its is a PROJECT REPORT ON FORMULATION AND EVALUATION OF DICLOFENAC SODIUMFAST DISSOLVING TABLET. #B.pharma 8th sem(NDDS) #fast dissolving tablet

1. PROJECT REPORT ON
FORMULATION AND EVALUATION OF DICLOFENAC SODIUM
FAST DISSOLVING TABLET
PRESENTED BY:
Gayatri sati
B.Pharm (VIII sem)
D.V.C.P. Lalpur (Rudrapur

2. TABLE OF CONTENT
S.NO. TITLE
1 AIM AND OBJECT OF STUDY
2 INTRODUCTION
3 LITERATURE REVIEW
4 DRUG PROFILE
5 PREFORMULATION STUDIES
6 PRECOMPRESSION STUDIES
7 MATERIAL AND METHODS
8 EVALUATION
9 RESULT AND DISCUSSION
10 REFERENCE

3. AIM AND OBJECT OF THE STUDY
 To study the formulation and evaluation of
Diclofenac sodium fast dissolving drug delivery
system.
 To decrease dose.
 Targeting of drug to better release.

4. INTRODUCTION
 In current decades, a variety of pharmaceutical
research has been conducted to develop new
dosage forms.
 Among the various dosage forms developed to
improve the ease of administration, Fast
Dissolving Tablet is the most widely preferred
commercial product.
 The concept of Fast Dissolving Drug Delivery
System emerged from the desire to provide
patient with conventional means of taking their
medication ally disintegrating tablets.

5. Advantages of fast dissolving tablet
 Administration without water
 Easy portability
 May produce rapid onset of action
 Improved patient compliance
 No need of water
 Improved stability
 No need of chewing
 Cost effective
 Better taste

6. Disadvantages of fast dissolving tablet
 The Tablet usually have insufficient mechanical
strength thus careful handling is required
 FDT requires special packaging for suitably
stabilization and safety of stable product.

7. DRUG PROFILE OF DICLOFENAC SODIUM
PRIMARY CHARACTERISTICS
 Structure of Diclofenac sodium

8.  Molecular weight-318.129g/mol
 Chemical formula-C14H10Cl2NNaO2
 Melting point-288-2900c
 Chemical Name- 2-[2-(2,6-dichloroanilino)phenyl]acetic acid
 Half-life- approximately 2 hours
 Solubility overview
Soluble in water (50 mg/ml), PBS pH 7.2 (6 mg/ml), ethanol (~35 mg/ml),
DMF (~35 mg/ml), DMSO (~35 mg/ml), methanol (>24 mg/ml), and acetone
(6 mg/ml).
 Category: NSAIDS

9.  Pharmacodynamics
Diclofenac is an acetic acid nonsteroidal antiinflammatory drug (NSAID) with
analgesic and antipyretic properties. Diclofenac is used to treat pain, dysmenorrhea,
ocular inflammation, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and
actinic keratosis.
 Mechanism of action
The anti-inflammatory effects of Diclofenac are believed to be due to inhibition of
both leukocyte migration and the enzyme cyclooxygenase (COX-1 and COX-2),
leading to the peripheral inhibition of prostaglandin synthesis. As prostaglandins
sensitize pain receptors, inhibition of their synthesis is responsible for the analgesic
effects of Diclofenac. Antipyretic effects may be due to action on the hypothalamus,
resulting in peripheral dilation, increased cutaneous blood flow, and subsequent
heat dissipation.
 Absorption
Completely absorbed from the gastrointestinal tract.
 Metabolism
Primarily hepatic. Isoniazid is acetylated by N -acetyl transferase to N -
acetylisoniazid; it is then biotransformed to Isonicotinic acid and
monoacetylhydrazine. Monoacetylhydrazine is associated with hepatotoxicity via
formation of a reactive intermediate metabolite when N-hydroxylated by the
cytochrome P450 mixed oxidase system. The rate of acetylation is genetically
determined. Slow acetylators are characterized by a relative lack of hepatic N -
acetyltransferase.

