Comparative study and quality evaluation of (ondansetron)Oro Dispersible Tablets between generic and branded

The ppt is about the research work thesis of mine ,,I have done the comparative study,between the branded and generic oro dispersible (ondansetron) by making four batches 2 of branded and 2 of generic ,and i had done the various evaluation parameters, weight variation , friability,dissolution, disintegration wetting time test masking and so on to find out the accuracy rate of effectiveness between the four batches

1. COMPARATIVE STUDY AND QUALITY EVALUATION OF ORODISPERSIBLE TABLET (BRANDED AND GENERIC).   Presented By Mohammad Ahfaz Zaid ( B.Pharmacy Student ) Guide Mr. Anwar Ahmad ( M.Pharm ) Assistant Professor CENTRAL INDIA COLLEGE OF PHARMACY Lonara , Nagpur – 441 111 2022 – 2023

2. AIM & OBJECTIVES

3. AIM & OBJECTIVES Aim: - Comparative Study And Quality Evaluation Of Oro dispersible Tablet (Branded And Generic).       Objective’s: -   1. to find out which one is most accurate between generic & branded tablets 2. quality evaluation of branded and generic tablet.  

4. Introduction INTRODUCTION   Direct ingestion is intended in most pharmaceutical dosage forms which are formulated for oral administration. The oral route is the best or convenient way of drug administration for patients and this way is used by most of the therapeutic agents for producing effects of the oral route. A term used by the "European Pharmacopoeia" orodispersibletablet , this table disperses in the mouth within 3 seconds before swallowing it.   Oro Dispersible Tablets (ODTs)   Oral dispersible tablets (ODTs) are the novel dosage form which  quicklydisintegrates in the mouth (1-3 min) without chewing upon oral administration and without the need of water, different other conventional oral solid dosage form. The best time for an orodispersible tablet to get separate is measured to be fewer than a minute.  

5. Ideal Properties of Oro-dispersible Tablets   ⮚ Not require water to absorb and should dissolve ordisintegrate  in the mouth within a few seconds. ⮚ High drug loading. ⮚ Have a pleasant mouthfeel. Limitations of Orodispersible Tablets ( Odts ) ⮚ Many times the soluble diluents used for formulating the ODTs might give hygroscopic dosage which may lead to stability issues. ⮚ The tablets are unpleasant to taste and/or roughness in the mouth if not formulated properly.

6. Some Examples Of Recently Prepared OrodispersibleTablets   Ofloxacin - Taste masked microspheres of the ofloxacin were prepared as a using Eudragit and orodispersible tablets of the formulated microspheres were using the nature of the superdisintegrant .   Ondansetron: is one of the medications most commonly used for the empiric treatment of nausea and vomiting. Ondansetron has excellent utility as an antiemetic drug, and it is effective against nausea and vomiting of various etiologies .

7. There Are Two General Terms Used To Describe Medicinal Products. 1. Branded Product A product which is developed for the first time by researcher and approved by regulatory agency. 2. Generic product - These are marketed once the patent expires for the innovator product. But, they may or may not hold specific brand name.   Why Generic Product:- a. The generic and branded products contain same API. b. Generics are sold at low cost as compared to innovator product. c. These are used for same therapeutic indication as that of innovator product. d. Excipient which are used in generic medicine are acceptable. e. The manufacturing of generic products follows same standard as the branded products.

8. PLAN OF WORK

9. PLAN OF WORK 1) Literature survey. 2) Selection of suitable tablets. 3) Evaluation of orodispersible tablets. Branded Generic   Evaluation parameters of the Orodispersible tablets  Weight variation  Hardness  Friability  Wetting time  Disintegration time  In Vitro dissolution  Assay

10. EXPERIMENTAL WORK

11. Selection of tablets Making four Batches a. Branded tablets B1. ( zofer md 4) B2. ( Vomikind md 4) b. Generic tablets G1. ( Vomiover md 4) G2 .( Onidinil md 4 )

12.   1. Hardness (crushing strength): Monsanto hardness tester. The Monsanto tester was developed 50 years ago. The design consists of " a barrel containing a compressible spring held between 2 plungers ". Procedure : Place the sample tablet in the vertically holding edges of the anvil of Monsanto Hardness Tester. Adjust the pointer at zero position on the scale by rotating the screw in forward direction. Now rotate the screw till break point of the tester. The breakage of tablet shows hardness on the scale. Repeat the procedure 8-10 times for average reading. Record the observation in Inspection Sheet and attach in BMR.

