Generic placeholder image

Recent Patents on Drug Delivery & Formulation


ISSN (Print): 1872-2113
ISSN (Online): 2212-4039

Perspective Article

Oral Disintegrating Tablets – An Updated Patent Perspective

Author(s): Shailesh Sharma* and Kuljit Singh

Volume 14, Issue 3, 2020

Page: [166 - 190] Pages: 25

DOI: 10.2174/1872211314999201123202930

Price: $65


Current Development in drug delivery system has been employed with an endeavour to enhance the bioavailability of the drug, mask its taste, induce the rapid onset of action and improve patient compliance. An alternative approach to the conventional dosage form is being employed to triumph over all these issues named as Orodispersible system. Over the past three decades, this novel dosage form has gained considerable attention as compared to other conventional solid dosage forms such as tablets and capsules. ODTs dissolve or disintegrate within a few seconds or a minute when put on the tongue, without the need for water. ODT has an advantageous effect on paediatrics and geriatrics patients with dysphagia. Over the last decade, widespread advances in the formulation of ODTs have been executed in academia and industry that resulted in the emergence of a large number of patents. Products developed from ODT mechanics launched in the market in the 1980s have grown bit by bit in demand and their products are rapidly escalating. Expanding in the technology forum based on industrialization, these systems include the use of lyophilization, cotton candy, sublimation, melt extrusion and direct compression in addition to the conventional wet granulation processes and patent techniques. The present study focused on non-patent and patent citations concerning ODT along with active ingredients, techniques used and results of the innovations.

Keywords: Disintegration, Orodispersible Tablets (ODT), Fast Disintegrating Tablets (FDT), superdisintegrants, lyophilization, sublimation.

