Test Midterms Ph116 Quizlet

12/6/22, 12:19 AM Test: MIDTERMS_PH116 | Quizlet 12/6/22, 12:19 AM Test: MIDTERMS_PH116 | Quizlet
Name: Score: Definition 4 of 135

● Fusion Method (Ampoules) : involves melting;
glass are melted through heating
135 Written questions

a. Pull sealing (neck part is being
Definition 1 of 135 heated)
molecules with a specific 3D structure that are

b. Tip sealing (tip is being
able to complex with metal ions. help stabilize cosmetics and prevent their deterioration by heated/melted)
catching (sequestering) metal ions.
Definition 5 of 135
Definition 2 of 135 wax-like substance
● Hydrophobic in nature and forms a water-

obtained from the wool of sheep (Ovis aries)
repellent layer over the skin. It physically

● 3 Types:
blocks, or at least retards, water loss

● Anhydrous Lanolin- nmt 0.25% MC
through the skin. ● Hydrous Lanolin- nmt 25% MC
● Modified Lanolin- lanolin that has been
processed to remove the free lanolin
alcohols and excess detergents

Definition 3 of 135
● solid or semisolid adhesive masses which is
spread upon a backing of paper, fabric,
Definition 6 of 135
moleskin or plastic
● employed to prolong the contact of the drug to

used for both local and
the site of absorption

systemic effects.
● example: Salicylic acid plaster (10-40% salicylic
acid)
● used to remove corns

Definition 7 of 135
provide a characteristic taste and/or smell to
products.
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Definition 8 of 135 Definition 10 of 135

● API - Soluble or miscible or at least partly
● Products claimed to produce fewer allergic
soluble or partly miscible in the vehicle

reactions than other non-hypoallergenic
(solvent)
cosmetic products.
● Solvent/Vehicle (majority of your formulation)

● No federal standard or definition for the use of
○ Water : most commonly used

the term "hypoallergenic."
● Viscosity enhancer/controllers
● Usually refers to products that do not contain
○ for stability purposes; delivery of drug;

ingredients known to cause allergic reactions,
prevents leakage
such as fragrances.
● Buffer/Acidifiers/pH adjusters
○ stability purposes; there are sensitive
APIs; to achieve a certain pH of the
solution (pH requirement)

Definition 11 of 135
● Sweetening agents
refers to an ingredient that is capable of
○ for syrups; to improve palatability

polishing or cleaning a harder surface by
(drugs are bitter in nature)

rubbing or grinding.
● Others: Co-solvents, Solubilizer, Preservatives*,
Flavor, Colorant*, Perfume**
or Magma, gels may thicken
on standing, forming thixotrope, and must be
Definition 9 of 135 shaken before to liquefy the gel and enable pouring
Anti-foaming 1-3
W/O 3-6
Wetting agent 7-9
O/W 15-18
Detergent 13-16
● Target groups
Solubilizes 20 ● Dosage Forms
● Legal status
● Application surfaces
● Functions


● Formulations containing:
● CLASS 100 (cleanest)
○ Higher amount of alcohol

● CLASS 1000
○ Low water content (anhydrous

● CLASS 10,000
formulation)
● CLASS 100,000
○ pH environment which does not
favor7 microbial growth
● Parabens - widely used preservatives
○ However, linked to breast cancer and
A procedure carried out at the end of the
endocrine disruption; can cause
allergy at low concentration.

processing when a product is in its final sealed
container; destroys all viable microorganisms.

