| THE FILL MATERIAL OF SOFT GELATIN CAPSULES | 1) 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 substances | 1) 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 USP | 1) 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 ingredient | Content labeling: |
| method: long-term stability testing, accelerated stability test
aim: storage condition, shelf life | Stability testing |
| single unit and unit dose container | Moisture permeation test: |
| INSPECTING, COUNTING, PACKAGING, AND STORING CAPSULES | 1) Inspecting
2) Counting
3) Packaging
4) Storing |
| 1 Inspecting:
2 Counting
3 Packaging
4 Storing | 1 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 |
