Immediate-release dosage form; focus on disintegrants use as a promising excipient
Abstract
Disintegrants are materials or mixtures of substances added in the drug formulations, which make easier dispersion or breakup of tablets and ingredients of capsules in small-scale particles for fast dissolution then it comes in contact with water in the GI tract. Immediate drug release dosage forms disintegrate rapidly after administration with an enhanced rate of dissolution. The superdisintegrants provide instantaneous disintegration of tablets after administration in the stomach. In this field, immediate-release liquid dosage forms and parenteral dosage forms have also been introduced for treating patients. The oral route is the most convenient route for the administration of solid dosage form, about 85% of solid dosage is administered by the oral route because of its advantages over others. The therapeutic activity of these formulations is obtained through a typical manner like disintegration followed by dissolution. Hence disintegration has a major role in facilitating drug activity. Diverse categories of superdisintegrants such as synthetic, semi-synthetic, natural, co-processed blends, multifunctional superdisintegrants, etc. have been employed to develop effectual orodispersible tablets and to overcome the limitations of conventional tablet dosage forms. The objective of the present review article is to highlight the various kinds of traditional, Natural crude drugs containing gum and mucilage, Co-processed, semisynthetic and synthetic disintegrants along with a concentration in tablet and capsule disintegration and effect on drug release, which are being used in the formulation to provide the safer, effective drug delivery with patient compliance. Also highlights the mechanism and use of disintegrants in the immediate release dosage form.
Keywords: Disintegrants, Natural, Co-processed, Immediate release
Keywords:
Disintegrants, Natural, Co-processed, Immediate release
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References
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26. Malviya R, Srivastava P, Bansal M, and Sharma PK: Preparation and an evaluation of disintegrating properties of Cucurbita maxima pulp powder. International Journal of Pharmaceutical Sciences 2010; 2(1):395-399. https://doi.org/10.1016/S0975-3575(10)80021-5
27. Divekar Varsha B, Mohan K. Isolation and characterization of mucilage from lepidium sativum linnseeds. Internaional journal of pharma research and development. 2010; 2:1-5.
28. Nagar M, Yadav AV. Cinnarizine orodispersible tablets: a chitosan based fast mouth dissolving technology. International Journal of PharmTech Research. 2009 Oct; 1(4):1079-91.
29. Ravikumar SA, Shirwaikar A, Prabu SL, Mahalaxmi R, Rajendran K, Kumar CD. Studies of disintegrant properties of seed mucilage of Ocimum gratissimum. Indian J Pharm Sci. 2007 Nov; 69(6):753-8. https://doi.org/10.4103/0250-474X.39428
30. Rao NR, Kulkarni U, Rao KD, Suresh DK. Formulation and evaluation of fast dissolving tablets of carbamazepine using natural superdisintegrant plantago ovata seed powder and mucilage. International Journal of Pharmacy and Pharmaceutical Sciences. 2010; 2(2):70-4.
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32. Odeniyi MA, Onu RN, Adetunji OA. Evaluation of bioadhesive properties of natural and modified banana starches. East and Central African Journal of Pharmaceutical Sciences. 2011; 14(2).
33. Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Isolation and evaluation of disintegrant properties of fenugreek seed mucilage. International Journal of PharmTech Research. 2009 Oct; 1(4):982-96.
34. Gresta F, Santonoceto C, Ceravolo G, Formantici C, Grillo O, Ravalli C, Venora G. Productive, qualitative and seed image analysis traits of guar ('Cyamopsis tetragonoloba'l. Taub.). Australian Journal of Crop Science. 2016 Jul 1; 10(7).
35. Shah DP, Jani GK. A newer application of physically modified gellan gum in tablet formulation using factorial design. Ars Pharmaceutica. 2010; 51(1):28-40.
36. Shah BN. Textbook of pharmacognosy and phytochemistry. Elsevier India; 2009..
37. Bhowmik D, Chiranjib B, Yadav J, Chandira RM, Kumar S. Emerging trends of disintegrants used in formulation of solid dosage form. Scholars Research Library Der Pharmacia Lettre. 2010; 2(1):495-504.
