Disintegrants for solid oral dosage forms
The Science Behind

Disintegrants for solid oral dosage forms

Peer-reviewed journal articles and scientific presentations describing the use of GLYCOLYS® sodium starch glycolate and SOLUTAB® croscarmellose sodium range as disintegrants in solid oral dosage forms 

Study Reference 

Related Roquette excipient(s) 

Summary of results regarding Roquette excipient(s) performances 

An easy-to-use approach for determining the disintegration ability of disintegrants by analysis of available surface area

Iwao, Y.; Tanaka, S.; Uchimoto, T.; Noguchi, S.; Itai, S. International Journal of Pharmaceutics. 2013 May 1; 448(1):1-8 
https://doi.org/10.1016/j.ijpharm.2013.03.012  

GLYCOLYS® (sdium starch glycolate) 

When sodium starch glycolate was mixed with ethenzamide (ETZ) granules, faster dissolution of ETZ from tablets was observed as sodium starch glycolate concentration increased from 1.0 % to 5.0 %. Dissolution of tablets containing 1.0 % sodium starch glycolate was also significantly faster than tablets containing no disintegrants. Sodium starch glycolate also showed good water absorption (Rw) and a fast water absorption rate, which peaked at 10 min.

Transfer from High‐Shear Batch to Continuous Twin Screw Wet Granulation: A Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes 

Beer, P.; Wilson, D.; Huang, Z.; De Matas, M. Journal of Pharmaceutical Sciences. 2014 Oct 1; 103(10):3075-82 
https://doi.org/10.1002/jps.24078  

GLYCOLYS® (sodium starch glycolate) 

Sodium starch glycolate was used in the formulation as a disintegrant (7.5 %, w/w) for continuous twin screw wet granulation, together with an active pharmaceutical ingredient, microcrystalline cellulose, mannitol, hydroxypropyl cellulose, pH modifier, lubricant and water. 

Tailored granule properties using 3D printed screw geometries in twin screw granulation 

Pradhan, S.U.;, Zhang, Y.; Li, J.; Litster, J.D.; Wassgren, C.R. Powder Technology. 2019 Jan 1; 341:75-84 
https://doi.org/10.1016/j.powtec.2017.12.068

GLYCOLYS® (sodium starch glycolate) 

Sodium starch glycolate (5.1 %, w/w) was used as disintegrant in the formulations for continuous twin screw wet granulation, together with an active pharmaceutical ingredient, mannitol, microcrystalline cellulose and hydroxypropyl cellulose. 

Liquisolid Tablet Formulation as a Tool to Improve the Dissolution of Olmesartan Medoxomil 

Bary, A.A.; Louis, D.; Sayed, S. Inventi Rapid: NDDS. 2014 (3):1-8, 2014 
https://scholar.cu.edu.eg/.../my_liquisolid_paper.pdf

GLYCOLYS® (sodium starch glycolate) 

Each liquisolid tablet formulation used in the study included 5 %, w/w sodium starch glycolate as superdisintegrant. The study demonstrated that an optimized formulation using the liquisolid method successfully improved dissolution rate of poorly soluble drug olmesartan medoxomil. 

Structure-Properties Relationship in the Evaluation of Alginic Acid Functionality for Tableting 

Benabbas, R.; Sanchez-Ballester, N.M.; Bataille, B.; Leclercq, L.; Sharkawi, T.; Soulairol, I. AAPS PharmSciTech. 2020 Apr; 21(3): 94 
https://doi.org/10.1208/s12249-020-1633-3

GLYCOLYS® (sodium starch glycolate) 

Sodium starch glycolate was used as one of the reference commercial disintegrants to benchmark the functionality of alginic acid as a disintegrating agent. All disintegrants were used at 5 %, w/w of the total formulation, with the filler being either microcrystalline cellulose or lactose. Disintegration time of tablets with sodium starch glycolate were comparable to tablets with crospovidone, or alginic acid. 

Dissolution rate enhancement of piroxicam by ordered mixing 

Saharan, V.A.; Choudhury, P.K. Pakistan Journal of Pharmaceutical Sciences. 2012 Jul 1; 25(3)521-533 
https://pubmed.ncbi.nlm.nih.gov/22713937/

GLYCOLYS® LV (sodium starch glycolate) 

Ordered mixture formulations with compositions of sodium starch glycolate (8 %, w/w), a water-soluble filler such as mannitol or lactose, sodium lauryl sulfate and the active pharmaceutical ingredient, piroxicam, were successfully demonstrated to improve the dissolution rate of piroxicam. 

Surface dissolution UV imaging for characterization of superdisintegrants and their impact on drug dissolution 

Zarmpi, P.; Flanagan, T.; Meehan, E.; Mann, J.; Fotaki, N.; International Journal of Pharmaceutics. 2020 Mar 15; 577:119080 
https://doi.org/10.1016/j.ijpharm.2020.119080

GLYCOLYS® LV (sodium starch glycolate) 

Pronounced dissolution enhancement was observed by using low viscosity sodium starch glycolate, especially for poorly soluble active pharmaceutical ingredients like carbamazepine. 

