Superdisintegrants in Orally Disintegrating Tablets (ODT)
The Science Behind

Superdisintegrants in Orally Disintegrating Tablets (ODT)

Peer-reviewed journal articles and scientific presentations describing the use of StarLac® co-processed lactose starch and PEARLITOL® Flash co-processed mannitol-starch as superdisintegrants in ODTs 

Study Reference 

Related Roquette excipient(s) 

Summary of results regarding Roquette excipient performances 

Taste-masked and affordable donepezil hydrochloride orally disintegrating tablet as promising solution for non-compliance in Alzheimer’s disease patients 

Liew, K.B.; Tan, Y.T.; Peh, K.K. Drug development and industrial pharmacy. 2015 Apr 3;41(4):583-93. 
https://doi.org/10.3109/03639045.2014.884130 
 

StarLac® Co-processed Lactose Starch  

Formulation containing 50% of StarLac® was found with shortest in vitro, in vitro in artificial saliva and in vivo disintegration times, respectively (21.7 ± 1.67 s), (22.5 ± 1.67 s) and (24.0 ± 1.05 s). Physical stability studies at 40 °C/75% RH for 6 months, showed that the formulation was stable. 

Formulation Design and in vitro Evaluation of Orodispersible Tablets of Orlistat by Direct Compression Method 

Wajid,S.; Yamsani, V.V.; Alsaleh, S.S.; Babelghaith, S.D.; Alsaleh, S.S.; Al-Arifi, M.N. Asian Journal of Pharmaceutics, 2017, 11 (2) 
http://dx.doi.org/10.22377/ajp.v11i02.1278 

 PEARLITOL® Flash Co-processed Mannitol-Starch 

Formulation containing 6% of PEARLITOL® Flash and 6% of Croscarmellose Sodium was found with very short in vitro disintegration time of 18s together with a fast dissolution of the API. 

Stability of Benzocaine Formulated in Commercial Oral Disintegrating Tablet Platforms 

Köllmer, M.; Popescu, C.; Manda, P.; Zhou, L.; Gemeinhart, R.A. AAPS PharmSciTech, 2013, 14 (4), 1333-1340 
https://doi.org/10.1208/s12249-013-0015-5  

PEARLITOL® Flash Co-processed Mannitol-Starch 

The stability of benzocaine Orally Disintegrating Tablets formulated with PEARLITOL® Flash was very high in drastic storage conditions (6 months at 40°C/77% RH): chemical inertness and no change of the physical appearance). 

Bioenhanced sublingual tablet of drug with limited permeability using novel surfactant binder and microencapsulated polysorbate: in vitro/in vivo evaluation 

El-Setouhy, D.A.; Basalious, E.B.; Abdelmalak, N.S. European Journal of Pharmaceutics and Biopharmaceutics, 2015, 94, 386-392 
https://doi.org/10.1016/j.ejpb.2015.06.006  

PEARLITOL® Flash Co-processed Mannitol-Starch 

Bioenhanced sublingual tablets of zolmitriptan containing 33% of PEARLITOL® Flash showed the shortest in vitro/in vivo disintegration times (<30 s), the highest dissolution at early time dissolution points and the highest enhancement of drug transport through mucosal membrane.

Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for paediatric use 

Stoltenberg, I.; Breitkreutz, J. European Journal of Pharmaceutics and Biopharmaceutics, 2011, 78, 462-469 
https://doi.org/10.1016/j.ejpb.2011.02.005

PEARLITOL® Flash Co-processed Mannitol-Starch 

Powder mixtures for direct compression containing PEARLITOL® Flash present the best flow properties. In addition, ODMTs using PEARLITOL® Flash show high performance in term of simulated wetting time (between 4s and 6s). 

Micronized Zaleplon Delivery via Orodispersible Film and Orodispersible Tablets 

Manda, P.; Popescu, C.; Juluri, A.; Janga, K.; Kakulamarri, P.R.; Narishetty, S.; Murthy, S.N.; Repka, M.A. AAPS PharmaSciTech, 2018, 19, 1358-1366 
https://doi.org/10.1208/s12249-017-0924-9  

PEARLITOL® Flash Co-processed Mannitol-Starch 

The use of PEARLITOL® Flash in the ODT formulation enabled to reach adequate harness together with smooth texture and short disintegration time of 30+/-5 seconds. 

® Registered trademark(s) of Roquette Frères, except for StarLac®. StarLac® is a registered trademark of Meggle AG. 

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