GPAT IMPORTANT PINPOINTS

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Information about GPAT IMPORTANT PINPOINTS

Published on October 12, 2016

Author: AmarRaval1

Source: slideshare.net

1. Assistant professor, BMCPER, MODASA PHARMAROCKS: THE WAY OF SUCCESS

2. DRUG ACTIVE METABOLITE Allopurinol Oxipurinol (Alloxanthine) Amytryptylline Nortryptalline Amphetamine P-Methoxy Amphetamine Carmapazepine Carmapazemine-10,11-Eporide Carbimazole Thiamazole Cephaloglycine Desacetyl Cephaloglycine Chloral Hydrate Trichloroethanol Chlordiazepoxide 7-hydroxy Chloropromazine Chlorpromazine 7-hydroxy Chloropromazine Chlorguanidine Cyclogunal Clofibrate Free acid metabolite Imipramine N-oxide metabolite Codeine Morphine,Norcodeine Guanethadine N-OxidePHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

3. Lignocaine N-Desmethyl metabolite Morphine Nor morphine Naloxane 6-hydroxy Naloxane Phenacetin Paracetamol Prednisone Prednisolone Premidone Phenobarbitone Spironolactone Canrenone Procainamide N-Acetyl metabolite Quinidine 3-Hydroxy quinone Thioridazine Mesoridazine Trimethedione Dimethedione Warfarin Warfarin alcohol Vit D 1,2 Dihydroxy metabolite Reserpine Methyl reserpate PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

4. DRUG PRODUCT ANIMAL USE FOR BIOASSAY Digitalis Pigeon Glycogen Cat Insulin inj, Rabbit Oxytocin Chicken Parathyroid Dog Vasopressin Rat Tubocurarine chloride Rabbit Cod liver oil Rachitic rat Heparin sodium Sheep Antiseptic and disinfectant Frog Fungicides and Herbicides Mouse Diphtheria toxoid Rat Atropine Rabbit Insulin inj. Guinea pig PRODUCTS AND ANIMALS USED FOR BIOASSAYSPRODUCTS AND ANIMALS USED FOR BIOASSAYS BIOASSAYS:BIOASSAYS: measurement of the concentration or potency of a substance by its effect on living cells or tissues. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

5. INJECTIONS TYPE GUAGE NUMBER OF NEEDLE INTRADERMAL 26G S.C 26G 25G 22G I.M 24G 23G 22G 20G I.V 22G 20G RECOMENDE NEEDLE SIZE FOR VARIOUS INJECTIONSRECOMENDE NEEDLE SIZE FOR VARIOUS INJECTIONS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

6. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020 TYPE OF INJECTION AND ANGELS USEDTYPE OF INJECTION AND ANGELS USED 9016312020

7. DRUG VARIETY 1 SENNA Indian senna Cassia angustifolia Alexandrian senna Cassia acutifolia Dog senna Cassia obovata Palthe senna Cassia auriculata 2 ALOE Cape Aloe Aloe ferox Curcao Aloe Aloe barbadensis Socotriene/ Zangibar aloe Aloe perryii 3 RHUBARB Indian Rhubarb Rheum emodi Chienese Rhubarb Rheum Webbianum DRUGS AND THEIR VARIETIESDRUGS AND THEIR VARIETIES PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

8. SR.NO. DRUG SYNONYMS 1 Cinchona Panama bark 2 Lanolin Wool fat 3 Crowfig seeds Nuxvomica 4 Deadly night shade Atropa beladona 5 Digitalis purpuria Foxglove 6 American podophyllum May apple 7 Indian tragacanth Gum karaya 8 Devil’s dung Asafoetida 9 Indian squill Urgenia 10 Indian tobacco Lobelia 11 Flax seeds Linseed 12 Periwinkle Vinca visea 13 Ashwagandha Withania somnifera DRUG AND THEIR SYNONYMSDRUG AND THEIR SYNONYMS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

9. 15 Tinevally senna Cassia angustifolia 16 Dog senna Cassia obovata 17 Pathe senna Cassia auriculata 18 Acasia Gum arabica 19 Sterculia Karaya 20 Agar Japnese is linglass 21 Plantago Psyllium 22 Starch Amylum 23 Rhubarb Rheam.emodi.(IND.Rhubarb) 24 Cascara Purshiana,sacred barc 25 Discoria Wild Yam 26 Glycerrhiza Liquarice 27 Quillalia Panama bark 28 Quassia Bitter wool PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020 DRUG AND THEIR SYNONYMSDRUG AND THEIR SYNONYMS