13. Sr No. B1 B2 G1 G2 1. 2.6 kg 2.5kg 2.0kg 2.6kg 2. 2.5 kg 2.5kg 2.0kg 3.0kg 3. 2.5kg 1.5kg 2.0kg 2.5kg 4. 2.5kg 2.0kg 2.5 kg 2.0kg 5. 2.0kg 2.5kg 2.0kg 2.4 kg 6. 2.5kg 2.5kg 2.0kg 2.5kg 7. 2.3kg 2.0kg 2.4kg 3.0kg 8. 2.0kg 2.5kg 2.5kg 2.6kg 9. 2.5 kg 2.5kg 2.0kg 2.6kg 10. 2.5kg 2.kg 2.3kg 2.6kg

14. Result : the average hardness of B1 : 2.39 kg B2: 2.25 kg G1: 2.17 kg G2 : 2.58 kg Conclusion : From above observation and result it is concluded that there is no difference in hardness test of brand and generic drugs.  

15. Friability. Friability of a tablet can determine in laboratory by Roche friabilator . This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets through a Distance of six inches in the friabilator which is then operate for 100 revolutions. The tablets are reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh are consider acceptable. The mechanical properties of pharmaceutical tablets are quantifiable by hardness and friability tests. Friability test of uncoated tablets is applicable to compressed tablets and is intended to determine the physical strength of tablets. Formula F=100 x (1-w2/w1)

16. Sr no. % of weight loss B1 0.9% B2 1.0% G1 0.8% G2 0.7%

17. NOTE : IP Standard for orodispersible friability is NMT 1.0%   Result : the % weight loss for B1 =0.9% B2= 1.0% G1= 0.8% G2= 0.7 % Conclusion : , From above observation and result it is concluded that the branded drugs are very closed to IP Standard , but there is no more difference in % weight loss between branded and generic drugs. so the conclusion is both of generic and branded drugs are accurate

18. Wetting time The wetting time of the tablets was measured using a simple procedure (20). Five circular tissue papers of 10-cm diameter were placed in a petri dish with a 10-cm diameter. NOTE: Wetting time should not be more then 2 min

19. Sr no B1 B2 G1 G2 1. 1.03min 0.58 min 0.55min 0.59min 2. 1.01min 0.48 min 1.20min 0.56min 3. 1.03 min 1.06 min 0.57min 0.58min Result& Conclusion : the wetting time of the all four batches (B1,B2,G1,G2) have no more difference ,so we conclude that both of generic and branded tablets are accurate at wetting time

20. Disintegration test. It is the time required for the tablet to break into particles, the disintegration test is a measure only of the time required under a given set of conditions for a group of tablets to disintegrate into particles. It is performed to identify the disintegration of tablet in particular time period. Disintegration test is not performed for controlled & sustained release tablets. According to the test the tablet must disintegrate and all particles must pass through the 10 mesh screening the time specified. If any residue remains, it must have a soft mass. Limit: If 1 or 2 tablets fail to disintegrate, test is repeated using 12 tablets, Of the 18 tablets tested, 16 must have disintegrated within given period of time.

