The quality by design (QbD) initiative is promoting a better understanding of excipient performance and the identification of critical material attributes (CMAs). Despite microcrystalline cellulose (MCC) being one of the most popular direct compression binders, only a few studies attempted identifying its CMAs. These studies were based either on a limited number of samples or on MCC produced on a small scale and/or in conditions that deviate from those normally encountered in production. The present work utilizes multivariate analyses first to describe a large database of MCCs produced on a commercial scale, including an overview of their physicochemical properties, and secondly to correlate the most significant material attributes with tabletability. Particle size and moisture content are often considered as the most common if not the sole CMAs with regard to MCC performance in direct compression. The evaluation of more than 80 neat MCCs and the performance of selected samples in a model formulation revealed the importance of other potential critical attributes such as tapped density. Drug product developers and excipient suppliers should work together to identify these CMAs, which may not always be captured by the certificate of analysis.
Understanding the impact of microcrystalline cellulose physicochemical properties on tabletability – ScienceDirect
-
Solving Poor Solubility with Amorphous Solid Dispersions – Courtesy (PharmTech)
Pharma Live, , Formulation Discussion, 0
The oral route remains the most preferred method for delivering drugs. It offers good patient compliance due to its...
-
Investigation of Excipient Compatibility and Associated Degradations for the Formulation Development of a Small Molecule Pharmaceutical Compound
Pharma Live, , Formulation Discussion, 0
Introduction Drug formulation starts with the selection of various suitable excipients for the desired or required dosage forms. Drug-excipient interactions can...
-
ROLE OF PRODRUGS IN SOLUBILITY ENHANCEMENT OF DRUGS
Pharma Live, , Formulation Discussion, 0
ABOUT AUTHORS:Kalyana Chakravarthi G*, Vijayaraj S, Venugopal A, Naresh Ch, Saritha BDepartment of Pharmaceutical Analysis, Sree Vidyanikethan College of...
-
A novel dissolution method for evaluation of polysaccharide based colon specific delivery systems: A suitable alternative to animal sacrifice
Pharma Live, , Formulation Discussion, 0
1-s2-0-s0928098715001128-mainDownload
-
Improved Dissolution Profile of API BCS Class IV Drugs Using Solubility Enhancement Technologies
Pharma Live, , Formulation Discussion, 0
PURPOSEThe purpose of the studies was to develop a formulation platform for BCS Class IV API’s, such that the...
-
Tanshinone IIA – loaded pellets developed for angina chronotherapy: Deconvolution-based formulation design and optimization, pharmacokinetic and pharmacodynamic evaluation
Pharma Live, , Formulation Discussion, 0
1-s2-0-s0928098711000108-mainDownload 1-s2-0-s0928098715002080-mainDownload
-
Safe and cost-effective capsule filling for pre-clinical and first-in-man studies
Pharma Live, , Formulation Discussion, 0
Hear how CoreRx has successfully implemented a flexible automated powder dosing solution for capsule filling, in order to save...
-
Status Quo, Challenges, and Opportunities of Transdermal Drug Delivery
Pharma Live, , Formulation Discussion, 0
Introduction Early work on transdermal drug delivery (TDD) goes back to the 1960s, and in 1971 the seminal US Patent titled...
![](https://ml7mn4k5dnn0.i.optimole.com/w:289/h:289/q:eco/f:best/https://interactivepharm.com/wp-content/uploads/2022/08/Show-your.jpg)