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level: Level 4 - CAPSULES

Questions and Answers List

CAPSULES

level questions: Level 4 - CAPSULES

QuestionAnswer
are a solid dosage form in which the drug is enclosed in a hard or soft soluble container, usually of a form of gelatinCapsules
2 TYPES OF CAPSULES1 HARD GELATIN CAPSULES 2 SOFT GELATIN CAPSULES
1 Consist of body and cap that filled with powder 2 Consist of one piece that is filled with liquid1 Hard gelatin capsule 2 Soft gelatin capsule
Tests for evaluation of CAPSULES1 Stability Test 2 Invariability Test 3 Disintegration Test 4 Dissolution Test 5 Moisture Permeation Test
Are performed to know the integrity of gelatin capsule shell and for determining the shelf life of capsules. Helps in improving the quality of contents of capsule shell and for choosing the appropriate retail packageStability Test - Shell integrity test - Determination of shelf life
Before performing Stability Test, the capsule shell are to be stabilized to know the atmospheric condition with relative humidity about __ and temperature __20-30% humidity 21-24 C
1 Performed to find out the integrity of capsule shell. 2 The standard capsule shells kept at __ and __ becomes more soft and swollen1 Shell integrity Test 2) 40C, 80% Relative Humidity
Invariability in the medicaments packed in the capsule shells can be determined by performing the following tests: __1 Weight variation test 2 Content Uniformity test
It's done by taking 20 capsule individually weighed and the average weight is determined. If 2 capsules fall outside the range of 10% of the average then should take another 40 capsules then determine the average of 60 capsules, the test requirement are met if 6 capsules fall outside the 10% of the average and none of the 6 capsules outside 25% range.Weight variation test
It’s done by taking 10 capsules and assay each individually by specified procedure, if 9 out of 10 within the requirement of ±15% (85%-115%) limits and the tenth tablet is not outside ±25% (75%-125%) so the batch should be accepted. While if 2 capsules out of 10 fall outside the range ±15% so take 20 capsules and assay them individually and take the average of 30 capsules, so the requirements are met if 27 capsules in the ±15% range and only 3 capsules in the ±25% range.Content uniformity test
is measured when the capsule shell rupture and all the contents pass through the mesh, in order the batch to be accepted the time must be less than 30 minutes.DISINTEGRATION TEST
DISINTEGRATION TEST method1.Introduce one capsule in each tube and suspend the apparatus in a beaker containing 60ml water at 37°C, - if hard capsules float on surface of water, the disc may be added. 2.Operate the apparatus for 30 min, remove the assembly from the liquid. 3.The capsule pass the test if - No residue remains on the screen of the apparatus or. - If the residue remains, it consists of fragments shells. If a soft mass with no palpable core, - If the disc is used any residue is remaining on its lower surface should only consists of fragments of shells.
The factors affecting the disintegration time1- The type of the gelatin shell. 2- The humidity of the capsule shell. 3- Dissolution media. 4- The type of the powder used. 5- The type and the amount of the binder used.