Author(s): Saravana Perumal Govindan, Senthamarai R., Anbarasu K.


DOI: 10.5958/0974-360X.2021.00124.4   

Address: Saravana Perumal Govindan1, Senthamarai R.2, Anbarasu K.3
1Research Scholar, Department of Biotechnology, PMIST, Vallam, Thanjavur (Tamil Nadu) - 613403, India.
2Principal, Periyar College of Pharmaceutical Sciences, Tiruchirappalli - 620021, (Tamil Nadu) - 620021, India.
3Assistant Professor, Department of Biotechnology, PMIST, Vallam, Thanjavur (Tamil Nadu) - 613403, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021

There are particular interests in the challenges to develop a flexible dispersible tablet with high drug loading to cover the age groups between >2 years to = 65 yearsin the condition of swallowing and chewing difficulty using a single dosage form design. The aim of this study to design asingle dosage form design, which facilitates dosage adjustment without the necessity of manufacturing different dosage forms. This quality by design concept seeks to provide a scientific basis for the design of a flexible dispersible tablet. This proof of concept study through quality by designwas demonstrated using a suitable model drug, the ceftibuten, one of third generation cephalosporin which fulfills the prerequisites for flexible dispersible tablet design, helps to, understand the feasibility and to identify the critical quality factors affecting the design of a flexible dispersible tablet with high drug loading.The outcome of this formulation design from proof of concept study through quality by design has demonstrated that the designed dispersible tablet with the model drug, ceftibuten has the potential as a flexible single dosage form design in the condition of swallowing and chewing difficulty.

Cite this article:
Saravana Perumal Govindan, Senthamarai R., Anbarasu K.. Design of Flexible Dispersible Tablet with high drug loading using quality by Design: Proof of Concept study using third generation Cephalosporins Model Drug. Research J. Pharm. and Tech. 2021; 14(2):705-714. doi: 10.5958/0974-360X.2021.00124.4

