LIQUID PREPARATIONS PART II Flashcards
All raw materials should conform to well thought out
specification. These specifications should assure
_______, _________, _________ and freedom from excessive
microbial contamination
identity, purity, uniformity
Although purified water (USP) is required in all
operations, it is particularly important in liquid
manufacturing, if __________ and other water treatment equipment is used, special attention must be given to
________ and ____________
deionized; routine microbiological and chemical testing
Storage tanks for __________ and _______ should
be constructed to facilitate examination as well as
cleaning
glycerin and propylene glycol
Aside from AI, ______________ is usually the most
important constituent in a liquid product
water
Techniques employed to upgrade the microbial purity of water supply in oral liquid:
reverse osmosis purification, UV sterilization, membrane filtration, constant circulation in piping system that have no “dead ends” where microorganism can thrive
most straightforward to scale up, but
require tanks of adequate size and suitable mixing capacity
Simple solutions
Most equipment should have _________ and ________
capabilities for rapid dissolution of formulation components
heating and cooling
Adequate ___________ and ___________transfer systems and filtration equipments are required, but they must be monitored to ensure that they can clarify the product without removing active or adjuvant ingredients
transfer systems and filtration;
All equipments must be made of suitable,____________,
sanitary materials and be designed and constructed to
facilitate easy cleaning
non-reactive
includes tanks, kettles,
pipes, mills, filter, housing are most frequently fabricated from
stainless steel
Liquid pharmaceutical processing
virtually non-reactive but may react with some
acidic pharmaceutical liquids
Stainless steel
Reaction of stainless steels with some acidic pharmaceutical liquids may be minimized by treating the stainless steel with
an acetic acid or nitric acid
solution to remove surface alkalinity
treatment the stainless steel with an acetic acid or nitric acid
solution to remove surface alkalinity
passivation
Interaction with metallic surfaces can be minimized by using
polytetrafluoroethylene (teflon) liners
is inert,
these liners have the potential disadvantages of cracking,
breaking, flaking and peeling with resulting product
contamination
teflon
Equipment and lines can be sterilized by such methods
as
alcohol, boiling water, autoclaving, steam or dry
heat
Dilute solutions of rapidly dissolving materials
are prepared by adding the __________ to the
___________ and __________ until the solution is
_____________
solute to the solvent; agitating; homogenous
Heat maybe required for _____________
solutions or when the solute is slow to dissolve
more concentrated
usually added in a specified
order to increase the rate of dissolution and
facilitate a rapid approach to equilibrium
Excipients
T/F: If the solutes were charged directly to the bulk mixing
tank, it would be difficult to detect small amounts of
undissolved material at the bottom of the tank
T
T/F: complete solution should be confirmed at
every stage in the manufacture of homogenous liquid.
In the laboratory, liquids are usually measured by
volume
T
In large scale production,
______________ means of measurements are used
gravimetric
this stage of
process is termed Polishing
filtered and clarified
requires the removal of
particulate matter down to at least 3 um in size
Highly polished solution
Filters used in the manufacture, processing liquid drug
products intended for human use should not release ____________
fibers
commonly used to improve clarity and
increase the flow rate, thus decreasing filtration time
Filter aids
Amount and type of filter aid must be determined during
the ________________ of the product, the amount usually does
not exceed _____________
development; 0.5 g/L
examples of filter aids are
diatomaceous earth, carbon, expanded perlite and
cellulose
liquid may be transported to the filling
line, either ____________ by filling into portable transport tanks or by
_______________ through a suitable liquid delivery conduit
manually; pumping (gravity flow)
Method of filling a pharmaceutical liquid depend on the
characteristic of the liquid:
viscosity, surface tension, foam
producing, compatibility of the material with the construction of
filling machine, type of package (bottle)
are
delivered by the stroke of the plunger of a syringe, which forces
the liquid through a 2 way valve that provides for alternative
filling of the syringe from a reservoir and delivery to a container.
Small volumes of liquids
For heavy, viscous liquids, ________________provides more
positive action
sliding piston valve
T/F: Large volume filling does not normally require the precision
required for small volumes.
T
bottles of solution are
usually filled by
gravity, pressure or vacuum devices
Methods of filling
gravity filling, pressure pump filling,
vacuum filling
require specially designed equipmen
High viscous solution r
To obtain a reasonable flow rate, ___________ must be
applied or containers with large openings must be used to
permit the entry of large delivery tubes
high pressure
can be employed to raise the
temperature of the product and thereby lower its viscosity
jacketed reservoir tanks
a problem common to all types of
machines that fill containers with liquid but is particularly
bothersome in high speed automatic equipmen
Excessive foaming
Foaming
during the filling operation can be reduced by employing
filling equipment that minimizes product _____________,
closed system filling to limit the introduction of air or other
gases that cause foaming, mechanical defoaming
devices, or reduction in the __________ of the filling line
turbulence; speed
Slow but simple process of filling
Gravity Filling
Often operated semi-automatically and differs
from the gravity filler principally in that the
liquid is under pressure
Pressure Pump Filler
usually equipped with an overflow tube
connected to a receiver to prevent excess
filling
Pressure Pump Filler
Filling method that is commonly used for large liquid volumes because it is
easier adapted to automation
Vacuum Filling
produced in a bottle when a nozzle gasket
makes seal against the lip of the bottle to be filled
Vacuum
Any liquid that has been drawn into the vacuum line is
collected in a receiver and returned to the __________
reservoir
Aqueous solutions
l Aromatic waters
l Aqueous acids
l Douches
l Enemas
l Gargles
l Washes
l Juices
l Sprays
Clear, saturated aqueous solutions of volatile
oils or other aromatic or volatile substances
Aromatic waters
ARomatic waters contain or do not contain preservatives
Do not contain preservatives
Aromatic waters are prepared by:
distillation, direct solutions or
alternated solutions
Acids that do not contain oxygen
Hydracids
Oxygen containing acid
Aqueous Acids
Aqueous solutions used as a cleansing or
antiseptic agent directed against a part or into
a cavity of the body
Douches
Most frequently dispensed in the form of
powder with directions for dissolving in a
specified quantity of water, usually warm
Douches
Rectal injections employed to evacuate the
bowel, to influence the general system by
absorption, or to affect locally the seat of
disease
Enemas
Enemas posess ___________, _________, __________ or ____________ , or they may contain
______________ substances for roentgenographic
examination of the lower bowel
anthelminthic, nutritive, sedative or
stimulating properties; radiopaque
Aqueous solution used for treating the pharynx
and nasopharynx by forcing air from the lungs
through the gargle which is held in the throat
Gargles
Gargles must be __________ with water before use
diluted
Aqueous solutions most often used for its
deodorant, refreshing or antiseptic effect.
