Soft Gelatin Capsules Quiz

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What method is primarily used to fill soft gelatin capsules?

Pressure filling

Vacuum filling

Gravity filling

Volumetric pumps (correct)

Which of the following is NOT a challenge in the liquid filling of capsules?

Choosing appropriate filling materials

Maintaining capsule mechanical strength

Adjusting dosage size (correct)

Preventing leakage

What is a significant feature of soft gelatin capsules that enhances their flexibility?

High molecular weight alcohols

The use of water

Addition of a plasticiser (correct)

Gelling agents

What is the first step in the sealing process of a capsule?

Spraying a sealing solution Signup and view all the answers

Which materials are avoided in the formulation of soft gelatin capsules to maintain mechanical integrity?

Materials that undermine capsule strength Signup and view all the answers

What is the purpose of blowing warm air during the sealing process of a capsule?

To complete melting and fusion Signup and view all the answers

Which type of liquid is typically avoided in the filling of soft gelatin capsules due to instability issues?

Water Signup and view all the answers

What is a characteristic feature of the sealing mechanism in capsules?

An increased number of dimples Signup and view all the answers

What is the primary role of the tamping fingers in the capsule filling process?

To compress powder plugs before indexing to the next position Signup and view all the answers

Which property is NOT essential for a formulation used in high-speed capsule production?

Ability to provide a pleasant taste Signup and view all the answers

What type of agents is used to enhance powder flow during capsule filling?

Gildants Signup and view all the answers

In the context of capsule manufacturing, what is the role of wetting agents?

Enhance water penetration of the powder mass Signup and view all the answers

Which challenge is typically encountered in the process of liquid filling of capsules?

Controlling the volume of liquid accurately Signup and view all the answers

What is a distinguishing feature of hard gelatin capsules compared to soft gelatin capsules?

Hard gelatin capsules consist of a cap and a body. Signup and view all the answers

Which of the following properties of gelatin makes it suitable for capsule manufacturing?

Solubility in biological fluids. Signup and view all the answers

What is an important factor to consider when filling soft gelatin capsules with liquids?

Non-aqueous liquids are acceptable in soft capsules. Signup and view all the answers

What technique is commonly used to seal hard gelatin capsules?

Mechanical crimping or banding. Signup and view all the answers

Which challenge is commonly associated with the liquid filling of capsules?

Potential for formation of air bubbles during the filling process. Signup and view all the answers

Which of the following does NOT represent an advantage of using pharmaceutical capsules?

Greater production speed compared to tablet presses. Signup and view all the answers

What role do lubricants play in capsule formulation?

They help facilitate the filling process. Signup and view all the answers

Which factor is important to ensure effective delivery when swallowing capsules?

Capsules should be taken with at least 100 ml of water. Signup and view all the answers

Study Notes

Capsule Filling

Capsule types: hard (two-piece), soft (one-piece)
Capsules are an advancement over unit dose powders, convenient for patients
Main component of capsule shell is gelatin, derived from animal collagen
Has excellent physicochemical and biological properties, including non-toxicity and good mechanical properties
Gelatin is soluble in biological fluids at body temperature
HPMC (hydroxypropylmethylcellulose) is a vegan alternative to gelatin
Capsules can be filled with powders, tablets, pellets, semi-solids, and liquids (non-aqueous)

Advantages of Capsules

More stable than liquid forms
Accurate dosing
Easy administration
Ability to mask unpleasant tastes
Controllable release characteristics
Easy to make light-resistant
Small particle size of the drug
Acceptable to patients

Disadvantages of Capsules

May be difficult to swallow
Unsuitable for very young children
Potential problems with use of animal gelatin

Pharmaceutical Capsule Advantages

Advantages of oral drug delivery
Convenient for oral administration of drugs with unpleasant odors or tastes
Better bioavailability compared to tablets
Easier to formulate compared to tablets
Protects the drug from air and moisture
Possibility of dispensing the exact dose for individual patients
Controlled-release capability
Easy product identification

Disadvantages of Pharmaceutical Capsules

Automatic capsule filling machines output is only about one-fifth that of high-speed tablet presses
Rapid drug release (especially for highly soluble salts) may cause gastric irritation, high local concentration
Potential for esophageal adhesion, requires standing for 90 seconds before swallowing with at least 100ml of water

Pharmaceutical Capsules

Two types: hard gelatin (two-piece), soft gelatin (one-piece) (softgels)