21. Note : IP Standard for oro dispersible tablets is NMT : 30sec   Sr no. Disintegration Time B1 25 sec B2 28 sec G1 37 sec G2 40 sec

22. Result : the average disintegration time of B1 and B2 is 25 sec & 28 sec respectively so it is less then 30 sec (IP Standard) and the disintegration time for G1 and G2 is 37 sec & 40 sec respectively that is more then 30 sec(IP Standard) Conclusion: From above observation and result it is concluded that there is very difference in disintegration time of brand and generic drugs, and the branded drug is much accurate then generic drugs  

23. Weight variation Weight variation was carried out to ensure that, each of tablets contains the proper amount of drug. The USP has provided limits for the average weight of uncoated compressed tablets. If the active ingredient represents not less than 50% weight of the tablet and greater than 50 mg, then one may establish uniformity of dosage units using the weight variation method. Weight variation=100% ( Iw -Aw)/Aw Where, Iw =Individual weight of tablet Aw=Avera Average Weight Of Tablets Percentage Deviation 80mg or less ± 10 % more then 80 mg but less then 250 mg   ±7,5% 250mg or more ±5%

24. Sr No. Tab Wtt 1 80mg 2 70mg 3 80mg 4 100mg 5 90mg 6 60mg 7 80mg 8 60mg 9 90mg 10 60mg 11 60mg 12 80mg 13 60mg 14 50mg 15 60mg 16 70mg 17 80mg 18 60mg 19 70mg 20 60mg Sr No. Tab Wtt 1 110mg 2 100mg 3 100mg 4 120mg 5 140mg 6 150mg 7 90mg 8 100mg 9 80mg 10 90mg 11 100mg 12 100mg 13 100mg 14 150mg 15 80mg 16 110mg 17 140mg 18 120mg 19 90mg 20 120mg For B1 For B2

25. Sr No. Tab Wtt 1 90mg 2 120mg 3 100mg 4 140mg 5 80mg 6 100mg 7 80mg 8 130mg 9 150mg 10 100mg 11 90mg 12 110mg 13 100mg 14 130mg 15 140mg 16 110mg 17 100mg 18 100mg 19 110mg 20 130mg Sr No. Tab Wtt 1 90mg 2 120mg 3 110mg 4 80mg 5 120mg 6 140mg 7 130mg 8 90mg 9 80mg 10 130mg 11 120mg 12 110mg 13 90mg 14 130mg 15 110mg 16 100mg 17 110mg 18 90mg 19 120mg 20 110mg For G1 For G2

26. CALCULATIONS For B1 Average weight :Sum of all tablets /20 =1420/20= 71 ± 10 % deviation allowed 61 mg _ 81 mg allowed For B2 Average weight :Sum of all tablets /20 =2190/20= 109.5 ± 7.5% deviation allowed 102mg _ 117 mg allowed

27. For G2 Average weight :Sum of all tablets /20 =2180/20= 109 ±7.5 % deviation allowed 101.5mg _ 116.5mg allowed For G1 Average weight :Sum of all tablets /20 =2210/20= 110.5 ±7.5 % deviation allowed 103 mg _ 118 mg allowed

28. Result & Conclusion : From above observation and calculation it is concluded that there is no difference in weight variation test of brand and generic drugs.      

29. Discussion and conclusion. we have done our comparative study and quality evaluation of oro -dispersible between the generic and branded drugs , and we found that the generic drugs have almost same potential as the branded drugs , as we done quality evaluation parameter the generic perform the same as the branded drugs except one parameter that is the disintegration time So we conclude that the generic and branded drugs of oro dispersible (Ondansetron) are have same performance and the generic medicine are acceptable.