10. 29 Pale calicher Gambier catechu 30 Blach caticher Cutch 31 Castor oil Ricinus oil 32 Arachis oil Reauut oil 33 Linseed iol Flax seed oil 34 Olive oil Saled oil 35 Hydro carpno oil Chanlmogra oil 36 Theobrona oil Cocoa butter 37 Cinnamon Chinese cassia 38 Saffron Crocus 39 Colchicum Autumn Crocus, Meadow saffron seeds 40 Nutmeg Mygistica 41 Chenopodium American wore 42 Lipstick tree Annato tree, Bixin DRUG AND THEIR SYNONYMSDRUG AND THEIR SYNONYMS

11. SR NO NAME OF THE DRUG SIDE EFFECTS 1 ACE Inhibitors Dry Cough 2 Amphotericin-B Nephrotoxicity 3 Ampicillin Hypersensitivity 4 Androgen Virilization 5 Antipsychotics Sedation, Orthostatic hypotension, Tardive dyskinesia 6 Anti- TB Hepatotoxicity 7 Aspirin (cox-I Inhibitors) Hepatotoxicity 8 Atropine Dryness of mouth, Blurred vision, Constipation 9 Celecoxib, Valdecoxib (cox-II Inhibitors) Hepatotoxicity 10 Chlorambucil Alopecia 11 Chloramphenicol Grey baby syndrome, Bone marrow depression 12 Chloroquine Phototoxicity NAME OF THE DRUG AND SIDE EFFECTSNAME OF THE DRUG AND SIDE EFFECTS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

12. 14 Clofazimine Pigmentation of skin, Discoloration of Urine 15 Clozapine Agranulocytosis 16 Erythromyicin Cholestatic Juandice 17 Ethambutol Optic Neuritis, Retrobulbular Neuritis 18 Hydrochlorthiazide Hypokalamia 19 Isoniazid Peripheral Neurtis 20 Metronidazole Disulfiram like reaction 21 Minoxidil Hirsutism 22 Morphine Constipation 23 Nimesulide Hepatotoxicity 24 Nitrogen Mustard Bone marrow depression 25 Nitroglycerin Palpitation 26 Penicillin-G Jarisch Heximer Reaction 27 Phenformin Lactic acidosis, GI disturbance, Metalic tastePHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020 NAME OF THE DRUG AND SIDE EFFECTSNAME OF THE DRUG AND SIDE EFFECTS

13. 28 Phenytoin Hirsutism 29 Quinidine Cinchonism 30 Quinine Sulphate Black Water Fever 31 Repaglinide Althralgia 32 Rosaglitazone Anemia,Weight gain 33 Sitagliptin Coldness 34 Spironolactone Hyperkalamia 35 Cimetidine Gynacomastia 37 Sulfonyl Ureas derivatives Bone marrow depression 38 Terfenadine Type-I arrhythmia 39 Tetracyclines Discoloration of teeth 40 Thalidomide Phocomelia PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020 NAME OF THE DRUG AND SIDE EFFECTSNAME OF THE DRUG AND SIDE EFFECTS

14. CAPSULE SIZE Mg Ml 000 (Largest) 950 1.37 00 650 0.95 0 450 0.68 1 300 0.50 2 250 0.37 3 200 0.30 4 150 0.21 5 (Smallest) 100 0.13 CAPSULE NO & THEIR APPROXIMATE CAPACITY IN mg & mlCAPSULE NO & THEIR APPROXIMATE CAPACITY IN mg & ml PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

15. PROPORTIONS REQUIRED FOR A PRIMARY EMULSIONPROPORTIONS REQUIRED FOR A PRIMARY EMULSION CODE: LPSO (APPLY THIS FOR TWEENS & SPANS) For eg. SPANS 20 MEAN SORBITAN MONO LAURATE TWEEN 80 MEAN POLYOXYETHYLENE SORBITAN MONOOLEATE •L : LAURATE - 20 •P : PALMITATE - 40 •S : STEARATE - 60 •O : OLEATE - 80 TYPE OF OIL OIL: WATER: GUM RATIO FIXED OILS 4:2:1 VOLATILE OILS 2:2:1 MINERAL OILS 3:2:1 OLEORESINS 1:2:1 PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

16. Descriptive Term Approx. Vol of Solvent in ml/gm of Solute Very soluble less than 1 Freely soluble 1 to 10 Soluble 10 to 30 Sparingly soluble 30 to 100 Slightly soluble 100 to 1000 Very slightly soluble 1000 to 10,000 Practically insoluble more than 10,000 SOLUBILITYSOLUBILITY PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

