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Manuf > LIQUID PREPARATIONS PART I > Flashcards

LIQUID PREPARATIONS PART I Flashcards

1
Q

Liquid Preparations may be
dispensed in one of 3 ways

A

-original container
-Repacking a bulk product
-Compounding the solution, suspension or
emulsion in the dispensary

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2
Q

Classification of Liquid Preparation

A
  • Solutions (single phase system)
  • Mixtures (two phase system)
  • Galenicals (extractives)
  • Sterile Products
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3
Q

Oral solutions are ______________ mixtures of one or more solutes
dissolved in suitable solvent or mixture of
mutually miscible solvents

A

homogenous;

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3
Q

These are homogenous mixtures of one or more solutes
dissolved in suitable solvent or mixture of
mutually miscible solvents

A

Oral solutions

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4
Q

classified on the basis of physical
properties, method of preparation, use and
type of ingredients

A

Oral solutions

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5
Q

Oral solutions areclassified on the basis of ________, _________, ________

A

classified on the basis of physical
properties, method of preparation, use and
type of ingredients

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6
Q

Examples of oral solutions

A

Syrup, Elixir, Spirit, Aromatic water, tincture,
fluidextract

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7
Q

ADVANTAGES OF SOLUTIONS AS AN ORAL DOSAGE FORM

A

-Liquids are easier to swallow than solids and
are therefore particularly acceptable for
pediatric and geriatric use
-A drug must usually be in solution before it can
be absorbed
-Solution is a homogenous system and
therefore the drug will be uniformly distributed
throughout the preparation

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8
Q

DISADVANTAGES OF SOLUTIONS AS AN ORAL DOSAGE FORM

A

-Liquids are bulky and therefore inconvenient to transport and store
-Stability of ingredients in aqueous solution is often poorer than if
formulated as a tablet or capsule
-Solutions often provide suitable media for the growth of
microorganisms and may therefore require the incorporation of a
preservative
-Many liquid preparations are designed so that the normal dosage
of the drug is present in 5mL, or a multiple of 5 mL, of the product
-The taste of a drug, which is usually unpleasant, is always more
pronounced when in solution than in solid form

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9
Q

The design and formulation of oral solutions involves the combination of ingredients with _____________
_________ to enhance the __________ of effectiveness of
the product

A

medicinal agents; acceptability

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10
Q

Several considerations in the design and formulation of oral solutions:

A

-concentration of the drug
-solubility of the drug, selection of the liquid vehicle
-physical and chemical stability
-preservation of the
preparation
-appropriate excipients such as buffers,
solubilizers, sweetening agents, viscosity controlling
agents, color and flavors

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11
Q

Successful design and formulation of liquids, as well as other dosage forms, requires both ________ and
______________ acuity

A

scientific and pharmaceutical acuity

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12
Q

concentration of the
dissolved solute in a saturated solution

A

Solubility

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13
Q

Is solubility qualitative or quantitative?

A

Quantitative

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14
Q

drugs are present in solution at
_____________ concentrations, otherwise, the drug may
crystallize as a result of changes in temperature or by
“_____________” from other ingredients or particulate matter present

A

unsaturated; seeding

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15
Q
A
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16
Q

Solubility is associated with the Effects of _________, effect of _____________, effect of
______________

A

pH, molecular structure, temperature

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17
Q

process by which the apparent
solubility of a poorly water soluble substances
is increased

A

Solubilization

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17
Q

Solubilization Techniques

A

addition of cosolvent, salt
formation, prodrug method, micellization

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17
Q

Drug substances in general are __________ (more/less) stable in liquid media
than in the solid dosage form.

