Comparative Performance of MCC PH-302 in Dapagliflozin Tablets
A comparative formulation study evaluating the tableting performance of DESU® MCC PH-302 against European and Asian PH-302 grades in a low-dose dapagliflozin tablet formulation.
Overview
Microcrystalline cellulose (MCC) is widely used as a functional pharmaceutical excipient because of its excellent compressibility, flowability and contribution to tablet integrity. In low-dose formulations, where the active pharmaceutical ingredient (API) represents only a small proportion of the tablet weight, excipient performance can significantly influence the manufacturing process and critical quality attributes of the finished tablet.
This study used dapagliflozin tablets as a model formulation to compare the tableting performance of DESU® MCC PH-302 from Westpoint Pharma with comparable European and Asian PH-302 grades.
The formulation contained approximately 5 mg API in a 125 mg tablet, with microcrystalline cellulose accounting for approximately 68.5% of the formulation. Other excipients included anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry II.
Study Design
The formulation was manufactured using a controlled dry granulation process. Three different main compression forces were applied during tablet compression to evaluate the effect of compression force on tablet hardness and overall tableting performance.
Formulation & Processing
Dapagliflozin propylene glycol monohydrate was pre-treated using a milling process. MCC and colloidal silicon dioxide were passed through a 40-mesh sieve before blending.
The pre-blended materials, anhydrous lactose and intragranular croscarmellose sodium were mixed at 30 Hz for 30 minutes. Magnesium stearate was then added and mixed for an additional 5 minutes.
The blend was processed using dry granulation with controlled roller compaction and milling parameters. Extragranular croscarmellose sodium and magnesium stearate were incorporated during final blending.
Tablet Compression
Tablet Performance Evaluation
Tablet Hardness
Ten tablets from each formulation were tested using a tablet hardness tester. Mean hardness and standard deviation (SD) were calculated.
Disintegration
Six tablets were tested using a disintegration apparatus. The final disintegration time was recorded when the last tablet completely passed through the test screen.
Dissolution
Dissolution testing was performed according to the 2025 edition of the Chinese Pharmacopoeia under controlled pH 1.2 conditions.
Dissolution Test Conditions
Results and Discussion
MCC PH-302 and Tablet Hardness
Under different main compression forces, tablets prepared with DESU® MCC PH-302 and the European/Asian PH-302 grades showed similar overall hardness trends.
At the same compression force, however, tablets prepared with DESU® PH-302 demonstrated higher tablet hardness.
Produced using a spray-drying process, DESU® PH-302 has a distinctive structural morphology that promotes interparticle bonding during compression. In the dapagliflozin formulation, its combination with anhydrous lactose maintained favorable compactibility following dry granulation, contributing to improved tablet mechanical strength.
Disintegration Performance
The disintegration results showed no significant difference between tablets prepared with DESU® MCC PH-302 and the European/Asian PH-302 grades.
The relatively uniform fibrous aggregates and internal pore structure of DESU® PH-302 can facilitate capillary water penetration into the compact.
When the tablet comes into contact with the dissolution medium, water can penetrate the tablet matrix through the porous structure, promoting tablet breakup and facilitating subsequent dispersion of the formulation components.
Dissolution Performance
Under the same pH 1.2 dissolution conditions, tablets prepared withDESU® MCC PH-302 and the European/Asian PH-302 grades showed comparable dissolution profiles across low, medium and high tablet hardness conditions.
The higher tablet hardness achieved with DESU® PH-302 did not result in a significant adverse effect on dissolution performance under the conditions investigated.
The porous structure of MCC PH-302 supports rapid penetration of the dissolution medium into the tablet, helping promote tablet disintegration and drug dispersion.
A Balanced Performance Profile of DESU® PH-302
Higher tablet hardness at comparable compression forces.
Comparable disintegration performance to reference grades.
Comparable dissolution profiles across hardness levels.
Porous structure supports water penetration and tablet breakup.
Conclusion
This study systematically evaluated the formulation performance of DESU® MCC PH-302 compared with European and Asian PH-302 grades in a low-dose dapagliflozin tablet formulation.
DESU® PH-302 achieved higher tablet hardness at comparable compression forces, while maintaining comparable disintegration and dissolution performance to the reference PH-302 grades evaluated.
As a major functional excipient in tablet formulations, MCC can influence powder compaction, tablet mechanical strength, disintegration and dissolution behavior. The results demonstrate that DESU® PH-302 offers strong compressibility and favorable disintegration performance for demanding tablet manufacturing applications.
Its structural characteristics and pore architecture support efficient water penetration and tablet disintegration, while its excellent compressibility contributes to robust tablet formation. These properties make DESU® PH-302 a promising pharmaceutical excipient for formulation development involving low-dose APIs, dry granulation processes and challenging tableting conditions.
Why Choose DESU® MCC PH-302?
High Compressibility
Higher tablet hardness can be achieved at comparable compression forces.
Balanced Tablet Performance
Combines mechanical strength with effective disintegration performance.
Comparable Dissolution
Maintains dissolution behavior comparable to the reference PH-302 grades evaluated.
Functional Porous Structure
Supports capillary water penetration and efficient tablet disintegration.
For Challenging Formulations
Particularly relevant for low-dose APIs, dry granulation and demanding tableting conditions.
Discover how functional excipient selection can support robust tablet formulation and manufacturing.