17. COLD TEMPERATURE 2 to 8 degree centigrade COOL TEMPERATURE 8 to 25 ROOM TEMPERATURE Prevailing in the working area WARM TEMPERATURE Between 30 to 40 EXCESSIVE HEAT > 40 degree STORAGE TEMPERATURESTORAGE TEMPERATURE PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

18. DIPAC 97 % sucrose + 3% moddified dextrose NUTAB 95 % sucrose + 4 % invert sugar SUGAR TAB 90 - 93 % sucrose + 7 - 10 % invert sugar SUCROSE BASED DILUANTSSUCROSE BASED DILUANTS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

19. •Carr’s index •The bulk density was the Ratio of weight to the volume of the sample. •Tapped density was determined as the ratio of weight of the sample to the volume after tapping a measuring cylinder for 500 times from a height of 2 inch. •The Carr’s index (percentage compressibility) was calculated as one hundred times the ratio of the difference between tapped density and bulk density to the tapped density % Carr’s Index = (Tapped density – Bulk density) / Tapped density * 100 % Carr’s Index = (TD – BD) / TD * 100 PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

20. Hausner’s Ratio = Tapped density / Bulk density H.R = TD / BD % CI FLOW CHARACTER HAUSNER RATIO < or = 10 Excellent 1 - 1.11 11 – 15 Good 1.12 - 1.18 16 – 20 Fair 1.19 - 1.25 21 – 25 passable 1.26 - 1.34 26 – 31 poor 1.35 - 1.45 32 – 37 very poor 1.46 - 1.59 >38 very very poor > 1.6 Hausner’s Ratio Hausner’s ratio is the ratio of tapped density to the bulk density. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

21. Angle of repose Tan Ø = h/r ANGLE OF REPOSE FLOW CHARACTER 25 – 30 Excellent 31 – 35 Good 36 – 40 Fair 41 – 45 Passable 46 – 55 Poor 56 – 65 Very Poor >66 Very Very Poor PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

22. NAME OF DISEASE DIAGNOSTIC TESTS SYPHILIS 1. VDRL TEST, 2. KAHN TEST, 3. WASSERMAN TEST 4. TREPONEMA IMMOBILIZATION TEST, 5. FLUROESCENT ANTIBODY-ABSORBED SERUM TEST. DIPTHERIA 1. SCHICK TEST, 2. ELEX TEST T.B TUBERCULIN, MANTOUX TEST LEPROSY LEPROMIN TSEST TYPHOID OR ENETRIC FEVER WIDAL TEST RHUMETOID ARTHRITIS ROSE WATER TEST IMP DIAGNOSTIC TESTSIMP DIAGNOSTIC TESTS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

23. PNEUMONIA 1. COLD HEMAGLUTINATION TEST, 2. STREPTOCOCCUS MG HEMAGLUTINATION TEST BRUCELLOSIS- COOMBS TEST(OPSONIZATION TEST) LYMPHOGRANULOMA VENERUM FREI TEST TYPHUS FEVER- WEIL FELIX TEST HEMOPHILLIUS- DUCREY TEST SCARLET FEVER- DICK TEST TO DETECT HUMAN CHORNIC GONADOTROPHIN IN SERUM OF WOMAN RADIO IMMUNO ASSAY(RIA) IMP DIAGNOSTIC TESTSIMP DIAGNOSTIC TESTS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

24. MOST IMP HETEROCYCLIC RING STRUCTURESMOST IMP HETEROCYCLIC RING STRUCTURES PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

25. MOST IMPORTANT FROM SIZE REDUCTION PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

26. GRADE OF POWDER AND SEIVE THROUGH PASS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

27. TABLET COATING STEP AND MATERIAL USED PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

28. DISSOLUTION TEST APPRATUS PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

29. TYPE CONTENT “A” Performa for forms no. 1 to 50( Application, issue, renewal, etc.) “B” Rates of fee for test or analysis by CDL or Govt. analysts “C” List of Biological and special products (Injectable) applicable to special provisions. Ex. Sera, Vaccines, Penicillin…..etc“C1” List of Biological and special products (nonparenteral) applicable to special provisions. Ex. Digitalis, Hormones , Ergot“D” List of drugs that are exempted from provisions of import “E1” List of poisonous substances under the Ayurvedic , Siddha and Unani systems “F” Provisions applicable to blood bank PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

30. TYPE CONTENT “F1” Special provision applicable to biological and special products, eg. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents“F2” Standards for surgical dressings “F3” Standards for umbilical tapes “FF” Standards for ophthalmic preparations “G” List of substances required to be used under medical supervision and labelled accordingly Ex. Metformin, Anti Histaminic, …etc“H” List of substances (prescription) that should be sold by retail only on prescriptions of R.M.P. Ex. Atenolol, Lorazepam, Dapson …etcPHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

