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Questions and Answers
Which type of softgel is specifically designed to release its contents when chewed?
Which type of softgel is specifically designed to release its contents when chewed?
What is a key advantage of soft gelatin capsules compared to other solid dosage forms?
What is a key advantage of soft gelatin capsules compared to other solid dosage forms?
What disadvantage is associated with using soft gelatin capsules for highly moisture sensitive materials?
What disadvantage is associated with using soft gelatin capsules for highly moisture sensitive materials?
Which characteristic makes meltable softgels suitable for patient-friendly applications?
Which characteristic makes meltable softgels suitable for patient-friendly applications?
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Which type of softgel allows access to the fill material by twisting or snipping off part of the capsule?
Which type of softgel allows access to the fill material by twisting or snipping off part of the capsule?
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Soft gelatin capsules can cause issues when incorporating which of the following materials?
Soft gelatin capsules can cause issues when incorporating which of the following materials?
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Which property of soft gelatin capsules enhances the bioavailability of liquid medications?
Which property of soft gelatin capsules enhances the bioavailability of liquid medications?
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What potential problem arises when using efflorescent materials in soft gelatin capsules?
What potential problem arises when using efflorescent materials in soft gelatin capsules?
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Which of the following is not an advantage of soft gelatin capsules?
Which of the following is not an advantage of soft gelatin capsules?
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What is the primary purpose of using a plasticizer in soft gelatin capsules?
What is the primary purpose of using a plasticizer in soft gelatin capsules?
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Which component is NOT typically found in the capsule shell of soft gelatin capsules?
Which component is NOT typically found in the capsule shell of soft gelatin capsules?
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Why are liquid medications advantageous when formulated into soft gelatin capsules?
Why are liquid medications advantageous when formulated into soft gelatin capsules?
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What role does titanium dioxide play in the formulation of soft gelatin capsules?
What role does titanium dioxide play in the formulation of soft gelatin capsules?
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What is the typical gel strength range for gelatin used in soft gelatin capsules?
What is the typical gel strength range for gelatin used in soft gelatin capsules?
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Why must the color of the capsule shell be darker than that of the encapsulated material?
Why must the color of the capsule shell be darker than that of the encapsulated material?
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What is the maximum allowed percentage of iron in raw gelatin used for soft gelatin capsule production?
What is the maximum allowed percentage of iron in raw gelatin used for soft gelatin capsule production?
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Which of the following is an example of a water-miscible liquid used in soft gelatin capsules?
Which of the following is an example of a water-miscible liquid used in soft gelatin capsules?
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What is the typical ratio of water to dry gelatin in the production of soft gelatin shells?
What is the typical ratio of water to dry gelatin in the production of soft gelatin shells?
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What is the initial step in the manufacture of gelatin mass for soft gelatin capsules?
What is the initial step in the manufacture of gelatin mass for soft gelatin capsules?
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What shape is NOT commonly associated with soft gelatin capsules?
What shape is NOT commonly associated with soft gelatin capsules?
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Which of the following statements about the packaging of soft gelatin capsules is true?
Which of the following statements about the packaging of soft gelatin capsules is true?
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Which of the following materials can NOT be encapsulated in soft gelatin capsules?
Which of the following materials can NOT be encapsulated in soft gelatin capsules?
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In the formulation of softgel fills, what does the term 'preconcentrate' refer to?
In the formulation of softgel fills, what does the term 'preconcentrate' refer to?
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What is a common preservative that may be used in soft gelatin capsules to prevent microbial growth?
What is a common preservative that may be used in soft gelatin capsules to prevent microbial growth?
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What characteristic of the softgel fill matrix allows for encapsulation of solid compounds that are semisolid below approximately 45°C?
What characteristic of the softgel fill matrix allows for encapsulation of solid compounds that are semisolid below approximately 45°C?
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Which type of emulsions have been utilized in recent formulations of softgel fills?
Which type of emulsions have been utilized in recent formulations of softgel fills?
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What is a primary advantage of using soft gelatin capsules over hard capsules?
What is a primary advantage of using soft gelatin capsules over hard capsules?
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What component is NOT typically found in the shell of a soft gelatin capsule?
What component is NOT typically found in the shell of a soft gelatin capsule?
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What therapeutic function is minimized when formulating soft gelatin capsules?
What therapeutic function is minimized when formulating soft gelatin capsules?