Hard Capsules

Consist of two halves ("cap" and "body") available in various sizes
Filled into the body then the cap is pushed on, with the cap overlapping the body
Capsule sealing may be performed
Different formulations for capsules: Gelatin, colourants, wetting agents, and lubricants
Components of capsule fill:
Diluents (e.g., lactose, maize starch, microcrystalline cellulose)
Lubricants (e.g., magnesium stearate)
Glidants (e.g., colloidal silicon dioxide) to reduce inter-particulate friction and aid powder flow
Disintegrants (e.g., maize starch, microcrystalline cellulose, sodium starch glycolate)
Surface-active agents
Viscosity modifiers
Stabilizers
Antioxidants

Hard Capsule Formulation Factors

Homogeneity of mix
Powder flowability
Powder packing properties (density)
Powder compatibility and compatibility with the capsule
Liquid/semi-solid fills (contains dissolved or dispersed drug):
Lipophilic oils: vegetable oils (e.g., sunflower, arachis), or fatty acid esters
Water-miscible liquids (e.g., PEGs, liquid Pluronics)
Impact on capsule stability
Equilibrium moisture content of 13-16% for optimal mechanical properties
Hygroscopic solvents destabilize capsule shell

Example Hard Capsule - Prozac 20mg

Contains 20mg of fluoxetine (as fluoxetine hydrochloride)
Green and yellow capsule, printed "Lilly 3105"
Contains maize starch (flowable), dimethicone, patent blue V, yellow iron oxide, titanium dioxide, gelatin

Hard Capsule Shell

Traditionally made from gelatin (animal origin)
Transitioning to non-animal source materials (e.g., HPMC)
Colourants (e.g., titanium dioxide)
Preservatives (e.g., sulphur dioxide or benzoic acid)
Water content (13-16%), dependent on storage conditions
Plasticizers
Other markings (company logo, symbol, banding, number code)

Gelatin

Non-toxic
Readily soluble in biological fluids at body temperature; not pH-dependent
Good film-forming material, resulting in a strong film
High concentrations (40% w/v) are mobile at 50°C, suitable for processing
Prepared by hydrolyzing collagen from animal skin and bones
Gelatin solutions can reversibly change between gel and sol states
Graded based on Bloom strength (measure of gel rigidity), and viscosity
Alternatives to gelatin (due to BSE scare) are HPMC

Hypromellose

Methyl and hydroxypropyl mixed ether of cellulose
Semi-synthetic, inert, viscoelastic
Plant-based polymer
Exhibits thermal gelation in aqueous solutions, solidifying above a critical temperature
Properties controlled by concentration of methoxy group and substitution pattern
Viscosity is related to the methoxy group
Use as a capsule shell material, coating agent, dispersing agent, emulsifying agent, film-forming agent, modified-release agent, solubilizing agent, suspending agent, tablet binder, and viscosity booster

Hypromellose (continued)

Wide range of functions (capsule shell material, coating agent, dispersing agent, emulsifying agent, film-forming agent, etc.)
Application depends on grade, chain length and concentration

Types of Fill for Hard Capsules

Dry solids: powders, pellets, granules, tablets
Semisolids: thermosoftening mixtures, thixotropic mixtures, pastes
Liquids: non-aqueous liquids

Commercial Liquids/Semi-solids in Hard Gelatin Capsules (examples):

Brand names/generic names and companies

Limitations in Filling Materials

Materials used for filling capsules must not react with gelatin or the shell materials
Must not contain high levels of free moisture (results in shell softening).
Fill volume cannot exceed available capsule size
Fill temperature should not affect the capsule shell

Industrial-Scale Filling Hard Capsules (methods)

Dependent: uses the body to measure the filling powder; uniformity of fill weight depends on completely filling the cap
Independent: measures powder separately from the body; independent of body filling completion

Types of Industrial-Scale Capsule Filling Methods (examples)

Bench scale (e.g., Feton)
Auger filling
Dosator filling
Tamping finger filling
Non-powder (semi-solid and liquid) filling

Steps in Capsule Filling

Feeding - capsules are introduced and oriented
Opening - capsule bodies are separated from caps using suction
Dosing - capsules are filled with materials using appropriate methods
Closing - caps are placed on filled bodies
Discharge - capsules are removed from the filling machine

Auger Filling Machine

Empty capsules are fed into a pair of ring holders.
Holds the cap and body pieces separately.
Powder hopper pulls over the top; revolving auger forces materials down to the body.

Dosator-Type Machine

Dosing tube with a movable piston; varying-volume chamber in the bottom
Powder is pushed into the capsule body as the piston lowers and pushes out the plug of material

Tamping Finger Principle

Dosing disc with several sets of holes.
Steel rods compress the material to form a plug inside the holes; rotates.
Placement of material via tamping fingers.