31. TYPE CONTENT “J” List of diseases and ailments that drug should not claim to cure Ex. Cancer, AIDS, Cataract, Diabetes…etc “K” List of drugs that are exempted from certain provisions regarding manufacture “M” Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments “M1” Requirements of factory premises for manufacture of Homeopathic medicines “M2” Requirements of factory premises for manufacture of cosmetics “M3” Requirements of factory premises for manufacture of medical devices “N” List of equipment to run a Pharmacy “O” Standards for disinfectant fluids Ex… Phenol, H2O2, alcohol…. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

32. TYPE CONTENT “P” Life period(expiry) of drugs Ex. Insuline Inj. – 24 months “Q” Coal tar colors permitted to be used in cosmetics Ex. Caramel, TiO2, Toney red….. “R” Standards for mechanical contraceptives “R1” Standards for medical devices “S” Standards for cosmetics “T” Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugs “U” Manufacturing and analytical records of drugs PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

33. TYPE CONTENT “U1” Manufacturing and analytical records of cosmetics “V” Standards for patent or proprietary medicines “W” List of drugs marketed under generic names- Omitted “X” List of narcotic drugs and psychotropic substances EX. Opium, Morphine, Barbital…… “Y” Requirement and guidelines on clinical trials for import and manufacture of new drugs

34. S.No. Category Type Sale Application Form Licence Form 1 Drugs other than those specified in Schedule C&C (1)&X Whole Sale 19 20-B Retail Sale 19 20 Restricted(Gen.Store) 19-A 20-A R-61 (1) 2 Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’ Whole Sale 19 21B Retail Sale 19 21 Restricted(Gen.Store) 19-A 21-A R-61 (1) 3 Drugs specified in Schedule ‘X’ Whole Sale 19-C 20-G Retail Sale 19-C 20-F R-61(1) 4 Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C&C (1) Whole Sale 19-AA 20-BB (2) Drugs specified in Schedule C&C (1) Whole Sale 19-AA 21-BB R-62-D 5 Homoeopathic Medicines Whole Sale 19-B 20-D Retail Sale 19-B 20-C R-67-C Form PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

35. SECTIONS COVER IN D& C ACT-1940 20. Government Analysts. 21. DRUG Inspectors. 22. Powers of Inspectors. 23.Procedure of Inspectors. 33C. Ayurvedic, Siddha and Unani Drugs Technical Advisory Board. 33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee. 33E. Misbranded drugs. 33EE. Adulterated drugs. 33EEA. Spurious drugs. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

36. ANDA - Abbreviated New Drug Application. IND – Investigational New Drug Application. NDA – New Drug Application. According to the BCS, drug substances are classified as follows: Class I - High Solubility, High Permeability Class II - High Permeability, Low Solubility Class III -High Solubility, Low Permeability Class IV - , Low Solubility Low Permeability PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

37. IP/BP Limit USP 80 mg or less 10% 130mg or less More than 80mg or Less than 250mg 7.5% 130mg to 324mg 250mg or more 5% More than 324mg IP Limit Less than 300mg 10% 300mg or More 7.5% Weight Variation Limits:- 1) For Tablets 2) For Capsule:- Friability Test:- This test is additional to check crushing strength of tablet by this test one can check Capping &/or Lamination. USP limit is 0.5 to 1%. Rotation: - 25 rpm or 100 rotations in 4 min. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

38. Uncoated Tablet NMT 15 min, in water with Disc 370 C ± 20 C Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet Enteric Coated Tab Intact for 1 hr in 0.1 N HCl & disintegrate within 2 hr in Mixed 6.8 Phosphate buffer. According to USP 1 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid. Dispersible/Solu ble Within 3 min in water at 250 C ± 10 C (IP) & 15 – 250 C (BP) Orodispersible Within 1 min Effervescent Tab 5 min in 250 ml water at 20 – 300 C (IP) & 5 min in 200 ml water at 15-250 C (BP) Buccal & Sublingual Not Applicable but dissolve within 15 – 30 min. TABLET Disintegration Time:- PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

39. Tablet Problems:- Capping:- ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling. Lamination / Laminating:- Definition: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers. Chipping:- ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operations. Cracking:- Small, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the sidewall are referred to as ‘Cracks’. Sticking / Filming:- ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

40. Picking:- ‘Picking’ is the term used when a small amount of material from a tablet is sticking to and being removed off from the tablet-surface by a punch face. The problem is more prevalent on the upper punch faces than on the lower ones. The problem worsens, if tablets are repeatedly manufactured in this station of tooling because of the more and more material getting added to the already stuck material on the punch face. Mottling:- ‘Mottling’ is the term used to describe an unequal distribution of colour on a tablet, with light or dark spots standing out in an otherwise uniform surface. Double impression:- ‘Double Impression’ involves only those punches, which have a monogram or other engraving on them. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