Washes
Washes example
Listerine, astring-osol and bactidol
Washes may contain _________, local anti-infective agents
such as __________ and ____________, glycerin,synthetic sweetners and
____________, flavoring, coloring agents
alcohol; hexetidine and cetylpyridinium chloride; surface-active
Prepared from fresh ripe fruit, aqueous in character
and are used in making syrups which are employed as
vehicles
Juices
Freshly expressed juice is preserved by __________; and is allowed to stand at room temperature for several
days, until the __________ which are naturally present are
destroyed by enzymatic action of pectinase as
indicated by the filtered juice yielding a clear solution
with alcohol
benzoic acid; pectins
Solutions of various drugs in aqueous vehicles
and are applied to the mucus membranes of
the nose and throat by means of nebulizer or
atomizer
Sprays
Sprays must be _________ with nasal secretions
isotonic
Sprays may contain ________, _________, ________ alcohol and suitable
solubilizing and wetting agents
antibiotic, antihistamins,
vasoconstritors
Sweet or other Viscid Aqueous
solutions
l Syrups
l Honeys
l Mucilages
l Jellies
Concentrated solutions of sugar or sugarsubstitute and intended for oral administration
Syrups
Basic methods of preparing syrups
solution with heat, agitation
without heat, addition of medicating liquids,
percolation
Combination of _________________ are
effective inhibitors of yeast
alkyl esters of p-hydroxybenzoic acid
Cannot be sterilized in an autoclave without some caramelization
Syrups
may be added to retard crystallization of
sucrose or increase the solubility of added ingredient
Glycerin or sorbitol m
When heat is employed, ___________ are produced
invert sugars
Invert Sugars example
Dextrose + levulose
More readily fermentable than sucrose
Invert Sugars
Tends to darken in color due to levulose
Invert Sugars
two reducing sugars are of value in
retarding the oxidation of other substances
Invert Sugars
1.23 times as sweet as sucrose. The relative
sweetness of levulose, sucrose and dextrose is
173:100:74
Oxymel and Squill Oxymel BPC
Honeys
All prone to decomposition, showing appreciable
decrease in viscosity on storage
Mucilages
they should never be
made in larger quantities than can be used
immediately, unless a preservative is added
Mucilages
Primarily used as aid in suspending insoluble
substances in liquid
Mucilages
Clear, pleasantly flavored, sweetened
hydroalcoholic liquids intended for oral use
Elixirs
Ethanol, water but glycerin, sorbitol, propylene
glycol, flavoring agents, preservatives and
syrups
Elixirs
Prepared by simple solution or admixture of
several ingredients
Elixirs
Essences
Spirits
Alcoholic solutions of volatile substances prepared
usually by simple solutions, admixture of the
ingredients, solution with maceration, chemical
reaction and distillation
Spirits
Spirits should be stored in _________ to prevent
loss by evaporation and to limit oxidative changes
tight, light resistant containers
Liquid preparation containing pyroxylin in a
mixture of ethyl ether and ethanol
Collodions
Applied to the skin by means of soft brush or
other suitable applicator and, when ether and
ethanol have evaporated, leave a film of
pyroxylin on the surface
Collodions
Made flexible by the addition of castor oil
Collodions
Solutions or mixtures of medicinal substances
in not less than 50% glycerin
Glycerites
Hydroscopic and should be stored in tightly
closed container
Glycerites
Most of them are extremely viscous and some
of them are of jelly-like consistency
Glycerites
Solutions of various substances in oil, alcoholic
solutions of soap or emulsion
Liniments
Usually applied with friction and rubbing of the
skin, the oil or soap base providing for case of
application and massage
Liniments
Fish liver oils diluted with edible vegetable oil
of solutions of the indicated vitamins or
vitamins concentrates (usually vitamin A and D)
in the fish liver oils
Oleovitamins
used generally for their
rubefacient, counter-irritant, mildly astringent
and penetrating effects
Alcoholic liniments
Popular commercial dosage form is the SOFT
Gelatin capsule
Oleovitamins
Clove oil and mixtures of phenol with camphor
or creosote
Toothache Drops
Drugs or solutions of drugs administered by the
nasal or respiratory route for local or systemic
effect
Inhalations
suitable for the administration of
inhalation solutions only if they give droplets
sufficiently fine and uniform in size so that the
mist reach the bronchioles
Nebulizers
Solutions may be nebulized by the use of _______
__________
inert gas
Consist of finely powdered or liquid drugs that
are carried into the respiratory passage by the
use of special delivery systems such as
pharmaceutical aerosol
Insufflations
Drugs or combination of drugs which by virtue
of their high vapor pressure, can be carried by
an air current into the nasal passage where
they exert their effect
Inhalants
