Category: Formulation and Quality
Purpose: Avicel® SMCC is a co-processed excipient which contains 98% microcrystalline cellulose (MCC) and 2% silicon dioxide (SiO2). The unique silicification process of microcrystalline cellulose is thought to improve the compaction and surface morphological properties of MCC and thereby the disintegration characteristics of the excipient. In the present study Metformin Hydrochloride was used as a model drug for preparing the directly compressible (DC) tablets. The objective of this study was to evaluate the disintegration time of Metformin Hydrochloride Oro-dispersible tablets (ODT) prepared using Avicel® SMCC (Silicified Microcrystalline Cellulose) by direct compression technique.
Methods: Metformin Hydrochloride tablets were prepared by direct compression technique. All powder ingredients of Metformin Hydrochloride (50% w/w), Perlitol 200SD (8% w/w), Avicel® SMCC (40% w/w) were sifted using a #40 sieve and blended in a Turbula blender for 15 minutes. Powders required in a small quantity like sucralose micronized (0.5% w/w), spray dried strawberry flavor (0.5% w/w) and Alubra PG100 (1% w/w), were sifted through a #60 sieve and mixed with the API blend for an additional 15 minutes. The final blend was added to the hopper of the tablet press fitted with 16 mm flat punches and tablets were compressed to desirable hardness. The DC tablets of Metformin HCl were evaluated for hardness and disintegration time
Results: The tablets containing Metformin Hydrochloride as model drug were found to have acceptable hardness and to show fast disintegration when dropped into the dissolution media. The disintegration time noted for the different grades of silicified MCC were: SMCC HD90 (20±1 sec); SMCC 90 (18±1 sec) and SMCC 50 (8±2 sec). The trials were run in triplicates (n=3).
Conclusion: It can be concluded that the SMCC as a binder in the ODT formulations can also play an important role of a disintegration agent. It also means that if SMCC is added with super-disintegrant like AC-Di-Sol SD711 (1-2%w/w) the disintegration properties can be further enhanced for an oro-dispersible Tablet.
Kevin O'Donnell– R&D Manager, DuPont Pharma Solutions, Midland, Michigan
Andrew Horton– Technologist, Dow Chemical, Midland, Michigan
Vinay Muley– Team Leader, Dow Dupont, Hyderabad, Telangana, India
Sreeramaiah Arunkumar– Bangalore, Karnataka, India