41. Problems for tablet coating:- Blistering:- It is local detachment of film from the substrate forming blister. Chipping: It is defect where the film becomes chipped and dented, usually at the edges of the tablet. Cratering: It is defect of film coating whereby volcanic-like craters appears exposing the tablet surface. Picking: It is defect where isolated areas of film are pulled away from the surface when the tablet sticks together and then part. Pitting: It is defect whereby pits occur in the surface of a tablet core without any visible disruption of the film coating. Blooming: It is defect where coating becomes dull immediately or after prolonged storage at high temperatures. Blushing: It is defect best described as whitish specks or haziness in the film. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

42. Colour variation: A defect which involves variation in colour of the film. Infilling: It is defect that renders the intagliations indistinctness. Orange peel/Roughness: It is surface defect resulting in the film being rough and nonglossy. Appearance is similar to that of an orange. Cracking/Splitting: It is defect in which the film either cracks across the crown of the tablet (cracking) or splits around the edges of the tablet (Splitting). PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

43. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

44. BLOOD GROUP COLOR OF LABEL O BLUE A YELLOW B PINK AB WHITE BLOOD GROUP AND ITS COLOR OF LABEL MOST IMP PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

45. SR NO ORGANISATION LOCATION 1 BCG Vaccine Lab Chennai 2 Central drug testing lab (CDTL) Mumbai 3 Central drug Laboratory (CDL) Kolkata 4 Central Drug Research Institute (CDRI) Lucknow 5 Central Research Institute (CRI) Kasauli 6 Indian Drug Manufactures Association (IDMA) Mumbai 7 Indian Society of Blood Trensfusion & Immunoheamatology Pune 8 Indian Veterinary Research Institute (IVRI) Izatnagar 9 Central Indian Pharmacoepia Laboratory (CIPL) Ghaziabad PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

46. 10 National Plasma Fractionation Centre (NPFC) Mumbai 11 National Institute for Communicable Disease (NICD) New Delhi 12 Indian Institute for Virology (IIV) Pune 13 Organization of Pharmaceutical Procedures Mumbai 14 Dabur Research foundaion Ghaziabad 15 Institute of applied man power research New Delhi 16 CD Testing Lab Mumbai 17 Synthetic Drug Plant Hyderabad 18 National Institute of Nutrition (NIN) Hyderabad 19 National Brain Research Institute (NBRI) Manesar (Gurgaon) PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

47. 1935 RBI established 1949 RBI Nationalized 2005 RTI ACT 2005 Product Patent In India 1956 Companies Act 1932 Partnership Act 1993 End of GATT era 1997 National Pharmaceutical Pricing Authority (NPPA) 1994 Dolly sheep – First clone 1950 First Planning Commission 1984 Hatch-Waxman Act 1955 SBI nationalized 2005 IPC constituted 1896 First Olympics PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

48. 1970 Indian Patents Act 1919 Poison Act 1948 Pharmacy Act 1940 Drug and Cosmetic Act 1930 Dangerous Drug Act 1857 Opium Act 1954 Drug and Magic Remedies Act 1971 Medical Termination of Pregnancy Act (MTP) 1989 First ICH Indian pharmacopoeias: 1955 1st Edition IP 1966 2nd Edition IP 1985 3rd Edition IP 1996 4th Edition IP 2007 5th Edition IP 2010 6th Edition IP PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

49. TABLET AND CAPSULE MACHINES 1. Rotosort- for filled/unfilled capsule sorting machine and for de- dusting. 2. Rotofill- to fill pellets in hard gelatin capsule 3. Rotoweigh- A high speed capsule weighing machine. 4. Accogel- filling of dry powder in soft gelatin capsule. 5. Accofill- fill exact powder dose in hard gelatin capsule 6. Wurster- for coating. 7. Osaka- capsule filling machine (powder, granules) 8. Zanasi- capsule filling (powder, pellets, tablets) 9. Lily/parke-davis: capsule filling (powder) 10. Farmatic, holfiger & kary-liquid filling in HGC. 11. Erweka- De-dusting and polishing capsule machine. 12. Seidender- Uses a Belt for visual inspection. 13. Vericap 1200- capsule weighing machine. PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020PHARMAROCKS: THE WAY OF SUCCESS MR. AMAR M. RAVAL HELPLINE: 9016312020

50. TO BE CONTINUE IN NEXT LECTURE

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