○ "Paraben-free"
● "No Preservatives Added"
● "Non-preservatives Preservatives"
Resistant bacterial spores in sealed ampoules
or impregnated in dry paper strips that are
Definition 15 of 135 used to prove the effectiveness of new
● Critical area in the production. Why? "Heart"

sterilization equipment or process
of production area
● Class 100 environment
● MOA: Protein coagulation
Definition 16 of 135 ● Tool: Autoclaving / Steam (121C, 15 psi, 30
I. Product (viscosity, surface tension, foam

min)
producing qualities, compatibility with the

● Biological Indicator: Bacillus
type of material used in the machine)

stearothermophilus
II. Package (size,shape, type)
III. Product output
1. Gravimetric filling
2. Volumetric filling
3. Constant level filling

A cosmetic product's intended use can be
a. Vacuum filling
established in a number of ways, including
b. Gravity-vacuum filling
claims, consumer perception of the product,
c. Pressure-vacuum filling and the history of an ingredient.


● Partitioned boxes, screw-capped glass
natural or synthetic compounds with a
containers
characteristic smell to create an aesthetic
● Individually strip-wrapped
impression for consumers and make them feel
○ Packaging
more attractive due to the nice smell.

■ Thermoplastic - PVC,
PVC/PE, PVC/PVDC/PE
■ Aluminum:
a. Duplex, aluminum foil
(ALU/PE)
b. Triplex aluminum foil

Hydroalcoholic solutions with high amount of
(PP/ALU/PE)
fragrances
c. Cold-formed aluminum foil
(AluAlu)
● Instability
Definition 23 of 135 ● Issues on clean environment
To destroy or remove microorganisms and

● Leaks (incomplete sealing)
their spores ● Sterilization technique problems
● Reflect the expected effects of a particular

● Clinical testing is not required for cosmetic
product
products that do not have drug claims.
● Examples:
● The "clinically proven" claim refers to the fact
○ "moisturizes skin"
that a product was tested in a clinical
○ "cleans hair"
environment on humans; however, the details of
○ "freshens breath,"
the clinical testing are usually not provided.
● Different from drug claims:
○ "reduces wrinkles"
○ "helps prevent chapped lips"
○ "restructures the deepest epidermal
layers."


are added to aerosol formulations to maintain a
● Present in the highest proportion
suitable pressure within the aerosol can and

● Non-toxic
expel the content of the container when the

● Therapeutically inactive
valve is open. They are usually compressed or

● Usually Water for Injection USP
liquefied gases. products, among others. ● Three types:
○ Aqueous (5% Dextrose Injection, 0.9%
Sodium Chloride Injection)
○ Water-miscible (Ethyl alcohol, PEG
400 and 600, propylene glycol, glycerol)
The components are mixed until a uniform
○ Nonaqueous (Non-vegetable oils:
preparation is attained
Benzyl benzoate, ethyl oleate,
isopropyl myristate)
made by BFS
process for packaging topical products. (Courtesy of
● MOA:DNA alkylation
Rommelag USA, Inc.)

● Tool: Ethylene oxide or beta-propiolactone
● Biological Indicator: Bacillus subtilis var.
niger
"Articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or

otherwise applied to the human body or any
● Viscosity
part thereof for cleansing, beautifying,
● pH
promoting attractiveness, or altering the
● Specific Gravity
appearance without affecting structure or
● Pourability
function." (US FDA)

● Organoleptic Properties
● Bulk Volume
● Stearyl alcohol + white wax + cholesterol +
white petrolatum
● Aquaphor®


obtained from the
bleached yellow wax
honeycomb of European honeybees (Apis
mellifera)
Class 1,000 Environment
○ Humectants
○ Emollients
○ Occlusives
○ Enhancers of the skin barriers ● matching the formulation's pH with that of the
application surface
● stabilizing formulations since certain
ingredients are stable at specific pH values
only
Sterilized water for injection and packaged single dose
● thickening formulations as certain thickeners
containers (USP limit: 1000 mL)
must be neutralized in order to achieve
Most difficult to prepare (due to the sterilization techniques)
optimum viscosity.
Used for extemporaneous
compounding (IM and IV)
is a chemical compound that is soluble in the
particular solvent in which it is dispersed (e.g.,
is a water-insoluble pigment formed by
oil or water). Examples include indigo and
chemically reacting dyes with a substratum, for
Green 3.
example, aluminum, calcium, or barium. These
pigments are widely used in lipsticks and nail
lacquers. An example is Yellow 5 Al Lake.

