Capsules Flashcards
Define a solid dosage form
a drug substance is enclosed in either a hard or soft shell or container generally prepared from a suitable form of gelatin
What is the advantages of capsules?
mask the unpleasant taste, aroma or appearance of a drug
powder can be dispensed in an uncompressed form, allowing quicker dissolution and absorption of the drug
What a disadvantages of capsules?
they are easily tampered with
are subject to the effects of relative humidity
gelatin is relatively stable in air when dry, however, is subject to microbial decomposition when exposed to moisture
are difficult to swallow for some individuals
What is the composition of HGC shells
gelatin
plasticizer
colorant
water - 12 to 16 %
What is gelatin?
obtained by the hydrolysis of collagen
Types of Gelatin
Type A
Type B
What is type A gelatin?
pork skin gelatin
derived mainly from pork skins by acid hydrolysis
contributes plasticity and clarity
What is type B gelatin?
derived mainly from bones and animal skins by alkaline processing
contributes firmness
What is Plasticizer
used to reduce the rigidity of gelatin and to make it more pliable
What is the most common plasticizer?
glycerin
Hard Gelatin
if no or very little plasticizer is added, gelatin will be more brittle
Soft Gelatin
used primarily for liquids but recently employed for solids and solids dispersed in oil
Colorant
The coloring agent
functions of coloring agents
esthetic effects
identification
light protection
What is esthetic effects
marks variation in color of contents, raises confidence of users
The purpose of coloring for identification
color is the simplest and best method for quick identiifction
the purpose of coloring - identification
color is the simplest and best method for quick identification
Purpose of coloring in light protection
color reflects both the amount and wavelength of light passing through the gelatin layer
Composition of HGC shells (high humidity)
additional moisture is absorbed by the capsule
often packaged with a desiccant as a precaution against absorbing atmospheric moisture
Composition of HGC shells (low humidity)
some of the capsules moisture may be lost
may become brittle and crumble when handled
T or F
Light sensitive drugs can not be used in capsules
False - we can protect with color/opaquence of the drug
T or F
liquid drugs can not be used in capsules
False - we can in soft
T or F
major component of capsule shell are protein constituents
True - high % gelatin
T or F
capsules are easier to swallow compared to tablets
True - not as bitter, can control size, soft gels
Body of a shell
larger portion which is filled with medication
Cap of a shell
small portion which covers or slips over the body
Size of HGC
shells are produced in standard sizes
eight standard sizes are generally ised in human drug therapy
000-5
Most common capsule size
0-4
Shape of HGC
the basic shape is oblong
variations depend on the manufacturer
Closure of HGC
to prevent separation of the cap from the body
to provide evidence of tmapering
Methods used to assure that capsules do not come apart
spot welded
banded
locking device
What spot welded capsules means?
by means of a heated metal pin pressed against the cap, fusing it to the body
What banded capsules means?
colored molten gelatin is laid around the joint between the 2 capsules parts in a strip and dried
What locking device means?
a pair of matched locking rings are formed in the cap and body portions of the capsule and engaged after filling
What is the most common capsule diluents?
lactose
microcrystalline cellulose
starch
Formulation of filling of hard gelatin capsules
diluent
disintegrants
lubricant and glidant
wetting agents
Function of diluent
to increase bulk for the dosage form, act as a vehicle and improve content uniformity
Function of disintegrants
serve assist in the break off the powder
mass/granules and help in distributing the drug throughout the stomach
Examples of disintegrants
pre-gelanized starch
croscarmellose
sodium starch glycolate
The purpose of lubricant and glidant
improve fluidity and flow of powders
decreases sticking of powders to metal surfaces
reduces friction on surfaces in contact with powder
Examples of lubricant and glidant
calcium stearate
polyethylene glycol
talc
Purpose of Wetting agents
surface active agent are often added to facilitate the wetting of the drug substance by the GI fluids thus enhancing dissolution
Examples of wetting agents
alcohol
water
Advantages of HGC
potential for rapid drug release
elegant, ide range of colors and possible opacity
often preferred by patients because their smooth, slippery, tasteless shell is easily swallowed
ease of use and portability
Disadvantages of HGC
limited number of shell suppliers
generally more costly to produce than tablets
not to be used for extremely soluble drugs
What are soft gelatin capsules?
