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Chewable softgels are designed to be swallowed without chewing.
Chewable softgels are designed to be swallowed without chewing.
False
Softgels can only be manufactured in one standard size and shape.
Softgels can only be manufactured in one standard size and shape.
False
Meltable softgels can be used as a patient-friendly alternative to traditional suppositories.
Meltable softgels can be used as a patient-friendly alternative to traditional suppositories.
True
Suckable softgels contain a gelatin shell with air inside the capsule.
Suckable softgels contain a gelatin shell with air inside the capsule.
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One of the advantages of soft gelatin capsules is their ability to mask odors and tastes.
One of the advantages of soft gelatin capsules is their ability to mask odors and tastes.
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Highly moisture-sensitive materials can be effectively incorporated into soft gelatin capsules.
Highly moisture-sensitive materials can be effectively incorporated into soft gelatin capsules.
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Dissolution rates of soft gelatin capsules are worse than those of other solid dosage forms.
Dissolution rates of soft gelatin capsules are worse than those of other solid dosage forms.
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Twist-off softgels are intended for easy access to the fill material without needing special tools.
Twist-off softgels are intended for easy access to the fill material without needing special tools.
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Water-soluble materials can be readily incorporated into soft gelatin capsules.
Water-soluble materials can be readily incorporated into soft gelatin capsules.
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Soft gelatin capsules provide poor product stability against oxidative degradation.
Soft gelatin capsules provide poor product stability against oxidative degradation.
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Soft gelatin capsules can encapsulate solid ingredients at room temperature.
Soft gelatin capsules can encapsulate solid ingredients at room temperature.
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Plasticizers in soft gelatin capsules are added to increase the elasticity of the gelatin.
Plasticizers in soft gelatin capsules are added to increase the elasticity of the gelatin.
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Soft gelatin capsules consist of a two-piece exterior that is open on both ends.
Soft gelatin capsules consist of a two-piece exterior that is open on both ends.
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The primary purpose of preservatives in soft gelatin capsules is to enhance their flavor.
The primary purpose of preservatives in soft gelatin capsules is to enhance their flavor.
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Soft gelatin capsules can be colored and flavored if desired.
Soft gelatin capsules can be colored and flavored if desired.
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Soft gelatin capsules are formulated to be the largest possible size for maximum amount of ingredient.
Soft gelatin capsules are formulated to be the largest possible size for maximum amount of ingredient.
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Nanoemulsions in soft gelatin capsules form larger droplets after oral administration.
Nanoemulsions in soft gelatin capsules form larger droplets after oral administration.
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Soft gelatin capsules can only contain liquid or semisolid substances.
Soft gelatin capsules can only contain liquid or semisolid substances.
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Significant advances in softgel formulation have included the development of microemulsions and nanoemulsions.
Significant advances in softgel formulation have included the development of microemulsions and nanoemulsions.
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The term 'preconcentrate' refers to a single type of liquid used in softgel filling.
The term 'preconcentrate' refers to a single type of liquid used in softgel filling.
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Soft gelatin capsules can be used as a suppository dosage form only for rectal use.
Soft gelatin capsules can be used as a suppository dosage form only for rectal use.
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The capsule shell is composed of gelatin, plasticizer, and water with a gel strength of 150-250 gm.
The capsule shell is composed of gelatin, plasticizer, and water with a gel strength of 150-250 gm.
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The ratio of water to dry gelatin in a capsule shell should ideally vary from 1.0 to 1.3.
The ratio of water to dry gelatin in a capsule shell should ideally vary from 1.0 to 1.3.
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Titanium dioxide is commonly used as a color agent in soft gelatin capsules.
Titanium dioxide is commonly used as a color agent in soft gelatin capsules.
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Chelating agents are used in soft gelatin capsules to increase the iron content.
Chelating agents are used in soft gelatin capsules to increase the iron content.
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Glycerin and sorbitol are examples of plasticizers used in making soft gelatin shells.
Glycerin and sorbitol are examples of plasticizers used in making soft gelatin shells.
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The gel for soft gelatin capsules is typically prepared at a temperature below 50 degrees Celsius.
The gel for soft gelatin capsules is typically prepared at a temperature below 50 degrees Celsius.
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The maximum concentration of an opacifier in a capsule shell formulation can reach up to 0.5%.
The maximum concentration of an opacifier in a capsule shell formulation can reach up to 0.5%.
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Water immiscible liquids in soft gelatin capsules include substances like vegetable oils and ethers.
Water immiscible liquids in soft gelatin capsules include substances like vegetable oils and ethers.
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Propyline glycol is used in soft gelatin capsules as a water miscible liquid at a concentration of 10-20%.
Propyline glycol is used in soft gelatin capsules as a water miscible liquid at a concentration of 10-20%.
