pharmaceutics exam 2 according to exam prep. sheet Flashcards
hard gelatin capsules
what is it made of
what does it consist of
how is it intended to be used?
what part of hard capsules is soluble in water
what part of hard capsules can be digested and absorbed
what happens when Gelatin is dissolved
how are most gelatins colored?
how is gelatin obtained?
what is the difference between gelatin in air vs when moist?
how much moisture do hard capsules contain?
how is the size of hard capsules determined
sizes of capsules
how many pharmacists compound capsules?
how do pharmacists fill hard capsules?
- used to make most capsules
- the capsule is made of:
gelatin, sugar & water - they are clear, colorless and tasteless
what it consists of
- has a long base or body with a small diameter
- cap to slide over the base
intended to be
- swallowed whole
- contents should be opened and administered in food or liquid with the acceptance of a pharmacist
- the gelatin is soluble in hot water & in warm gastric fluids
- gelatin is digested by proteolytic enzymes and absorbed
- When gelatin dissolves it exposes its medicinal contents to the gastric (or intestinal) bodily fluids
- Most are colored with FD&C and D&C dyes and made opaque by adding titanium dioxide.
Gelatin is obtained by the partial hydrolysis of collagen obtained from
- skin,
- white connective tissue, and
- bones of animals
- While stable in air, gelatin is subject to microbial decomposition when moist
- Hard capsules: contain between 13-16% moisture, but poor storage conditions can increase this level. Not good!
- size is determined by how much material will go inside
- sizes: 000 (largest) to 5 (smallest), 8 actual sizes [000,00,0,1,2,3,4 and 5]
- A pharmacist may compound capsules of a single medicinal agent, or combination of agents at the precise dosage prescribed for the patient
pharmacists use the punch method to fill capsules:
- Start with the exact number of capsules to be filled
- Powder to be encapsulated and placed on a sheet of paper, clean glass, or porcelain plate
- Using a spatula powder is formed into a cake
- Empty capsule body is held between the thumb and forefinger and “punched” vertically into the powder cake repeatedly until filled
soft gelatin capsules
how do they look/are they elegant?
what are they prepared to contain? what kind of liquids cannot be in soft capsules?
when should soft capsules not be used?
what preservatives are used to retard microbial growth
- they are pharmaceutically elegant and easily swallowed
Prepared to contain liquid, paste & dry fills
– Liquids that can easily migrate through the capsule shell cannot be encapsulated into soft gelatin capsules– so if the liquid can easily move through the shell, then it cannot be used
When not to be used?:
– When water content is > 5%
– When low molecular weight water-soluble and organic compounds are employed such as
* alcohols, ketones, amines, and esters.
Preservatives such as methylparaben and/or
propylparaben is used to retard microbial growth – these are antifungal
capsule size
how is the size determine
what are the size ranges for humans
how many sizes are there for capsules
how can pharmacists utilize the sizes?
- the size is always determined by the amount of material to be incorporated
- For human use: 000 (the largest) to 5 (the smallest) are commercially available.
- There are 8 actual sizes [000,00,0,1,2,3,4 and 5]
* Numerical designations are arbitrary, and do not indicate the capsule’s capacity - A pharmacist may compound capsules of a single medicinal agent, or combination of agents at the precise dosage prescribed for the patient
preparation & filling
if things are to be added to preparations to facilitate manufacturing, what must be be
what are the two types of ways to fill capsules?
what must you keep in mind when cleaning and polishing capsules?
they must be:
– Harmless (in the quantities used)
– Do not exceed the minimum amounts required to provide their intended effect
– Do not impair the bioavailability of the product
– Do not interfere with assays to evaluate dosage form
method 1 to fill capsule: torbial torsion scale
- Formulation must be weighed directly to the capsule. It wouldn’t be accurate otherwise.
- To compensate for the weight of the empty capsule being filled, the same capsule must be placed on the other side of the balance with a weight equal to the amount to be filled
method 2: punch method
Pharmacists use the “punch” method
– Start with the exact number of capsules to be
filled
– Powder to be encapsulated and placed on a sheet of paper, clean glass, or porcelain plate
– Using a spatula powder is formed into a cake
An empty capsule body is held between the thumb and forefinger and “punched” vertically into the powder cake repeatedly until filled.
when cleaning and polishing capsules:
- Small amounts of powder may adhere to the outside of capsules after filling
cleaning & polishing
- what may adhere on the outside of the capsule
what must you do before packaging and dispensing and how do you do it
for large-scale cleaning, what can remove extraneous materials?
Small amounts of powder may adhere to the outside of capsules after filling
- Must remove before packaging and dispensing, wipe with clean gauze or cloth
- On large-scale cleaning, a vacuum can remove extraneous materials
compendial requirements
Things added to preparations to facilitate their manufacture can only be used if?
