This document provides an overview of mouth dissolving tablets (MDT), including promising drug candidates, popular disintegrants used, formulation techniques, marketed products, and evaluation methods. MDTs are designed to dissolve rapidly in the mouth within 3 minutes before swallowing for improved patient compliance. Common techniques for MDT formulation include lyophilization, moulding, direct compression, and sublimation. Evaluation of MDTs involves testing of granules, tablets, and dissolution properties. Future research aims to identify suitable drug candidates and excipients while improving dissolution times and patient acceptability.

1. PREPARATION AND EVALUATION OF MOUTH DISSOLVING TABLETPresented By: Under the guidance of:Sachin Mr. NarendraPandey

2. ContentsLiterature ReviewIntroductionPromising drug candidates for MDTPopular Disintegrants used in MDTTechniques for MDT formulationMarketed Products of MDT EvaluationFuture Planning2

3. Literature ReviewMahapatra A K, Murthy P N, Sahoo J, Biswal J, Sahoo S K Formulation design and optimization of mouth dissolving tablets of levocetirizine hydrochloride using sublimation technique. Indian J. Educ. Res. 2009; 43(1):39-45.

4. Shirsand S B, Suresh S, Para M S, Swamy P V, Kumar N D, Plantagoovata mucilage in the design of fast disintegrating tablets. Indian J. Pharm. Sci. 2009;41-46.

5. Gattani S. G, Shiyani B.G, KakadeK.N,Patil A.B, Surana S.J. Formulation and evaluation of mouth dissolving tablet of ondansetron hydrochloride by using superdisintegrants. Indian drugs. 2009; 46(1): 44-50.

6. Shoukri A R, Ahmed S I, Shamma N R. In vitro and in vivo evaluation of nimesulidelyohilized orally disintegrating tablets.Eur. J. Pharm. biopharm. 2009; 30: 1-10.

7. Goswami J P, Sharma S, Gupta G D. An effervescent and reproducible method for prepration of fast disintegrating tablets. Pharma Buzz. 2009; 4(3): 46-52.3

8. Continued...Kumar S R, Lakshmi S V P. Reprimelts: A novel approach in drug delivery systems. Pharma buzz. 2009; 4(5): 18-20

9. Shukla D, Chakraborty S, Singh S, Mishra B. Mouth dissolving tablets: An overview of Formuation technology. ScientiaPharmaceutica. 2009; 77: 309-326.

10. Fini A, Bergamante V, Ronchi C, Moraes F A C. Fast Dispersible/slow releasing ibuprofen tablets. Eur. J. Pharm. Biopharm. 2008; 69: 335-341.

11. Shah P P, Rajashree C M. Formulation and evaluation of primaquine phosphate taste- masked rapidly disintegrating tablet. J. Pharm. Pharmcol. 2008; 60: 1279-1285.

12. Rashid I, Remawi A M, Eftaiha A A,BadwanA.Chitin –Silicon Dioxide coprecipitate as a novel superdisintegrant. Indian J. Pharm. Sci. 2008; 97(11): 4955-4969.

13. Patel D M, Patel M M..Optimization of etorocoxib tablets prepared by sublimation technique. Indian J. Pharm. Sci. 2008; 70(1): 71-76.

14. Chaudhri P.D, Chaudhari S.P, Lanke S.D, Patel N. Formulation and in vitro evaluation of taste masked orodispersible dosage form of levocetirizinedihydrochloride. Indian J. Pharm. Edu. Res. 2007; 41(4): 319-327.4

15. Continued...Lakade S H, formulation development and evaluation of mouth dissolving tablets of ondansetron hydrochloride. Asian J. Pharm. 2007; 1(2-3): 150-153.

16. Qalaji R M M, Simons R E F, Simons J K. Fast-disintegrating sublingual epinephrine tablets: Effect of tablet dimension on tablet characteristics. Drug Dev. Ind. Pharm. 2007; 33: 523-530.

17. Shishu, AshimaB,Singh T. Preparation of tablets Rapidly disintegrates in the saliva containing bitter taste masked granules by compression method. Indian J. Pharm. Sci. 2007; 69(1):80-84.

18. Ciper M, Bodmeier R. Modified conventional hard gelatin capsules as fast disintegrating dosage form in the oral cavity. Eur. J. Pharm. biopharm. 2006; 62: 178-184.

19. Mizumoto T, Masuda Y, Yamamoto T, Yonemochi E, Terada K.formulation design of a novel fast-disintegrating tablet. Int. J. Pharm. 2005; 306: 83-90.

20. Valleri M, Mura P, Cirri M, Balllerini R. Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique.Drug Dev. Ind. Pharm. 2004; 30(5): 525-534.5

21. IntroductionMDTs are also called as orodispersible tablets, quick disintegrating tablets, fast disssolving tablets, porous tablets and reprimelts.

