Čes. slov. farm. 2018, 67(2):59-65 | DOI: 10.36290/csf.2018.008
Superdisintegrants used in pharmaceutical technology
- Ústav technologie léků, Farmaceutická fakulta, Veterinární a farmaceutická univerzita, Brno
Disintegrants are substances which promote disintegration of the solid dosage form in the dissolution medium or body fluids. Efficient disintegration is an important prerequisite for ensuring release of the active substance and its good bioavailability. Several mechanisms of disintegrants' action are currently recognized, but disintegration is a complex process, and the majority of substances act by combining multiple mechanisms. Superdisintegrants as an innovative materials allow more efficient disintegration of the dosage form in lower concentrations, without any negative impact on processability and mechanical properties of the final dosage form. Currently are in pharmaceutical technology used synthetic, modified (semi-synthetic), and also natural superdisintegrants, whose main representatives discribes this article.
Keywords: disintegrants; superdisintegrants; solid dosage forms; tablets; disintegration time; excipients
Grants and funding:
Rozvolňovadla představují nedílnou součást většiny pevných lékových forem. V současné době již široce používané inovativní materiály v podobě vysoce efektivních superdesintegrantů podstupují další vývoj vycházející z principu spoluzpracování pomocných látek, s jasným cílem o zjednodušení procesu výroby pevných lékových forem v průmyslovém měřítku.
Received: March 6, 2018; Accepted: March 16, 2018; Published: February 1, 2018 Show citation
References
- Bhowmik D., Chiranjib B., Yadav J., Chandira R. M., Kumar S. Emerging trends of disintegrants used in formulation of solid dosage form. Pharm. Lett. 2010; 2, 495-504.
- Mangal M., Thakral S., Goswami M., Ghai P. Superdisintegrants: An updated review. Int. J. Pharm. Pharm. Sci. 2012; 2, 26-35.
- Roy D., Bhowmik D., Kumar K. S. A comprehensive review on superdisintegrants used in orodispersible tablets. Indian J. Res. Pharm. Biotechnol. 2014; 2, 1297-1303.
- Mohanachandran P. S., Sindhumol P. G., Kiran T. S. Superdisintegrants: An overview. Int. J. Pharm. Sci. Rev. Res. 2011; 6, 105-109.
- Priyanka S., Vandana S. A review article on: Superdisintegrants. Int. J. Drug Res. Technol. 2017; 3, 11.
- Guyot-Hermann A. M., Ringard D. J. Disintegration mechanisms of tablets containing starches. Hypothesis about the particle-particle repulsive force. Drug Dev. Ind. Pharm. 1981; 7, 155-177.
Go to original source...
- Naga A. T., Sambasiva R. A. Traditional and emerging disintegrants: A review. Int. J. Pharm. Sci. Rev. Res. 2013; 22, 205-212.
- Moreton R. CH. Disintegrants in tableting. In: Augsburger L. L., Hoag S. W. (eds.) Pharmaceutical dosage forms - Tablets, 3rd ed. New York: Informa Healthcare 2008.
- Nagar P. K., Parvez N., Sharma P. K. Superdisintegrants - current approach. J. Drug Deliv. Therapeutics. 2014; 4, 37-44.
Go to original source...
- FE Pharma. Superdisintegrants: Technical papers: Introduction to chemistry and performance. http://www.dfepharma.com/en/excipients/superdisintegrants/technical-documents.aspx (5. 3. 2016).
- Medicines complete. Excipient: sodium starch glycolate (Glycolys). https://www.medicinescomplete.com/mc/excipients/current/login.htm?uri=https%3A%2F%2Fwww.medicinescomplete.com%2Fmc%2Fexcipients%2F2012%2F1002062746.html (25. 4. 2016).
- Rowe R. C., Sheskey P. J., Owen S. C. Handbook of pharma-ceutical excipients. 6th ed. Washington DC: American Pharmacists Association 2009.
- Ministerstvo zdravotnictví ČR. Český lékopis 2009. Praha: Grada Publishing 2009.
- Zhao N., Augsburger L. L. The influence of swelling capacity of superdisintegrants in different pH media in the dissolution of hydrochlorothiazide from directly compressed tablets. AAPS PharmSciTech. 2005; 6, E120-E126.
Go to original source...
Go to PubMed...
- Medicines complete. Excipient: croscarmellose sodium (Ac-Di-Sol). https://www.medicinescomplete.com/mc/excipients/current/login.htm?uri=https%3A%2F%2Fwww.medicinescomplete.com%2Fmc%2Fexcipients%2F2012%2F1002154757.html (25. 4. 2016).
- Bindra D. S., Stein D., Pandey, P., Barbour N. Incompatibility of croscarmellose sodium with alkaline excipients in a tablet formulation. Pharm. Dev. Technol. 2014; 19, 285-289.
Go to original source...
Go to PubMed...
- Larsen J., Melander C. Study of interaction between croscar-mellose and escitalopram during sample preparation. Drug Dev. Ind. Pharm. 2012; 38, 1195-1199.
Go to original source...
Go to PubMed...
- Bühler V. Polyvinylpyrrolidone Excipients for Pharmaceuticals, 1st ed. Berlin: Springer 2005.
- Prokopová I. Makromolekulární chemie. 2. vydání. Praha: VŠCHT 2007.