30. References 1.[ Anupam Roy, ORODISPERSIBLE TABLETS: A REVIEW, Asian J Pharm Clin Res. 2.[ kumarV.Dinesh , Sharma Ira, Sharma Vipin , A comprehensive review on fast dissolving tablet technology, Journal of Applied Pharmaceutical Science,.   3.[C. Gothainayaki , A.N. Rajalakshmi , Fixed dose combination products as Oro-dispersible tablets: A review, Journal of Drug Delivery and Therapeutics.   4.[ S.Ramu,Y.Ashok Kumar, D.Srinivasa Rao, G.Ramakrishna , Formulation and evaluation of Valsartan Oral Dispersible Tablets by Direct Compression Method, American Journal of Advanced Drug Delivery,   5.[ K.Aithal , N.M Rathanand , A.Shirwaikar and M.Dutta . Once daily fast dissolving tablet of granisteron HCl formulation in vitro evaluation , Indian drug 2006, 43(7) 576-581].     6.[ T.V.Rao and S.Viddhyadhara , formulation and evaluation of orodispersible tablet of Simwastatin by direct compression technique. The pharma review 2008, 6(34), 137-139].   7.[ C.Mallikarjuna Settee, D.V.K prasad , V.R.M Gupta developed of oro dispersible aceclofenac tablet. Indian journal of pharmaceutical science 2008, 70(2) 180-182].   8.Basani Gavaskar , Subash Vijaya Kumar, Guru Sharan , Nagaraju M, Y Madhusudan Rao; Present investigations and future prospects of disintegrating tablets: a review; International Journal of Pharmaceutical Sciences and Research, 2010, vol 1, issue 8, 14-28. 9.M.Swamivelmanickam, R.Manavalan , K.Valliappan ; Mouth dissolving tablets: An overview; International Journalof Pharmaceutical Sciences and Research, 2010, vol 1 isuue 12, 43-55.   10. Dali Shukla, Subhashis Chakraborthy , Sanjay Singh, Bramheswar Mishra; Mouth dissolving tablets II- an over view of evaluation techniques; Scientia Pharmaceutica , 2009, vol 77, 327-341.  

31. Tanmoy Ghosh, Amitava Ghosh, Devi Prasad; A review on new generation orodispersible tablets and its future prospective; International Journal of Pharmacy and Pharmaceutical Sciences, 2011, vol 3, issue 1, 1-7.   Prashant Khemariya , Kavitha R, Gajbhiye , Vikas Deep Vaidya, Rajesh Singh Jadon, Sachin Mishra, Amit Shukla, Mohit Bhargava, Sanjay K.Singhani , Sanjay Goswami; Preparation and evaluation of mouth dissolving tablets of meloxicam; International Journal of Drug Delivery, 2010, vol 2, 76-80.     Metker Vishal, Kumar Anju, Pathak Naveen, Padhee Kumud, Sahoo Sangram; Formulation and evaluation of orodispersible tablets of lornoxicam; International Journal of Drug Development and Research, jan -march 2011, vol 3, issue 1, 281-285.   15.Swathi Daram , Prabhakar Reddy Veerareddy , Raju Jukanti , Suresh Bandari; Formulation and evaluation of ketorolac tromethamine fast dissolving tablets; Scholars Research Library, Der pharmacia letter, 2011, vol 3, issue 2, 97-103.   16. Dr. Srinivasa Rao, Doddayya H, Shrishail S Patil, Vamshidar Reddy.D ; Design and evaluation of fast dissolving tablets of taste masked ondansetron hydrochloride; International Journal of Pharma. Research and Development, april 2011, vol 3, issue2, 64-76.\   17.Uddav Bagul , Kishore Gujar, Nancy Patel, Sanjeevani Aphale , Shalaka Dhat ; Formulation and evaluation of sublimed fast melt tablets of levocetirizine dihydrochloride; International Journal of Pharmaceutical Sciences, 2010, vol 2, 76-80.   18.Basawaraj.S.Patil, N.G.Ragavendra Rao; Formulation and evaluation of fast dissolving tablets of granisetron hydrochloride by vaccum drying technique; Journal of Applied Pharmaceutical Science, 2011, vol 01, issue 04, 83-88.   19. Nagendra Kumar D, Raju S A, Shirsand S B; Formulation design of fast dissolving tablets of fexofenadine hydrochloride by sublimation method; International Journal of Pharma and Bio Sciences, 2010, vol 1, issue 1, 1-7.   20. D.G.Umalkar , B.Stephen Rathinaraj , G.S.Bangale , G.V.Shinde , D.Kumaraswamy , Ch.Rajveer , K S Rajesh; Design and evaluation of mouth dissolving tablets of zopiclone using different superdisintegrants ; Journal of Pharmaceutical Sciences and Research, 2010, vol 2, issue 8, 527-533  

32. Thank You PRESENTED BY: AHFAZ ZAID