MINI TABLETS IN MODERN PHARMACEUTICS: A COMPREHENSIVE REVIEW OF FORMULATION, EVALUATION, AND CLINICAL APPLICATIONS

Authors

DOI:

https://doi.org/10.22159/ijpps.2025v17i9.55477

Keywords:

Mini tablets, Solid oral dosage forms, Modified drug release, Pharmaceutical evaluation, Pediatric and geriatric formulations

Abstract

The purpose of this review is to analyze the new role of mini tablet technology in pharmaceutical sciences by assessing its formulation approach, manufacturing process, quality evaluation parameters, and therapeutic use, especially in improving patient compliance and maximizing drug delivery. A systematic review of literature was performed using peer-reviewed journals, patents, and regulatory guidelines related to mini tablet formulation and testing. Manufacturing processes like direct compression, wet granulation, dry granulation, and melt-extrusion were critically appraised. Important test parameters like weight variation, hardness, friability, disintegration, dissolution profiles, and drug-excipient compatibility studies were evaluated. Mini tablets, often smaller than 3 mm in diameter, present benefits like enhanced accuracy of dosing, swallowability, and the possibility of multi-unit dosage forms. Mini tablets can be formulated for immediate, delayed, or prolonged drug release. Pediatric, geriatric, and dysphagic patients are especially well-served by such forms. Specialized systems such as enteric-coated and bioadhesive mini tablets have also indicated favorable results in controlled and targeted drug delivery. Multiple reports of successful therapeutic uses in cardiovascular, neurological, and gastrointestinal diseases have been documented in various studies. Mini tablet technology offers a flexible and patient-friendly option to traditional dosage forms. Its flexibility, ease of manufacture, and advantageous therapeutic profiles favor its wider application in contemporary pharmaceutics. Additional industrial uptake and research are necessary to fully maximize its potential in personalized and precision drug delivery systems.

Downloads

Download data is not yet available.

References

1. Banker GS, In ANR. The theory and practice of industrial pharmacy. 3rd ed Lachman L, Lieberman HA, Kanig JL, editors. Philadelphia: Lea & Febiger; 1991. p. 293.

2. Lennartz P, Mielck JB. Minitabletting: improving the compactability of paracetamol powder mixtures. International Journal of Pharmaceutics. 1998;173(1-2):75-85. doi: 10.1016/S0378-5173(98)00206-3, PMID 9871234.

3. Mitra B, Chang J, Wu SJ, Wolfe CN, Ternik RL, Gunter TZ. Feasibility of mini-tablets as a flexible drug delivery tool. Int J Pharm. 2017;525(1):149-59. doi: 10.1016/j.ijpharm.2017.04.037, PMID 28432019.

4. Sastry SV, Nyshadham JR, Fix JA. Recent technological advances in oral drug delivery a review. Pharm Sci Technol Today. 2000;3(4):138-45. doi: 10.1016/S1461-5347(00)00247-9, PMID 10754543.

5. Biradar SS, Bhagavati ST, Kuppasad IJ. Fast dissolving drug delivery systems: a brief overview. Internet J Pharmacol. 2006;4(2).

6. Katakam VK, Reddy S, Panakanti PK, Yamsani MR. Design and evaluation of a novel gas formation-based multiple-unit gastro retentive floating drug delivery system for quetiapine fumarate. Trop J Pharm Res. 2014;13(4):489-96. doi: 10.4314/tjpr.v13i4.1, PMID 30123456.

7. Igwe JC, Emenike IV, Oduola AR. Formulation and evaluation of finasteride sustained release matrix tablets using different rate-controlling polymers. Univ J Pharm Res. 2016;1(2):25-31. doi: 10.22270/ujpr.v1i2.R3.

8. Tawfeek HM, Saleem IY, Roberts M. Dissolution enhancement and formulation of rapid-release lornoxicam mini-tablets. J Pharm Sci. 2014;103(8):2470-83. doi: 10.1002/jps.24073, PMID 24995853.

9. Tehseen N, Rao V, Hadi MA. Design and characterization of twice daily mini-tablet formulation of pregabalin. Int J Pharm Pharm Sci. 2013;5(1):168-75.

10. Mastoi SM, Ali A, Aslam H, Niaz K. Comparison of antidyslipidemic potential of 80 mg of fenofibrate with 8 g of Nigella sativa seeds daily. Univ J Pharm Res. 2017;2(6):50-2.

