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85 Cards in this Set

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USP definition of solutions
liquid preparation that contains one or more chemical substances dissolved/molecularly dispersed in a suitable solvent or mixture of mutually miscible solvents
Solution route of administrations (9)
1) oral
2) topical
3) vaginal: douches
4) rectal: enemas
5) otic: aural
6) nasal
7) opthalmic
8) irrigating
9) parenterals
2 types of solvents used
1) Aqueous: oral solutions, syrups, aromatic volatile flavorant waters
2) non-aqueous: elixirs, tinctures (higher alcoholic content), spirits, others
7 advantages of solutions
1) homogeneous doses
2) immediate availability for absorption, miscible with body fluids
2) most routes of administration can be used
3) good for patients who can't swallow tab/caps
4) easy dose adjustment
5) eneteral feeding
6) nursing home, psychiatric and incarcerated patients: ease delivery
6 disadvantages of solutions
1) less stability than dry form
2) potential for microbial contamination
3) solubility in acceptable solvents only
4) taste + smell: additives required
5) bulk and weight of package: increase cost
6) bulk containers: dosage measurement errors
6 compounding principles for solutions
1) solubility of chemicals in solvents: CONSTANT, never changed but can force dissolution by head or additives but precipitation can occur
2) time to dissolve increased by heat
3) chemicals stay in solution
4) stability of chemicals in solution
5) additives: organoleptic properties if oral
6) preservation: water present, needed especially but not needed in newborn injectables or single dose opthalmics
What is organoleptic properties?
Additives give good smell, good taste, good texture, good feeling in mouth --> related to senses
5 main preparation principles of solutions
1) comminution of solids by trituration or micronization
2) viscosity of solvents (thicker = difficult to dissolve drug)
3) solubilizing agent/levigation agent used
4) agitation via stirrer, shaker, sonicator
5) temperature using hot plate, indirect heat or thermostatically controlled mixing tanks
Solids solubility of solutions
Like dissolves like
1) inorganic compounds have HIGH water solubility
2) organic compounds (weak acids/bases) solubility depends on pH of solvent
3) salts of organic compounds: HIGH water solubility
4) heating of solvent may cause precipitation if ingredient does not mix well with heat: some gelling agents
5) cosolvent system: helps attain solubility of ingredients with difficult water solubility
6) volatile substances used
Miscibility of liquids
Oil + water = immiscible
Miscibility not always predicted:
water + alcohol = ok
glycerin + water = ok
glycerin + alcohol = ok
alcohol = mineral oil = NO!
alcohol + castor oil = ok 50/50
cottonseed oil + mineral oil = ok
castor oil + mineral oil = NO
Components of solutions
1) drugs
2) excipeints: solvents, sweetners, flavorant/odorant, colorants, preservatives, buffers, stabalizers