- Basf S. E. Products & Industries: Kollidon® CL-F. https://industries.BASFSE.com/en/Drug-Formulation/Kollidon-CL-F.html (1. 11. 2017).
- Shin-Etsu Chemical. Low-Substituted Hydroxypropyl Cellulose NF. http://www.elementoorganika.ru/files/lhpc.pdf (12. 4. 2017).
- Colorcon. Product brochure: Starch 1500. https://www.colorcon.com/literature/marketing/ex/Starch%201500/COLORCON_Starch_1500_Brochure_2008.01.15_Webiste.pdf (14. 8. 2017).
- Kaur A. L. P. Superdisintegrants: An arising exemplar in orodispersible tablets. Int. J. Drug Res. Technol. 2015; 5.
- Bele M. H., Derle D. V. Effect of polacrilin potassium as disintegrant on bioavailability of diclofenac potassium in tablets: A technical note. AAPS PharmSci Tech. 2012; 13, 756-759.
Go to original source...
Go to PubMed...
- Yadav N. D., Pingale P. L., Tatane, S. R. Comparative study on effect of natural and artificial superdisintegrant in the formulation of fast dissolving aspirin tablet. J. Pharm. Res. 2010; 3, 1594-1597.
- Hřivna L. Technologie sacharidů. Brno: Mendelova univerzita v Brně 2014.
- Biotox. Slizy a kleje. http://www.biotox.cz/naturstoff/chemie/ch-sach-slizy.html (16. 5. 2016).
- Pawan P., Sudhir CH., Mayur P. Natural superdisintegrants: Recent investigations and current approaches. Int. J. Pharm. Sci. 2012; 3, 2015-2026.
- Mehta D. M., Shelat P. K., Parejiya P. B., Patel A. J., Barot, B. Investigations of Plantago ovata husk powder as a disintegrating agent for development of famotidine tablets. Int. J. Pharm. Sci. Nanotechnol. 2011; 4, 1412-1417.
Go to original source...
- Shirsand S. B., Suresh S., Para M. S., Swamy P. V., Kumar, D. N. Plantago ovata mucilage in the design of fast disintegrating tablets. Indian J. Pharm. Sci. 2009; 71, 41.
Go to original source...
Go to PubMed...
- Kumar M. U., Babu M. K. Design and evaluation of fast dissolving tablets containing diclofenac sodium using fenugreek gum as a natural superdisintegrant. Asian Pac. J. Trop. Biomed. 2014; 4, S329-S334.
Go to original source...
Go to PubMed...
- Shah V., Patel R. Studies on mucilage from Hibiscus Rosa-Sinensis Linn as oral disintegrant. Int. J. App. Pharm. 2010; 2, 18-21.
- Velíšek J. Chemie potravin. 1. vyd. Tábor: OSSIS 1999. 339 s.
- Shrivastava M., Kapoor V. P. Seed galactomannana: An overview. Chem. Biodivers. 2005; 2, 295-317.
Go to original source...
Go to PubMed...
- Sharma B. R., Kumar V., Soni, P. L. Carbamoylethylation of Cassia tora gum. Carbohydr. Polym. 2003; 54, 143-147.
Go to original source...
- Soni P. L., Sharma P. Cassia tora gum as viscosifier and fluid loss control agent in oil well drilling. India Patent Application No. 680/DEL/2000. 25. 7. 2000.
- Osmałek T., Froelich A., Tasarek S. Application of gellan gum in pharmacy and medicine. Int. J. Pharm. 2014; 466, 328-340.
Go to original source...
Go to PubMed...
- Gohel M. C., Parikh R. K., Brahmbhatt B. K., Shah A. R. Preparation and assessment of novel coprocessed superdisintegrant consisting of crospovidone and sodium starch glycolate: a technical note. AAPS PharmSciTech. 2007; 8, E63-E69.
Go to original source...
Go to PubMed...
- Vraníková B., Pavloková S., Gajdziok, J. Experimental design for determination of effects of superdisintegrant combinations on liquisolid system properties. J. Pharm. Sci. 2017; 106, 817-825.
Go to original source...
Go to PubMed...
- Mirani G. A., Patankar P. S., Borole S. V., Pawar S. A., Kadam J. V. Direct compression high functionality excipient using coprocessing technique: A brief review. Curr. Drug Deliv. 2011; 8, 426-435.
Go to original source...
Go to PubMed...
- Basf SE. Products & Industries: Ludipress®. https://industries.basf.com/en/Drug-Formulation/Ludipress.html (18. 8. 2016).
- Avantor. Performance Profile: PanExcea® MH300G. https://www.avantormaterials.com. (18. 8. 2016).
- F-Melt. Product Information. http://www.f-melt.com/product/ (9. 8. 2017).
- Basf S. E. Products & Industries: Ludiflash®. https://industries.basf.com/en/Drug-Formulation/Ludiflash.html (18. 8. 2017).
- Colorcon. Product brochure: Starcap 1500®. http://www.colorcon.com/products-formulation/all-products/excipients/capsules/starcap-1500 (14. 8. 2016).
- Bala R., Khanna S., Pawar P. Polymers in fast disintegrating tablets - A review. Asian J. Pharm. Clin. Res. 2012; 8-14.