38. Alebiowu G, Itiola OA. The influence of pregelatinized starch disintegrants on interacting variables that act on disintegrant properties. Pharmaceutical technology. 2003; 27(8):28-.
39. Dey P, Maiti S, Sa B. Locust bean gum and its application in pharmacy and biotechnology: an overview. International Journal of Current Pharmaceutical Research. 2012; 4(1):7-11.
40. Malik K, Arora G, Singh I. Locust bean gum as superdisintegrant-formulation and evaluation of nimesulide orodispersible tablets. Polimery w medycynie. 2011 Jan 1; 41(1):17-28.
41. Laphookhieo S, Phungpanya C, Tantapakul C, Techa S, Tha-in S, Narmdorkmai W. Chemical constituents from Aegle marmelos. Journal of the Brazilian Chemical Society. 2011; 22:176-8. https://doi.org/10.1590/S0103-50532011000100024
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43. Choudhary PD, Pawar HA. Recently investigated natural gums and mucilages as pharmaceutical excipients: An overview. Journal of pharmaceutics. 2014; 2014. https://doi.org/10.1155/2014/204849
44. Srivastav S, Singh P, Mishra G, Jha KK, Khosa RL. Achyranthes aspera-An important medicinal plant: A review. J Nat Prod Plant Resour. 2011;1(1):1-4.
45. Agarwal SS. Clinically useful herbal drugs. Ahuja Book Company Pvt. Ltd; 2005.
46. Bansal J, Malviya R, Malaviya T, Bhardwaj V, Sharma PK. Evaluation of banana peel pectin as excipient in solid oral dosage form. Global journal of Pharmacology. 2014; 8(2):275-8.
47. Mohanachandran PS, Sindhumol PG, Kiran TS. Superdisintegrants: an overview. International journal of pharmaceutical sciences review and research. 2011 Jan 1; 6(1):105-9.
48. Shihora H, Panda S. Superdisintegrants, utility in dosage forms: a quick review. J Pharm Sci Biosci Res. 2011; 1(3):148-53..
49. Deshmkh H, Chandrashekhara S, Nagesh C, Murade A, Usgaunkar S. Superdisintegrants: A recent investigation and current approach. Asian Journal of Pharmacy and Technology. 2012; 2(1):19-25.
50. Alebiowu G, Itiola OA. The influence of pregelatinized starch disintegrants on interacting variables that act on disintegrant properties. Pharmaceutical technology. 2003; 27(8):28-.
51. Pahwa R, Gupta N. Superdisintegrants in the development of orally disintegrating tablets: a review. International journal of pharmaceutical sciences and research. 2011 Nov 1;2(11):2767.
