| PREPARATION OF FILLED HARD GELATIN CAPSULES
The general steps of preparation: | 1) developing and preparing the formulation and
selecting the size of capsule.
2) filling the capsule shells.
3) capsule sealing (optional)
4) cleansing and polishing the filled capsules. |
| DEVELOPING THE FORMULATION AND SELECTION OF CAPSULE SIZE
1 GOAL:
2 How to get to the goal? | 1 a capsule with accurate dosage, good bioavailability, ease of filling and production, stability and elegance
2
pharmaceutical processing
pharmaceutical excipient |
| 1) uniform powder mix, uniform drug distribution
2) 50~1000 mm, suitable for a drug of low dose (10mg or
greater)
3) 10~20 microns, suitable for Drugs of lower dose, small particles required | 1) blending
2) comminution/milling
3) micronization |
| 1 to produce the proper capsule fill volume; to provide cohesion to the powders,
2 to assist the break-up and distribution of the capsule contents
3 to enhance the flow properties of the powder mix
4 to facilitate wetting of the dry powder | 1 diluent/filler (e.g. Lactose, microcrystalline cellulose and starch)
2 disintegrants/disintegration agents (e.g. pregelatinized starch, croscarmellose and sodium starch glycolate)
3 lubricant or glidant (e.g. fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid, or talc (0.25%-1%))
4 wetting agents (e.g. surfactants, as sodium lauryl sulfate) |
| The form of filling material in capsules: | 1) powder or granulate
2) pellet mixture
3) paste or wetted mass: the mixture of liquid and an
inert powder (for aq. Liq)
4) capsule and
5) tablet
6) liquids: fixed or volatile oils (locking or sealed gelatin
capsules)
7) Eutectic mixtures: |
| 1 Why are capsule and tablet are in form of filling material in capsules?
2 Why are eutectic mixtures are in form of filling material in capsules? | 1 *employed to separate chemically incompatible agents
or to add premeasured (as tablets) amounts of potent
drug substances
2 mixed with a diluent or absorbent to separate the interacting agents and to absorb any liquefied material
*magnesium carbonate, kaolin, light
magnesium oxide |
| Examples of Fill in hard gelatin capsules | 1 Powder or granulate
2 Pellet mixture
3 Paste
4 Capsule
5 Tablet |
| FILLING HARD CAPSULE SHELLS Methods | 1 The “punch” method
2 The pouring method
3 Hand-operated capsule filling machines
4 Machines for industrial use |
| 1 suitable for filling a small number of capsules in the pharmacy | 1 The “punch” method |
| 1 Punch Method Steps
2 Punch Method for Non potent drugs
3 Punch Method for Potent Drugs | 1
1) placing the powder on paper, glass/ porcelain plate
2) forming the powder mix into a cake
3) punching the empty capsule body into the powder
cake
2 The first filled capsules should be weighed. The other capsules should be weighed periodically.
3 Each capsules should be weighed. |
| Hand filling capsules can done by what method? | Punch Method |
| suitable for filling a small number of capsules in
the pharmacy
suitable for granular material | The pouring method |
| The process of working:
separating the caps from empty capsules → filling the bodies → scraping the excess powder → replacing the caps → sealing the capsules → cleaning the outside of the filled capsules | Machines for industrial use |
| 1 CAPSULE SEALING Steps
2 Make the capsules tamper-evident | 1
1) heat welding
2) Thermally bonding at 40-45℃ with the
help of a melting-point-lowering liquid
wetting agent
3) extemporaneously, by lightly coating the
inner surface of the cap with a warm
gelatin solution
2 seal with a colored band of gelatin |
| CLEANING AND POLISHING CAPSULES
1 Small amount of powder may adhere to the outside of capsules after filling. True or False
2 On a small scale, clean with a __
3 On a large scale, clean with a __ | 1 True
2 clean gauze or cloth.
3 cleaning vacuum |
| are made of gelatin, glycerin (or a polyhydric alcohol such as sorbitol) and water.
Used to hermetically seal and encapsulate
liquids, suspensions, pasty materials, dry
powders and even preformed granules, pellets,
tablets.
oblong, oval or round in shape.
Preservatives
Single colored / two toned | SOFT GELATIN CAPSULES |
| 1 Soft Gelatin Capsules may have preservative to __
2 Preservatives: | 1 retard microbial growth
2 methyl/ propyl paraben |
| 1 The advantages of soft gelatin capsules | 1
1) pharmaceutically elegant
2) easily swallowed by the patient |
| SOFT GELATIN CAPSULES: COMPONENTS | 1) gelatin
2) glycerin or polyhydric alcohol
3) water/moisture
4) preservative and colorant
6) marking and opaquants
8) Flavors may be added and up to 5% sucrose may
be included for its sweetness and to produce a
chewable shell. |
| PREPARATION OF SOFT GELATIN CAPSULES | 1 The plate process
2 The rotary die process (Robert Scherer,1933)
- more efficient and productive
3 The reciprocating die process |
| 1 (using a set of molds)
2 more efficient and productive
3 is similar to the rotary process in that ribbons of
gelatin are formed and used to encapsulate the fill,
but it differs in the actual encapsulating process. | 1 The plate process
2 The rotary die process
3 The reciprocating die process |
| 1 The plate process | 1) placing a warm sheet of gelatin on the
bottom plate of the mold
2) pouring the liquid-containing medications
3) placing the second sheet of gelatin on top
of medication
4) putting the top plate of the mold into place
5) pressing the mold to form, fill, and seal the
capsules simultaneously
6) removing and washing the capsule
Today, this equipment can no longer be
purchased. |
| The rotary die process | 1) Liquid gelatin is formed into two ribbons
2) The two ribbons are brought together bet twin
rotating dies
3) Metered fill material is injected between the ribbons
4) These pockets of fill-containing gelatin are sealed |
| The reciprocating die process | 1) A set of vertical dies continually open and close to
form rows of pockets in the gelatin ribbons.
2) These pockets are filled with the
medication and are sealed, shaped, and cut
out of the film.
3) The capsules fall into refrigerated tanks
which prevent the capsules from adhering to
one another. |