no colorants in opthalmics orparenterals but some colorants are inherent from drugs used
Solvents for liquid preparations (12)
1) purified water, USP: simplest, used for everything except parenterals or opthalmics (b/c not sterile)
2) water for injection, USP: pyrogen free
3) Sterile water for injection, USP: sterile
4) bacteriostatic water for injection, USP: sterile for injection + antimicrobial preservative (never used for newborns or ppl w/ liver disease: preservatives have toxicity)
5) alcohol, USP (ethanol): 94.6-96%v/v
6) dehydrated alcohol, UPS: >99.5%v/v: 200 proof
7) diluted alcohol, NF: 49% v/v:ethanol, 51% water
8) rubbing alcohol USP: 70% v/v ethanol + denaturants (formula 23-H: 8p acetone + 1.5p methyl isobutyl ketone + 100p ethanol)
9) Isopropyl rubbing alcohol: 70% v/v isopropanol, not for internal use
10) glycerin/glycerol, USP
11) propylene glycol, USP
12) vegetable oils, USP/NF: used in injectables
What are pyrogens
metabolic degredations from bacteria or microbes
All alcohols are what?
Hygroscopic, pull water from atmosphere or environment
Sweeteners general and classifications
Added to give flavor sweetness and viscosity
GRAS list (generally recognized as safe) 1958 Food additives amendment
1) glycogenetic: nutritive sweeteners: may be converted into energy, calories
2) non-glycogenetic: non-nutritive, non-caloric sweeteners, sugar substitutes
2 type of glycogenic sweeteners
1) Sugars
2) Non-sugars: polyols/sugar alcohols
3 types of sugar glycogenic sweeteners
1) sucrose: sugar (cane, beets, carrots); agave nectar (low glycemic index), fruits
2) dextrose (D-glucose): L-glucose is very salty
3) Fructose (levulose): slightly bitter
6 types of non-sugar glycogenic sweeteners
1) sorbitol (sorbitol sol = 64% w/w
2) glycerin/glycerol
3) propylene glycol
4) mannitol: in chewable tablets too
5) erythritol
6) xylitol: 30% few calories than sugar, anti-cavity properties
3 Main characteristics of non-glycogenetic sweeteners
1) most no-calor sweeteners: contain small amount of carbs from other ingredients needed to provide volume and texture
2) other ingredients: erythritol, sugar, molasses contribute to a few calories/services: meed FDA criteria of no-calorie if under 5 calories/serving
3) erythritol is an all-natural, no calorie, sugar alcohol fermented from sugars and found in vegetables and fruits
2 types of non-glycogenetic sweeteners
1) natural: not hydrolyzed and not absorbed
2) artificial: 1950's diet soft drinks, used in combinations with multiple artificial agents to decrease bitterness and achieve sweetness
4 types of natural non-glycogenetic sweeteners
1) methylcellulose: vegetables
2) hydroxyethyl cellulose: vegetables
3) Stevia leaves: natural, 30X sweeter than sucrose, heat stable, mixed with erythritol
4) monk fruit: 100X sweeter than sugar, mixed with erythritol, powder and liquid form
Most cellulose derivatives can be used as what?
6 types of artificial non-glycogenetic sweeteners
1) Saccharin/Sweet'n Low: restricted use since 1977, un-metabolized, heat stable
2) Cyclamate: banned in USA, used in Europe, metabolized, carinogenicity and tetatogenicity
3) Aspartame/Equal/NutraSweet: heat labile
4) Acesulfame Potassium/Sunett: approved in 1998, similar to saccharin, 130X sweeter than sucrose, unmetabolized, some heat stability, bitter taste
5) sucralose/splenda: approved 1998, modified sucrose, unmetabolized, 600X sweeter than sucrose, heat-stable
6) neotame/nutraSweet: 2002, aspartame analog, flavor enhancer, 30-60X sweeter than aspartame, lower amounts of phenylalanine, no accumulation in body, moderate head stable
Aspartame is broken down into what 3 metabolites and can be an issue with people who have what issue?
PKU: hyperphenylalaninemia and phenoketonuria, broken down into 3 metabolites: phenylalanine, aspartic acid, methanol
What are the artificial non-glycogenetic artificial sweeteners that are heat stable?
Saccharin/Sweet'n Low
Acesulfame Potassium/Sunett: some stability
What are the artificial non-glycogenetic artificial sweeteners that are heat labile?
What are the artificial non-glycogenetic artificial sweeteners that are un-metabolized in the body?
Saccharin/Sweet'n Low
Acesulfame Potassium
What are the artificial non-glycogenetic artificial sweeteners that are metabolized in the body?
Flavorants/Odorants general characteristics
1) 10,000 taste buds with 60-100 receptors/bud
2) Taste: complex blend of flavor, smell, texture, temperature and color
3) Age preferences: children: sweet, adults: citrus
What do patients expect from flavorings? (5)
1)Psychogenic balance with color (if grape, should be purple)
2) Immediate flavor identification
3) Acceptable mouth feel
4) Brief aftertaste
5) no undesirable sensations
Predication of drug's taste is what?
Flavorants are what?
Water-soluble or oli-soluble liquids or dry powders diluted in carriers to make for easier dissolution
What are the 3 types of flavor ants?
1) synthetic: artificial
2) natural: volatile oils, vanillin
3) spice: aromatic vegtetable substance/food seasonings
What are the 3 usual taste predictors?
1) low MW salts = salty
2) high MW salts = bitter
3) organic compounds: more -OH groups = sweeter
esters, alcohols, aldehytdes (volatile = odor) and pleasant
Addition of flavors, sweeteners, and colorings rule of thumb?
Always possible to add more, too late to remove it
Colorants (dyes and lakes) enhance what?
Enhance the appeal of a dosage form and should have a pyschogenic balance with flavor: liquids
Agents with inert color examples: (3)
Sulfur + riboflavin = yellow
Cupric sulfate = blue
Cyanocobalamine = red
Natural colorants (2) and synthetic (1)
Natural: mineral (red ferric oxide + zinc oxide = pink calamine) and vegetal (carrots, beets, fruit extracts)

