Topic 6: Hard and Soft Gelatin Capsules
Topic 6: Hard and Soft Gelatin Capsules
Topic 6: Hard and Soft Gelatin Capsules
Advantages of Capsules
a. Capsules avoids many unit operations
c. Ease of swallowing
d. Difficult to counterfeit
e. Stability
Disadvantages of Capsules
a. The requirement for specialized manufacturing equipment.
b. Potential stability problems associated with capsules containing liquid fills.
c. Problems regarding the homogeneity of fill weight and content may be associated with capsule formulations.
B. RAW MATERIALS
Similar raw materials have been used in the manufacture of both types of capsule. Traditionally both contains:
1. Gelatin Water is the plasticizer for gelatin capsule
- Is a mixture of proteins that is extracted from animal collagen by either partial acid or partial alkaline hydrolysis.
- A measure of relevance cohesive strength of gelatin film
- Bloom strength: is defined as the weight (in grams) required to push a standard plunger 4 mm into the gel.6/6% w/w
Measure of its rigidity, sturdiness
Typa A: skin 7-10 days Pork skin
Type B: Bones, 10x longer hydrolysis
- Viscosity
Single most important factor controlling shell thickness 100 mcm
SGC -150g
Properties of Gelatin
a. Non-toxic.
b. Soluble in biological fluids at body temperature.
c. It is a good film-forming material.
d. Solutions of high concentration, 40% w/v, are mobile at 50°C.
3. Process Aids
a. Wetting agent
SLS sodium lauryl sulfate .15%
Aids in disintegration
Enhance spreading
b. Preservative
Sulfur dioxide .15%
Not a concern for hard gel cap (13-16% moisture content is low)
CONI SNAP
Locking rings for leak-free closure
High humidity
Softening, deformation
Extreme dryness / low humidity
Brittle, crumble shell
d. Stripping
Removal of shells from the pins
e. Trimming
Cuts excess portions of the shells
f. Joining
Cap + body
g. Sorting
h. Imprinting
Capsule filling
a. Capsule sizes
Sealing of hard gelatin capsules may also be performed using two further methods:
1. Gelatin band sealing
Powder formulation
1. API : dose of the drug and its solubility
2. Fillers : reproducibility of dose, flow, compressibility, dose of medicament and capsule size
: Starch, lactose and MCC
3. Glidants : fluidity of formulation. Cohesion, clumping
: Colloidal silicas, cornstarch, talc, and magnesium stearate.
4. Lubricants : dosing-metal-powder adhesion. Magnesium stearate, calcium stea- rate, and stearic acid
5. Surfactant : wetting of powder mass and enhance drug dissolution
Capsule shell:
a. GELATIN
b. PLASTICIZER
- glycerol, sorbitol and propylene glycol
c. WATER
d. PRESERVATIVE, COLORING, AND OPACIFYING AGENT
c. There is a more intimate contact between the shell and its liquid contents than exists with dry-filled hard gelatin capsules.
b. Chewable softgels
c. Suckable softgels
d. Twist-off softgels
e. Meltable softgels
3. ACCOGEL PROCESS
STERN
2. PLASTICIZER
a. 20-30% less would result to brittle, more-tacky, too flexible
b. GLYCEROL, sorbitol and propylene glycol
3. WATER
a. 30 – 40% of the wet gel formulation
b. 5 – 8%
4. COLORANTS /OPACIFIERS
b. Hydrophilic liquids
High mw peg400
c. Self-emulsifying oils
*nonionic surfactant, poleoxyethylene sorbitan monooleate
e. Suspensions
Evaluation of Capsules
1. PHYSICAL APPEARANCE
2. WEIGHT VARIATION
3. CONTENT UNIFORMITY
4. DISINTEGRATION TEST
5. DISSOLUTION TEST
6. LEAKING TEST for semi-solid and liquid ingredients from soft capsules
ASSIGNMENT
Piroxicam drug has low solubility. For experimental use, HGC (powder weight of 300 mg) of 20 mg dose being made using a blend of
75% lactose anhydrous and 25% MCC and stearic acid (2mg/cap). If the final powder has a tapped density of 0.62g/cm3, select a
capsule size and calculate the amount of each ingredient needed in making a batch of 50 capsules.
Solution:
ACTIVITY