52. Shaji J, Jain V, Lodha S. Chitosan: a novel pharmaceutical excipient. Int. J. Pharm. Appl. Sci. 2010; 1:11-28.
53. Ritthidej GC, Chomto P, Pummangura S, Menasveta P. Chitin and chitosan as disintegrants in paracetamol tablets. Drug Development and Industrial Pharmacy. 1994 Jan 1; 20(13):2109-34. https://doi.org/10.3109/03639049409050225
54. Antony PJ, Sanghavi NM. A new disintegrant for pharmaceutical dosage forms. Drug development and industrial pharmacy. 1997 Jan 1; 23(4):413-5. https://doi.org/10.3109/03639049709146146
55. Patel DM, Prajapati DG, Patel NM. Seed mucilage from Ocimum americanum linn. as disintegrant in tablets: Separation and evaluation. Indian Journal of pharmaceutical sciences. 2007 May 1; 69(3). https://doi.org/10.4103/0250-474X.34556
56. Arfin T, Sonawane K. Alginate: recent progress and technological prospects. Alginates: applications in the biomedical and food industries. 2019 Feb 13:45. https://doi.org/10.1002/9781119487999.ch3
57. Juneja P, Kaur B, Odeku OA, Singh I. Development of Corn Starch-Neusilin UFL2 conjugate as tablet superdisintegrant: Formulation and evaluation of fast disintegrating tablets. Journal of drug delivery. 2014; 2014. https://doi.org/10.1155/2014/827035
58. Adeoye O, Alebiowu G. Flow, packing and compaction properties of novel coprocessed multifunctional directly compressible excipients prepared from tapioca starch and mannitol. Pharmaceutical development and technology. 2014 Dec 1; 19(8):901-10. https://doi.org/10.3109/10837450.2013.840843
59. Dzever J, Adewale Adetunji O. Evaluation of the Disintegrant Properties of Silicified Oryza sativa Starch Co-Processed with Dioscorea dumentorum Starch in Directly Compressed Paracetamol Tablet Formulations. ScienceOpen Preprints. 2021 Nov 8. https://doi.org/10.14293/S2199-1006.1.SOR-.PPP8CEI.v1
60. Salah AL. Study of the Tableting Properties of MCR, a Newly Coprocessed Cellulose-based Direct Compression Excipient. Turkish Journal of Pharmaceutical Sciences. 2019 Jun; 16(2):161. https://doi.org/10.4274/tjps.galenos.2018.81300
61. Teaima MH, Abdel-Haleem KM, Osama R, El-Nabarawi MA, Elnahas OS. A promising single oral disintegrating tablet for co-delivery of pitavastatin calcium and lornoxicam using co-processed excipients: Formulation, characterization and pharmacokinetic study. Drug Design, Development and Therapy. 2021 Oct 7:4229-42. https://doi.org/10.2147/DDDT.S332729
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2. Tonglairoum P, Ngawhirunpat T, Akkaramongkolporn P, Opanasopit P, Nattapulwat N. Effect of particle size and diluent type on critical parameters for disintegration of tablets containing croscarmellose sodium as a disintegrant. Tropical Journal of Pharmaceutical Research. 2017 Jul 3; 16(6):1215-21. https://doi.org/10.4314/tjpr.v16i6.2
3. Shihora H, Panda S. Superdisintegrants, utility in dosage forms: a quick review. J Pharm Sci Biosci Res. 2011;1(3):148-53.
4. Pahwa R, Gupta N. Superdisintegrants in the development of orally disintegrating tablets: a review. International journal of pharmaceutical sciences and research. 2011 Nov 1; 2(11):2767.
5. Kaur T, Gill B, Kumar S, Gupta GD. Mouth dissolving tablets: a novel approach to drug delivery. Int J Curr Pharm Res. 2011; 3(1):1-7.
6. Vimal VV, Aarathi TS, Anuja SB, Baby J. Superdisintegrants in fast disintegrating drug delivery systems: A brief review. International Journal of Pharmacy. 2013;3(2):380-5.
7. Mangal M, Thakral S, Goswami M, Ghai P. Superdisintegrants: an updated review. Int J Pharm Pharm Sci Res. 2012; 2(2):26-35.
8. Bele MH, Derle DV. Analysis of patents pertaining to superdisintegrants used in tablet manufacturing.
9. Silva DA, Webster GK, Bou-Chacra N, Löbenberg R. The significance of disintegration testing in pharmaceutical development. Dissolution Technol. 2018 Aug 1; 25(3):30-8. https://doi.org/10.14227/DT250318P30
10. El-Barghouthi M, Eftaiha AA, Rashid I, Al-Remawi M, Badwan A. A novel superdisintegrating agent made from physically modified chitosan with silicon dioxide. Drug development and industrial pharmacy. 2008 Jan 1; 34(4):373-83. https://doi.org/10.1080/03639040701657792
11. Brittain HG. Profiles of drug substances, excipients and related methodology. Academic Press; 2016 Feb 26.
12. Bruscato FN, Danti AG, inventors; Bruscato Frank N, Danti August G, assignee. Pharmaceutical tablets containing chitin as a disintegrant. United States patent US 4,086,335. 1978 Apr 25.
