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DDS III Big Quiz 1 > Capsules > Flashcards

Capsules Flashcards

1
Q

Capsule

A

Solid dosage form in which the drug is enclosed within either hard of soft soluble shell

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2
Q

Advantages of Capsules

A 
Mask bitter and unpleasant taste
Increased bioavailability 
Easy to formulate
Protection to drug
Easy to swall and admin
Suitable for delivering liquids, semisolids, and solid drugs
Extemporaneous compound is easy
Adjustable to individual dosages
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3
Q

Disadvantages of Capsules

A

Cannot be dispensed
Not suitable for highly soluble salts –> irritate the stomach
Not suitable for highly efflorescent (soften) or deliquescent (brittle) materials
Not suitable for children
Shell quality
Capsule filling is slower than tablet press

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4
Q

Gelatin capsule

A

Glycine and alanine + other a.a.
Hydrolysis of collagen
- Combo of type A and B is the best

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5
Q

Type A Gelatin

A

Produced by acid hydrolysis and is mainly manufactured from pork skin
- Plasticity and clarity

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6
Q

Type B Gelatin

A

Produced by alkaline hydrolysis and is obtained from animal bones
- Firmness

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7
Q

Colorants

A

Soluble synthetic dyes and insoluble pigments

- Product ID and patient compliance

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8
Q

Opaquing agents

A

Titanium dioxide

Provide protection against light

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9
Q

Preservatives

A

Parabens are used

- Water controlls viscosity

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10
Q

Steps to make a hard gelatin capsule shell

A

Step 1/2: Mix gelatin and water in melting system and transfer to feed tanks
Step 3: Dyes, opacifiers and water are added
Step 4: Gelatin is fed in dipper sections and capsules are molded onto pin bars dipping
Step 5: Pin bars then rise to the upper deck allowing setting
Step 6: Pin bars are passed through a drying system
Step 7: Monitor humidity, temp and gelatin viscosity
Step 8/9: Capsule halves are stripped from the pin
Step 10: Trimmed
Step 11: Bodies are joined
Step 12/13: Packed and monitored
Step 14/15: Visual inspection and imprinted; ready to be sterilized

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11
Q

Successful filling requires?

A

Lubricity
Compactibility
Flowability

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12
Q

Fillers

A

Increase the bulk of the formulation

- Starch, lactose, dicalcium phosphate

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13
Q

Glidants

A

Improve flowability
Coat powder particles
Fill surface irregularities and reduce the roughness, reduce attractive forces
Modify electrostatic charges
Act as moisture scavengers
Serve as ball bearing between host
- Colloidal silicas, talc, magnesium stearate

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14
Q

Lubricants

A

Help ejects pluds
Reduce filming on pistons and adhesion of powders to metal surfaces
Reduce friction
Increase hydrophobic lubes, retard drug release
- Magnesium stearate, stearic acid

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15
Q

Surfactants

A

Increase the wetting of powder mass and enhance dissolution

- Sodium lauryl sulfate, sodium docusate

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16
Q

Hydrophilization

A

Hydrophilic polymers increase the wettability of poorly soluble drugs
- Metylcellulose, hydroxymethyl cellulose

17
Q

Capsule filing process

A 
Blending ingredients (excipents and active)
Loading of capsules (body end downwards)
Separation of caps and body (vacuum separation)
18
Q

Automated filling process

A

Dosing of fill material (fill, replace the cap and eject)

Cleaning and polishing (remove powders adhere to shell)

19
Q

Quality assurance

A

Uniformity of mass and content
- Check for homogeneity in weights and chemical analysis for uniformity
Disintegration (will it break apart in a reasonable time)
Dissolution testing

20
Q

Dissolution testing

A

Measure the rate at which drug is released from the capsule

21
Q

Capsule from manufacturer to pharmacist?

A 
Raw material/capsule shelf
Storage
Quality control
Weighing
Mixing
Packing
Quality control
Polishing
FIlling
Quality control
Finished capsules
Quality control
Storage
Delivery
Pharmacist
22
Q

Liquid filled hard gelatin capsules

A

Must not dissolve or alter the shell
Thixotropic formulation, thermal-Setting/thermosoftened
Mixed thermal-thixotropic system

23
Q

Thixotropic formulation

A

Shear thinning –> pumpable
Agitation stops, system rapidly reestablishes a gel structure –> avoid leakage
Liquid excipents and gell forming agent

24
Q

Thermal-setting/Thermosoftened formulation

A

Excipients used are liquid at filling temp but gel or solidifiy in the capsule
Contains PEG or poloxamer

25
Q

Mixed-thermal-Thixotropic systems

A

Improved resistance to leakage

26
Q

Sealing of liquid filled hard gelatin capsules

A

Sealed by coating the gap between the cap and body with a layer of gelatin called banding

27
Q

Soft gelatin capsules

A

Single unit dosage forms that contain liquid or semisolid fill enveloped by a one pience hermitically sealed elastic outer layer

28
Q

Composition of soft gelatin capsules

A

Gelatin
Plasticizers (glycern, sorbitol, propylene glycol)
Ratio of plasticizers to gelatin determine hardness
+ dyes, opacifiers, preservatives

29
Q

Filling composition?

A

Lipophilic solutions, suspensions, low melting point drugs (vit A, D, E)
PEG
Self emulsifying systems
Micro-emulsions

30
Q

Advantages of soft gelatin capsules

A 
Higher degree of content uniformity
Easier
Enhanced bioavailability
Hermitically sealed
Wide variety
31
Q

Disadvantages of soft gelatin capsules

A

More likely to interact with gelatin
Proteolytic activity disrupt the shell
Oily vehicles migrate to the shell

32
Q

Rotary Die Process

A

Shell material is converted into the liquid state in jacketed tanks
Spreader boxes are fed with shell forming material from tank
Shell ribbons are formed by a rotating casting drum
Ribbons are then guided over counter rotating rolls containing sharp-edged dies
Each die cavity has the size and shape of half of the capsule to be formed
While passing through the rolls, the two ribbons form a sack like structure
Sacks are filled with drug materials
As the shell ribbon pass between the die rolls, the capsules will be fully sealed

33
Q

Defects for filled hard gelatin capsules

A 
Presence of cracks, pinholes
Uniformity
Capsule is empty
Surface spot and contamination 
Free from particulate substances
Undesirable odor 
Void space of the container should be filled
34
Q

Minor defects filled hard gelatin capsules

A

Presence of pits and dents
Surface of the capsules are not smooth
Presence of particulate substance on the surface
Presence of spots or blemishes

DDS III Big Quiz 1 (4 decks)

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