A

less stable

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17
Q

consider both the pH solubility profile
and stability profile in order to select the optimum pH for
formulating the liquid oral dosage form

A

Chemical Stability

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17
Q

involves the formation of precipitate, less
soluble polymorph, adsorption of the drug substances onto
container surfaces, microbial and product appearance

A

Physical Stability

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18
Q

Solvent for aq solutions

A

Purified Water (water for injections)

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18
Q

obtained by deionization,
distillation, ion exchange, reverse osmosis,
filtration or other suitable procedures

A

Water

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18
Q

T/F: Although water is very widely used for inclusion
in pharmaceutical preparations, it may not be
possible to ensure complete solution of all
ingredients at all normal storage temperatures.

A

T

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18
Q

Water for
parenteral administration

A

Water for Injections, Bacteriostatic Water for
Injections, or Sterile Water for Injections

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18
Q

The acceptability of the product is a ___________ evaluation
and includes properties such as color, odor, taste and clarity

A

subjective

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19
Q

Major impurities in water are:

A

calcium, iron, magnesium, silica and sodium

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19
Q

Non-Aqueous solutions

A
  • Fixed oils of vegetable origin
  • Alcohols
  • Polyhydric alcohols
  • Dimethylsulphoxide
  • Ethyl ether
  • Liquid paraffin
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19
Q

When mixed with water, a ____________ ___________ is
formed capable of dissolving both alcohol-soluble and water-soluble substances, a feature especially useful for extraction and purification of active constituents from crude drugs and synthetic procedures

A

hydroalcoholic mixture;

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19
Q

Example of alcohols

A

Alcohol, diluted alcohol, rubbing alcohol, isopropyl
rubbing alcohol

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19
Q

Second most commonly used solvent in
pharmaceutical industry for many organic compounds

A

Alcohols

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19
Q

Recommended Alcohol content (OTC oral drugs) for children over 12 years of age and adults

A

10%

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19
Q

Recommended Alcohol content (OTC oral drugs) for children 6 to 12 years of age

A

5%

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19
Q

Recommended Alcohol content (OTC oral drugs) for children under 6 years of age

A

0.5%

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19
Q

In topical preparations, glycerin is used for its
___________ and _________ properties

A

humectant; emollient

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19
Q

Glycerin is used in pharmaceutical formulations including:

A

oral, otic, ophthalmic, topical and parenteral
preparations

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19
Q

Clear, syrupy liquid with a sweet taste and is miscible
with water and alcohol

A

Glycerin

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19
Q

Viscous liquid and miscible with water and alcohol

A

Propylene Glycol

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19
Q

In oral preparations, glycerin is used as ________,
____________ agents, ___________________ and
viscosity increasing agent

A

solvent; sweetening; antimicrobial preservatives;

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20
Q

Widely used as solvent, extractant, preservative in a
variety of liquid pharmaceutical formulations including parenteral

A

Propylene Glycol

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20
Q

Often used in place of glycerin

A

Propylene Glycol

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20
Q

As an antiseptic it is similar to ethanol, and against
molds it is similar to glycerin and only slightly less
effective than ethano

A

Propylene Glycol

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21
Q

__________ is used as carrier for emulsifiers and as vehicle for
flavors, as opposed to ____________, due to its lack of
____________

A

Propylene Glycol; ethanol; volatility

22
Q

Miscellaneous Solvents

A
  • Isopropyl myristate and isopropyl palmitate
  • Dimethylformamide and dimethylacetamide
  • Kerosene
  • Xylene
  • Glycofurol
23
Q

Other Formulation Additives

A
  • Buffers
  • Density modifiers
  • Isotonicity modifiers
  • Viscosity enhancement
  • Preservatives
  • Reducing agents and antioxidant
  • Sweetening agents
  • Flavors and perfumes
  • Colors
24
Q

These are materials which, when dissolved in a solvent, will enable the solution to resist any change in pH should an acid or alkali be added

A

Buffers

25
Q

Examples of buffers

A

Carbonates, citrates, gluconates, lactates, phosphates,
tartrates

26
Q

Most body fluids has a

A

pH of 7.4

27
Q

Although buffers ensure pH stability, the buffer system can effect other properties such as

A

solubility and kinetics

27
Q

Can act as general-acid or general-base catalysts and
cause degradation of the drug substance