13. Bagul US, Bagul NS, Kulkarni MS, Swant SD, Gujar NK and Bidkar AA. Current status of tablet disintegrants: a review. Retrieved 2006 March 5; 2011.
14. Bolhuis GK, Arends-Scholte AW, Stuut GJ, De Vries JA. Disintegration efficiency of sodium starch glycolates, prepared from different native starches. European journal of pharmaceutics and biopharmaceutics. 1994 Oct; 40(5):317-20.
15. Singh I, Rehni AK, Kalra R, Joshi G, Kumar M, Aboul-Enein HY. Ion exchange resins: Drug delivery and therapeutic applications. Fabad Journal of Pharmaceutical Sciences. 2007 Jun 1; 32(2):91.
16. Kumar GP, Nirmala R. Fundamental aspects of superdisintegrants: a concise review. Journal of Global Pharma Technology. 2012 Feb; 4(2):1-2.
17. Van Veen B, Bolhuis GK, Wu YS, Zuurman K, Frijlink HW. Compaction mechanism and tablet strength of unlubricated and lubricated (silicified) microcrystalline cellulose. European journal of Pharmaceutics and Biopharmaceutics. 2005 Jan 1; 59(1):133-8. https://doi.org/10.1016/j.ejpb.2004.05.009
18. Purvani S, Wadhavani AI. 414 as novel superdisintegrants. Indian J. Pharm. Sci. 2006; 61(1):117-9.
19. Kharade S, Bhutkar MA. Novel superdisintegrants interpolymeric chitosan-alginate complex and chitin in the formulation of orodispersible tablets. Int. J. Pharm. Res. Dev. 2013; 5(5):87-94.
20. Yadav ND, Pingale PL, Tatane SR. Comparative study on effect of natural and artificial superdisintegrants in the formulation of fast dissolving aspirin tablet. Journal of Pharmacy Research. 2010; 3(7):1594-7.
21. Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Isolation and evaluation of disintegrant properties of fenugreek seed mucilage. International Journal of PharmTech Research. 2009 Oct; 1(4):982-96.
22. Shah V, Patel R. Studies on mucilage from Hibuscus rosasinensis linn. as oral disintegrant. International journal of applied pharmaceutics. 2010; 2(1):18-21.
23. Prabhu, K.H., Omer, S., Rajanna, S.G. and Pranesh, K.P. Formulation and evaluation of mouth disintegrating tablets of famotidine by using Hibiscus rosa-sinensis mucilage and treated agar. International Journal of Research in Ayurveda and Pharmacy, 2010; 1(2):497-505.
24. Shirsand SB, Suresh S, Para MS, Swamy PV, Kumar DN. Plantago ovata mucilage in the design of fast disintegrating tablets. Indian Journal of Pharmaceutical Sciences. 2009 Jan; 71(1):41. https://doi.org/10.4103/0250-474X.51952
25. Srinivas K, Prakash K, Kiran HR, Prasad PM, Rao ME. Study of Ocimum basilicum and Plantago ovata as Disintegrants in the Formulation of. Indian J. Pharm. Sci. 2003; 65(2):180-3.
26. Malviya R, Srivastava P, Bansal M, and Sharma PK: Preparation and an evaluation of disintegrating properties of Cucurbita maxima pulp powder. International Journal of Pharmaceutical Sciences 2010; 2(1):395-399. https://doi.org/10.1016/S0975-3575(10)80021-5
27. Divekar Varsha B, Mohan K. Isolation and characterization of mucilage from lepidium sativum linnseeds. Internaional journal of pharma research and development. 2010; 2:1-5.
28. Nagar M, Yadav AV. Cinnarizine orodispersible tablets: a chitosan based fast mouth dissolving technology. International Journal of PharmTech Research. 2009 Oct; 1(4):1079-91.