11. Mohamed FA, Roberts M, Seton L, Ford JL, Levina M, Rajabi Siahboomi AR. Film-coated matrix mini-tablets for the extended release of a water-soluble drug. Drug Dev Ind Pharm. 2015;41(4):623-30. doi: 10.3109/03639045.2014.891128, PMID 24564797.

12. Keerthi ML, Kiran RS, Rao VU, Sannapu A, Dutt AG. Pharmaceutical mini-tablets: its advantages, formulation possibilities and general evaluation aspects: a review. Int J Pharm Sci Rev Res. 2014;28(1):214-21.

13. Mahajan KV, Akarte AM, Sapate MK, Baviskar DT, Jain DK. Designing and evaluation of compressed mini-tablets of ramipril as a biphasic delivery system. Indo Am J Pharm Res. 2013;3(9):7277-8.

14. Lopes CM, Sousa Lobo JM, Costa P, Pinto JF. Directly compressed mini matrix tablets containing ibuprofen: preparation and evaluation of sustained release. Drug Dev Ind Pharm. 2006;32(1):95-106. doi: 10.1080/03639040500388482, PMID 16455608.

15. Pogula AH, Nazeer S. Extended release formulation. Int J Pharm Technol. 2010;2(2):625-84.

16. Modi SA, Gaikwad PD, Bankar VH, Pawar SP. Sustained release drug delivery system: a review. Int J Pharm Res Dev. 2011;2(11):147-98.

17. C Shaikh SC, Sanap D, Bhusari DV, Jain S, Kochar PP, Sanchati VN. Formulation and evaluation of ibuprofen gastro-retentive floating tablets. Univ J Pharm Res. 2018;3(4):20-5. doi: 10.22270/ujpr.v3i4.178.

18. Shah BA, Patel AS, Patel BJ, Patel DJ, Qu A. Mini-tablet drug delivery system for pediatric dosage form: a review of manufacturing perspectives. Int J Drug Dev Res. 2018;10(3):47-52.

19. Lopes CM, Lobo JM, Pinto JF, Costa P. Compressed mini-tablets as a biphasic delivery system. Int J Pharm. 2006;323(1-2):93-100. doi: 10.1016/j.ijpharm.2006.05.063, PMID 16828999.

20. Rao NG, Hadi MA, Panchal H. A novel approach to sustained montelukast sodium release: differentially coated mini-tablets in HPMC capsules. Int J Pharm Biomed Sci. 2011;2(2):90-7.

21. Singh S, Virmani T, Virmani R, Mahlawat G, Kumar P. Fast dissolving drug delivery systems: formulation preparation techniques and evaluation. Univ J Pharm Res. 2018;3(4):60-9. doi: 10.22270/ujpr.v3i4.185.

22. Klingmann V, Seitz A, Meissner T, Breitkreutz J, Moeltner A, Bosse HM. Acceptability of uncoated mini-tablets in neonates a randomized controlled trial. J Pediatr. 2015;167(4):893-896.e2. doi: 10.1016/j.jpeds.2015.07.010, PMID 26259675.

23. Opeyemi OT, Adegbenro OO. Development and characterization of direct compressed matrix mini-tablets of naproxen sodium. Univ J Pharm Res. 2018;3(5):7-11. doi: 10.22270/ujpr.v3i5.205.

24. Karthikeyan D, Vijayalaxmi A, Santhosh Kumar C. Formulation and evaluation of biphasic delivery system of aceclofenac mini-tablets in hard gelatin capsules. Int J Novel Trends Pharm Sci. 2013;3(2):39-45.

25. Solanki B, Patel R, Barot B, Parejiya P, Shelat P. Multiple unit dosage forms: a review. Pharmtechmedica. 2012;1(1):11-21.

26. Nweje Anyalowu PC. Design and evaluation of a chronotherapeutic pulsatile drug delivery system of cilnidipine. UJPR. 2017;2(5):18-22. doi: 10.22270/ujpr.v2i5.R4.

27. Bodea M, Tomuta I, Leucuta S. Identification of critical formulation variables for obtaining metoprolol tartrate mini-tablets. Farmacia. 2010;58(6):719-27.

28. Chauhan V. Fast dissolving tablets: a promising approach for drug delivery. UJPR. 2017;2(4):58-64. doi: 10.22270/ujpr.v2i4.RW4.

29. Garg D, Saini V, Gupta S, Kapoor DN, Joshi L. Controlled release multiple units and single-unit doses: a literature review. DHR Int J Pharm Sci. 2013;4(2):66-73.