● Limulus amoebocyte lysate from the horseshoe
crab Limulus polyphemus
● (+) coagulation (formation of gel clot) →
White petrolatum
presence of pyrogen
+ white wax


Semisolid dosage forms intended for topical
● Two types:
applications ● Those that permit the incorporation of
aqueous solutions resulting in the formation
of water-in-oil (W/O) Emulsions
○ Eg Hydrophilic Petrolatum
● Those that are W/O emulsions (syn: emulsion
bases) that permit the incorporation of
a. Prefilter : 95% efficient against dust and
additional quantities of aqueous solutions
lint; made up of cloth or plastic
○ Eg: Lanolin
b. Blower : positive pressure
● Offers emollient and occlusive effects w/o
c. HEPA Filter : High Efficacy Particulate Air
emulsions
; 99.97% efficient against 0.3 μm or larger

● not easily removed from skin with water
washing
● may permit incorporation of aqueous
Definition 49 of 135 solutions in small amount

Deliverable Volume (250mL and above container)
● Assures that oral liquids, when transferred
from the original container, delivers the
volume declared on the label.
● Desired release rate of the drug substance
● Applicable for products packaged not less than
from the ointment base
250 mL containers individually

● Desirability of topical or percutaneous drug
absorption
● Desirability of occlusion of moisture from the
Definition 50 of 135 skin.
● Replenish oils and lipids in the skin. They

● Stability of the drug in the ointment base
soften and smooth the skin by filling void

● Effect of the drug on the consistency or other
spaces on the skin surface and replacing lost

features of the ointment base
lipids in the SC.

● Desire for a base easily removed by washing
● Provide protection and lubrication on the

with water
skin surface, minimize chafing, and enhance

● Characteristics of the surface to which it is
the skin's aesthetic properties. applied.


the macromolecules are
provide protection against oxidative reactions.
uniformly distributed throughout a liquid with

This property is generally utilized to provide
no apparent boundaries between the dispersed

stability to cosmetic formulations and can also
macromolecules and the liquid. be used to slow down skin aging caused by
various oxidative mechanisms.
add moisture to the skin and help retain
moisture in the skin. They make the skin feel

injections of 100mL or less may either be
softer and smoother and reduce roughness,

single-dose or multiple dose products
cracking, and irritation.
Definition 55 of 135 ● Ointment bases may be used for their physical
purified mixture
effects or as vehicles for medicated ointments.
of semisolid HC obtained from petroleum

● Classifications/ Types of Ointment Bases:
that has been nearly or wholly decolorized

○ oleaginous bases
(White Vaseline®) ○ absorption bases
○ water-removable bases
○ water-soluble bases
Single-dose injections containing more than
100mL of solution that are intended for

intravenous use. ○ Rolling and hand-shaping
○ Compression-molding
○ Fusion or melt-molding
used to describe the air
quality in a designated area.


● Antibacterials
Ingredient Amount (grams)
● Antifungals
● Methylparaben 0.25
● Antivirals
● Propylparaben 0.15
● Antipruritic
● Sodium lauryl sulfate 10.00
● Local anesthetics
● Propylene glycol 120.00
● Anti-inflammatories
● Stearyl alcohol 250.00
● Analgesics
● White petrolatum 250.00
● Keratolytics
● Purified water 370.00
● Astringents
● Mydriatic agents
● "airlocks"
● A room adjacent to the cleanroom.
● typically liquids used to dissolve solid
ingredients, mix with liquids, provide a vehicle
for formulations, and contribute to the texture
of products.
● Polar: water and glycols, such as glycerin and
● Microbial Content
propylene glycol.
● Minimum Fill
● Semi-Polar: alcohols, such as ethanol and

● Packaging and Labeling, Storage
isopropyl alcohol; ketones, such as acetone;
● Sterility and metal particles(for ophthalmic
and esters, such as ethyl acetate.

preparations)
● Non-Polar: oils, such as mineral oil,
petrolatum, sunflower oil, almond oil; silicone
oils; hexane; toluene; and dimethyl ether.

