Pharmaceutical Capsules History and Advantages

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Questions and Answers

Who invented the soft gelatin capsule?

  • Mothes (correct)
  • Stearate
  • Murdock
  • Lauryl

What is the advantage of filling capsules with liquids rather than powders?

  • Improved bioavailability (correct)
  • Reduced cost
  • Easier administration
  • Increased mechanical strength

How is the size of the capsule required for the formulation determined?

  • By the weight of the API
  • By the volume of the capsule
  • By the moisture content of the granules
  • By the tapped bulk density and capsule volume (correct)

What is the purpose of a glidant in a capsule formulation?

<p>To improve the flow of the powder (D)</p> Signup and view all the answers

What is the process of producing pellets?

<p>Extrusion (B)</p> Signup and view all the answers

What is the role of sodium lauryl sulfate in a capsule formulation?

<p>Wetting agent (B)</p> Signup and view all the answers

What is the primary function of a spheroniser in pharmaceutical manufacturing?

<p>To round particles into spheroids of uniform size (C)</p> Signup and view all the answers

Which of the following is an example of a capsule-filled pellet formulation?

<p>Morphine Sulfate (Avinza) (B)</p> Signup and view all the answers

What is the primary purpose of a capsule filling equipment?

<p>To position the capsules the correct way up (A)</p> Signup and view all the answers

What is the main difference between SGCs and HGCs in terms of gelatine formation?

<p>Much of the gelatine is replaced by water initially in SGCs (D)</p> Signup and view all the answers

What is the most widely used method of sealing capsules?

<p>Locking (B)</p> Signup and view all the answers

What is the advantage of SGCs over HGCs and tablets in terms of patient compliance?

<p>SGCs are easier to swallow (C)</p> Signup and view all the answers

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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

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