22. USP and EP used the term ODT for the tablets that disperses readily and within 3 minutes in mouth before swallowing.

23. US-FDA defined ODT as “A solid dosage form containing medicinal substances or active ingredient which disintegrates rapidly usually with in a matter of seconds when placed on the tongue.”Shukla et al., Mouth Dissolving Tablet: An overview of Evaluation Techniques. Sci. Pharm. 2009; 77: 309-326. 6

24. Why MDT..??Preferred route of administration

25. Improved patient compliance

26. Beneficial for travelling patients

27. Bypass First pass metabolism

28. Benefit of both liquid and solid dosage formGopala et al., An Effective and Reproducible Method For Preparation Of Fast disintegrating tablet. Pharma Buzz. 2008; 3(9): 38-407

29. Promising drug candidates for MDT. 8Sharma et. al. Mouth dissolving tablet : A Review. Pharma Buzz. 2009; 4(1): 30-41

30. Continued...9

31. 10Continued...

32. Popular Disintegrants used in MDT11Sharma et al., Mouth dissolving tablet: A review.Pharma Buzz.2009; 4(01): 30-41.

33. Continued...12

34. Mechanism of action of superdisintegrants13Sharma et al., Mouth dissolving tablet: A review.Pharma Buzz.2009; 4(01): 30-41.

35. Techniques for MDT formulationLyophilisationMouldingDirect compression Cotton candy processSpray dryingSublimationMass extrusionNanonizationFast dissolving films14Shukla et al., Mouth Dissolving Tablet: An overview of formulation technology. Sci. Pharm. 2009; 77: 309-326.

36. Sublimation technique for prepration of mdt15Sharma et al., Mouth dissolving tablet: A review.Pharma Buzz.2009; 4(01): 30-41.

37. 16List of Patented Technology Based Branded ProductsShukla et al., Mouth Dissolving Tablet: An overview of formulation technology. Sci. Pharm. 2009; 77: 309-326.

38. 17Continued...

39. Marketed Products of MDT Sharma et al., Mouth dissolving tablet: A review. Pharma Buzz.2009; 4(01): 30-41.18

40. EVALUATIONGranules:Angle of repose

41. Bulk density

42. Tapped density

43. Powder flow propertiesBhise et. al. Formulation and evaluation of fast disintegrating tablets of Diphenhydraminetannate. 2006; 1(1): 41-45. 19

44. EVALUATION OF TABLETSWeight Variation

45. Hardness And Friability

46. Tensile Strength

47. Wetting time and water absorption Ratio

48. Friability

49. Disintegration test

50. Dissolution test Terada et. al. Evaluation of rapidly disintegrating tablets containing glycine and carboxymethylcellulose. Int. J. Pharm., 2006; 310: 101-109.20

51. in vitro dispersion test21Kumar S R, Lakshmi S V P. Reprimelts: A novel approach in drug delivery systems.Pharma buzz. 2009; 4(7): 72-76

52. 22Electroforce Disintegration Test ApparatusShukla et. al ,Mouth Dissolving Tablet: An overview Of Evaluation Techniques. Sci. Pharm. 2009; 77: 309-326.

53. Disintegration test with rotary shaft method23Shukla et. al ,Mouth Dissolving Tablet: An overview Of Evaluation Techniques. Sci. Pharm. 2009; 77: 309-326.

54. Modified Dissolution Test Apparatus For Disintegration TestShukla et al., Mouth Dissolving Tablet: An overview Of Evaluation Techniques. Sci. Pharm. 2009; 77: 309-326. 24

55. how mdt dissolves25

56. Future Aspects Search for the suitable and promising drug candidate.

57. Search for suitable and cheap superdisintegerant.

58. Select the feasible manufacturing technique

59. To make tablet which should disintegrate or dissolve in the mouth within a few seconds

60. To improve patient compliance

61. To allow high drug loading

62. To develop tablet with pleasing a mouth feel

63. To formulate MDT which will be compatible with taste masking and other excipients26

64. Frequently asked questionsHow mouth dissolving tablets are better than others? Fast dissolving tablets are better than others because oral cavity has large blood supply, huge network of blood vessels. Mouth dissolving tablets get dissolved in the saliva and drug molecule get directly absorbed into blood stream after crossing thin epithellium of oral and tongue mucosa thus the drug acts fast, then normal oral route.Is there is any need to take tablet with water? No, there is no need to take the tablet with water. As it gets dissolved in the saliva with in a few secondsWill it be cost effective? Yes, simple technology and can be formulated with cheap excipients.What is the real advantage of taking a Fast Melting Tablet? It allows you to take the active ingredients and/or nutrients without swallowing the pill.27

65. 28“If we knew what we were doing it wouldn't be RESEARCH…” ---Albert Einstein