MW < 600- clear, colorless liquid
MW > 1000- wax-like, white materials
MW 600-1000- semisolids


● have both a negative and a positive charge
1. Toothpaste
in their hydrophilic head.

a. C: Clean and refresh the teeth and oral
● Examples: −betaines, such as: coco betaine,

cavity
lauryl betaine, cocamidopropyl betaine, and

b. D: Fluoride - prevents tooth decay
hydroxysultaine 2. Deodorants
a. C: mask bad body odor
b. D: may contain antiperspirants which
alters the normal process of
Definition 69 of 135 perspiration.
test for incompletely sealed

3. Mouthwash
ampoule; 1% methylene blue a. C: Freshens the mouth from bad

breath
b. D: contains ingredients to prevent
and/or treat gingivitis (inflammation
of gums)
4. Facial foundations − also contain sunscreens
to protect the skin from the harmful radiation
of the sun.
5. Facial cleansers − contain anti-acne active
ingredients to prevent and/or treat acne
vulgaris.
6. Hand soaps − may contain antibacterial agents
to kill germs.


● Homogeneity and surface morphology
● Generally collapsible tubes, tight containers,
● pH
or other well -closed containers are
● Alcohol content,
recommended.
● Rheological properties
● Stored in either a cool place or at controlled
● Bioadhesion
room temperatures. In some cases, special
● Stability
storage conditions are recommended:
● Ex vivo penetration ○ Protect from light
○ Avoid exposure to excessive heat
○ Avoid exposure to direct sunlight
○ Avoid strong fluorescent lighting
○ Do not refrigerate, and
● Semisolid preparations containing one or

○ Avoid prolonged exposure to
more medicinal agents dissolved or dispersed

temperatures exceeding 30C.
in either a W/O emulsion or O/W emulsions or
in another type of water-washable base.
● Vanishing Creams - O/W
● Hydrophilic creams contain large amounts of

water in their external phase (e.g., vanishing
● Are oil-in-water emulsions resembling
cream)
creams.
● Hydrophobic creams contain water in the

● Advantages:
internal phase (e.g., cold cream). ○ Because the external phase of the
emulsion is aqueous, they are easily
washed from the skin (hence: often
called water-washable bases)
○ May be diluted with water or
aqueous solutions.
○ They can absorb serous discharges
○ Example: Hydrophilic Ointment
is a component that is insoluble in the
particular solvent in which it is dispersed. An
example is black iron oxide.


● MOA: Lethal mutation
● To allow complete reaction
● Tool: High-energy radiation

● To allow precipitation
● Biological Indicator: Bacillus pumilus ● To allow (even) distribution (of API)
○ Milling
○ Separation
provides a LAF that is completely
○ Mixing
enclosed.
○ Emulsification
○ Deaeration
A "dermatologist recommended" claim is
Definition 78 of 135 probably based on a product survey, and one or
● Minimum fill
many dermatologists could have endorsed the
● pH
product.
● Viscosity
● Microbial screening
● Assay.
● Container content
● Completeness and clarity of solution
Definition 79 of 135 ● Particulate matter test
● Hygroscopic ingredients
● Visible particulate matter
● Two functions
● Subvisible particulate matter
● contribute to skin hydration by drawing
water from the deeper layers of the
epidermis and dermis to the outer layer of
the skin (SC).

● Examples: glycerin, sorbitol, urea, and
propylene glycol.


