“FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET OF NIMESULIDE”
M.PHARM DISSERTATION PROTOCOL
SUBMITTED TO THE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
BY
MANDA TIRUMAL REDDY
Under the guidance of
MR. SUSHIL KUMAR PATIL
M.Pharm

DEPARTMENT OF PHARMACEUTICS
S.V.E.TRUST’S COLLEGE OF PHARMACY
HUMNABAD-585330
(2013-2014)

RAJIV GANDHI UNIVERSITYOFHEALTHSCIENCES,BANGALORE, KARNATAKA.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR M.PHARM DISSERTATION

1 / Name of the candidate
(In block letters) / MANDA TIRUMAL REDDY
Permanent Address / SHIVPUR GALLI, HUMNABAD-585 330 TAL-HUMNABAD, DIST: BIDAR
2 / Name of the Institution / S.V.E.T’S COLLEGE OF PHARMACY
HUMNABAD, DIST –BIDAR.
3 / Course of study and subject / MASTER OF PHARMACY
(PHARMACEUTICS)
4 / Date of Admission to course / 24/01/2013
5 / Title of the Topic / FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET OF NIMESULIDE
6 / BRIEF RESUME OF THE INTENDED WORKS:
6.1 Need for the study:
In recent decades, a variety of pharmaceutical research has been conducted to develop new dosage forms. Considering quality of life, most of these efforts have been focused on ease of medication. Among the various dosage forms developed to improve the ease of administration, the mouth dissolving tablet (MDT) is the most widely preferred commercial products.1The MDT is also known as fast melting, fast dispersing,orodispersible, rapiddissolve, rapid melt or quick disintegrating tablet etc.
Fast disintegrating tablets are very popular now-a- days as they get dissolved or easily disintegrated in mouth within few seconds of administration without the need of water. Active drug is released immediately from the tablet when is placed on the tongue. FDTs have several advantages over solid and liquid dosage form like these are very easy to handle. They are easily administered as it is a unit dosage form and do not need water to swallow they are taken anywhere at any time and also during travelling for motion sickness. In case of FDTs there is no risk of suffocation as it does not need water to swallow and there is no chance of sticking of tablet in the mouth, FDTs have more bioavailability than conventional tablets because when it is placed in the mouth it gets easily dissolved in the saliva, absorbed in the oral cavity and release the active drug within few seconds increasing the bioavailability of the tablet, FDTs have quick onset of action as its absorption is very fast within few seconds, FDTs are better in taste and hence the palatability of the tablet is improved, it also improve the patient compliance.2-4
The main objective of fast dissolving drug delivery is to improve performance, convenience and compliance. It is suited for tablets undergoing high first pass metabolism and is improving bioavailability with reducing dosing frequency to minimize side effect.5,6
So, in order to treat the epilepsy immediately and to deliver more efficiently, we have preparing nimesulideorodispersible tablets.