– Harmless (in the quantities used)
– Do not exceed the minimum amounts required to provide their intended effect
– Do not impair the bioavailability of the product
– Do not interfere with assays to evaluate dosage form
inspecting, counting, storage, and handling
are capsules or tablets easier to store and transport
inspecting
counting:
handling:
capsules are Easier storage and transport
influences of food on gastric emptying
for light and heavy objects, do they float or sink
- the more food in your stomach, the longer it takes for gastric emptying to occur and for the capsule to be absorbed
light objects float on gastric contents
heavy objects fall to the base of greater curvature
different types of tablets
are tablets all the same size
why are there smooth tablets
C
M
S
F
G
E
B
I
E
V
- Often vary in size,
shape, hardness, thickness, and in their ability to dissolve In fluids. - These tablets are grooved
- Are therefore intended
to be broken into two parts.
- Why? Offers flexibility - Patients can swallow
them easily or use in divided
doses
Compressed tablets (C.T.):
Usually contain the following in addition to medicinal agents
* Diluents or Fillers: Add bulk to prepare a certain size
* Binder or Adhesives: Promote adhesion of the particles
of the formulation
* Disintegrants: Promotes breakup of tablets/drug availability
* Antiadherents/ glidants/ or lubricating agents
* Miscellaneous Adjuncts: Colorants and flavorants to
enhance overall appearance
- Multiple compressed tablets (M.C.T.):
More than a single compression - Produces multiple-layered tablet or a tablet within a tablet
- Each layer may contain diff. medicinal agents. Why? * Separation may be required to avoid chemical and
physical incompatibility - Staged drug release
- General appearance of multiple-layered tablet
- Sugar-coated tablets (S.C.T):
Compressed tablet can be covered with a colored or an uncolored sugar layer
– The coating is water soluble
– The coating is quickly dissolved after swallowing
– The coating protects the enclosed drug from the environment
– The coating enhances the general appearance of tablets and permits imprinting of identifying manufacturer’s info.
– Disadvantages to sugarcoating tablets are,
– the time and expertise required in the coating process,
– the increase in size, weight, and shipping costs. * May be 50% larger and heavier than uncoated tablets - Film-coated tablets (F.C.T.):
These compressed tablets are coated with a thin layer of a polymer capable of forming a skin-like film over the tablet - Usually colored
- More durable, less bulky, and less time-consuming to apply than sugar-coatings.
- Designed to rupture and expose the core tablet at the desired location within the gastrointestinal tract
- Gelatin-coated tablets:
GElCAP,
– Capsule-shaped compressed tablets
– Facilitates swallowing and compared to unsealed capsules, gelatin tablets are more tamper-evident - Enteric-coated tablets (E.C.T.):
Have delayed release characteristics - Designed to pass unchanged through stomach intestines where the tablets disintegrate and allow drug dissolution.
- Mainly used when by-passing
the stomach to improve drug absorption - Buccal or sublingual tablets:
These are flat, oval tablets intended to be dissolved in the buccal pouch, or beneath the tongue through absorption through the oral mucosa
– An alternative for drugs that are poorly absorbed from the G.I. Tract
– Buccal tablets designed to erode slowly
– Sublingual tablets designed to provide rapid release
Buccal: In direction of the cheek Sublingual: Below or beneath the tongue
The dosage form must remain in place - Total area of absorption is low compared to
other routes- 100 to 170 cm2
– Taste must be bland, or not acceptable for use – must also be a non-irritant
– Drug should not discolor or erode teethLining of the epithelium is keratinized for buccal and
sublingual, but the epithelium for sublingual is thinner. - What does this tell us about drug absorption?
chewable:
Have a creamy base usually of specially flavored and colored mannitol
* Rapid disintegration when chewed or allowed to dissolve in mouth
* Ideally suited for children and adults who have difficulty swallowing solid dosage forms.
molded tablets
ablet triturates (TT) may be prepared by compression and by molding.
* In terms of appearance very soft and soluble
* Diluent: Lactose and Sucrose usually
* Designed for rapid dissolution
* Pharmacists may insert TT inside a capsule or
dissolved in liquids to provide accurate amounts
of potent drugs.
Instant Disintegrating/ Dissolving tablets * Extended Release Tablets (E.R.)
- Vaginal Tablets:
Also called vaginal inserts - Uncoated and bullet or ovoid shaped tablets * Inserted in vagina for localized effects
– Antibacterials for the treatment of Vaginitis caused by Hemophilus vaginalis or
– Antifungal for treatment of vulvo vaginitis candidiasis caused by Candida albicans and related species
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quality standards
dissolution
which tablet is designed for rapid dissolution
molded tablet (M: T)
* Designed for rapid dissolution
wet granulation
packaging and storage
dry granulation
lozenges
