CIPROFLOXACIN FLUOROQUINOLONE ANTIBIOTIC-1.pptx

The ppt has detailed information about the ciprofloxacin tablets, such as its testing and analysis, which includes various tests such as friability and weight variation tests. This PowerPoint presentation is in reference to the project being done for the completion of the project students of B.Pharm. do in the semester 7(Practice school).

1. Pharmacopoeial Evaluation of Ciprofloxacin tablets as per I.P. 2014 Presenter’s name: Harsh Shukla

2. Introduction Drug information Pharmacodynamics Pharmacokinetics Experiments Methodology Results CONTENT:

3. To learn the various techniques of Quality Control and Quality Assurance which are used for the evaluation of tablets. OBJECTIVE

4. Ciprofloxacin: An antibiotic drug belonging to the class of Fluoroquinolones. Uses: For treatment of various bacterial infections such as pneumonia, gonorrhoea, tuberculosis, infectious diarrhoea and many other infections occurring due to a bacterial attack or invasion on the bod y. The antimicrobial drug was patented by Bayer A.G . in 1983 subsequently approved by controlling authority USFDA Different brands of ciprofloxacin marketed around the world are: INTRODUCTION COUNTRY BRAND NAME 1) AUSTRALIA C-FLOX, CIPROXIN 2) INDIA CILOXAN, CIPRO 3) NEW ZEALAND UFEXIL, TOPESITIN 4)UNITED STATES CILOXAN, CIPROXIN

5. IUPAC NAME: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazin-1-yl)quinoline-3-carboxylic acid. Molecular formula : C 17 H 18 FN 3 O 3 Molecular weight : 331.4gm/mol Drug class : Fluoroquinolone antibiotic Melting point : 290ºC Absorbance wavelength: 276nm 2. Drug information(Ciprofloxacin )

6. . 3. PHARMACODYNAMICS Inhibition of the supercoiling inhibits the bacterial growth The inhibition of enzymes inhibits the supercoiliing of DNA The drug acts at DNA level and inhibits DNA Gyrase and Topoisomerse IV enzymes .

7. 4.ADVERSE EFFECTS: * Gastrointestinal: Nausea, vomiting, anorexia, *CNS: Dizziness, headache, restlessness, anxiety, insomnia, impairment of concentration and dexterity. *Skin/Hypersensitivity . 5.PHARMACOKINETICS: Ciprofloxacin is primarily metabolised by the enzyme CYP1A2. Oral bioavailability of ciprofloxacin is about 60-80% . Plasma protein binding of drug is about 20-35%. Its elimination or t 1/2 is about 3-5 hrs. Do not cross blood brain barrier. The 20% of the whole concentration of the drug get metabolized by liver.

8. EXPERIMENTS HARDNESS TEST FRIABILITY TEST DISINTEGRATION TIME TEST SIZE DETERMINATION WEIGHT VARIATION TEST ORGANOLEPTIC EVALUATIONS

9. 7.INSTRUMENTATION FOR EVALUATION S.NO EXPERIMENT INSTRUMENT 1 Weight variation test Digital weighing balance 2 Friability test Roche type friabilator 3 Disintegration test Tablet disintegration tester 4 Hardness test Monsento hardness tester Pfizer tester 5 UV Spectroscopic test UV spectrophotometer 6 Evaluation test For length measurement Organoleptic properties Vernier calliper

10. a) Organoleptic test: PROCEDURE: One tablet was taken and observed and their shape and color were analysed by visualization. The surface of the tablets was observed using touching the tablet surface 8.METHODOLOGY OF EVALUATION TEST PERFORMED : Shape Oval Color White Surface Smooth

11. b) Size: PROCEDURE: The vernier calliper was taken and the tablet of ciprofloxacin was placed between the jaws of vernier calliper and thickness was observed.

12. Procedure : 10 tablets were taken. The tablets were weighed individually and there weight was recorded. Now the average weight of 10 tablets was calculated by applying the formula: Average = sum of all observations/no. of observations . Now the % weight variation was calculated by using the formula: % weight variation=(weight of tablets/average weight of tablets) x 100 % difference was calculated by applying the formula. % difference= (100%-%weight variation). 2.Weight variation test DIGITAL WEIGHING BALANCE Sr.no Average weight of tablets % weight variation 1. Less than 80mg ±10% 2. 80-250mg ±7.5% 3. More than 250mg ±5%

13. Procedure: Using Monsento hardness tester the hardness of tablets was checked. a tablet was taken and placed in the cavity of the tester. The knob of the tester was operated. The starting point before operation was noted down. After operation the point at which tablet broke down was noted. The experiment was repeated for 10 tablets and the avergae hardness was calculated Hardness of tablets should not be less tha 4kg/cm and more than 10kg/cm . 3.Hardness test: For determination of hardness of tablets . MONSENTO’S HARDNESS TESTER

14. Test is performed to determine the disintegration of tablets in stomach using the D.T. apparatus by providing the enviornment of enviornment . 4.Disintegration time test Disintegration test apparatus

15. PROCEDURE: Firstly it was checked that in which solution the drug gets dissolved.(ciprofloxacin- water). The beaker was filled upto 85% percent of its quantity with distilled water. Six tablets were taken and transferred to the 6 tubes of the D.T. apparatus. The tubes were then covered with perforated plastic discs which provide abrasion to the tablets. Machine was operated and the time was noted when the tablets got completely disintegrated. The experiment was repeated 3 times and there average time of disintegration was calculated . Standard disintegration time of tablets(as per I.P.)