Excipients in Powder-Filled Capsules

Crucial for reliable capsule production
Diluents promote plug formation
Lubricants reduce metal-powder adhesion
Glidants enhance powder flow
Wetting agents promote water penetration
Disintegrant aids in the disruption of the powder mass

Non-powder Fills

Pellets
Tablets (placed in hoppers, allowed to fall through tubes, transferred mechanically into capsules)
Liquids (filled using volumetric pumps; similar to formulas for softgels)

Semisolid & Liquid Filling

Preventing leakage from capsules
Using sealing solutions (spraying between the cap and body)
Raising the melting point of gelatin in sealing areas
Increasing the number of dimples
Using a tighter fit between capsule body and cap
Using banding
Stage 1: Sealing solution is sprayed in between the cap and body, lowering the melting point of gelatin
Stage 2: Warm air is blown across the sealing area, to complete melting and fusion.
Stage 3: Gelatin hardens and seals

Soft Capsules

Flexible capsules (spherical, ovoid, or cylindrical)
Mechanical properties are manipulated by adding plasticisers (e.g., glycerol, sorbitol)
Usually manufactured, filled, and sealed in one operation

Fill Materials for Soft Capsules

Lipophilic liquids (vegetable oils, fatty acid esters)
Self-emulsifying systems (contain non-ionic emulsifiers, etc.)
Water-miscible liquids (high-molecular-weight alcohols, PEG 400, non-ionic surfactants)

Excipients for Soft Capsules

Viscosity modifiers
Surfactants
Colors
Co-solvents

Softgel Capsules (types)

Orally administered softgels
Chewable softgels
Suckable softgels
Twist-off softgels
Meltable softgels

Softgel Shell Formulation

Different softgel formulations based on liquid fill matrix
Plasticizer (e.g., glycerol, sorbitol, propylene glycol) to make the shell elastic and pliable (20-30% of wet gel formulation).
Concentration and type affects dissolution and disintegration.
Water content: 30-40% of wet gel (controlled drying); equilibrium: 5-8%

Vegicaps

Innovative solution for encapsulation challenges
Uses a plant-derived shell instead of gelatin.
Fill temperatures are considerably higher than conventional softgels.

Softgels - Fill Matrix, Choice of Excipients

Capacity to dissolve or suspend the drug
Rate of dispersion in the GI tract after shell rupture and release
Ability to retain the drug in the GI fluid, especially for hydrophobic drugs
Compatibility with the softgel shell
Optimizing the rate, extent, and consistency of drug absorption

Softgels - Fill Matrix, Choice of Excipients (lipophilic liquids/oils)

Drug can be suspended in oils
Examples include triglycerides

Softgels - Fill Matrix, Choice of Excipients (hydrophilic liquids)

Polar liquids (e.g., PEG 400) can be used to dissolve or suspend the drug in the capsule
Can interact to varying degrees with the shell of the capsule

Softgel Manufacturing

Rotary die press
Continuous formation of a heat-sealed ribbon
Fill of liquid into capsules
Gelatin is dissolved in water (around 80°C)
Plasticizer, colorants, opacifiers, and flavors are added.
Process yields two ribbon components
Gel ribbon and liquid fill matrix are combined.

Softgel Manufacture (continued)

Three parameters need to be controlled:
Temperature (controls capsule seal formation)
Timing (controls dosing liquid into the proper portion of the softgel during forming).
Pressure (controls softgel shape and final cut)

Dosing and Drying

Accurately metered volume of liquid fill matrix is injected between the gelatin ribbons as they pass through die rolls.
Using a wedge-shaped system, with the system being heated to approximately 40 degrees Ceilcius.
Ribbon injection of the liquid between the gel to force expansion.
Gel ribbon proceeds via heated wedge system and is pressed between die rollers.
Two softgel capsule halves are sealed together via heat and pressure.
Capsule halves are detached from ribbon by rims surrounding the rollers.
Capsules passed through tumble dryer.
Drying using air.

Capsules - Quality Control

Content of active ingredient (90-110)%
Uniformity of content (2.9.6)
Uniformity of weight of capsule contents (2.9.5)
Disintegration Test (2.9.1)
Dissolution Test (2.9.3)

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

Test your knowledge on the various aspects of soft gelatin capsules, including their filling methods, challenges, and sealing processes. This quiz covers key materials and characteristics that define these capsules, making it perfect for students of pharmacology or pharmacy practices.