| are solid dosage forms in which medicinal
agents and/or inert substances are enclosed within a
small shell of gelatin. Gelatin capsule shells may be hard
or soft depending on their composition. | Capsules |
| Administration route of capsules | Orally (whole or mixed with food or drink after
opening capsules) |
| ADVANTAGES OF CAPSULES FOR ORAL ADMINISTRATION | 1. conveniently carried
2. readily identified
3. easily taken
4. prescribing flexibility
5. Efficiently and productively manufactured
6. Packaged and shipped at lower cost and with
less breakage
7. More stable and have a longer shelf-life
8. Empty hard gelatin capsules are often used in
the extemporaneous compounding of prescriptions.
9. Tablets and capsules are sometimes used as
the source of a medicinal agent when it is not
otherwise available. |
| TYPES OF CAPSULES | Hard gelatin capsules
Soft gelatin capsules |
| 1 Shells of capsules may be composed of __ | 1 two pieces ( body and cap)
2 single piece |
| Applications:
used to manufacture most medicated agents
employed in clinical trials
used in the extemporaneous compounding | HARD GELATIN CAPSULES |
| HARD GELATIN CAPSULES empty capsule shells consist of: | 1 gelatin,
2 sugar,
3 water,
4 colorants (various dyes), and
5 opaquant (titanium dioxide).
Pneumonics: GSW CO |
| 1 Gelatin is obtained by __
2 HARD GELATIN CAPSULES Commerce
3 Normally, hard gelatin capsules contain between __ moisture
4 If hard gelatin capsules absorbed additional moisture:
5 If hard gelatin capsules lose their contained moisture:
6 (dried silica gel, clay, and activated
carbon) | 1) partial hydrolysis of collagen
2) available in the form of fine powder, coarse powder, shreds, flakes or sheets
3) 13 to 16%
4) become distorted and lose their rigid shape
5) become brittle and crumble when handled
6 Dessicant |
| The solubility property of gelatin: | Insoluble
cold water: soften through the absorption of
up to ten times its weight of water
soluble in hot water and in warm gastric fluid.
Gelatin, being a protein, is digested by
proteolytic enzymes. |
| METHODS USED TO TRACK THE PASSAGE OF CAPSULES IN GIT | 1 Gamma scintigraphy
2 Heidelberg capsule |
| 1 Noninvasive procedure
use of a gamma ray-emitting radiotracer incorporated intro the formulation with gamma camera coupled to a data recording system. | 1 GAMMA SCINTIGRAPHY |
| GAMMA SCINTIGRAPHY METHOD IS USEFUL IN: | 1 Determining whether correlation exist between in vivo
and in vitro bioavailability of immediate release
product
2 Assessing the integrity and transit time of enteric
coated tab through stomach en route to the intestines
3 Drug and dosage form evaluation in new product
development |
| pH sensitive nondigestible radiotelemetric device
Approximate size is No. 0 gelatin capsule
Nonradioactive means to measure gastric pH, gastric residence time, gastric emptying time of solid dosage forms in fasting and non fasting human subjects | HEIDELBERG CAPSULE |
| Heidelberg pH diagnostic systems are used for: | 1 Long Term Migratory Studies
2 Pharmacokinetic Research and Clinical Research on Animals and Humans
Major Pharmaceutical Companies use this system
Researchers rely on this system |
| THE MANUFACTURE OF HARD
GELATIN CAPSULE SHELLS
The process of capsule shell production
with the peg/pin method: | dipping→ drying → stripping→ trimming→
joining
a) The thickness of the gelatin walls must be
strictly controlled.
b) The caps are slightly larger in diameter
than the bodies.
Pneumonic: DDSTJ |
| THE MANUFACTURE OF HARD GELATIN CAPSULE SHELLS
Some improvements to hard gelatin capsule shells
1 rounded shape
2 tapered end pegs
3 Bodies and caps highly tapered | 1 cap
2 Pulvules
3 Spansule capsules |
| 1 Tapered rim to avoid telescoping
2 Grooves which lock the two halves together once the capsule has been filled | 1 CONI-SNAP
2 SNAP-FIT |
| THE MANUFACTURE OF HARD GELATIN CAPSULE SHELLS
Tamper-evident sealing through various capsule sealing
techniques
Imprinting: __ | a) names and monograms of the manufacturer
b) the assigned national drug code (NDC) number
c) other markings making the product identifiable and
distinguishable from other products |
| CAPSULE SIZES
How to select capsule size? | 1) the amount of fill material to be encapsulated
2) the density and compressibility of the fill
3) The final determination largely may be the
result of trial. |
| The sizes of empty capsules
1 For human use:
2 For veterinary use: | 1)
000(the largest),
00, 0, 1, 2, 3, 4, 5 (the smallest)
2) Larger capsules are available. |