6.2 Review of Literature:
Literature review shows no published reports of any work on design and development of oral disintegrating oxcarbazepine tablets. Some of the published reports of similar work for various medicinal agents are:
Perissutti et al.[9]Prepared a fast dissolving tablets of carbamazepine by melt granulation process using PEG 400as a melting binder and lactose monohydrate as a hydrophilic filler, crospovidone as a dissolution enhancer. It showed no significant differences between the dissolution profile of the granules containing lactose or crospovidone. Extra granular addition of small amount of crospovidone gave rise to further amelioration of the disintegration and dissolution performances.
Kuchekar et al.[10]Formulated mouth dissolving tablets of salbutamol sulphate by factorial design technique. Tablets were prepared by direct compression method using superdisintegrants such as sodium starch glycolate, croscarmellose sodium and treated agar along with microcrystalline cellulose as diluents.
Mizumoto et al.[11]Designed novel fast disintegrating tablets of acetaminophen by direct compression method using saccharides. Saccharides are divided into high/low compressible categories to improve particle modification by coating and granulating low compressibility saccharide with high one, enable the production of fast disintegrating tablet.
Manvi FV et al.[12]have studied a comparative formulation and evaluation study on mouth dissolving tablets of Granisetron with different super disingredients including croscarmellose sodium, sodium starch glycolate and crospovidone and lowest dissolution time was reported in crosscarmellose tablets in 2 min.
Furtado S et al.[13]have developed and evaluated orodispersible tablets of famotidine using camphor as subliming agent and sodium starch glycollate together with crosscarmellose sodium as superdisintegrants and formulations showed low weight variation with dispersion time less than 30 seconds and rapid in vitro dissolution.
Patel et al.[14]have studied development and invitro evaluation of fast dissolving tablets of Glipizide by using ingredients crospovidone, croscarmellose, PVP-K30 and desired disintegration time was found in tablets with PVP-K30 in 38 seconds.
Gudas GKet al.[15]have formulated and evaluated of fast dissolving tablets of Chlorpromazine HCl using five superdisintegrants like Sodium starch glycolate , Crospovidone ,Croscarmellose, L-HPC, Pre-gelatinised starch and lowest dissolution time was found to be within 1 min in crospovidone tablets.
Gaur et al.[16]Prepared fast disintegrating tablets of aceclofenac by sublimation method using superdisintegrants such as crospovidone and sodium starch glycolate in different ratio (2-8%w/w) along with camphor (30%w/w) as subliming agent.It concluded that the formulation F3 containing 8 % w/w of crospovidone along with 30 % w/w of camphor as sublimingagent was found to be promising & has showed in-vitrodisintegration time of 21 s
Goel et al.[17]Developed a mathematical model for predicting the disintegration time of fast disintegrating tablets (FDTs) by estimating the powder characteristics of powder blend prior to compression. A combination of chitosan-alginate complex and glycine in the ratio of 50:50 was used for preparing FDTs. The developed mathematical model allowed water absorption time, effective pore radius and swelling index of powder mixture as well as tablet crushing strength to be successfully correlated with disintegration time (DT) of FDTs. The predicted model showed that disintegration time of FDTs to be directly correlated with powder characteristics and inversely correlated with tablet crushing strength.
Dekivadia et al.[18]Prepared fast dissolving tablets of levocetrizine HCl using sodium starch glycolate, croscarmellose sodium and crosspovidone as superdisintegrants by direct compression method. The tablets prepared were evaluated for various parameters like weight variations, hardness, friability, in vitro dispersion time, drug content, wetting time, in vitro drug release, FTIR and XRD. The formulation (MD6) contains crosspovidone and sodium starch glycolate shows better disintegration time and 99% drug release within 20 min.
Degwy et al.[19]Formulated diclofenac potassium orally disintegrating tablet(ODT) using lyophilization technique. The tablets were evaluated for uniformity of weight, uniformity of content, friability, in vitro disintegration time, in vitro dissolution, wetting time, in vivo disintegration time, moisture analysis and scanning electron microscopy. The best formula results showed that lyophilized ODT disintegrated within few seconds and showed significantly faster in vitro dissolution rate of diclofenac potassium in comparison with commercially available immediate release tablet diclofenac potassium tablet (Cataflam).
Kamble et al.[20]Prepared patient-friendly tablets of antihypertensive amlodipine besylate to increase patient’s adherence to antihypertensive therapy. In the present study bitterly tasting antihypertensive drug amlodipine besylate was successfully taste-masked by complexing with β–cyclodextrin (β-CD) and formulated as MDT. Six MDT formulations were prepared and evaluated. Formulation F5 was found to be optimum with 15.3 sec in vitro disintegration time, 2.83 kg/cm2 hardness, 0.44% friability and 98.09% drug release in 30 minutes.
6.3Objectives of the study:
The objective of present work is to design and evaluate mouth dissolving tablets ofNimesulide
1) To ensure Fast disintegrating.
2) Increased patient compliance by pleasant taste.
3) Greater therapeutic efficacy.
4) Reduce chances of degradation of drug.