Graphical Abstract
Joseph A. Pharmaceutical dosage forms and drug delivery systems. J Pharm Sci 1990; 79: 1044.
Thakur K, Sharma G, Singh B, Katare OP. Topical drug delivery of anti-infectives employing lipid-based nanocarriers: Dermatokinetics as an important tool. Curr Pharm Des 2018; 24(43): 5108-28.
[] [PMID: 30657036]
Rashid M, Malik MY, Singh SK, Chaturvedi S, Gayen JR, Wahajuddin M. Bioavailability enhancement of poorly soluble drugs: The holy grail in pharma industry. Curr Pharm Des 2019; 25(9): 987-1020.
[] [PMID: 30706801]
Mukker JK, Singh RSP. Pharmacokinetic modeling in nano-formulations: Concept, implementation and challenges. Curr Pharm Des 2018; 24(43): 5175-80.
[] [PMID: 30706804]
Barich DH, Munson EJ, Zell MT. Physicochemical properties, formulation and drug delivery. In: Drug delivery: principles and applications. Wang B, Ed. USA: John Weily Sons Inc, Hoboken NJ2005; pp. 57-71.
Pade V, Stavchansky S. Estimation of the relative contribution of the transcellular and paracellular pathway to the transport of passively absorbed drugs in the Caco-2 cell culture model. Pharm Res 1997; 14(9): 1210-5.
[] [PMID: 9327450]
Hannan PA, Khan JA, Khan A, Safiullah S. Oral dispersible system: A new approach in drug delivery system. Indian J Pharm Sci 2016; 78(1): 2-7.
[] [PMID: 27168675]
Bardal SK, Waechter JE, Martin DS. Pharmacokinetics Appl Pharmacol. Elsevier 2010; pp. 17-34.
Neal-Kluever A, Fisher J, Grylack L, Kakiuchi-Kiyota S, Halpern W. Physiology of the neonatal gastrointestinal system relevant to the disposition of orally administered medications. Drug Metab Dispos 2019; 47(3): 296-313.
[] [PMID: 30567878]
Kuppens IELM, Bosch TM, van Maanen MJ, et al. Oral bioavailability of docetaxel in combination with OC144-093 (ONT-093). Cancer Chemother Pharmacol 2005; 55(1): 72-8.
[] [PMID: 15316750]
Guidance for industry orally disintegrating tablets 2008. Available from:
Hirani JJ, Rathod DA, Vadalia KR. Orally disintegrating tablets: A review. Trop J Pharm Res 2009; 8(2): 161-72.
Masareddy RS, Kadia RV, Manvi FV. Development of mouth dissolving tablets of clozapine using two different techniques. Indian J Pharm Sci 2008; 70(4): 526-8.
[] [PMID: 20046788]
Sekar V, Chellan VR. Immediate release tablets of telmisartan using superdisintegrant-formulation, evaluation and stability studies. Chem Pharm Bull 2008; 56(4): 575-7.
[] [PMID: 18379110]
Alyami H, Koner J, Huynh C, Terry D, Mohammed AR. Current opinions and recommendations of paediatric healthcare professionals-The importance of tablets: Emerging orally disintegrating versus traditional tablets. PLos ONE 2018; 13(2): 1-16.
Bae J, Johnston TA, Chaiittianan R, Sutthanut K, Jay M, Marson L. Characterization and in vivo efficacy of a heptapeptide ODT formulation for the treatment of neurogenic bladder dysfunction. Int J Pharm 2018; 536(1): 397-404.
[] [PMID: 29195918]
Bhagavan HN, Wolkoff BI. Correlation between the disintegration time and the bioavailability of vitamin C tablets. Pharm Res 1993; 10(2): 239-42.
[] [PMID: 8456071]
Imbs TI, Ermakova SP, Fedoreyev SA, Anastyuk SD, Zvyagintseva TN. Isolation of fucoxanthin and highly unsaturated monogalactosyldiacylglycerol from brown alga Fucus evanescens C Agardh and in vitro investigation of their antitumor activity. Mar Biotechnol (NY) 2013; 15(5): 606-12.
[] [PMID: 23748883]
Aguilar JE, Montoya EG, Lozano PP, Negre JMS, Carmona MM, Grau JRT. New SeDeM-ODT expert system: An expert system for formulation of orodispersible tablets obtained by direct compression. Formul Tools. Pharm. Dev 2013; pp. 137-54.
Issa A, Mansour O, Hammad T. Orally disintegration tablets- Paitent friendly. Int J Pharm Sci Rev Res 2015; 31(1): 35-42.