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Study Notes
Soft Gelatin Capsules
- Soft gelatin capsules consist of one hermetically-sealed soft shell
- The shell is composed of gelatin, water, and a plasticizer (e.g., glycerin or sorbitol)
- Plasticizers make the gelatin elastic
- Soft gelatin capsules contain more moisture than hard capsules
- Preservatives like methylparaben and/or propylparaben can be added to prevent microbial growth
- Can be coated with enteric-resistant or delayed release material
- Can be transparent, dark, coloured, and flavoured
- Used to encapsulate liquids, suspensions, pasty materials, dry powders, and even preform tablets
- Available in various shapes (oblong, oval, or round)
Formulation of Soft Gelatin Capsules
- Formulated to be the smallest possible capsule size while maintaining a maximum amount of ingredient and physical stability
- Formulated for therapeutic effectiveness and production efficiency
- The name for this dosage form is now changed to soft gel (soft elastic)
Description of Soft Gelatin Capsule Dosage Form
- Softgels consist of liquid or semisolid matrix inside a one-piece outer gelatin shell
- Ingredients solid at room temperature can be encapsulated into softgels, at least semisolid below ~45°C
- The drug can be in solution or suspension in the capsule matrix
- The matrix can be hydrophilic (e.g., polyethylene glycols) or lipophilic (e.g., triglyceride vegetable oils) or a mixture of both
Significant Advances
- Recent advances include microemulsions and nanoemulsions encapsulated as preconcentrates in softgels
- "Preconcentrate" means a combination of lipophilic and hydrophilic liquids and surfactants, that disperse to form, for example, a microemulsion
- In the nanoparticle range, the dispersion is known as a nanoemulsion
Softgel Drug Delivery Systems
- Orally administered softgels containing solutions or suspensions release contents in the stomach for easy swallowing
- Chewable softgels have flavored shells that are chewed to release the drug liquid matrix
- Drug(s) may be present in both the shell and fill matrix
- Suckable softgels have a gelatin shell containing flavored medicament, and a liquid matrix inside capsule for sucking
- Twist-off softgels are designed with a tag to twist or snip for accessing the fill material, useful for unit dosage of topical medicine, inhalations, paediatric products
- Meltable softgels are designed for use as patient-friendly suppositories
Advantages of Soft Gelatin Capsules
- Easy to swallow, tasteless, available in various shapes, colours, and sizes
- Accurate and uniform dosage
- Easy to manufacture, available in small to large sizes
- Portable
- Can mask odors and tastes, and create specialized dosage forms (e.g., chewable, extended release)
- Good product stability (protects drugs against oxidative degradation by lipid vehicles)
- Liquid medications easily encapsulated, increasing bioavailability
- Low melting point drugs can be easily incorporated
- Safer handling of highly potent/cytotoxic drugs
- Better dissolution/disintegration rates compared to solid dosage forms
Disadvantages of Soft Gelatin Capsules
- Water-soluble materials are difficult to incorporate
- Highly moisture-sensitive
- Efflorescent/deliquescent materials can cause softening/leaching or hardening/brittle capsules
- Liquids migrating through shell are unsuitable
- Needs special equipment
Applications of Soft Gelatin Shell Capsules
- Oral dosage forms for humans or animals
- Suppositories for rectal or vaginal use
- Topical, ophthalmic, and ear preparations
- Cosmetic products (breath fresheners, perfumes, bath oils, skin creams, etc.)
Capsule Shell Contents
- Capsule shell mostly composed of gelatin, plasticizer, and water
- Additional ingredients: preservatives, colourings, opacifying agents, flavorings, sugars, and medicaments to achieve desired effects
- Gelatin is obtained from partially hydrolyzing collagen (from animal skin, connective tissue, and bones)
- Gelatin strength is 150-250 g
- Water ratio (w/w) varies from 0.7 to 1.3 (water) to 1.0 (dry gelatin), depending on gelatin viscosity
- Plasticizers (e.g., glycerin, sorbitol) make the soft-gel shell elastic; ratio is 0.3 to 1.8
Colour
- Shell color should be darker than the encapsulating material; can be natural or synthetic
Opacifier
- Usually titanium dioxide; added to create a suspension shell for protecting light-sensitive ingredients
- Concentration of up to 0.5%
Chelating Agents
- Iron is always present in raw gelatin and should not exceed 15%; chelating agents prevent iron reaction with materials/colours.
Vehicles Used with Soft Gelatin Capsules
- Water-miscible liquids: PEG-400, polysorbates (non-ionic surfactants), 5-10% propylene glycol, ethanol, glycerin
- Water-immiscible liquids: vegetable oils, esters, ethers; aliphatic and aromatic chlorinated hydrocarbons
Gelatin Mass Manufacture
- Prepared in a 300-litre stainless steel vessel
- Gelatin powder mixed with water and glycerin, heated and stirred until gelatin mass is formed, decanted into 200 kg vessels
- Colours and flavors can be added during mixing
- Ensures consistency of gelatin mass at constant temperature until next stage
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Description
This quiz explores the features, formulation, and uses of soft gelatin capsules. It covers their composition, moisture content, and design variations. Participants will also learn about the role of plasticizers and preservatives in these dosage forms.