MATERIALS AND METHODS:
7.1 Source of Data:
  1. RGUHS (helinet).
  2. Thomson Reuters Pharma (Drug and Scientific Database)
  3. I.I.C.T Library, Hyderabad.
  4. International Pharmaceutical Abstracts.
  5. S.V.E.T’S College library.
  6. Internet.

7.2Materials:
  1. Drug:Nimesulide
  2. Excipients:Dicalcium Phosphate, Mannitol, Microcrystallinecellulose, crospovidone, Croscarmellose sodium, Magensium Stearate and Aspartame, Crospovidone, Starch, Naturalsuperdisintegrantsetc.
  3. Equipments: 1) UV- visible spectrophotometer (1800-Shimadzu)
2) Digital PH-meter
3) Electronic weighing balance(Shimadzu)
4) USP tablet dissolution test apparatus (Campbell, TDR-06N)
5) Monsanto hardness tester
6) Tablet punching machine
7) Hot air oven
8) Roche friabilator
Preparation of Fast Dissolving Tablets
Method: The fast dissolving tabletswere prepared by following method.
Direct Compression method: In this method, the drug, polymers, and other additives will be passed through #40 sieveseparatelythen weighed accurately and mixed to geometrical order. Then lubricant and glidant were added, weighed in required quantity and then compressed to tablet using single punch tablet machine.
Evaluation: The prepared formulation will be evaluated for:
1.Hardness:Hardness of tablets will be determined using Monsanto hardness tester.
2. Friability: Friability of the tablets will be checked using Roche friabilator. Pre-weighed sample of tablets(10) will be placed in the friabilator, operated for 100 revolutions. Tablets will be then dusted and reweighed.
3. Weight variation:20 tablets will be selected randomly and the average weight will be determined. Then individual tablets will be weighed and are compared with the average weight
4.Wetting Time and Water absorption ratio:A piece of paper folded twice was kept in aPetri dish containing 6 ml purified water. A tablet having small amount of Rosaline dye powder on the upper surface was placed on the tissue paper. The time required to develop red colour on the upper surface of the tablet was recorded as wetting time. The same procedure without usingRosaline dye powder was followed for determining the water absorption ratio R was determined according to the following equation.
R = [(Wa – Wb)/Wb ]× 100
Wb= weight of the tablet before use
Wa= weight of the tablet after use
5.Disintegration time:The 6 tablets will be weighed and placed in distilled water as a disintegrating mediaat 25°C± 2°C.
6.Invitro Drug release: Drug release was carried out by USP Type II apparatus in phosphate buffer PH 6.8 and the release was tested at rotational speed of 50 rpm. Samples were withdrawn at various intervals with in aperiod of 60 min and analyzed using UV/Vis spectrometer at wave length of 306nm.
7.3 Does the study require any investigation or intervention to be conducted on patients or other human or animals? If so please describe briefly.
………………………Not under the plan of our work…………………………......

