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level: Level 3

Questions and Answers List

level questions: Level 3

QuestionAnswer
THE FILL MATERIAL OF SOFT GELATIN CAPSULES1) liquids 2) Solids
THE FILL MATERIAL OF SOFT GELATIN CAPSULES: LIQUIDS 1 water-immiscible volatile and nonvolatile liquids: __ 2 water-miscible, nonvolatile liquids: __ 3 water-miscible and relatively nonvolatile liquids 4 Liquids that can easily migrate through the capsule shell cannot be encapsulated into soft gelatin capsules:1 ether, esters, alcohols, hydrocarbons 2 PEG, non-ionic surfactants 3 No examples 4 ketones, acids, amines, 5% above water
THE FILL MATERIAL OF SOFT GELATIN CAPSULES: SOLIDS(solutions, suspensions, pasty mass, dry powders, granules, pellets, or small tablets.)
COMPENDIAL REQUIREMENTS FOR CAPSULES The requirements for added substances1) are harmless in the quantities used 2) do not exceed the maximum amounts required to provide their intended effect 3) do not impair the product’s bioavailability, therapeutic efficacy or safety 4) do not interfere with requisite compendial assays and tests
THE CONTAINER AND PRESERVATION CONDITION DESCRIBED IN USP1) light resistant container 2) well-closed container 3) tight container 4) Hermetic Container
1) Method The capsules are placed in the basket-rack assembly, which is repeatedly immersed 30 times per minute into a thermostatically controlled fluid at 37 ℃ and observed over the time described in the individual monograph. 2) To fully satisfy the test, the capsules disintegrate completely into a soft mass having no palpably firm core, and only some fragments of the gelatin shell.Disintegration test for capsules
1) The apparatus, dissolution media and test is the same as that for uncoated and plain coated tablets. 2) Generally, when a dissolution test is applied to an existing capsule product, the disintegration test is unnecessary.Dissolution test for capsules
DISSOLUTION APPARATUS-2 (PADDLES) 1 VESSEL: 2 Shaft: 3 Stirring Elements: 4 Rotation Speed: 5 Water-Bath: 6 Sinkers: 7 USE:1 Same as basket apparatus 2 Fused with blade at bottom 3 Coated with teflon, For laboratory purpose, stainless steel is used 4 25-50 RPM 5 Maintains at 37+-0.5 C 6 Platinum wire use to prevent tablet/ capsule from floating 7 Orally disintegrating tablets, chewable tablets, etc
1 show the uniformity of dosage units. 2 For hard capsules, Weight of __ should match Weight of __ 3 For soft capsules:1) Weight variation and content uniformity 2) Capsule, Emptied shell 3) 10 intact capsules weigh individually, then remove contents #1: evaporating the washing solvent over 30 mins #2: avoid uptake or loss of moisture
The amount of active ingredient should be within the range of __ of the label amount for 9 of 10 capsules, with no unit outside the range of __ of label amount.1) 85% to 115% 2) 70% to 125%
COMPENDIAL REQUIREMENTS FOR CAPSULES Other requirements:1 Content labeling 2 Stability testing 3 Moisture permeation test
the quantity of each active ingredientContent labeling:
method: long-term stability testing, accelerated stability test aim: storage condition, shelf lifeStability testing
single unit and unit dose containerMoisture permeation test:
INSPECTING, COUNTING, PACKAGING, AND STORING CAPSULES1) Inspecting 2) Counting 3) Packaging 4) Storing
1 Inspecting: 2 Counting 3 Packaging 4 Storing1 visual or electronic inspection → uniform in appearance 2 a) counting tray; b) counting and filling machines 3 unit dose and strip packaging (sanitary, identifiable, safe) 4 in tightly capped container in a cool, dry place