12 Questions
Who invented the soft gelatin capsule?
Mothes
What is the advantage of filling capsules with liquids rather than powders?
Improved bioavailability
How is the size of the capsule required for the formulation determined?
By the tapped bulk density and capsule volume
What is the purpose of a glidant in a capsule formulation?
To improve the flow of the powder
What is the process of producing pellets?
Extrusion
What is the role of sodium lauryl sulfate in a capsule formulation?
Wetting agent
What is the primary function of a spheroniser in pharmaceutical manufacturing?
To round particles into spheroids of uniform size
Which of the following is an example of a capsule-filled pellet formulation?
Morphine Sulfate (Avinza)
What is the primary purpose of a capsule filling equipment?
To position the capsules the correct way up
What is the main difference between SGCs and HGCs in terms of gelatine formation?
Much of the gelatine is replaced by water initially in SGCs
What is the most widely used method of sealing capsules?
Locking
What is the advantage of SGCs over HGCs and tablets in terms of patient compliance?
SGCs are easier to swallow
Study Notes
Invention and History
- The soft gelatin capsule was invented by Mothes, a French pharmacist, in 1833.
- Murdock patented the two-piece hard gelatin capsule in 1848.
Capsule Characteristics
- Capsules are solid dosage forms that contain a drug substance enclosed in a hard or soft, soluble container or shell of gelatin or other suitable material.
- Gelatin capsules are available as hard (HGC) and soft (SGC) capsules.
Advantages of HGC and SGC
- Improve patient compliance
- Enhance attractiveness (psychological advantages)
- Easy to administer, as the capsules become slippery when moist
- Mechanically strong but flexible
- Bioavailability may be further increased by filling capsules with liquids rather than powders
Hard Gelatin Capsules (HGC)
- Available in 8 sizes, ranging from 5 to 000, with larger ones available for veterinary products
- Capsule size required for formulation is determined by Caps Fill Wt = tapped bulk density X caps vol
Filling Materials
- Typical formulation consists of:
- API
- Diluent (Maize starch and lactose)
- Wetting agent (sodium lauryl sulfate)
- Glidant (talc or fumed silicon dioxide)
- Lubricant (magnesium stearate)
Pellet Production Process
- Extrusion: wet mass through a metal screen to produce rod-shaped particles of uniform diameter
- Spheronization: to form extrudate into spheroids of uniform size
- Spheroniser: a bowl with fixed sides and a rotating bottom plate (or disc) to round particles
Examples of Capsule Formulations
- Capsules filled with coated granules: Venlafaxine HCL (Extended Release)
- Capsules filled with pellets: Morphine Sulfate (Extended-release product)
- Capsules filled with powders: Celecoxib (Celebrex) NSAID
Capsule Filling Equipment
- 4 types of equipment with different principles, all allowing:
- Positioning of capsules
- Separation of 2 halves
- Filling with formulation
- Refitting and locking of 2 halves
Sealing Methods
- Spot Welding: hot probe used to weld 2 halves of capsule shell together
- Banding: a band of molten gelatin forms round the joint between the 2 halves
- Locking: most widely used method
Soft Gelatin Capsules (SGC)
- More appealing dosage form than HGCs or tablets, with greater bioavailability
- May reduce dose required and size of capsule required, increasing patient compliance
- Produced using special types of encapsulation machines for lipophilic liquids, such as:
- Globlex method
- Rotary die method
Learn about the invention and evolution of capsules, including their advantages and types. Discover the history of hard and soft gelatin capsules and their benefits in pharmaceuticals.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