8. / 7.4 Has ethical clearance been obtained from your institution in case of 7.3?
……….……………………….Not applicable……………………………......
List Of References:
  1. Nayak S, Amlan S, Deep VV, Khemariya P, Sumbhate S, Nayak S. Taste masking of Lornoxicam by polymer carrier system and formulation of oral disintegrating tablets. Int J Drug Del 2009:27-31.
  2. Sharma S, Garg R, Naruka PS, Gupta GD. Fast dissolving tablet: The future of compaction. Pharmainfo.net:2007.
  3. Panigrahi D, Baghel S, Mishra B; Mouth dissolving tablets: An overviewof prepration techniques, evaluation and patented technologies. J.Pharma Res 2005;4:33-8.
  4. Bhandari S, Mittapalli RK, Ramesh G, Rao YM. Orodispersable tablets: An overview. Asian J Pharm 2008;2(1):2-11.
  5. BhowmikD, Chiranjib B, Krishnakanth, Pankaj,Margret RC, Fast dissolving tablet: An overview. J Chem Pharm Res 2009;1(1):163-77.
  6. Arunachalam A, Karthikeyan M, Ashutosh Kumar S, Konam K, Pottabathula HR, Sethuraman S, Manidipa S. Fast dissolving drug delivery systems: A review.J Global Trends in Pharma sci 2010;1(1):92-110.
  7. Sweetman SC, Martindale (Eds): The Complete Drug Reference, 35thedition, London Pharmaceutical Press. 2007: p.1093. 95.
  8. Goodman and Gilmans. The Pharmacological basis of therapeutics, 11th edition, Chicago New York MCG Raw-Hill medical publishing division 2006: p.284.
  9. Perissutti B, Fulvio R, Moneghini M, Voinovich D. Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique. Int J Pharm 2003;256:53-63.
  10. Kuchekar BS, Badhan AC, Mahajan HS. Mouth dissolving tablets of salbutamol sulphate: A novel drug delivery system. Indian Drugs 2004;41:592-8.
  11. Mizumotoa T, Masudaa Y, Yamamotob T, Yonemochi E, Terada K. Formulation design of a novel fast-disintegrating tablet. Int J Pharm 2005;306:83-90.
  12. Manvi FV, Khalandar DKS. A Comparative study on mouth dissolving tablets of granisetron with different super disintegrants: Formulation and Evaluation. Int J Pharm 2008;5(2):71-89
  13. Furtado S, Deveswaran R. Development and characterization of orodispersible tablets of famotidine containing a subliming agent. Trop J Pharm Res 2008;7(4):1185-9.
  14. Patel B, Patel D, Parmari R. Development and in vitro evaluation of fast dissolving tablets of glipizide. Int J Pharm Pharma Sci 2009;1:267-74.
  15. Gudas GK, Manasa B. Formulation and evaluation of fast dissolving tablets of Chlorpromazine HCl. J Pharm Sci Tech 2010;2(1):99-102.
  16. Gaur K, Tyagi LK, Kori ML, Sharma CS, Nema RK. Formulation and characterization of fast dissolving tablet of aceclofenac by using sublimation method. Int J Pharm Sci Drug Res 2011;3(1):19-22.
  17. Goel H, Arora A, Tiwary AK, Rana V. Development and evaluation of mathematical model to predict disintegration time of fast disintegrating tablets using powder characteristics.Pharm Dev Tech 2011;16(1):57-64.
  18. Dekivadia M, Gudigennavar A, Patil C, Umarji B. Development & optimization of fast dissolving tablet of levocetirizine HCl. Int J Drug Dev Res 2012;4(2):237-46.
  19. Degwy MA, Tayel S, El-Nabarawi M, El-Rehem RT. In vitro and in vivo evaluation of diclofenac potassium lyophilized orally disintegrating tablets. Int J Pharm sci Res 2013;4(1):248-59.
  20. Kamble MS, Vaidya KK, Aute PP, Chavan RP. Development and evaluation of mouth dissolving tablet of taste-masked amlodipine besylate for the treatment of hypertension. Int J Pharm Chem Bio Sci 2013;3(1):55-62.

9. / Signature of the Candidate
10. / Remarks of the Guide:
Fast dissolving tablets have definite advantages in improving patient compliance and enhancing oral bioavailability.
11. / Name & Designation (in BLOCK LETTERS)
11.1 Guide / MR. SUSHIL KUMAR PATIL
Assistant Professor
S.V.E.T’S College of Pharmacy,
Humnabad,Dist-Bidar,Karnataka.
11.2 Signature of Guide / . ROHINI R. M.)
11.3 Co-Guide
11.4 Signature of Co-Guide
11.5 Head of the Department / Dr.D.NAGENDRAKUMAR
Professor and HOD,
Department of pharmaceutics,
S.V.E.T’S College of Pharmacy,
Humnabad,Dist-Bidar,Karnataka.
11.6 Signature of HOD:
12. / 12.1 Remark of the Principal:
The facilities are available for the project undertaken.
12.2 Signature of the Principal / Dr. D.NAGENDRAKUMAR

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