RYZER PHARMACEUTICAL PRIVATE LIMITED.pptx

Presentation for industrial visit

1. RYZER PHARMACEUTICAL PRIVATE LIMITED REPORT ON MONTELUKAST AND SOME QC INSTRUMENT INTERNSHIP REPORT SUBMMITED TO SHREE MANEKLAL M. PATEL INSTITUTE OF SCIENCE &RESERCH GANDHINAGAR GUIDE :MS LIPSA PATEL PRESENT BY :PATEL HARDIKKUMAR RAMABHAI MR HITENDRA PATEL ENROLLMENT NO :21MSCCHEM22093 INTERNAL GUIDE : DR RAKESH AMETA M.SC CHEMISTRY (ORGANIC) SEM 4

2. INTRODUCTION MONTELUKAST IS DRUG DEVLOPED BY MEECK FOR THE MAINTENANCE TREATMENT OF ASTHMA AND RELIEVING ALLERGY SYMPTOMS Montelukast is an orally dosed drug (available as a film-coated tablet, chewable tablet, or oral granules) that is FDA-approved for treating chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction.It is also approved to relieve seasonal.and perennial allergic rhinitis symptoms . MONTELUKAST IS FROM A GROUP OF MEDICINES CALLED LEUKOTRIENE RECEPTOR (LTRAs) A LEUKOTRIENE RECEPTOR ANTAGONIST FOR THE TREATMENT OF ASTHMA IT’S NAME TAKES FROM “MONTREAL” (THE CITY WICH IT WAS DISCOVERED)

3. STRUCTURE

4. MONTELUKAST SODIUM BP 10 MG Product name : MONTELUKAST Trade name : singulair (us) montair (IN) lukotas (IN) Molecular formula : C 35 H 35 CLNNAO 3 S Molecular weight : 586.19 GM/MOL BIOAVAILABILITY : 63-73% PROTEIN BINDING : 99% MELTING POINT : 145-148 C Devloped by merck in montreal Devloped as a maintenance therapy for asthma & seasonal allergies

5. MECHANISM OF ACTION Montelukast is a leukotriene receptor antagonist. Montelukast is an  inhibitor  of the drug metabolizing enzyme  CYP2C8 , part of the  cytochrome P450  system. Therefore, it is theoretically possible that the combination of montelukast with a CYP2C8 substrate (e.g.  amodiaquine , an anti-malarial drug) could increase the plasma concentrations of the substrate. However, clinical studies have shown minimal interactions between montelukast and other CYP2C8 substrate drugs, which is most likely due to the high  plasma protein binding  exhibited by montelukast.

6. USES OF MONTELUKAST Montelukast is used for a number of conditions. Asthma exercise induced  bronchospasm   allergic rhinitis   urticaria Trouble breathing It may also be used as an adjunct therapy in symptomatic treatment of  mastocytosis .  It is taken  by mouth , as a tablet, chewable tablet, or as granules.

7. A STHMA A LLERGIC RHINITIS U RTICARIA

8. ADVERSE EFFECTS (SIDE EFFECTS) A normal side effect of montelukast Diarrhea Nausea Vomitting Mild rashes Fever Serious side effect of montelukast Behavioral changes ( including suicidal thought) Angioedema Erythema multiforme Liver problem

9.   ANGIOEDEMA Erythema multiforme Hepatitis

10. FRIABILITY TESTER Tablet friability testing involves   weighing the sample of tablets and then placing them into a rotating drum.   The drum is then rotated 100 times.   The sample is then reweighed to find the % weight loss . A maximum weight loss of no more than 1% is considered acceptable for most tablets . WT. BEFORE ROTATION –WT.AFTER ROTATION . 100

11. DISINTIGRATION TEST APPRATUS we use a basket which holds 1 to 6 tablets. This is then raised and lowered into a beaker of water, which is used to simulate conditions in the stomach at  37°C . Disintegration refers to the mechanical break up of a compressed tablet into small granules upon ingestion and therefore it is characterized by the breakdown of the interparticulate bonds, which were forged during the compaction of the tablet .   film-coated tablets disintegrate within 30 minutes and other coated tablets disintegrate within 60 minutes .

12. HARDNESS TESTER We test the hardness by placing the tablet between two jaws. One of the jaws then moves towards the tablet pushing it against the fixed jaw until the tablet breaks. The load at which the tablet fails across the diameter is then recorded. Official standards for Hardness is  5-8 kg/cm2   for standard compressed tablet except Effervescent tablet,Dispersible tablet,Orodispersible tablet,Chewable tablet,etc . Tablet hardness testing is a laboratory technique used by the pharmaceutical industry to determine the breaking point and structural integrity of a tablet and find out how it changes "under conditions of storage, transportation, packaging and handling before usage" The breaking point of a tablet is based on its shape

13. CONCLUTION The observation and results obtained for each parameter compared with acceptance criteria including specificity, linearity, Limit of Detection  (LOD), and Limit of Quantitation (LOQ) repeatability, intermediate, precision, accuracy & robustness well with limit. The observation and results are within the limit of acceptance criteria for all validation parameter therefore the method can be considered as validation suitable for intended use.