Rebaz H. Ali, Ph.D....• Gelatin capsule shells may be hard or soft, depending on their...
Transcript of Rebaz H. Ali, Ph.D....• Gelatin capsule shells may be hard or soft, depending on their...
University of Sulaimani School of Pharmacy3rd level
Rebaz H. Ali, Ph.D.
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Outlines
• Introduction
• Raw materials
• Hard gelatin capsules
• Soft gelatin capsule
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Introduction
• The word ‘capsule’ is derived from the Latin capsula, meaning a small box.
• In pharmacy, the word is used to describe an edible package made from gelatin or
other suitable material which is filled with medicines to produce a unit dosage,
mainly for oral use.
• Gelatin capsule shells may be hard or soft, depending on their composition.
• Two-piece capsules are commonly referred to as hard-shell capsules, and one-
piece capsules are often referred to as soft-shell capsules.
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Advantages
• It is a convenient dosage form to the patient.
• Tasteless
• Identification is easy (shape and color)
• Capsules are packaged and shipped by manufacturers at lower cost.
• They are more stable than liquid dosage forms.
• Uses empty hard gelatin capsules for extemporaneous compounding of prescriptions
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Outlines
• Introduction
• Raw materials
• Hard gelatin capsules
• Soft gelatin capsule
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Raw materials
Raw materials
Main material
Gelatin, water, colorant's.
Optional materials
Process aids and preservatives
Plasticizers
Glycerin and sorbitol.
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Gelatin
• Is the major component used for capsules.
• Animal skins and bones are the raw materials used for the manufacture.
Gelatin
Type B
Produce by base hydrolysis
10 times longer
Bovine bones
Type A
Produce by acid hydrolysis
Take about 5-7 days
Mainly porcine skin
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Gelatin
• The properties of gelatin that are most important to capsule manufacturers are the
Bloom strength and viscosity.
• The Bloom strength is a measure of gel rigidity, which defined as the load in
grams required to push a standard plunger 4 mm into the gel.
• A standard gel (6.66% w/ v) and maturing it at 10 °C.
• The gelatin used in hard capsule manufacture is of a higher Bloom strength
(200–250 g)
• For soft capsules (150 g)
• It is readily soluble in biological fluids at body temperature.
4 mm
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Outlines
• Introduction
• Raw materials
• Hard gelatin capsules
• Formulation
• Capsule size
• Filling
• Materials for filling and excipients
• Soft gelatin capsule
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Hard gelatin capsule
• The empty capsule shells are made of gelatin, sugar, and water.
• They can be clear, colorless, and essentially tasteless.
• Titanium dioxide could be added to make the shell opaque.
• Normally, hard gelatin capsules contain 13% to 16% of moisture.
• The standard moisture content for hypromellose capsules is 3% to 6% and
when they lose moisture they do not become brittle.
• Many capsules are packaged along with a small packet of a desiccant material.
• Gelatin capsules are unsuitable for aqueous.
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Formulation cont.
• The Snap-fit construction enables the two halves of the capsule shells to be
positively joined through locking grooves in the shell walls.
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Capsule sizes
• Empty gelatin capsules are manufactured in various lengths, diameters, and
capacities.
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Filling of hard gelatin capsules
• Care in blending is especially important for low-dose drugs.
• Diluent could be added like lactose, MCC or starch.
• To achieve uniform drug distribution, it is advantageous if the density and
particle size of the drug and nondrug components are similar.
• free-flowing powder
• Lubricant and glidant could be use (up to 1%).
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Materials for filling and excipients
Types of material for filling into hard gelatin capsules
Types of excipient used in powder-filled capsules
Dry solids, Powders, Pellets,
Granules, Tablets
Diluents, which give plug-forming properties.
Lubricants, which reduce powder-to-metal
adhesion.
Glidants, which improve powder flow.
Wetting agents, which improve water penetration.
Semi-solids
Thermo-softening mixtures
Pastes
Non-aqueous liquids
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Outlines
• Introduction
• Raw materials
• Hard gelatin capsules
• Soft gelatin capsule
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Soft gelatin capsule
• Soft gelatin capsules are made of gelatin to which glycerin or sorbitol has been
added.
• They are elegant and are easily swallowed and could be oblong, oval, or round.
• Preservative like as methylparaben and/or propylparaben, is used.
• They are used to encapsulate and hermetically seal liquids, suspensions, pasty
materials, dry powders, and tablets.
• They are not suitable for:
• Volatile organic compounds such as alcohols, ketones, acids, amines, and esters.
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Softgels for different drug delivery
Drug solution in hydrophilic matrixDrug solution in hydrophobic matrix
Enteric coated
Suspension Suspension
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Softgels for different drug delivery cont.
Twist-off softgels Meltable softgelsOrally administered softgels Chewable softgels
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Reasons for softgel
Increased rate of absorption
• For poorly water-soluble drugs, ideally the dosage form would present the
drug to the gastrointestinal tract in solution form.
Patient compliance
• Easy to swallow. Absence of poor taste or other sensory problem.
Safety (cytotoxic drugs)
• Avoids dust-handling problems during dosage form manufacture
Oils and low melting point drugs
• Overcomes problems with manufacture as compressed tablet or hard-shell
capsules
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Formulation of softgels
• Gelatin (40%)
• Plasticizer (20-30 %), to make the it elastic and pliable.
• Water (30-40%)
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Thank you