Physicochemical characterization of dipeptidyl peptidase-4 inhibitor alogliptin in physical mixtures with excipients 

Bertol, C.D.; Pereira, R.N.; Mendes, C.; Paulino, A.S.; Silva, M.A.; Froehlich, P.E. Journal of Thermal Analysis and Calorimetry. 2017 Dec 1; 130(3):1575-84
https://doi.org/10.1007/s10973-017-6543-6

SOLUTAB® (croscarmellose sodium) 

Binary formulations of alogliptin (ALG) and each excipient in a 1:1 (w/w) proportion were used to investigate compatibility in this study. ALG was found to be compatible with croscarmellose sodium. 

Solid-state compatibility studies of a drug without melting point 

Veiga, A.; Oliveira, P.R.; Bernardi, L.S.; Mendes, C.; Silva, M.A.; Sangoi, M.S.; Janissek, P.R.; Murakami, F.S. Journal of Thermal Analysis and Calorimetry. 2018 Mar 1; 131(3):3201-9 
https://doi.org/10.1007/s10973-017-6756-8

SOLUTAB® (croscarmellose sodium) 

Binary formulations of omeprazole sodium (OMS) and excipients in a 1:1 ratio were used. OMS was found to be compatible with croscarmellose sodium. 

A single-dose, randomized, cross-over, two-way, open-label study for comparing the absorption of boswellic acids and its lecithin formulation 

Riva, A.; Morazzoni, P.; Artaria, C.; Allegrini, P.; Meins, J.; Savio, D.; Appendino, G.; Schubert-Zsilavecz, M.; Abdel-Tawab, M. Phytomedicine. 2016 Nov 15; 23(12):1375-82 
https://doi.org/10.1016/j.phymed.2016.07.009
Licensed under a Creative Commons Attribution License

SOLUTAB® (croscarmellose sodium) 

Croscarmellose sodium was used in the formulation delivered as hard gelatin capsules at a quantity of 9.0 mg, together with Boswellia extract (BE)/lecithin formulation (CSP), corn starch and pregelatinized starch, silicon dioxide, magnesium stearate and talc. 

Application of thermal analysis in study of binary mixtures with metformin 

Santos, A.; Basilio, I.; De Souza, F.; Medeiros, A.; Pinto, M.; De Santana, D.; Macedo, R. Journal of thermal analysis and calorimetry. 2008 Aug 1; 93(2):361-4 
https://doi.org/10.1007/s10973-007-7876-3

GLYCOLYS® Low Solvent (sodium starch glycolate) 
SOLUTAB® (Croscarmellose Sodium) 

Sodium starch glycolate and croscarmellose sodium were found to be compatible with metformin using thermogravimetric studies, differential thermal analysis and differential scanning calorimetry techniques. 

Functional assessment of four types of disintegrants and their effect on the spironolactone release properties 

Rojas, J.; Guisao, S.; Ruge, V. AAPS Pharmscitech. 2012 Dec 1; 13(4):1054-62 
https://doi.org/10.1208/s12249-012-9835-y 

GLYCOLYS® Low Solvent (sodium starch glycolate) 

Sodium starch glycolate (SSG) was found to have the largest water uptake ability. Its ability to swell decreased when placed in acid media. SSG presented a large water sorption ratio due to its high ability to draw and retain water leading to a size increase. Compact disintegration times of SSG were virtually not affected by the presence of lubricant and media pH. 

Design and optimization of a child-friendly dispersible tablet containing isoniazid, pyrazinamide, and rifampicin for treating tuberculosis in pediatrics 

Suárez-González, J.; Santoveña-Estévez, A.; Soriano, M.; Fariña, J.B. Drug Development and Industrial Pharmacy. 2020 Feb 1;46(2):309-17 
https://doi.org/10.1080/03639045.2020.1717516

GLYCOLYS® Low Solvent (sodium starch glycolate) 

Tablets developed with 9 %, w/w of sodium starch glycolate and a compression force of 16 kN disintegrated in less than 3 min and showed a friability below 1 % when 15 mm punches were used.  

Controlled release of oral tetrahydrocurcumin from a novel self-emulsifying floating drug delivery system (SEFDDS) 

Setthacheewakul, S.; Kedjinda, W.; Maneenuan, D.; Wiwattanapatapee, R. AAPS Pharmscitech. 2011 Mar 1; 12(1):152-64 
https://doi.org/10.1208/s12249-010-9568-8

GLYCOLYS® Low Solvent (sodium starch glycolate) 

Higher concentrations of sodium starch glycolate resulted in rapid uptake of water, followed by rapid and enormous swelling which resulted in easy pellet disintegration. Sodium starch glycolate in the range of 0.8 – 1.6 %, w/w resulted in better controlled drug release and gradually increased the tetrahydrocurcumin release to nearly 80% within 8 h. 

Influence of the Superdisintegrants in Nifedipine Release from Osmotic Push-Pull Tablets 

Torres, J.H.; Baltazar, E.H.; Bernad, M.B.; Contreras, L.M. International Journal of Pharmaceutical Sciences and Research. 2019 May 1; 10(5):2164-71 
https://doi.org/10.13040/IJPSR.0975-8232.10(5).2164-71
Licensed under a Creative Commons Attribution License

GLYCOLYS® Low Solvent (sodium starch glycolate) 
SOLUTAB® (croscarmellose sodium) 

Sodium starch glycolate was found to have the greatest drug release rate compared to crospovidone and croscarmellose sodium when used in the formulation of push-pull tablets containing Nifedipine as a model drug. 

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