A

Buffers

28
Q

pH and usual conc (%) of acetic acid and salt

A

ph 3.5-5.7, 1-2%

28
Q

_________ strength contribution of the buffer systems can also effect stability.

A

Ionic

28
Q

pH and usual conc (%) of Citric acid and a
salt

A

2.5-6 pH; 1-3%

28
Q

pH and usual conc (%) of Phosphoric acid
salts

A

6-8.2 pH; 0.8-2%

28
Q

Most widely used material for density
modification is ____________

A

DEXTROSE

28
Q

pH and usual conc (%) of Glutamic acid

A

8.2-10.2 pH; 1-2%

28
Q

Solutions of lower density than cerebrospinal
fluid will tend to ___________ after injection and those of
higher density will _________

A

rise; fall

28
Q

It is rarely necessary to control the density of
solutions EXCEPT when formulating ___________

A

spinal anesthetics

28
Q

Compounds contributing to the _____________ of a
product reduce the pain of injection in areas
with nerve ending

A

isotonicity

28
Q

example of Viscosity Enhancement

A

Povidone, hydroxyethylcellulose, carbomer

28
Q

alcohol content of __________% by weight in acid solutions and _____________% by weight, in alkaline solutions is sufficient to prevent microbial growth

A

15% by weight in acid solutions and
18% by weight, in alkaline solutions

29
Q

may serve as tonicity contributors as
well as stabilizers for pH

A

Buffers

29
Q

examples of Isotonicity Modifiers other than buffers

A

Dextrose and NaCl

29
Q

Propylene glycol is used as solvent in oral solution and topical preparations, and it can function as a
preservatives in the range of ____________

A

15 to 30%

29
Q

____________ concentrations of
gelling agents can be used to increase the
apparent viscosity of the product

A

low

29
Q

alcohols used in lower
concentrations (about 1%) as preservatives

A

Chlorobutanol and phenylethyl alcohol,

29
Q

acid that has low solubility in water,
inhibitory action varies from 0.1-0.5%, activity
depends on the pH of the medium because
only the undissociated acid has antimicrobial
properties

A

Benzoic acid

29
Q

useful as preservatives when it is used as
solvent, however, it does need a relatively high
concentration, somewhat greater than 15% to be
effective

A

Ethanol

29
Q

criteria for acceptability of preservatives

A
  • safety and lack of toxicity after oral intake
  • must be soluble, stable and
    microbiologically active
  • compatible with the active ingredients as well as other components of the formulation
29
Q

Optimum activity of Benzoic acid occurs at pH
values below _________ and pH values above pH _______,
benzoic acid is almost inactive

A

4.5; 5

29
Q

Most alcohol containing preparations such as _________, ________, ___________ are self preserving and will not require preservation

A

elixirs, spirits, tinctures

29
Q

esters of p-hydroxybenzoic acid and
include methyl, ethyl, propyl, butyl derivatives

A

Parabens

29
Q

When choosing a suitable preservative it must be ensured that:
_____________ of the preservative onto the container from the product
does not occur; and its efficiency is not impaired by the ___________ of the
solution or by the interactions with other ingredients

A

adsorption; pH

30
Q

Too ____________ concentration of alcohols may result in incompatibilities in
suspension and emulsion system

A

high

30
Q

Water solubility of the parabens _____________ as the
molecular weight increases, from 0.25% for the methyl
ester to 0.02% for the butyl ester

A

decreases

30
Q

Esters are stable over a pH range _________

A

4-8

30
Q

Has Broad spectrum of antimicrobial activity,and most
effective against molds and yeasts

A

Esters

30
Q

Antimicrobial activity _____________ as the chain length of the alkyl moiety is increased but aqueous solubility
__________, therefore a mixture of parabens is frequently used to provide effective preservations

A

increases; decreases

31
Q

Quarternary Ammonium Compounds Example

A

Benzalkonium Chloride

32
Q

mixture consisting principally
of homologs C12H25 and C14H29. This preservative is
used at relatively low concentrations (0.002-0.02%)