● contain a positive charge in their
● also known as surface active ingredients, are the
hydrophilic head.
most widely used ingredients in cosmetics.
● Examples:
○ Anionic
● quaternized ammonium compounds:
○ Cationic
○ cetrimonium chloride
○ Non-ionic
○ stearalkonium chloride
○ Amphoteric
○ benzalkonium chloride,
● quaternium and polyquaternium molecules.
PEG is a polymer of ethylene oxide and
Definition 85 of 135 water represented by the formula
viscosity enhancing agents H(OCH2CH2)nOH, in which n represents
the average number of oxyethylene groups.
The numeric designations associated with
PEGs refer to the average molecular weight
of the polymer.
used to prevent undesirable growth of molds,
yeast, and bacteria in liquid, semisolid, and
powder products.
aka laminar flow hoods;
provides filtered air and aseptic work area

● A homogenous mixture of two or more
components prepared by dissolving a solid,
liquid, or gas in another liquid.

● In pharmacy context: liquid dosage forms are ingredients that can soften films and impart
flexibility to films, such as nail polish film or
hair spray film, as the film dries.
Creams and ointments in batch sizes up to 1,500 kg are
manufactured in this______________, which has
counter sweep agitation and a built-in homogenizer.
(Courtesy of Lederle Laboratories.)


with heat jacketed
● Hygroscopic ingredients
vessel, high - shear mixer, scrapper, vacuum

● Two functions:
attachments, and control station. (Courtesy of Ross,

● contribute to skin hydration by drawing
Inc.) water from the deeper layers of the
epidermis and dermis to the outer layer of
the skin (SC). Examples: glycerin, sorbitol,
urea, and propylene glycol.
● inhibit water evaporation from cosmetic
● Hydrophobic in nature and forms a water-
products, i.e., provide protection against
repellent layer over the skin. It physically blocks, or at least retards, water loss
drying out. Typically, sorbitol and glycerin
through the skin.

are used.
Sterile water for injection withbacteriostatic agents* and packaged in single or multiple
dose containers (USP limit: 30mL)

● Liquids, creams and ointments may be particularly susceptible to contamination (microbial and
Benzyl Alcohol
others) during manufacture. Therefore, special measures must be taken to prevent any
Extemporaneous parenterals
contamination.
*inhibits growth of bacteria ● Instability
○ compatibility of API with excipient/s
● Many drugs are insoluble in water
● Liquids are bulky and less easy for the patient to carry
Definition 96 of 135 ● More expensive to transport (cost of medicines)

purified mixture of
semisolid HC obtained from petroleum
● aka Yellow Petrolatum
● commercially available: Vaseline®
The presence of a pharmacologically active
ingredient in a therapeutically active
concentration can make a product a drug, even in the absence of explicit drug claims.


● contain a negative charge in their
Prepared by:
hydrophilic head
● Distillation
○ stearic acid
● Reverse osmosis
○ triethanolamine stearate
● Ion exchange
○ potassium laurate
● UV light (can
○ Sodium lauryl sulphate

destroy/kill
○ ammonium lauryl sulphate

microorganisms)
○ sodium laureth sulphate

● Filtration
○ Taurates
○ Isothionates
○ olefin sulfonates

○ disodium laureth sulfosuccinate.
● add moisture to the skin and help retain
moisture in the skin. They make the skin feel
softer and smoother and reduce roughness,
cracking, and irritation.

● Latin: unguentum - ung
● semisolid dosage form applied externally on
the skin or mucous membranes

● Two types:
● Aka skin rejuvenators
○ Medicated - with Active Ingredient

● Help restore, protect, and enhance the skin's
○ Non-medicated - used as base for the

barrier function. Additionally, they create a
preparation of medicated ointments film over the skin surface that aesthetically
smoothens the skin and stretches out fine
lines.
● Examples: collagen, keratin, and elastin.

operations performed between preparation and
the final sealing of its package; operations
carried out in a laminar airflow workbench or
barrier isolator.