a continuous, soft, globular gelatin shell which surrounds a liquid fill material
Composition
Gelatin
plasticizer
colorant
water
preservative
What is the purpose of plasticizer?
added to render gelatin soft or plastic like
Examples of plasticizer
glycerol
sorbitol
propylene glycol
What is the purpose of preservation?
added due to the high water-content which makes them more susceptible to microbial growth
Examples of preservative
methylparaben
propylparaben
sorbic acid
What types of size and shapes do SGC?
varies considerably
maybe round, oval, oblong tubes, etc.
What should the pH of a SGC?
liquid 2.5-7.5
If the SGC is too acidic
add hydrolyse gelatin
If the SGC is too basic
decrease gelatin solubility
Examples of SGC fill materials
pure liquid drugs
vegetable oils
mineral oils
water miscible liquids
some solids
Why is liquid filling soft gelatin capsules concerned the most accurate?
filled as a liquid homogeneous
filled volumetrically with a syringe like apparatus
SGC Advantages
permits liquid drugs to become easily portable
adaptable
pt. preference
accurate dosage form as volumetrically filling
can be made opaque to prevent light penetration
bioavailability
product security
What bioavailability advantages does SGC have?
have faster dissolution rate than other solid dosage forms, including HGCs
What is the advantage of SGC for product security
nearly impossible because of complete sealing or tampering easy to identify
What are some hints for pt who have difficulty swallowing capsules?
try placing the capsule on the back of tongue before drinking
place the capsule in warm water for a few seconds prior to taking –> makes it slide over more easily
Tips for dispensing Capsules
when dispensing SGCs, no cotton should be used in the vial. It is generally accepted to use with HGCs
SGCs tend to adhere to one another –> store in a cool, dry place
Selecting a capsule size
the size selected for use is determined by the amount of material to be encapsulated
capacity will vary depending on the density of the powdered drug material
The Rule of Sixes
Based on experimental observation that the bulk densities of many powders average about 0.6 mg/ml
Preparing the capsule formulation
if the dose is large enough, a capsule can be filled with just the drug
to fill more adding bulk
Examples of Bulking
lactose
microcrystalline cellulose
starch
What is done to manage powders fluffiness?
a few drops of alcohol, water or mineral oil
Methods for extemporaneously filling HGCs
some powder will be lost during filling
powder blending and sizing
two methods of filling hard gelatin capsule shells
List two methods of filling hard gelatin capsule shells
punch method
hand operated machines
How do you account for lost powder?
use 10% extra powder
or 2 extra capsules
What is the punch method used for?
used to fill a relatively small number of capsules
How use the punch method?
place the powder on an ointment slab
to prevent hand contact with powder
place the exact number of empty capsules on the powder paper
separate the capsule bodies and caps
repeatedly push or “punch” the open end into the powder until the capsule is filled
replace the cap on the body
weight each filled capsule, add or remove power until the correct weight
What is a Hand operated machines
also called plate process
special equipment capable of filling 30-300 capsules per cycle
used in large pharmacies, hospitals and development laboratories
What is the finishing procedure for punching method?
sealing
- use locking capsules
or
-wet the outer edge of the body with moist towel
cleaning
- rolling the capsule between the folds of a towel
What are the drug content uniformity tests?
Weight variation
physical stability tests
packaging
Explain weight variation
test performed by weight determination
assesses uniformity of content without actually assaying each dosage unit
normal within the range to 85% to 115%
Explain for physical stability tests
observe the capsules on a weekly basis for signs of discoloration
record a description of the changes in appearance on a form, for future reference
packaging
capsule vials
different sizes
children resistant or non child resistant