29. Ravikumar SA, Shirwaikar A, Prabu SL, Mahalaxmi R, Rajendran K, Kumar CD. Studies of disintegrant properties of seed mucilage of Ocimum gratissimum. Indian J Pharm Sci. 2007 Nov; 69(6):753-8. https://doi.org/10.4103/0250-474X.39428
30. Rao NR, Kulkarni U, Rao KD, Suresh DK. Formulation and evaluation of fast dissolving tablets of carbamazepine using natural superdisintegrant plantago ovata seed powder and mucilage. International Journal of Pharmacy and Pharmaceutical Sciences. 2010; 2(2):70-4.
31. Zhang P, Whistler RL, BeMiller JN, Hamaker BR. Banana starch: production, physicochemical properties, and digestibility-a review. Carbohydrate polymers. 2005 Mar 15; 59(4):443-58. https://doi.org/10.1016/j.carbpol.2004.10.014
32. Odeniyi MA, Onu RN, Adetunji OA. Evaluation of bioadhesive properties of natural and modified banana starches. East and Central African Journal of Pharmaceutical Sciences. 2011; 14(2).
33. Kumar R, Patil S, Patil MB, Patil SR, Paschapur MS. Isolation and evaluation of disintegrant properties of fenugreek seed mucilage. International Journal of PharmTech Research. 2009 Oct; 1(4):982-96.
34. Gresta F, Santonoceto C, Ceravolo G, Formantici C, Grillo O, Ravalli C, Venora G. Productive, qualitative and seed image analysis traits of guar ('Cyamopsis tetragonoloba'l. Taub.). Australian Journal of Crop Science. 2016 Jul 1; 10(7).
35. Shah DP, Jani GK. A newer application of physically modified gellan gum in tablet formulation using factorial design. Ars Pharmaceutica. 2010; 51(1):28-40.
36. Shah BN. Textbook of pharmacognosy and phytochemistry. Elsevier India; 2009..
37. Bhowmik D, Chiranjib B, Yadav J, Chandira RM, Kumar S. Emerging trends of disintegrants used in formulation of solid dosage form. Scholars Research Library Der Pharmacia Lettre. 2010; 2(1):495-504.
38. Alebiowu G, Itiola OA. The influence of pregelatinized starch disintegrants on interacting variables that act on disintegrant properties. Pharmaceutical technology. 2003; 27(8):28-.
39. Dey P, Maiti S, Sa B. Locust bean gum and its application in pharmacy and biotechnology: an overview. International Journal of Current Pharmaceutical Research. 2012; 4(1):7-11.
40. Malik K, Arora G, Singh I. Locust bean gum as superdisintegrant-formulation and evaluation of nimesulide orodispersible tablets. Polimery w medycynie. 2011 Jan 1; 41(1):17-28.
41. Laphookhieo S, Phungpanya C, Tantapakul C, Techa S, Tha-in S, Narmdorkmai W. Chemical constituents from Aegle marmelos. Journal of the Brazilian Chemical Society. 2011; 22:176-8. https://doi.org/10.1590/S0103-50532011000100024
42. Shah KA, Patel MB, Patel RJ, Parmar PK. Mangifera indica (mango). Pharmacognosy reviews. 2010 Jan; 4(7):42. https://doi.org/10.4103/0973-7847.65325
43. Choudhary PD, Pawar HA. Recently investigated natural gums and mucilages as pharmaceutical excipients: An overview. Journal of pharmaceutics. 2014; 2014. https://doi.org/10.1155/2014/204849
44. Srivastav S, Singh P, Mishra G, Jha KK, Khosa RL. Achyranthes aspera-An important medicinal plant: A review. J Nat Prod Plant Resour. 2011;1(1):1-4.
45. Agarwal SS. Clinically useful herbal drugs. Ahuja Book Company Pvt. Ltd; 2005.
46. Bansal J, Malviya R, Malaviya T, Bhardwaj V, Sharma PK. Evaluation of banana peel pectin as excipient in solid oral dosage form. Global journal of Pharmacology. 2014; 8(2):275-8.
47. Mohanachandran PS, Sindhumol PG, Kiran TS. Superdisintegrants: an overview. International journal of pharmaceutical sciences review and research. 2011 Jan 1; 6(1):105-9.
