Abbott was already working on a new 200 mg version of Ritonavir in a soft elastic capsule (SEC) form, but Abbott needs to demonstrate the quality of the new form before the FDA will issue marketing approval. In the interim, patients are being given the liquid form of Ritonavir, which has a distinctly unpleasant flavor. The company conducted a survey to determine which foods best mask the flavor of the liquid, and these results are listed. Other methods for taking the liquid are discussed, but no studies have been conducted using these methods.

NEWSLETTER ARTICLE Biological Availability Capsules Crystallization HIV Infections/*DRUG THERAPY HIV Protease Inhibitors/*ADMINISTRATION & DOSAGE Human Quality Control Ritonavir/*ADMINISTRATION & DOSAGE

www.aegis.org