Douroumis D. Orally disintegrating dosage forms and taste-masking technologies; 2010. Expert Opin Drug Deliv 2011; 8(5): 665-75.
[] [PMID: 21438776]
Jain RA, Ruddy SB, Cumming KL, Clancy MJA, Codd JE. Rapidly disintegrating solid oral dosage form US 6316029. 2001.
Badgujar BP, Mundada AS. The technologies used for developing orally disintegrating tablets: a review. Acta Pharm 2011; 61(2): 117-39.
[] [PMID: 21684842]
Manallack DT. The pKa distribution of drugs: Application to drug discovery. Perspect Medicin Chem 2007; 1: 25-38.
[] [PMID: 19812734]
Khan S, Kataria P, Nakhat P, Yeole P. Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets. AAPS PharmSciTech 2007; 8(2): 46.
[] [PMID: 17622121]
Faisal W, Farag F, Abdellatif AAH, Abbas A. Taste masking approaches for medicines. Curr Drug Deliv 2018; 15(2): 167-85.
[] [PMID: 29034835]
Pein M, Preis M, Eckert C, Kiene FE. Taste-masking assessment of solid oral dosage forms--a critical review. Int J Pharm 2014; 465(1-2): 239-54.
[] [PMID: 24509066]
Saihi D, Vroman I, Giraud S, Bourbigot S. Microencapsulation of ammonium phosphate with a polyurethane shell part I: Coacervation technique. React Funct Polym 2005; 64(3): 127-38.
Panigrahi D, Baghel S, Mishra B. Mouth dissolving tablet: an overview of preparation techniques, evalution and patented technologies. J Pharma Res 2005; 4(3): 33-8.
Patel DM, Patel MM. Optimization of fast dissolving etoricoxib tablets prepared by sublimation technique. Indian J Pharm Sci 2008; 70(1): 71-6.
[] [PMID: 20390084]
Gugulothu D, Desai P, Pandharipande P, Patravale V. Freeze drying: Exploring potential in development of orodispersible tablets of sumatriptan succinate. Drug Dev Ind Pharm 2015; 41(3): 398-405.
[] [PMID: 24384027]
Cantor SL, Khan MA, Gupta A. Development and optimization of taste-masked Orally Disintegrating Tablets (ODTs) of clindamycin hydrochloride. Drug Dev Ind Pharm 2015; 41(7): 1156-64.
[] [PMID: 25000481]
Dey P, Maiti S. Orodispersible tablets: A new trend in drug delivery. J Nat Sci Biol Med 2010; 1(1): 2-5.
[] [PMID: 22096326]
Koizumi K, Watanabe Y, Morita K, Utoguchi N, Matsumoto M. New method of preparing high-porosity rapidly saliva soluble compressed tablets using mannitol with camphor, a subliming material. Int J Pharm 1997; 152(1): 127-31.
Shukla D, Chakraborty S, Singh S, Mishra B. Mouth Dissolving Tablets I: An overview of formulation technology. Sci Pharm 2009; 77(2): 309-26.
Olmez SS, Vural I, Sahin S, Ertugrul A, Capan Y. Formulation and evaluation of clozapine orally disintegrating tablets prepared by direct compression. Pharmazie 2013; 68(2): 110-6.
[] [PMID: 23469682]
Kuno Y, Kojima M, Ando S, Nakagami H. Evaluation of rapidly disintegrating tablets manufactured by phase transition of sugar alcohols. J Control Release 2005; 105(1-2): 16-22.
[] [PMID: 15955365]
Kande KV, Kotak DJ, Degani MS, Kirsanov D, Legin A, Devarajan PV. Microwave-assisted development of orally disintegrating tablets by direct compression. AAPS PharmSciTech 2017; 18(6): 2055-66.
[] [PMID: 27995465]
Rahman Z, Siddiqui A, Khan MA. Orally disintegrating tablet of novel salt of antiepileptic drug: Formulation strategy and evaluation. Eur J Pharm Biopharm 2013; 85(3 Pt B): 1300-9.
[] [PMID: 23800704]
Hooper P, Lasher J, Alexander KS, Baki G. A new modified wetting test and an alternative disintegration test for orally disintegrating tablets. J Pharm Biomed Anal 2016; 120: 391-6.
[] [PMID: 26774944]
Desai S, Poddar A, Sawant K. Formulation of cyclodextrin inclusion complex-based orally disintegrating tablet of eslicarbazepine acetate for improved oral bioavailability. Mater Sci Eng C 2016; 58: 826-34.
[] [PMID: 26478377]
Elkhodairy KA, Hassan MA, Afifi SA. Formulation and optimization of orodispersible tablets of flutamide. Saudi Pharm J 2014; 22(1): 53-61.
[] [PMID: 24493974]