10. Food Interactions
 Drug interactions may change how your medications work or increase your risk
for serious side effects.
 This document does not contain all possible drug interactions. Keep a list of all
the products you use (including prescription/nonprescription drugs and herbal
products) and share it with your doctor and pharmacist.
Side effects
 Upset stomach
 Nausea
 heartburn
 Diarrhoea
 Constipation
 Gas
 Headache
 drowsiness, and
 dizziness

11. Uses:
Diclofenac is used to relieve pain, swelling
(inflammation), and joint stiffness caused by
arthritis. Reducing these symptoms helps you do
more of your normal daily activities. This
medication is known as a nonsteroidal anti-
inflammatory drug (NSAID).
Dose:
Diclofenac sodium immediate-release tablets: 50
mg orally 2 or 3 times a day.

12. EXCIPIENT PROFILE
Sodium bicarbonate
 Synonym : Baking soda
 Chemical name: Sodium Hydrogen Carbonate
 Empirical formula: NaHC03
 Molecular weight: 84.0
 Category: Electrolytereplenisher; systemic alkaliser.
 Description: Free-flowing, white to light tan powder.
 pH: Neutral to litmus
 Solubility: free soluble in water
 Applications: it reduces stomach acid

13. Microcrystalline cellulose
 Empirical formula:(C6H1005)n
 Molecular weight: Variable
 Functional category: Pharmaceutical aid (suspending agent; tablet and
capsule adjuvant).
 Description: A fine or granular, white or almost white powder odorless.
 pH: Neutral
 Solubility: free soluble in water
 Applications: as a caking agent, and a bulking agent

14. Crospovidone
• water-soluble polymer made from the monomer N-
vinylpyrrolidone
 Formula: (C6H9NO)n
 Melting point: 150 °C
 IUPAC ID: Polyvinylpyrrolidone
 Density: 1.2 g/cm³
 Soluble in: Water
 Molar mass: 2,500 – 2,500,000 g·mol−1

15. Magnesium stearate
 Empirical formula: (C18H35O2)n
 Chemical name: Magnesium octadecanoate
 Molecular weight :591.27
 Functional category: Pharmaceutical aid (suspending agent; tablet and
capsule adjuvant).
 Description: A fine or granular, white or almost white powder odorles
 Solubility: free soluble in water
 Applications: as a caking agent, and a bulking agent

16. TALC
 Empirical formula: Mg3Si4O10(OH)
 Molecular weight : Variable
 Functional category: Pharmaceutical aid
 Description: Light to dark green, brown, white, grey
 Solubility: free soluble in water
 Applications: as a caking agent

17. Citric acid
 Synonym: Baking soda
 Chemical name: 2-Hydroxypropane-1,2,3-tricarboxylic acid
 Empirical formula: C6H8O7
 Molecular weight:192.12
 Description: Free-flowing, white to light tan powder.
 pH: Neutral to litmus
 Solubility: free soluble in water
 Applications: it increase stomach acid

18. PREFORMULATON STUDIES
Organoleptic Properties Of Diclofenac sodium
 Colour :white crystalline powder
 Odour : odourless
 Taste : Bitter
 Melting point: 288-2900c
 Solubility:
 λmax: 340 nm
Sparingly soluble Slightly soluble Very slightly soluble
Water Methanol Ethanol

19. PRECOMPRESSION STUDIES
 Angle of repose: angle of repose was determined using fixed funnel method. The blend was poured
though a funnel that can be raised vertically until a maximum cone height(h) was obtained. Radius of the
heap(r) was measured and angle of repose was calculated using formula.
Ø =tan-1(h/r)
 Where ø is angle of repose, h is height of pile and r is the radius of base pile
 Bulk Density:It is the ratio of total mass of powder and bulk volume of powder. It is determined by
weigh accurately 10 gm of drug and transfered in 50 ml graduated cylinder. Calculated bulk density in
gm/ml by following formula.
 Bulk Density = Weight of Powder/Bulk Volume
 It is expressed by: D b = M/ V b
 Where
 M -mass of powder
 V b- bulk volume of the powder


20.  Tapped Density: It is the ratio of total mass of the powder and tapped volume of the
powder. Calculated tapped density in gm/ml by following formula.
 Tapped Density = Weight of Powder / Tapped Volume
 Dt = M / V t
 Where, M is the mass of powder
 V t is the tapped volume of the powder
 Carr’s index or % compressibility: It is measurement for observe tendency of
powders to be compressed. It can be calculated as follows:
Carr’s Index = (Tapped Density – Bulk Density) / Tapped Density × 100
 Hausner ratio:
 Hausner’s Ratio = Tapped Density / Bulk Density

