The document discusses capsule dosage forms. Some key points include: 1. Capsules can be used to mask unpleasant drug tastes, smells, or appearances. They also allow powders to be dispensed uncompressed, aiding faster drug dissolution and absorption compared to tablets. 2. Capsules offer versatility in preparing varied drug doses and administration routes like oral, inhalation, and others. They can also be easier than tablets for some patients to swallow. 3. Capsule production involves filling empty shells with powders, granules, beads, pastes, liquids or other formulations. Both manual and automated high-output filling machines exist. Quality control ensures proper capsule appearance, weight, content uniform

1. Capsule Dosage formCapsule Dosage form
Mr. Nitin M. KadamMr. Nitin M. Kadam
nitkadam@gmail.com

2. 1. They may be used to mask the unpleasant tastes, aromas, or
appearance of a drug.
2. They allow powders to be dispensed in an uncompressed form, thus
allowing for quicker dissolution and absorption of the drug following
oral dosing (as compared with tablets).
3. They offer the pharmacist versatility to prepare any dose desired for a
variety of administration routes(e.g. oral, inhalation, rectal, or to be
diluted for vaginal, rectal, oral or topical use).
4. They may be easier than tablets for some people to swallow.
5. They can be make to alter the release rate of the drug.

3.  Easy to administer
 Easy to Manufacture
 Liquids can be encapsulated ( non water soluble) Small to large sizes
possible
 Elegance
 Portability
 Odour and taste masking
 Ready availability of drug hence faster action.
 Specialised dosage forms can be made
e.g. chewable, extended release, captabs etc. Can be used for ophthalmic
preparations e.g. aplicaps, vaginal / rectal suppositories

4. 1. They are easily tampered
2. They are subject to the effects of relative humidity and to
microbial contamination.
3. They may be difficult for some people to swallow.
4. More expensive (commercially).

5. Water soluble material are difficult to incorporate
Highly Moisture sensitive Efflorescent material
cannot be incorporated, they may cause
softening / leaching
Deliquescent materials cannot be incorporated,
they may cause hardening or brittle capsules.

7. Capsule shell compositionCapsule shell composition
Gelatin blend, certified dyes, opaquing agents, plastisizers, and preservatives.
Methods of formationMethods of formation
 Pin method
 Centrifugal casting
ModificationsModifications
With methyl cellulose and polyvinyl alcohols and denatured gelatin
for solubility modification and enteric effect.

8. BONE
DEGREASING
CLARIFICATION
DEMINERALISATION
WASHING
FILTRATION
STERILISATION
EXTRACTION
CONCENTRATION
ACIDIFICATION
HIDE
DEIONISATION
DELIMING
LIMING
BLENDING
GRADING
GRINDINGDRYING
CHILLING
GRADING
FILTRATION

10. Size
Outer
Diameter
(mm)
Height or
Locked
Length
(mm)
Actual
Volume (ml)
Typical Fill
Weights
(mg) 0.70
Powder
Density
000 9.91 26.14 1.37 960
00 8.53 23.30 0.95 665
0 7.65 21.70 0.68 475
1 6.91 19.40 0.50 350
2 6.35 18.00 0.37 260
3 5.82 15.90 0.30 210
4 5.31 14.30 0.21 145
5 4.91 11.10 0.13 90

11. Dry solids- Powders, pellets, granules or
tablets, caplets,etc.
 Semisolids- Suspensions,pastes, etc.
Liquids- Non-aqueous liquids
FILLING OF
CAPSULES

12. Capsules are used for filling different materials
like…
es of formulation such as:
Powder Granules Beads
PastesCapletsTablets

13. Capsule Filling, Problems in Filling & Remedies
Filling capsule with a
semisolid mass.
Forming a pipe or pouring a melt.
 Pipe:
Consistency is important.
[For fluid- cornstarch or similar material for firm
cosistancy.]
 Semisolid melt:
For too firm with satisfactory M.P. materials.
For enhancing the bioavailability of poorly soluble drugs.
[Drug + melt of materials like PEG]

14. Filling of Liquids in Capsule
 Manual Small Scale
 Solubility of gelatin.
 Alcoholic solutions, fixed oils & volatile oils
 Filling and sealing
 Industrial Scale Filling
 Variety of shapes and sizes
 Semi-to fully automatic
 Output from 5000 to 15000 per hour.

15. Filling of Solids in Capsule
 Homogeneous mixture
 Adequate flow properties
 Physical incompatibilities
 Choice of excipients:
Diluents, lubricants & glidants, wetting agents,
disintegrants.

16. DIFFICULTIES IN CAPSULE FILLING
1. Deliquescent / Hygroscopic powders.
Remedy: Adsorbent [magnesium carbonate, heavy / light
magnesium oxide]
2. Eutectic mixture
Remedy: Use of adsorbent [magnesium carbonate, kaolin]
3. Small dose of drug
Remedy: Addition of inert powder.
4. Incompatibilities of materials
Remedy: Use of two capsules – small in large
5. Lack of adhessiveness difficult to fill by punch method
Remedy: moistened with alcohol , granules reduced to powders

17. ALTERNATIVE MATERIAL
FOR
HARD GELATIN CAPSULES
Substitute for gelatin in two piece hard capsules
HPMC
QUALI-V by Shionogi Qualicaps: First HPMC Capsule

18. Capsule Processing
Empty Capsule
Filling [Formulation]
Finishing
# Dusting [Cloth Dusting]
# Polishing [Pan Polishing]
# Brushing
Inspection
Bottling
Labeling

19. Special Techniques of Processing
Imprinting
Special purpose Capsules
[To retard solubility of gelatin to delay absorption of drug]
* Formalin treatment
* Various coatings
Separation of Incompatible materials

20. Capsule Filling Equipments
Hand Operated

21. Semi-automatic capsule filling
machine

22. Fully Automatic Capsule Filling Machine

23. In-process Quality And
Quality Control Parameters
Choice of suitable control procedure for filling operation:
[should desirable to provide 100% weight checking after filling]
Capsule Appearance
Weight veriation
Content uniformity
Solubility
Disintegration test

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