Mesnier X, Althaus TO, Forny L, et al. Novel method to quantify tablet disintegration. Powder Technol 2013; 238: 27-34.
Türkmena O, Zeynep AŞ, Baloğlu E. Formulation and evaluation of fexofenadine hydrochloride orally disintegrating tablets for paediatric use. J Drug Deliv Sci Technol 2018; 43: 201-10.
Azad M, Moreno J, Davé R. Stable and fast-dissolving amorphous drug composites preparation via impregnation of neusilin® UFL2. J Pharm Sci 2018; 107(1): 170-82.
[] [PMID: 29031953]
Brniak W, Maślak E, Jachowicz R. Orodispersible films and tablets with prednisolone microparticles. Eur J Pharm Sci 2015; 75: 81-90.
[] [PMID: 25889975]
Pathan IB, Shingare PR, Kurumkar P. Formulation design and optimization of novel mouth dissolving tablets for venlafaxine hydrochloride using sublimation technique. J Pharm Res 2013; 6(6): 593-8.
Ibrahim MA, Abou El Ela AESF. Optimized furosemide taste masked orally disintegrating tablets. Saudi Pharm J 2017; 25(7): 1055-62.
[] [PMID: 29158715]
Singh S, Shah D. Development and characterization of mouth dissolving tablet of zolmitriptan. Asian Pac J Trop Dis 2012; 2(1): S457-6.
Rajpurohit H, Sharma P, Sharma S, Purohit S, Bhandari A. Hordeum vulgare hull in the design of fast disintegrating tablets. J Young Pharm 2011; 3(3): 211-5.
[] [PMID: 21897660]
Abdelbary A, Bendas ER, Ramadan AA, Mostafa DA. Pharmaceutical and pharmacokinetic evaluation of a novel fast dissolving film formulation of flupentixol dihydrochloride. AAPS PharmSciTech 2014; 15(6): 1603-10.
[] [PMID: 25142820]
Ahmed TA, El-Say KM, Mahmoud MF, Samy AM, Badawi AA. Miconazole nitrate oral disintegrating tablets: in vivo performance and stability study. AAPS PharmSciTech 2012; 13(3): 760-71.
[] [PMID: 22585373]
Basu B, Aviya KR, Bhattacharya A. Development and characterization of mouth dissolving tablets of prednisolone. J Pharm Investig 2013; 44(2): 79-102.
Liew KB, Peh KK. Investigation on the effect of polymer and starch on the tablet properties of lyophilized orally disintegrating tablet. Arch Pharm Res 2015.
[] [PMID: 25579848]
Sheshala R, Khan N, Chitneni M, Darwis Y. Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants. Arch Pharm Res 2011; 34(11): 1945-56.
[] [PMID: 22139694]
Mahmoud AA, Salah S. Fast relief from migraine attacks using fast-disintegrating sublingual zolmitriptan tablets. Drug Dev Ind Pharm 2012; 38(6): 762-9.
[] [PMID: 22023340]
Sadeghi M, Hemmati S, Hamishehkar H. Synthesis of a novel superdisintegrant by starch derivatization with polysuccinimide and its application for the development of ondansetron fast dissolving tablet. Drug Dev Ind Pharm 2015; 42(5): 769-75.
Abd El Rasoul S, Shazly GA. Propafenone HCl fast dissolving tablets containing subliming agent prepared by direct compression method. Saudi Pharm J 2017; 25(7): 1086-92.
[] [PMID: 29158720]
Wang C, Hu S, Sun CC. Expedited development of a high dose orally disintegrating metformin tablet enabled by sweet salt formation with acesulfame. Int J Pharm 2017; 532(1): 435-43.
[] [PMID: 28844896]
Dave V, Yadav RB, Ahuja R, Yadav S. Formulation design and optimization of novel fast dissolving tablet of chlorpheniramine maleate by using lyophilization techniques. Bull Fac Pharm Cairo Univ 2017; 55(1): 31-9.
Husseinya RA, Abu Lila AS, Abdallaha MH, El-ghamry HA. Fast disintegrating tablet of valsartan for the treatment of pediatric hypertension: in vitro and in vivo evaluation. J Drug Deliv Sci Technol 2018; 43: 194-200.
Kumar MU, Babu MK. Design and evaluation of fast dissolving tablets containing diclofenac sodium using fenugreek gum as a natural superdisintegrant. Asian Pac J Trop Biomed 2014; 4(Suppl. 1): S329-34.
[] [PMID: 25183106]
