LIQUID PREPARATIONS PART II Flashcards by Kim Grace

All raw materials should conform to well thought out
specification. These specifications should assure
_______, _________, _________ and freedom from excessive
microbial contamination

identity, purity, uniformity

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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

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Storage tanks for __________ and _______ should
be constructed to facilitate examination as well as
cleaning

glycerin and propylene glycol

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Aside from AI, ______________ is usually the most
important constituent in a liquid product

water

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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

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most straightforward to scale up, but
require tanks of adequate size and suitable mixing capacity

Simple solutions

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Most equipment should have _________ and ________
capabilities for rapid dissolution of formulation components

heating and cooling

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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;

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All equipments must be made of suitable,____________,
sanitary materials and be designed and constructed to
facilitate easy cleaning

non-reactive

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includes tanks, kettles,
pipes, mills, filter, housing are most frequently fabricated from
stainless steel

Liquid pharmaceutical processing

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virtually non-reactive but may react with some
acidic pharmaceutical liquids

Stainless steel

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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

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treatment the stainless steel with an acetic acid or nitric acid
solution to remove surface alkalinity

passivation

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Interaction with metallic surfaces can be minimized by using

polytetrafluoroethylene (teflon) liners

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is inert,
these liners have the potential disadvantages of cracking,
breaking, flaking and peeling with resulting product
contamination

teflon

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Equipment and lines can be sterilized by such methods
as

alcohol, boiling water, autoclaving, steam or dry
heat

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Dilute solutions of rapidly dissolving materials
are prepared by adding the __________ to the
___________ and __________ until the solution is
_____________

solute to the solvent; agitating; homogenous

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Heat maybe required for _____________
solutions or when the solute is slow to dissolve

more concentrated

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usually added in a specified
order to increase the rate of dissolution and
facilitate a rapid approach to equilibrium

Excipients

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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

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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

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In large scale production,
______________ means of measurements are used

gravimetric

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this stage of
process is termed Polishing

filtered and clarified

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requires the removal of
particulate matter down to at least 3 um in size

Highly polished solution

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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.

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

LIQUID PREPARATIONS PART II Flashcards

(105 cards)