48. Shihora H, Panda S. Superdisintegrants, utility in dosage forms: a quick review. J Pharm Sci Biosci Res. 2011; 1(3):148-53..
49. Deshmkh H, Chandrashekhara S, Nagesh C, Murade A, Usgaunkar S. Superdisintegrants: A recent investigation and current approach. Asian Journal of Pharmacy and Technology. 2012; 2(1):19-25.
50. Alebiowu G, Itiola OA. The influence of pregelatinized starch disintegrants on interacting variables that act on disintegrant properties. Pharmaceutical technology. 2003; 27(8):28-.
51. Pahwa R, Gupta N. Superdisintegrants in the development of orally disintegrating tablets: a review. International journal of pharmaceutical sciences and research. 2011 Nov 1;2(11):2767.
52. Shaji J, Jain V, Lodha S. Chitosan: a novel pharmaceutical excipient. Int. J. Pharm. Appl. Sci. 2010; 1:11-28.
53. Ritthidej GC, Chomto P, Pummangura S, Menasveta P. Chitin and chitosan as disintegrants in paracetamol tablets. Drug Development and Industrial Pharmacy. 1994 Jan 1; 20(13):2109-34. https://doi.org/10.3109/03639049409050225
54. Antony PJ, Sanghavi NM. A new disintegrant for pharmaceutical dosage forms. Drug development and industrial pharmacy. 1997 Jan 1; 23(4):413-5. https://doi.org/10.3109/03639049709146146
55. Patel DM, Prajapati DG, Patel NM. Seed mucilage from Ocimum americanum linn. as disintegrant in tablets: Separation and evaluation. Indian Journal of pharmaceutical sciences. 2007 May 1; 69(3). https://doi.org/10.4103/0250-474X.34556
56. Arfin T, Sonawane K. Alginate: recent progress and technological prospects. Alginates: applications in the biomedical and food industries. 2019 Feb 13:45. https://doi.org/10.1002/9781119487999.ch3
57. Juneja P, Kaur B, Odeku OA, Singh I. Development of Corn Starch-Neusilin UFL2 conjugate as tablet superdisintegrant: Formulation and evaluation of fast disintegrating tablets. Journal of drug delivery. 2014; 2014. https://doi.org/10.1155/2014/827035
58. Adeoye O, Alebiowu G. Flow, packing and compaction properties of novel coprocessed multifunctional directly compressible excipients prepared from tapioca starch and mannitol. Pharmaceutical development and technology. 2014 Dec 1; 19(8):901-10. https://doi.org/10.3109/10837450.2013.840843
59. Dzever J, Adewale Adetunji O. Evaluation of the Disintegrant Properties of Silicified Oryza sativa Starch Co-Processed with Dioscorea dumentorum Starch in Directly Compressed Paracetamol Tablet Formulations. ScienceOpen Preprints. 2021 Nov 8. https://doi.org/10.14293/S2199-1006.1.SOR-.PPP8CEI.v1
60. Salah AL. Study of the Tableting Properties of MCR, a Newly Coprocessed Cellulose-based Direct Compression Excipient. Turkish Journal of Pharmaceutical Sciences. 2019 Jun; 16(2):161. https://doi.org/10.4274/tjps.galenos.2018.81300
61. Teaima MH, Abdel-Haleem KM, Osama R, El-Nabarawi MA, Elnahas OS. A promising single oral disintegrating tablet for co-delivery of pitavastatin calcium and lornoxicam using co-processed excipients: Formulation, characterization and pharmacokinetic study. Drug Design, Development and Therapy. 2021 Oct 7:4229-42. https://doi.org/10.2147/DDDT.S332729
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Kute VG, Patil RS, Kute VG, Kaluse PD. Immediate-release dosage form; focus on disintegrants use as a promising excipient. JDDT [Internet]. 15Sep.2023 [cited 2Oct.2023];13(9):170-8. Available from: https://jddtonline.info/index.php/jddt/article/view/6217
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