Synthetic: 90% from aniline (derivative of benzene)
Permitted vs Certified and 3 types of certified
Permitted: can be used in medication because already on GRAS list
Certified: FD&C: food, drug and cosmetics
D&C: drug and cosmetics
external D&C: external only drug and cosmetics
Colorants studied for what?
FD&C red 2 and 4?
FD&C yellow #5
Studied for toxicity, carinogenesis and safety
FD&C red 2 and 4: external application
FD&C yellow #5: tartrazine: must be listed, allergies to aspirin
What are liquid dyes and lakes?
Pigments adsorbed to or precipitated (lakes) in aluminum hydroxide medium
Selections you must consider with colorants (5)
1) water or oil solubility
2) pH of preparation
3) stability of other formulative ingredients
4) dye chemical stability
5) photostability (light sensitivity)
5 general characteristics of antimicrobial/antifungal preservative agnets
1) long-term stability of dosage forms with water
2) effect of refrigeration
3) sterility for opthalmics and injectables
4) Mineral oil not used for internal use - has toxicity
5) Free water = microbial contamination, not water bound to solutes,
What are preservatives used in medicated syrups?
0.1% - 0.2% benzoic acid or sodium benzoate
0.1% mixture of parabens
Inherent antimicrobial effect/self preservation
1) syrup, NF: simple syrup, self-preserved is used soon (85% sucrose in 100mL solution, almost saturated (85.5%), not a lot of free water
2) 15% or higher alcohol in acid media and 18% or higher in alkaline media
3) flavoring oils (thymol, cresol) and sweeteners (glycerol, propylene glycol)
Glycerol is more what and what than propylene glycol?
Stronger antimicrobial and thickener
6 categories/classifications of preservatives
1) alcohols and glycols
2) organic acids
3) parabens
4) mercurial derivatives
5) salts of quaternary ammonium bases
6) chlorobutanol
Alcohol and glycols classification of preservatives used for:
mostly for oral and topical dosage forms (parenterals, limited use)
Examples of alcohol and glycol preservatives (4)
1) ethyl alcohol
Alcohol USP (95-06%v/v) or used at 15-17% of free water present in preparation to be effective; pH dependent (15% acid, 17.5% neutral or middy alkaline)
2) Propylene glycol: similar to ethyl alcohol
3) Glycerin/glycerol: preserves an equivalent quantity of volume
4) Benzyl Alcohol: bactericidal at 1-2% total solution, sharp burning takes but still approved for oral
Best used for topical and parenteral, not effected by pH of solution
2 Organic acid examples of preservatives used
1) Benzoic acid, Na Benzoate salt, K benzoate salts: effective at 0.1-03%, oral, topica (incl opthalmics) and parenterals
2) sorbic acid, potassium sorbate salts: effective at 0.05-0.2%, irritating for skin, used for oral and opthalmics
Paraben preservatives general characteristics (6)
1) esters and salts of p-hydroxybenzoic acid
2) used individually or mixtures of to low concentrations up to 0.1%
3)m most effective against fungi
4) for all dosage forms including opthalmics EXCEPT NOT FOR PARENTERALS
5) irritating to broken skin
6) tend to partition in presence of flavoring oils
Examples of paraben preservatives
methyl-paraben, methyl-paraben sodium
Mercurial derivative preservatives (2 generals), 2 examples
1) may but sensitizing and cause allergies
2) used for topical, nasal and opthalmic and parenterals

1) Phenylmercuric nitrate (PMN) and phenylmercuric acetate (PMA): effective topical 0.002% - 0.01%, 0.004% = maximal conc for eye and parenterals
2) thimerosal: effective: 0.001 - 0.04%
max for eye: 0.01%
max for parenteral: 0.04%
Salts of quaternary ammonium base preservative (3 general), 3 examples
1) may be sensitizing and accuse allergies
2) topical, nasal, opthalmic, parenterals
3) cause chemical incompatibilities

1) Benzalkonium chloride: effective 0.004 - 0.02%
max for eye: 0.013%
2) benzethonium chloride: effective 0.01 - 0.02%
max for eye: 0.01%
3) cetylpyridinium chloride: effective 0.01 - 0.02%
Chlorobutanol preservative (4)
1) opthalmic and parenteral
2) stable at acidic pH only
3) effective 0.5%
4) not used of oral (camphor taste and odor)
MOA of preservatives and free water definition
1) MOA: interference with microbial growth, multiplication and/or metabolism
2) water in a preparation not bound to other molecules, determines effective concentration of a preservative required for a given liquid water used formulation
What preservatives are used for topical use?
alcohols and glycols
organic acids (except sorbic acid)
mercurial derivatives
salts of quaternary ammonium bases
What preservatives are used for oral use?
Alcohols and glycols
Organic acids
What preservatives are used for parenterals
Alcohols and glycols (limited use)
Mercurial derivatives
Salts of quaternary ammonium bases
Organic acids (except sorbic acid)
What preservatives are used for opthalmics?
Organic acids
Mercurial derivatives
Salts of quaternary ammonium bases
Dry mixtures for solutions
insufficient in aqueous medium to meet extended shelf life so reconstituted and refrigerated for 7 -14 days then discgarded
What 2 ways are dry mixtures reconstituted?
1) lyophilization
2) spray drying
both remove liquid from preparation to form dry mixture
Why are buffers used in solutions?
Maintenance of ideal pH for drug solubility, stability and product shelf-life and attention to interaction with antimicrobial preservatives
What are buffers?
ionic active ingredients and/or other components
What are stabilizers?
Any additional excipient required to: maintain drug in solution, protect drug in active form (prevent degradation), keep compatibility among components, prevent degradation of drug or product