Sharma SK, Sharma R, Sagar VG. Fast dissolving tablet–a review and recent advances in manufacturing technologies. Res J Pharm Dos Forms Technol 2010; 2(2): 120-4.
Siddiqui MN, Garg G, Sharma PK. Fast dissolving tablets: preparation, characterization and evaluation: an overview. Int J Pharm Sci Rev Res 2010; 4(2): 87-96.
Kumari S, Visht S, Sharma PK, Yadav RK. Fast dissolving drug delivery system: review article. J Pharm Res 2010; 3(6): 1444-9.
Puttalingaiah L, Kavitha K, Mani TT. Fast disintegrating tablets: an overview of formulation, technology and evaluation. Res J Pharm Biol Chem Sci 2011; 2(2): 589-601.
Khanna K, Xavier G, Joshi SK, Patel A, Khanna S, Goel B. Fast dissolving tablets-a novel approach. Int. J. Pharm. Res. Allied. Sci 2016; 5(2): 311-22.
Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies. Crit Rev Ther Drug Carrier Syst 2004; 21(6): 433-76.
[] [PMID: 15658933]
Lafon L. Galenical form for oral administration and its method of preparation by lyophilization of an oil-in-water emulsion European Patent 0159237 1988.
Lagoviyer Y, Levinson RS, Stotler D, Riley CT. Means for creating a mass having structural integrity. US6465010, 2002.
Goel H, Rai P, Rana V, Tiwary AK. Orally disintegrating systems: innovations in formulation and technology. Recent Pat Drug Deliv Formul 2008; 2(3): 258-74.
[] [PMID: 19075912]
Flanner H, Chang R, Pinkett J, Wassink S, White L. Rapid immediate release oral dosage form. US6384020, 2002.
Cremer K. Fast dissolving technologies in detail Orally disintegrating dosage forms. Pharma Con GmbH 2001; pp. 62-97.
Diallo O, Philip M, Talwar N. Orally disintegrating tablet of nabilone comprising mannitol-based granules. US20170014340, 2019.
Kondo M, Ochiai N, Sakakura Y. Orally disintegrating tablet US 20160136091. 2016.
Narisawa S, Sugimoto M, Kitaoka K, Ookawa A, Morimoto M. Orally disintegrating tablet. US20140073671 2014.
Yoshida N, Obae K. Orally disintegrating tablet containing bitterness- masking granules. U. S. Patent 9,744,134, 2017.
Chen JC, Day K, Szymczak CE. Orally disintegrating tablet US 20130295175. 2016.
Pevzner V, Moses-Heller S. Stable orally disintegrating pharmaceutical compositions US 20170360697. 2018.
Djordjevic J, Bommana MM, Phuapradit W, Shah NH, Pizzo CA. Orally disintegrating tablet formulation for enhanced bioavailability. US20190083403, 2019.
Gossel N. Corticosteroid containing orally disintegrating tablet compositions for eosinophilic esophagitis. US20160206627, 2019.
Sekiguchi G, Hayakawa R, Hara Y. Orally disintegrating tablet and production process therefor. US20150110880, 2017.
Sivert A, Andrès C, Benameur H. Orally disintegrating tablet containing solid lipid particles and methods for their preparation and use US 20170112762,. 2017.
Cifter U, Turkyilmaz A, Yelken G. Orally disintegrating tablets of zolmitriptan and process for preparing the same. US 20110288138, 2014.
Sun W. Orally-disintegrating oseltamivir tablet and method for preparing the same US 20160120802. 2016.
Chawla M, Biradar S, Sharma AK. Stable orally disintegrating tablets of hyoscyamine. US20150283068, 2016.
Sa AH, Mohammed El. Combining sildenafil with caffeine in an oral disintegrating dosage form. US20150250791, 2015.
Broman CT, Sheu E. Orally disintegrating dosage form for administration of avanafil, and associated methods of manufacture and use. US10028916, 2018.
Decorte I, Gendrot E, Prevost Y. Orodispersible tablets obtained by compression molding. US20150335581, 2018.
Gupta S, Phaldesai SP, Kumar NSKS, Sathe MV. Tofacitinib orally disintegrating tablets. US10034882, 2018.
Tsue S, Shimotori T, Kato T. Orally disintegrating tablet containing hydroxyalkyl cellulose microparticles. US20140356427, 2016.
Ahuja V, Gunjikar T, Gundu B. Fast dissolving pharmaceutical composition. US20150045300, 2017.