● MOA: Physical means
● Advantages: Emollient, protect against the
● Tool: Membrane filter

escape of moisture, effective as occlusive
● Biological Indicator: Pseudomonas diminuta dressings, can remain on the skin for long
periods without drying out.
● Disadvantage: Difficult to wash off.
● Examples: Petrolatum, White Petrolatum,

White Ointment, and Yellow Ointment
Patenting a product is often related to the
● origin: petroleum
technology of how the product is

● characteristic: emollient effect
manufactured and not the actual effect of the

● best occlusive dressing
product.
● difficult to wash-off

● Established through the product's reputation.
● This means asking consumers to fill out 1. Water Phase + Wax Phase Vessel
questionnaires about why they buy a product

2. Manufacturing or Mixing Vessel
and what they expect the product to do. 3. Homogenizer
4. Storage Vessel
5. Ointment Filling Machine

● plastic masses applied to the skin using a fine
brush
● components: glycerin (40%), water (35%),
Most frequently used surfactants in
gelatin (15%), AI (10%)

cosmetics.
● example: Zn gelatin (10% ZnO)- Tx of varicose
ulcers

room that is designed to prevent
contamination


Purified water which is free of pyrogens
● Cosmetics + Pharmaceuticals
Pyrogen: fever-causing metabolites of bacteria

● Generally advertised to contain bioactive
Depyrogenation Techniques:
ingredients that, although are not drugs, have
● Ion exchange
visible and measurable short-term and long-
chromatography
term effects on the skin.
● Ultrafiltration (for
endotoxins > 300,000 Da)
● Distillation
● Oxidation (hydrogen
peroxide)**
● Drug is already dissolved in the solvent system
● Acid-base hydrolysis**
○ During the process of absorption, the
● Heating (Dry Heat

process of liberation and dissolution
Oven at 250C in 30
are already skipped.
mins)*
● Treatment of anaphylaxis
● Sodium Hydroxide** ○ anaphylaxis : extreme form of
allergies, hypersensitivity reactions
● Readily available for absorption
○ API is already dissolved in the solvent

● Provide dose uniformity, and specific volumes
While all topical and transdermal
of the liquid
compounds are applied to the skin,
● provide accurate measurement
only the transdermal formulations are
● Easily administered
designed to penetrate through the skin
● Easily swallowed
layer and exert their effects on deeper
or more distant tissues.

Simple ointment

Petrolatum, USP + Yellow Wax
Viscosity and for in vitro drug release to
ensure within-lot and lot-to-lot uniformity;
water content; leakage test


"Articles intended for use in the diagnosis,
● Polishing : filtering to remove 2-3 micron-size
cure, mitigation, treatment, or prevention of

particles
disease"and "articles (other than food)

● Cold Sterilization : Filtering to remove 0.2-0.3
intended to affect the structure or any function

micron particle; also known as Bacterial
of the body of man or other animals." (US FDA) Filtration

● Do not contain oleaginous components.

● used for incorporation of solid substances
● MOA:Oxidation
● Advantages:
● Tool: Oven (heat at 140C)
○ Completely washable
● Biological Indicator: Bacillus subtilis

○ Greaseless
○ Used for incorporation of solid
substances.

Performed to compare the weight or volume of
product filled into each container with their

labeled weight or volume.
● semisolid preparation intended for application
to the skin
● contains a larger proportion of solid materials
than ointments
● stiffer than ointments
● add color to cosmetic and OTC drug-cosmetic
● example: ZnO Paste (Lassar's Plain Zinc Paste)
products, making them attractive, appealing,
● 25% each of ZnO and starch with white
appetizing, and informative.
petrolatum
● "colorant" or "coloring agent," however, the
● used for absorption of serous discharges
official term used by the FDA is "color
● not to be applied to hairy parts additive."