1.    Logrippo S, Ricci G, Sestili M, et al. Oral Drug therapy in elderly with dysphagia: between a rock and a hard place. Clinical Interventions in Aging. 2017; 12: 241-251.
2.    Figueiredo D, Peres M, Luchi C, et al. Chewing impairment and associated factors among adults. Rev Saúde Pública.2013; 47(6): 1028-1038.
3.    Orenstein SR. Oral, pharyngeal, and esophageal motor disorders in infants and children. GI Motility online. Available from: URL: gimo38.html/2006.
4.    Robbins JA, Bridges AD, Taylor A. Oral, pharyngeal and esophageal motor function in aging. GI Motility online. Available from: URL: gimo39.html/2006    .
5.    Govindan SP, Senthamarai R, Anbarasu K. Refrigeration and the Shelf Life of Oral Cephalosporin Powder for Suspension Dosage Form: Review and Proposal. International Journal of Emerging Technologies.2019; 10(2): 376–383.
6.    World Health Organization (WHO). Development of Paediatric Medicines: Points to consider in Pharmaceutical Development. Available from: URL: MedicinesDevelopment_QAS08-257Rev3_17082011.pdf/2011.
7.    World Health Organization (WHO). Development of Paediatric Medicines: Points to consider in Formulation. Available from: URL: docs/en/m/abstract/Js 19833en/2012.
8.    Walsh J, Ranmal SR, Ernest T B, et al. Patient acceptability, safety and access: a balancing act for selecting age-appropriate oral dosage forms for paediatric and geriatric populations. International journal of pharmaceutics.2018; 536(2): 547-562.
9.    Hoppu K. Time to change the paradigm of children's medicines from liquid formulations to flexible solid oral dosage forms. The Ceylon Medical Journal.2016; 61(3):93-95.
10.    Orubu SF, Tuleu C. Medicines for children: Flexible solid oral formulations. Bull World Health Organ.2017; 9:238-240.
11.    Van Riet-Nales DA, Kozarewicz P, Aylward B, et al. Paediatric Drug Development and Formulation Design-a European Perspective. AAPS Pharm Sci Tech. 2017;18(2):241-249.
12.    Lopez FL, Ernest TB, Tuleu C, et al. Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert opin. Drug Deliv. 2015;12(11):1727-1740.
13.    Dey P, Maiti S. Orodispersible tablets: A new trend in drug delivery. J Nat Sci Biol Med.2010;1(1):2-5.
14.    Preis M. Orally Disintegrating Films and Mini-Tablets-Innovative Dosage Forms of Choice for Pediatric Use. AAPS Pharm Sci Tech. 2015; 16(2):234-241.
15.    Van Riet-Nales DA, Schobben AF, Vromans H. Safe and effective pharmacotherapy in infants and preschool children: importance of formulation aspects. Arch Dis Child.2016;101:662-669.
16.    Ivanovska V, Rademaker CMA, Dijk LV, et al. Pediatrics Drug Formulations: A Review of challenges and Progress. Pediatrics.2014;134(2): 361-372.
17.    Dispersible Tablets (2010). Available from: URL:
18.    ICH Harmonised Tripartite Guideline. Pharmaceutical Development Q8 (R2). Available from: URL: https://
19.    U.S Food and Drug Administration (U.S.FDA). Quality by Design for ANDAs: An Example for immediate-Release Dosage Forms. Available from: URL: media/83664/ download/2012.
20.    Pramod K, Tahir MA, Charoo NA, et al. Pharmaceutical product development: A quality by design approach. Int J Pharm Investing.2016;6(3):129-138.
21.    Why is it good to have a Proof of Concept (POC)?. Available from: URL: /08/why-is-it-good-to-have-a-proof-of-concept-poc/.
22.    What is the difference between proof of concept and prototype. Available from: URL: https://www.cleverism.Com/what–is-the-difference-between-proof-of –concept-and-prototype/2019.
23.    Ayad MH. Rational formulation strategy from drug discovery profiling to human proof of concept. Drug Delivery.2015; 22(6):877- 884.
24.    Thabane, et al. A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology. 2010; 10(1):877-884.1-10.
25.    Shanyinde M, Pickering RM, Weatherall M. Questions asked and answered in pilot and feasibility randomized controlled trials. BMC Medical Research Methodology.2011;11(117):1-11.
26.    Byrn SR, Zografi G, Chen X. Accelerating Proof of Concept for small Molecule Drugs Using Solid-State Chemistry. Journal of Pharmaceutical Sciences.2010; 99(9): 3665-3675.
27.    E Teijlingen V, V Hundley. The importance of pilot studies. Nurs Stand. 2002;16(40):33-36.
28.    B Schmidt. Proof of Principle studies. Epilepsy Res.2006;68(1):48-52.
29.    SH Preskorn. The role of proof of concept (POC) studies in drug development using the EVP-6124 POC study as an example. J Psychiatr Pract. 2014;20(1): 59-60.
30.    Borowitz SM. Comparison of the oral cephalosporins. Pediatric Pharmacotherapy Therapy.1996;2(6):1-8.
31.    Harrison CJ, Bratcher D. Cephalosporins: A Review. Pediatrics in Review.2008;29(8):264-273.
32.    Drugs@FDA: FDA Approved Drug Products. Available from:URL:
33.    World Health Organization (WHO). Critically Important Antimicrobials for Human Medicine. Available from: URL:
34.    United States Patent and Trademark Office (USPTO). Available from: URL:    
35.    European Patent Office (EPO). Available from: URL: https://worldwide.
36.    Bolfar Y, Shayanfar A. Prediction of Biopharmaceutical Drug Disposition Classification System (BDDCS) by Structural Parameters. J Pharm Sci.2019; 22: 247-269.
37.    Cedax®. Available from: URL: drusatfda_docs/label/2009.pdf.
38.    Ceftibuten. Availble from: URL: DB01415.
39.    Ceftibuten Product Data sheet (2019). Available from: URL:
40.    Seftem® . Available from: URL:
41.    United States Patent 5599557. Available from: URL:
42.    European Patent 3031450(A1). Available from: URL: https://worldwide.     
43.    Ceftibuten Hydrate. The Japanese Pharmacopoeia Sixteenth Edition (Supplement I,JP XVI).
44.    World Health Organization (WHO). Revision of Monograph on Tablets (QAS/09.324/Final). Available from: URL:>Tabs-General Mono-rev-Final_ 31032011. pdf.
45.    U. S Food and Drug Administration (U.S.FDA). Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. Available from: URL: /81626/ download/.
46.    U. S Food and Drug Administration (U.S.FDA). Guidance for Industry Orally Disintegrating Tablets. Available from: URL:
47.    U. S Food and Drug Administration (U.S.FDA). Guidance for Industry Size, Shape, and other Physical Attributes of Generic Tablets and Capsules. download/.

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DOI: 10.5958/0974-360X 

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