30. Rosenson RS. Low high-density lipoprotein cholesterol and cardiovascular disease: risk reduction with statin therapy. Am Heart J. 2006;151(3):556-63. doi: 10.1016/j.ahj.2005.03.049, PMID 16504615.

31. Zhu T, Ansquer JC, Kelly MT, Sleep DJ, Pradhan RS. Comparison of the gastrointestinal absorption and bioavailability of fenofibrate and fenofibric acid in humans. J Clin Pharmacol. 2010;50(8):914-21. doi: 10.1177/0091270009354995, PMID 20145261.

32. Chen Y, Qiu Y, Reiland TL. Pharmaceutical compositions comprising effervescent agents and fenofibrate. United States Patent Application US20100021393. Vol. A1; 2010.

33. Venkat Tumuluri. Pharmaceutical mini-tablets. In: Drug delivery trends. Amsterdam: Elsevier; 2020. p. 123-39. doi: 10.1016/B978-0-12-817870-6.00006-7.

34. Vogt M, Kunath K, Dressman JB. Dissolution enhancement of fenofibrate by micronization cogrinding and spray-drying: comparison with commercial preparations. Eur J Pharm Biopharm. 2008;68(2):283-8. doi: 10.1016/j.ejpb.2007.05.010, PMID 17574403.

35. Gundu RK, Gali VR, Deshpande A, Reddy PS. Formulation and evaluation of sustained-release matrix tablets of fenofibrate. Int J Pharm Sci Res. 2015;6(5):2105-12. doi: 10.13040/IJPSR.0975-8232.6(5).2105-12.

36. Sahni J, Raj S, Ahmad FJ, Khar RK. Design and in vitro characterization of buccoadhesive drug delivery system of insulin. Indian J Pharm Sci. 2008;70(1):61-5. doi: 10.4103/0250-474X.40333, PMID 20390082.

37. Al Ameri MN, Nayuni N, Anil Kumar KG, Perrett D, Tucker A, Johnston A. The differences between the branded and generic medicines using solid dosage forms: in vitro dissolution testing. Results Pharma Sci. 2012;2:1-8. doi: 10.1016/j.rinphs.2011.12.001, PMID 25755988.

38. Sampath K. Method development and validation of pravastatin sodium in human plasma by using LCMS/MS. JBB. 2011;3(3). doi: 10.4172/jbb.1000057.

39. Patil P, Joshi P, Paradkar A. Effect of formulation variables on preparation and evaluation of gelled self-emulsifying drug delivery system (SEDDS) of ketoprofen. AAPS PharmSciTech. 2004;5(3):e42. doi: 10.1208/pt050342, PMID 15760075.

40. Zhang Y, Huo M, Zhou J, Zou A, Li W, Yao C. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J. 2010;12(3):263-71. doi: 10.1208/s12248-010-9185-1, PMID 20373062.

41. Reza MS, Quadir MA, Haider SS. Comparative evaluation of plastic hydrophobic and hydrophilic polymers as matrices for controlled-release drug delivery. J Pharm Pharm Sci. 2003;6(2):282-91. PMID 12935440.

42. Dhas SK, Deshmukh G. Formulation and evaluation of meloxicam microspheres for colon-targeted drug delivery. Asian J Pharm Clin Res. 2021 Aug;14(8):45-51. doi: 10.22159/ajpcr.2021.v14i8.38482.

43. Ashwin Kumar K, Rathnam G. Development and evaluation of controlled porosity osmotic tablets of candesartan cilexetil using inclusion complex system. Asian J Pharm Clin Res. 2025 Jan;18(1):46-51. doi: 10.22159/ajpcr.2025v18i1.53194.

44. Raj R, Kolay A, Havelikar U. A review on solid lipid nanoparticles. Int J Curr Pharm Sci. 2023 Sep;15(5):10-6. doi: 10.22159/ijcpr.2023v15i5.3051.

45. Hemalatha B, Ramu A, Vidyadhara S. Formulation and evaluation of azelnidipine fast-dissolving tablets. Int J App Pharm. 2025;17(1):113-22. doi: 10.22159/ijap.2025v17i1.52398.

Published

01-09-2025

How to Cite

SARKAR, BISHAL. “MINI TABLETS IN MODERN PHARMACEUTICS: A COMPREHENSIVE REVIEW OF FORMULATION, EVALUATION, AND CLINICAL APPLICATIONS”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 17, no. 9, Sept. 2025, pp. 8-14, doi:10.22159/ijpps.2025v17i9.55477.

Issue

Section

Review Article(s)

Similar Articles

<< < 1 2 3 4 5 > >> 

You may also start an advanced similarity search for this article.