16. Procedure: 6 tablets were taken and weighed using a weighing balance . The average weight of tablets was recorded. The tablets were kept in the friability apparatus. The machine was operated for 4 minutes. The tablets were again weighed and weight was recorded. The %weight loss was calculated using formula : 5. Friability test: The friability test was done to check the loss of drug which can occur during transport of tablets due to friction while transport . As per I.P . the drug loss should be in range between 0.5%-1.0% %weight loss = (initial weight-final weight/initial weight) x 100

17. RESULTS AND DISCUSSIONS

18. 1.Organoleptic evaluations a)For branded tablets S.No Parameters Observations 1 Color Yellow 2 Odor Odorless 3 Taste Tasteless 4 Shape Hexagonal 5 Surface Smooth

19. 1.Organoleptic evaluations a)For generic tablets S.No. Parameters Observations 1 Color White 2 Odor Odorless 3 Taste Tasteless 4 Shape Rectangular 5 Surface Smooth

20. Discussion: For weight variation tests according to I.P. not more than 4 tablets should deviate from the batch of 20 tablets RESULT: Not a single tablet deviate from given I.P. standards are showing deviation hence the tablets pass the weight variation test. 1. Weight variation test: a) For Branded tablets: S.NO INITIAL WEIGHT(mg) WEIGHT DIFFERENCE % Variataion Results 1 720 7 0.98% Pass 2 690 -23 -3.22 Pass 3 720 7 0.98 Pass 4 720 7 0.98 Pass 5 720 7 0.98 Pass 6 710 -3 0.48 Pass 7 710 -3 0.48 Pass 8 710 -3 0.48 Pass 9 720 7 0.98 Pass 10 710 -3 0.48 Pass

21. Discussion: For weight variation tests according to I.P. not more than 4 tablets should deviate from the batch of 20 tablets RESULT: Not a single tablet deviate from given I.P. standards are showing deviation hence the tablets pass the weight variation test B)FOR GENERIC TABLETS S.NO INITIAL WEIGHT(mg) WEIGHT VARIATION % VARIATION RESULTS 1 730 15 -2% Pass 2 710 -5 0.6% Pass 3 730 15 2% Pass 4 710 -5 0.6% Pass 5 700 -15 -2% Pass 6 710 -5 0.6% Pass 7 690 -25 -3% Pass 8 720 5 0.6% Pass 9 710 -5 0.6% Pass 10 710 -5 0.6% Pass Average 715

22. A)For branded tablets: Initial weight of 6 tablets= 7.22gm Final weight of 6 tablets= 7.20gm Friability =(initial weight –final weight /final weight )x 100 %weight loss= (7.22-7.20/7.20) x 100 = 0.27% 2.FRIABILITY TEST Discussions: As per I.P. friability for a batch of tablets should not more than 1%. Results : t=The obtained friability limit is in range of I.P. standards therefore the tablets passed the test.

23. A)For generic tablets: Initial weight of 6 tablets= 4.35gm Final weight of 6 tablets= 4.32gm Friability =(initial weight –final weight /final weight )x 100 %weight loss= (4.35-4.32/4.32) x 100 = 0.69% Discussions: As per I.P. friability for a batch of tablets should not more than 1%. Results : t=The obtained friability limit is in range of I.P. standards therefore the tablets passed the test.

24. FOR BRANDED TABLETS: 3.Hardness S.NO HARDNESS(g/cm) 1 1.6 2 1.3 3 1.5 AVERAGE 1.46 Discussions: As per I.P. standards the average hardness of tablets should not be less than 4kg/cm. Results: none of the tablets deviated from the standards of I.P. therefore the tablets passed the test

25. FOR GENERIC TABLETS: 3.Hardness S.NO HARDNESS(g/cm) 1 1.5 2 1.4 3 1.2 AVERAGE 1.36 Discussions: As per I.P. standards the average hardness of tablets should not be less than 4kg/cm. Results: none of the tablets deviated from the standards of I.P. therefore the tablets passed the test

26. 4.DISINTEGRATION TIME S.NO NO. OF TABLET DISINTEGRATION TIME(MIN.) 1 6 2 2 6 3 3 6 2 Average =2.3min DISCUSSIONS: As per I.P. standards the average time for the disintegration of the uncoated tablets is 15 minutes. Results: The tablets got dissolved in the range of time standards hence the tablets passed the test. a)For branded tablets:

27. 4.DISINTEGRATION TIME S.NO NO. OF TABLET DISINTEGRATION TIME(MIN.) 1 6 2 2 6 3 3 6 2 Average =2.3min DISCUSSIONS: As per I.P. standards the average time for the disintegration of the uncoated tablets is 15 minutes. Results: The tablets got dissolved in the range of time standards hence the tablets passed the test. a)For generic tablets:

28. Leon Lachman’s book of “Industrial pharmacy” https://www.researchgate.net/publication/253241839_Formulation_and_quality_evaluation_of_two_conventional_release_tablet_formulations REFERENCES

29. THANK YOU