Greinwald R, Mueller R, Proels M, Wilhelm R. Optimized pharmaceutical formulation for the treatment of inflammatory conditions of the esophagus. US20180185277, 2019.
Okushima T, Nakamura K, Okuda Y. Orally disintegrating tablet. US20190125666, 2019.
Park SY, Lim HJ. Highly robust fast-disintegrating tablet and process for manufacturing the same. US9526789, 2016.
Rawas-Qalaji M, Rachid O, Simons K, Simons E. Epinephrine nanoparticles encapsulated with chitosan and tripolyphosphate, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine. US10568836, 2020.
Gerard DE, Schoelkopf J, Gane PAC. Fast disintegrating solid dosage form formulation comprising functionalized calcium carbonate and method of their manufacture. US20150283082, 2015.
Jeong HJ, Chang Ik. High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient US 20150025084. 2018.
Nielsen BP, Nielsen KA. Nicotine tablet. US20190175581, 2019.
Choonara YE, Du Toit LC, Kumar P, Pillay V, Moosa RM, Jhetam R. Fast dissolving ocular insert. US20150209275, 2015.
Higashiyama Y, Izui W, Harada A, Ogihara S, Nozawa K, Kikuoka H. Additive composition for orally disintegrating tablet US 20190151247. 2019.
Okada K, Mori H, Tsujihata S, Sakata Y. Orally disintegrating tablet and method for producing same. US20170304196, 2017.
Cifter U, Turkyilmaz A, Mutlu O. Novel orally administered pharmaceutical formulations. US20150216798, 2015.
Oikawa M, Yamamoto H. Orally disintegrating tablet coated with film. US20160346199, 2016.
Al Husban FAKM, Glad LHC, Hallstein JMC, Moir AJ, Thompson MP. Orally disintegrating tablets. US20190117577, 2019.
Hiramura T, Itaya S, Hashikawa N, Okabayashi T. Ultrafast-disintegrating tablet and method for manufacturing same US 20160136097. 2016.
Bond CO. Orally disintegrating tablets for treatment of peptic ulcer. US20190083391, 2019.
Turkyilmaz A, Aygul FC, Celik D. Orally disintegrating tablet formulations of donepezil. US20150025112, 2015.
Bondu VKR, Karunanidhi AA, Malluru SR, Namballa RK, Irukulla S, Bhagwatwar HP. Taste masked pharmaceutical formulations. US20120276199, 2012.
Kim YS, Shi JH. Fast-dissolving oral film preparation comprising aripiprazole. US20150196558, 2017.
Krekeler A. Orodispersible film. US20170182105, 2019.
Karavas E, Koutris E, Samara V. Orodispersible film composition comprising enalapril for the treatment of hypertension in a pediatric population. US20170165315, 2017.
Cilurzo F, Grigoli MD, Minghetti P, Pagani S. Orodispersible films having quick dissolution times for therapeutic and food use. US20170143623, 2017.
Steiner D, Kwade A. Structured orodispersible films. US20200108011, 2020.
Koshiishi D, Tanaka T. Bacteria-containing oral rapidly disintegrating tablet. US20180185293, 2018.
Rawas-Qalaji M, Aodah AH. Atropine sulfate rapidlydisintegrating sublingual tablets, methods for manufacture thereof, and methods for use thereof for treatment of acute organophosphate toxicity. US20170246158, 2017.
Padmanabhan B, Sen H, Bhushan I, Kulkarni V. Rapidly disintegrating tablet compositions of dpp-iv inhibitors with low mineral content. US20190060242, 2019.
Kothari SH, Desai DS. Flashmelt oral dosage formulation US 9358207,. 2016.
Chin SF, Dong L, Gupta S. Rapidly disintegrating formulations and methods of use. US20190365641, 2019.
Swartout CT. Rapidly dissolving pharmaceutical compositions and method of manufacturing. US20200022945, 2020.
Venkatesh GM, Swaminathan V, Lai JW. Rapid dissolve tablet compositions for vaginal administration. US20180147152, 2018.
Lorenz DA, Konagurthu S, Wald RJ. Formulations of enzalutamide. US20170224624, 2017.
Cherukuri SR. Rapid melt controlled release taste-masked compositions. US20130071476, 2013.

Rights & Permissions Print Export Cite as
© 2023 Bentham Science Publishers | Privacy Policy