A

Benzalkonium Chloride

33
Q

Optimal activity of Quaternary Ammonium Compounds is met at pH ____________ and at _______ temperature

A

pH 4-10; Stable at room
temperature

33
Q

Used as external preservatives

A

Quarternary Ammonium Compounds

33
Q

Antifungal Preservatives

A

Butyl parabens, methyl paraben, ethyl
paraben, propyl paraben
Benzoic acid, potassium sorbate
Sodium benzoate, sodium propionate
Sorbic acid

33
Q

Antimicrobial Preservatives

A

Benzalkonium chloride, benzathonium chloride,
benzyl alcohol, bronopo
Centrimide, cetylpyridinium chloride,
chlorhexidine, chlorobutanol, chlorcresol,
creso
Ethanol, glycerin, hexetidine, imidurea, phenol,
phenoxyethanol, phenylmercuric nitrate
Propylene glycol, thimerosa

33
Q

Because of its cationic nature – it is incompatible with
many anionic compounds such as surfactants and can bind to nonionic surfactants

A

Quarternary Ammonium Compounds

33
Q

examples of reducing agents

A

sodium metabisulfite, or antioxidants
such as butylated hydroxyanisole or butylated
hydroxytoluene

33
Q

Polyhydric alcohols examples

A

Maltilol, lactilol,
isomalt, fructose, xylitol

33
Q

For unit dose parenteral products, such as injections of nicotinamide and ascorbic acid, it is possible to use _____________ free from dissolved air and to replace the air in the headspace by nitrogen or another inert gases

A

Water for Injections

33
Q

traditionally the most widely used sweetening
agents

A

Low molecular weight carbohydrates, such as sucrose

33
Q

has the advantage of being colorless, very
soluble in water, stable over a pH range of about 4 – 8,
and by increasing the viscosity of fluid preparations,
will impart to them a pleasant texture in the mouth

A

Sucrose

33
Q

The decomposition of pharmaceutical products by the oxidation can be controlled by the addition of ___________

A

reducing agents

33
Q

also possess
sweetening power and can be included in the
preparations for diabetic use

A

Polyhydric alcohols

33
Q

Sweetening agent with unpleasant aftertaste

A

Saccharin

33
Q

Artificial sweetener examples

A

E954, E951, E950, E957,
E952, E959

33
Q

Most commonly
used sweetening agent

A

Sucrose

33
Q

Banned sweetening agent

A

Sodium
cyclamate

33
Q

T/F: The simple use of sweetening agents may not be
sufficient to render palatable a product containing a
drug with a particularly unpleasant taste

A

T

33
Q

Sweetening agent that is not very stable in
solution

A

aspartame

33
Q

The inclusion of __________ has the additional advantage of
enabling the easy identification of liquid products

A

flavors

33
Q

Particularly useful in pediatric formulation to ensure
patient compliance

A

Flavors and Perfumes

33
Q

Suitable Masking Flavors for Salty

A

Apricot, butterscotch, liquorice, peach,
vanilla, maple, wintergreen

33
Q

Suitable Masking Flavors for Sour

A

Citrus fruits, liquorice, raspberry

33
Q

Suitable Masking Flavors for Bitter

A

Anise, chocolate, mint, passion fruit,
wild cherry

33
Q

Suitable Masking Flavors for Sweet

A

Vanilla, fruits, berries

33
Q

are pigments that are insoluble in water and which impart
color by dispersing and reflecting light, they are not used for
aqueous solutions

A

Lakes

33
Q

are water soluble and exhibit color by transmitting light,
should be used at the lowest possible concentration required to
produce the desired color, higher concentration result in a dull
color

A

Dyes

34
Q

present in trace amounts

A

dyes

35
Q

coloring agents that should
be dissolved prior to mixing with the bulk of the formulations.

A

dye

Manuf (12 decks)

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