capsules Flashcards
Characteristics of Capsules
Solid dosage form
In shell
She’ll prepared from gelatin, starch, or other
Hard or soft capsules
capsules are used in different forms/ways, they are:
Oral
Sprinkle over food
Dry Powder inhalers for inhalation delivery
Partial hydrolysis of collagen from the skin,
connective tissue, and bones of animals
Gelatin, USP
____ is stable in air if dry, but subject to microbial
decomposition when moist or in solution
Gelatin, USP
- Insoluble in cold water, but can absorb up to
10X its weight - Soluble in hot water and gastric fluid
Gelatin, USP
Hard gelatin capsules: basic gelatin formulation consist of —-, —–, —–
Gelatin
Water
Sugar
hard gelatin capsules are a 2 piece design
containing a capsule ____ and shorter cap
body
Manufactured by mechanical dipping of
metal pegs into gelatin mixtures
Hard Gelatin Capsules (HGC)
Advantages of Hard Gel Capsule (HGC)
Rapid dissolution Flexibility in formulation Taste/odor masking Some protection against light/oxygen Common in clinical trials
Disadvantages of Hard gel capsules (HGC)
Cost
Filling equipment is slower than tableting
Issues with powder blending, power fluidity
Hygroscopic/ deliquescent materials
Rapid release of highly soluble salts
Adhesion to esophagus
Not suitable for strict vegetarians
absorbing or attracting moisture from the air.
Hygroscopic
to become liquid by absorbing moisture from the air, as certain salts.
deliquescent
what are the capsule sizes from large to small
000, 00, 0, 1, 2, 3, 4, 5
Tamper Proofing Methods for hard gel capsule
Heat to seal capsule in 1-2 spots
Cracks when pulled apart
3 types of fill for HGC: (3)
dry powders, semisolids, and liquid
Dry powders used for filling HGCs are
powders granules pellets tablets capsules
semisolids used to fill HGCs:
thixotropic mixtures
thermosoftening mix
pastes
Liquids used to fill HGCs:
Oily liquids
Suspensions
Solutions
Fill Material Formulation consist of:
Powders and Granules
Active Filler/diluent Disintegrant Glidant Lubricant Surfactant
Materials Not Suitable for Capsule Formulation (HGC)
Aqueous-based liquids
Deliquescent material
Hygroscopic materials
Why can’t the following be used in hard gel capsule formulation?
- Aqueous-based liquids
- Deliquescent materials
- Hygroscopic materials
BC gelatin already contains some moisture
Gelatin is able to absorb and release moisture
Methods to separate/minimize
chemical incompatibilities
Add more diluent
Add absorbent
Put small capsule of one ingredient inside larger capsules with other excipients
Produces granules from one excipients to minimize physical contact
Gelatin Capsule vs. HPMC Capsules
Gelatin Cap: high moisture content protein derived from animals chemical stability BSE concerns Allergy issues Microbiological pollution
HPMC Cap:
low moisture
cellulose derived from plants
- Suited for Moisture-Sensitive Formulations
- Resistant to Cross-linking (i.e. Aldehydes)
- Accepted for pharmaceutical use in all major global-markets
- TSE certification not required
- Non-animal capsule
- Meets Cultural and Dietary needs
HPMC Capsules
100% Natural
• Made of Water-Soluble Vegetable derived
polysaccaride produced by fermentation
• Odorless, tasteless & biodegradable
• Impermeable to oxygen transmission
• Starch, Preservative & Glutten free
• Non-GMO
Pullulan Capsules
Advantages of Liquids in HGC
In house development and production
Low oxygen permeability
Enhanced bioavailability
Relatively easy to formulate
Disadvantages of liquids in HGC
Physical and chemical stability
- possible leaking, requires sealing/banding
for Leak Proofing, ____ is used around capsule joint
band-sealing
Unique dosage form consisting of a high-gloss gelatin coating that
encases a caplet core.
Press Fit Capsule
Soft Gelatin Capsules (SGC) contain ___ in gelatin
plasticizer
Soft Gelatin Capsules (SGC) shapes:
oblong,
spherical
tube-shaped
elliptical
Applications of SGC are:
Oral
Rectal/vaginal suppositories
Ophthalmic and Topical
Cosmetics
Advantages of SGC
Good uniformity Rapid release Good bioavailability Taste/odor masking Overcome problems associated with tableting Easy to swallow Tamper evident
Disadvantages of SGC
- Specialized equipment required
- More intimate contact of fill with shell (compared to hard gelatin capsules)
- Limited excipient choices
Composition of SGC Shell
Gelatin Plasticizers Preservatives Colorant Residual moisture : 6-10%
Examples of plastisizers (used in SGC shell)
glycerin
propylene glycol
sorbitol
Liquids Used in Soft Gelatin
Capsules
Water immiscible volatile or nonvolatile
Water miscible nonvolatile
Requirements to Fill Materials for a SGC
Ph 2.5 - 7.5
Low water conc. <5%
Ethanol as cosolvent
Drug chemically stable in water… Not water soluble
Do not use: aldehydes and aqueous emulsions
Examples of SGC
Vitamin E
Chloral hydrate
Pro cardio capsules
OTC cough/cold/allergy products
Hard Gelatin vs. Soft Gelatin
Capsules
Shorter disintegration of HGC In house manufacturing (lower costs) Absence of hygroscopic plasticizers Less drug migration into shell Multiple fills
Suited for moisture sensitive formulations
Resistant to cross linking
Non-animal capsule
HPMC capsules
This capsule is 100% natural
Water soluble vegetable derived by fermentation
Impermeable to oxygen transmission
Non-GMO
Pullulan Capsules