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Study Notes
Soft Gelatin Capsules
- Soft gelatin capsules are one-piece, hermetically sealed, soft shells
- The shell is made of gelatin, water, and a plasticizer (glycerin or polyhydric alcohol like sorbitol) which makes the gelatin elastic.
- They contain more moisture than hard capsules.
- Preservatives (methylparaben and/or propylparaben) are sometimes added to prevent microbial growth.
- They can be coated with enteric-resistant or delayed-release material.
- Capsules can be transparent, dark, coloured, and/or flavoured.
- They are used to encapsulate liquids, suspensions, pasty materials, dry powders, and even preform tablets.
- Available in various shapes (oblong, oval, round) with and without twist-offs.
- Formulated for the smallest possible size consistent with maximum ingredient amount and physical stability.
- Designed for therapeutic effectiveness and production efficiency. The name has been changed to soft gel (or soft elastic).
- The capsule fill matrix can be hydrophilic (e.g., polyethylene glycols) or lipophilic (e.g., vegetable oils), or a mixture of both.
- Ingredients which are solids at room temperature can be put inside softgels. Those materials are at least semi-solid below 45°C.
- Drugs in softgels can be in solution or suspension in the capsule fill matrix.
- Significant recent advances include microemulsions and nanoemulsions as preconcentrates in softgels.
- The term "preconcentrate" refers to a combination of lipophilic and hydrophilic liquids with surfactants, that disperse into a microemulsion (or a nanoemulsion if the droplets become even tinier.)
Softgel Formulation Types and Advantages
- Orally administered softgels: Contain solutions or suspensions that release contents in the stomach, easy to swallow.
- Chewable softgels: Their shell is flavoured, chewed to release liquid fill matrix.
- Suckable softgels: Gelatin shells containing a flavoured medicament to suck, a liquid matrix or just air.
- Twist-off softgels: Designed with a tag to twist or snip off, allowing access to the fill material. Useful for unit dosing in topical, inhaled, or pediatric products.
- Meltable softgels: Designed for ease of use as suppositories.
Advantages of Soft Gelatin Capsules
- Easy to swallow, with variety of shapes, colors, and sizes.
- Accurate and uniform dosage.
- Easy to manufacture.
- Portable sizes (small to large).
- Can mask odor and taste.
- Specialized dosage forms (chewable, extended release).
- Increased product stability (protective from oxidative degradation)
- Liquid medications can be readily encapsulated, increasing bioavailability
- Easy incorporation of low-melting-point drugs
- Safer handling of highly potent/cytotoxic drugs.
- Faster dissolution/disintegration compared to other solid formulations.
Disadvantages of Soft Gelatin Capsules
- Issues incorporating water-soluble materials.
- Sensitive to moisture.
- Issues with efflorescent or deliquescent materials (these can make capsules either soften or harden.)
- Liquid migration through the capsule shell (materials that dissolve easily in water, such as Alcohols, ketones, acids, amines, and esters).
- Need special equipment for manufacture.
Capsule Shell Components
- Gelatin: Derived from partial hydrolysis of collagen in animal connective tissues and bones. Its strength is 150-250 g.
- Water: Ratio of water to dry gelatin can vary within a range (0.7-1.3 water part relates to 1.0 dry gelatin). Viscosity of the gelatin affects the ratio.
- Plasticizer: Glycerin or sorbitol are a good example, makes soft gelatin capsules more flexible and elastic. Ratio is 0.3 to 1.8 (comparing soft to hard).
Other Components
- Colors: Can be natural or synthetic, to make the capsule shell more attractive and distinguishable.
- Opacifiers (like TiO2): Added to create a more opaque effect and prevent light degradation of light-sensitive ingredients in the fill. Concentrations can match up to 0.5%.
- Chelating agents: Crucial to control undesirable reactions of iron with other ingredients. Raw gelatin often contains iron so it's very important to control the levels of iron below 15%.
Vehicles Used with Soft Gelatin Capsules
- Water-miscible liquids: PEG-400, polysorbates (nonionic surfactants), propylene glycol, ethanol, glycerin.
- Water immiscible liquids: Vegetable oils, esters, ethers and aromatic/aliphatic chlorinated hydrocarbons.
Gelatin Mass Manufacture
- Gelatin powder is mixed with water and glycerin in a large vessel (300L).
- Heated and stirred until it creates a homogenous gelatin mass.
- Molten gelatin mass is decanted into smaller containers (200 kg).
- Colors and flavors can be added during mixing.
- Temperature is kept controlled until next stage of process.
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Description
Explore the fascinating world of soft gelatin capsules, their composition, and unique characteristics. This quiz covers their uses, benefits, and design considerations. Understand their importance in the pharmaceutical industry and how they differ from other forms of capsules.