● Semisolid systems consisting of dispersions of
All or some of the components of an ointment
small or large molecules in an aqueous liquid

are combined by being melted together and
vehicle rendered jellylike by the addition of a

cooled with constant stirring until congealed.
gelling agent.
Components not melted are added to the
● Sometimes called Jellies

congealing mixture as it is being cooled and
● Gelling agent: Carbomer 934, cellulose

stirred.
derivatives (CMC, HPMC) natural gums
(tragacanth)

● Rotating cooling turntable
Definition 128 of 135 ● Feeding Device and filling hopper
Many claims commonly used today for

● Scraping device
cosmetic products are not recognized or used

● Refrigerant inlet and outlet
by the FDA in any sense and have only limited

● Suppository ejection table
scientific evidence behind them. However, the
use of these words is not prohibited, which is
why they are used.

used for preparation of
gels. (Courtesy of FrymaKoruma - Rheinfelden,
Definition 129 of 135 Switzerland.)

● Solubilizer
● Isotonicity adjuster
● Antioxidant (Bisulfate)

● Chelating agent (EDTA)
● Buffer (Phosphates)
● Legal difference is determined by a product's
● Preservative (Antimicrobials)
intended use or what the product is used for.
● Inert gas (Nitrogen gas ; for stability)

● Certain products can be cosmetics and drugs
● Antifoaming agents (for drugs w/ surfactants)

at the same time if they meet the definitions of
● Hydrolysis inhibitors (for APIs that are prone

both cosmetics and drugs.
to hydrolysis)

12/6/22, 12:19 AM Test: MIDTERMS_PH116 | Quizlet

● Anti-caries
● Anti-dandruffs
● Skin protectants - astringents, lip protectants,
sunscreens
● Anti-acne

○ Protectants
○ Emollients
○ Lubricants
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12/6/22, 12:19 AM Test: MIDTERMS_PH116 | Quizlet 12/6/22, 12:19 AM Test: MIDTERMS_PH116 | Quizlet

Name: Score: Definition 4 of 135

glass are melted through heating

135 Written questions

Definition 1 of 135 heated)

molecules with a specific 3D structure that are

catching (sequestering) metal ions.

Definition 2 of 135 wax-like substance

● Hydrophobic in nature and forms a water-

repellent layer over the skin. It physically

blocks, or at least retards, water loss

through the skin. ● Hydrous Lanolin- nmt 25% MC

● Modified Lanolin- lanolin that has been

processed to remove the free lanolin

alcohols and excess detergents

spread upon a backing of paper, fabric,

● employed to prolong the contact of the drug to

the site of absorption

● example: Salicylic acid plaster (10-40% salicylic

● used to remove corns

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Definition 8 of 135 Definition 10 of 135

soluble or partly miscible in the vehicle

● Solvent/Vehicle (majority of your formulation)

○ Water : most commonly used

○ for stability purposes; delivery of drug;

○ stability purposes; there are sensitive

APIs; to achieve a certain pH of the

solution (pH requirement)

○ for syrups; to improve palatability

(drugs are bitter in nature)

Flavor, Colorant*, Perfume**

on standing, forming thixotrope, and must be

Wetting agent 7-9

Solubilizes 20 ● Dosage Forms

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Definition 14 of 135 Definition 17 of 135

○ Higher amount of alcohol

○ Low water content (anhydrous

favor7 microbial growth

● Parabens - widely used preservatives

A procedure carried out at the end of the

endocrine disruption; can cause

allergy at low concentration.

container; destroys all viable microorganisms.

● "No Preservatives Added"

or impregnated in dry paper strips that are

Definition 15 of 135 used to prove the effectiveness of new

● Critical area in the production. Why? "Heart"

● Class 100 environment

Definition 16 of 135 ● Tool: Autoclaving / Steam (121C, 15 psi, 30

I. Product (viscosity, surface tension, foam

producing qualities, compatibility with the

type of material used in the machine)

III. Product output

3. Constant level filling

c. Pressure-vacuum filling and the history of an ingredient.

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Definition 22 of 135 Definition 25 of 135

natural or synthetic compounds with a

characteristic smell to create an aesthetic

impression for consumers and make them feel

more attractive due to the nice smell.

a. Duplex, aluminum foil