21. METHOD OF PREPARATION OF FAST DISSOLVING
TABLET
 Formulation of Fast Dissolving Tablets by
Direct Compression Method
All the ingredients were weighed .Then the ingredients
were mixed and compressed in to tablet using 6.5mm
flat-faced punches on 10 station rotary tablet machine.
The blend was compressed into tablets. Formulations
of Diclofenac sodium FDTs by direct compression
method are shown in Table

22. EVALUATION PARAMETERS OF FAST DISSOLVING TABLETS
 Hardness
 The Tablet hardness, which is the force required to break a tablet in a diametric compression force .the
hardness tester used in the study was Pfizer hardness, which applies force to the tablet diametrically with
the help of an inbuilt spring
 Friability
 The Friability of a sample of 20 tablets was measured using Roche friabilator twenty tablets were weighed,
rotated at 25rpm for 4 minutes. Tablets were reweighed after removal of fines and the percentage of weight
loss was calculated. Friability below 1% was considered acceptable
 Weight variation test
 Weight variation test was done by weighing 20 tablets individually, calculating the average weight and
comparing the individual tablet weight to the average weight.
 Wetting time
 A piece of tissue paper folded twice was placed in a small petri dish (ID= 6.5 cm)containing 6 ml of
simulated saliva pH 6.8, a tablet was put on the paper, and the time for complete wetting was measured.

23. RESULT AND DISCUSSION
 Diclofenac fast dissolving tablet were prepared by direct compression method
was carried out by using super disintergrants like crosprovidone and
microcrystalline cellulose. Angle of repose range from 23.72-27.65 show good
flow. Bulk density and tapped density range 0.235-0.249, and 0.94-1.26
respectively. The prepared tablets were evaluated for physical parameters such
as weight variation. Hardness and friability. %weight variation was observed
between ±4.5-6.0%, hardness of tablet were found to be in the range of 3.6-
3.8kg/cm2friability was observed between 0.40-0.48%, which was below 1%
indicating the sufficient mechanical integrity and strength of the prepared
tablets. Dissolution study in P
H 6.8 phosphate buffer was performed
formulationfer was performed formulation f4 showed maximum % drug release
(92.3% in 15 mint) hence formulation f4 was conceded as optimized hence
formulation.


24. CONCLUSION
Fast Dissolving Drug Delivery Systems have better patient
compliance and may propose improved Biopharmaceutical
properties, better efficacy and good safety. FDT dosage forms
obtained by some of these technologies have sufficient mechanical
strength, quick dissolution /disintegration in the mouth. However,
geriatric and pediatric patients experience difficulty in swallowing
conventional tablets, which leads to low patient compliance. To
decrease this weakness, scientists have developed innovative drug
delivery systems known as FDT. Their characteristic advantages
such as administration without water where anytime lead to their
suitability to geriatric and pediatric patients.

25. REFERANCE
 1. H Seager. Drug delivery products andzydis fast dissolving dosage
form.J.Pharm. Pharmacol 1990; 50: 375-382.
 2. RK Chang, X Guo, BA Burnside, RACough. Fast dissolving tablets.
PharmTech 2000; 24: 52-58.
 3. L Dobetti. Fast-melting tablets:Developments and technologies.
PharmaTech.Suppl 2001; 44-50.
 4. BS Kuchekar, V. Arumugam.Fastdissolving tablets. Indian J Pharm
Educ2001; 35: 150-152.
 5. KD Tripathi. Essentials of MedicalPharmacology. 4th ed. New Delhi:
MedicalPublishers (p) Ltd.; 1999. p. 142-44.
 6. BS Kuchekar, AC Badhan, HS Mahajan.Mouth dissolving tablets of
salbutamolsulphate: A novel drug delivery system.Indian Drugs 2004 41: 592-598.
 7. GS Banker, NR Anderson. In: LLachman, HA Lieberman, JL Kanig. The
 Theory and Practice of IndustrialPharmacy. 3rd ed. Mumbai:
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