2012
DOI: 10.14227/dt190112p52
|View full text |Cite
|
Sign up to set email alerts
|

Mycophenolate Mofetil: Use of a Simple Dissolution Technique to Assess Generic Formulation Differences

Abstract: Mycophenolate mofetil (MMF) is an immunosuppressive agent indicated for the prophylaxis of acute rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. It is a Biopharmaceutics Classification System Class II substance that has a strongly pH-dependent solubility profile. Consequently, differences in solid-state properties, formulation, and manufacturing processes of MMF can lead to disparities in bioavailability between brands of the same drug. This study was conducted to compare the… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
1

Citation Types

0
8
0

Year Published

2014
2014
2022
2022

Publication Types

Select...
7

Relationship

0
7

Authors

Journals

citations
Cited by 9 publications
(8 citation statements)
references
References 8 publications
0
8
0
Order By: Relevance
“…1). It belongs to BCS Class II of drugs characterized by a strongly pH-dependent solubility profile [1]. It is an immune-suppressant and prodrug of Mycophenolic Acid (MPA), extensively used to prevent rejection in organ transplantation [2].…”
Section: Introductionmentioning
confidence: 99%
“…1). It belongs to BCS Class II of drugs characterized by a strongly pH-dependent solubility profile [1]. It is an immune-suppressant and prodrug of Mycophenolic Acid (MPA), extensively used to prevent rejection in organ transplantation [2].…”
Section: Introductionmentioning
confidence: 99%
“…Therefore, dissolution profiles may be similar at a pH of 1.2 but differ at higher pH values. Such differences may alter drug absorption from the gastrointestinal tract . This, however, does not appear to be the case for the Teva generic.…”
Section: Discussionmentioning
confidence: 99%
“…It then appears that mycophenolate mofetil dissolution needs only to be assayed at a pH of 1.2, as established in the FDA recommendations . In vitro dissolution data at higher pH values are irrelevant to in vivo bioavailability, as demonstrated by the fact that several mycophenolate mofetil generics are bioequivalent to the innovator product in adult healthy volunteers , despite variations in dissolution at higher pH values . The interaction with proton pump inhibitors may have relevance, as they increase the gastric pH and slow the hydrolization of mycophenolate mofetil resulting in a reduction of maximum exposure and availability .…”
Section: Discussionmentioning
confidence: 99%
See 2 more Smart Citations