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Capsule
Capsule
CONTENTS
2. • INTRODUCTION • ADVANTAGES • DISADVANTAGES • QUALITY
CONTROL OF CAPSULES Physical tests Chemical tests •
PACKAGING OF CAPSULES • PHARMACEUTICAL ASPECTS 3
3. 4. 4 DEFINITION •
Capsule is the most versatile of all dosage forms
4. . Capsules are solid dosage forms in which one or more medicinal and
inert ingrédients are enclosed in a Small Shell or container usually
made of gelatin. 4
5. 5. 5 ADVANTAGES OF CAPSULES •
6. Capsules mask the taste and odour of unpleasant drugs and can be
easily administered. •
7. They are slippery when moist and hence easy to swallow with a
draught of water. • As compared to tablets less adjuncts are required. •
The shells are physiologically inert and easily and quickly digested in
the gastrointestinal tract. • They are economical . • They are easy to
handle and carry. • The shells can be opacified (with titanium dioxide)
or coloured, to give protection from light. 5
8. 6. 6 DISADVANTAGES OF CAPSULES
9. The drugs which are hygroscopic absorb water from the capsule shell
making it brittle and hence are not suitable for filling into capsules. The
concentrated solutions which require previous dilution are unsuitable
for capsules because if administered as such lead to irritation of
stomach. 6
10. 7. 7 OFFICAL CAPSULE COMERCIAL AVAILABILITY
STRENGTHS CATEGORY
11. Amoxicillin Wymox 250-500 mg Antibacterial
12. Ampicilin Omnipen 250-500 mg Antibacterial Aspirin 300 mg
Analgesic
13. Cephalexin Keflex 250-500 mg Analgesic Cloxacillin sodium
Tegopen 250-500 mg Antibacterial Dipenhydramine HCL Benadryl
HCL 25-50 mg Antihistamine 7 SOME EXAMPLES OF OFFICAL
CAPSULES
14. 8. 8 QUALITY CONTROL OF CAPSULES
15. 9. 9 QUALITY CONTROL OF CAPSULES Whether capsules are
produced on a small scale or large scale all of them are required to
pass through certain tests i.e., quality control tests to test the quality of
the finished product. 9
16. 10. 10 Quality control tests are divided into PHYSICAL TEST •
Disintegration test • Weight variation CHEMICAL TEST • Dissolution
test • Assay • Content uniformity • Stability testing • Moisture
permeation test 10
17. 11. 11 PHYSICAL TESTS OF CAPSULES 11
18. 12. 12 Finally physical control processing and packing may be
accomplished by the following in line continuous operations 1.A
capsule diameter sorter allows to pass to the next unit of any capsule
with in + or _ 0.020 inch of theoretical diameter .
19. 2.A capsule colour - the capsules are fed to it automatic from the
diameter sorter by a pneumatic conveyer .In this unit, any capsule
whose colour does not conform to the reference colour standard for
that particular product is discarded others passes the test. 12
20. 13. 1313 DISINTERATION TEST-
21. • The disintegration test determines the whether capsules
disintegrated with a prescribed time when placed in a liquid medium
under the prescribed integral conditions .
22. METHOD- • According to B.P and which applies to both hard and
soft capsules
23. 1.introduce one capsule in each tube and suspend the apparatus
in a beaker containing 60ml water at 370 C, – if hard capsules float on
surface of water, the disc may be added.
24. 2.Operate the apparatus for 30 min, remove the assembly from
the liquid.
25. 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. 14
48. 48 the capsulated solution was 36% higher than the tablet, while in healthy
volunteers it was 20% higher then tablets. Ex-2. The bioavailability of theophylline
from soft gelatin capsule in comparison to a commercially available liquid
aminophylline preparation and to a non-alcoholic Aminophylline were studied and
found that two dosage forms were bioequivalent as measured by the area under the
plasma level time curves. This shows that capsule providing a convenient portable
dosage form for a liquid medication.
61. 49. 49 • 5.The pharmaceutical chemist should certainly consider
the bioavailability potential of soft gelatin formulations. The
biopharmaceutical characteristics of such formulations can be altered
easily than solid dosage forms . Through the selection and use of
liquids and combinations of liquids that range from water immiscible
through emulsifiable to completely water miscible and by altering the
type and quantity of thickening or suspending agents . • 6.Orally
administered drugs, particularly if used chronically ,can be irritating to
the stomach .The dosage form of such drugs can affect gastric
tolerance.
62. 50. 50 When compared the ulcerogenic potential of soft gelatin
capsule of dexamethasone with tablet the capsule had reduced
ulcerogenic potential.