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level: Level 3

Questions and Answers List

level questions: Level 3

Question	Answer
A process by which a solid solute enters a solution. Amount of drug substance that goes into solution per unit time under standardized conditions of liquid/solid interface, temperature and solvent composition	Dissolution
DISSOLUTION USP SPECIFICATIONS, 1 All tablets/capsules are subject to a general dissolution standard of __ of the labeled content is dissolved in __	. 1 NLT 75%, NMT 45 MINS in 900 ML Water
Used to measure the degree of force required to break a tablet	Hardness Test
Minimum FORCE requirement for a satisfactory tablet	4kg force
1 Hardness of Oral Tablets 2 Hardness of Hypodermic and Chewable tablets 3 Hardness of Sustained released tablets	1) 4 to 10 KG 2) 3KG 3) 10-20 KG
Factors affecting HARDNESS	1 Compression 2 Amount of binder (more binder=more hardness) 3 Method of granulation (Wet method= more hardness)
Limit of tablet hardness is __ minimum and __ maximum	5 KG, 8 KG
HARDNESS TEST APPARATUS USED	1 Monsanto tester 2 Strong Cobb tester 3 Pfizer tester
1 It is the tendency of tablets to powder, chip, or fragment 2 It is designed to evaluate the ability of tablet to withstand ABRASION in packaging, handling and shipping.	1 Friability 2 Friability Test
Friability Test procedure	1 Weigh 20 TABLETS 2 Put in FRIABILATOR and adjust at 100 RPM (25 RPM for 4 MINS) 3 Weight the intact ones
uncoated tablets that generally contain acid substances and carbonates or bicarbonates and that react rapidly in the presence of water by releasing CO₂	Effervescent tablets
SPECIFIC TESTS FOR Effervescent tablets 1 British Pharmacopoeia 2 Indian Pharmacopoeia	. 1 DISINTEGRATION TEST, UNIFORMITY OF WEIGHT 2 DISINTEGRATION/DISSOLUTION/DISPERSION TEST
are administered by placing them in the mouth between the gum and the cheek. These medications dissolve rapidly and are absorbed through the mucous membranes of the mouth where they enter into the blood stream.	Buccal medications
BUCCAL MEDICATIONS Parameters of evaluation:	1) Determination of residence time 2) Permeation studies 3) Swelling studies 4) Release rate studies 5) Toxicity and irritation study 6) Bioadhesion measurement 7) Content uniformity
A drug dosage form available for a LIMITED RANGE OF OVER-THE-COUNTER (OTC) and prescription medications. DIFFER from traditional tablets in that they are DESIGNED TO BE DISSOLVED ON THE TONGUE rather than swallowed whole.	Orally Disintegrating Tablet or Orodispersible Tablet (ODT)
DISSOLUTION OF ORALLY DISINTEGRATING TABLETS: 1 Density and Hardness: __ 2 Disintegration time:__ 3 Media:__ 4 Type of apparatus: __ 5 Speed:	. 1 Low D and H 2 LESS THAN 1 MIN 3) 0.1 N HCl, buffers 4 Apparatus 2 5) 50 RPM