Ex: EDTA: chelating agent, chelates heavy metals in formulations Ethylenediaminetetraacetic acid
What is a topical tincture?
oldest dosage form around, solution with hydroalcoholic or alcoholic vehicles (simple solution of chemicals or vegetable materials)
What is in a tincture and how is it produced?
Maceration (soak in water to extract) or percolation (coffee making)
Contain 15-80% alcohol --> self preserved, and can contain a die
How is a tincture dispensed and what are some examples?
Dispensed in small volumes: glass or plastic bottles with applicator tip or plastic squeeze drops

ex: iodine tincture, thimerosal tincture: anti-infectives
Compound benzoin tincture for bronchitis
What are sprays and what are the mechanical devices it is dispensed in?`
Aqueous or oleaginous solutions (coarse droplets with finely divided solids), contain no gase

Devices break up solution into small particles, facilitate spraying of powders (spray bottles, one-way pumps)
Examples of medicated sprays
Nasopharyngeal: sore thraot
Skin: antiseptics, local anesthetics, anti-fungals
Vaginal Solutions: douches
NEVER for systemic effect, solutions prepared from powders or just regular solutions for feminine hygiene or anti-infective agents for LOCAL action
Rectal solutions: enemas
rectal liquid preparations for:
1) retention: for local effect or for systemic effect
2) evacuation: cleanse bowel
Define syrups
Aqueous, sweetened flavored, viscous solution
2 Types of syrups
1) non-medicated or flavored syrups (vehicles) for water soluble drugs (stability)
2) medicated: antiemetics, antihistamines, antitussives, antivirals
3 examples of non-medicated syrups
1) syrup, NF (simple syrup): 85% sucrose in purified water
2) sucrose-based: cherry syrup (acidic), cocoa syrup (bitter tasting drugs masked), orange syrup (source of tartness), raspberry syrup (disguise sour or salty)
3) Commercial: Ora-Sweet and ora-Sweet SF: acidic pH and alcohol free
Components of Syrups (3)
1) drugs: water solubility
2) solvents: purified water, alcohol (low concentration, also used to help ingred that are not fully water soluble)
3) Pharmaceutical excipeints: sweeteners, flavorants, colorants, preservatives
6 techniques to prepare syrups
1) with aid of heat: sucrose syrups: if heated to much turn into inverted syrups: monosaccharides formed and change color and taste (more bitter) of syrup
Some artificial sweeteners are destroyed by heat
2) agitation
3) heat and agitation
4) addition of sucrose to a medicated or flavored liquid
5) percolation: extracts of drugs in comminuted form (ipecac syrup: emetic)
6) maceration: soak drug to extract
Define elixirs
syrup with more alcohol
Clear, sweetened, flavored, hydroalcoholic solutions for oral use
2 Types of elixirs
1) Non-medicated: vehcile,
ex: aromatic elixir, NF: 21-23% alcohol
2) jMedicated: therapeutic effect
Components of elixirs
1) drugs: alcohol-soluble and water-soluble components dissolved separately
2) Solvents
3) pharmaceutical excipients: sweeteners, flavorants, colorants, preservatives, stabalizers
What % alcohol elixirs do not need a preservative?
10-15% alcohol is self-preserving
What are 3 examples of solvents for elixirs?
1) purified water
2) Alcohol
3) adjunct solvents: glycerin, propylene glycol, sorbitol syrup, co-solvent of hydroalcoholic vehicle, stability, viscosity
What are the % alcohol for solvents in elixirs?
0.5% children under 6
5% ages 6 -12
10-15% adults
2 Techniques to prepare elixirs
1) simple solution with agitation
2) mixture of alcoholic solution with aqueous solution with aqueous added to alcoholic to slow dilution to mix without drugs coming out of solution
Final filtration with talc if separation of flavoring oil
Storage of elixirs
Tight, light resistance containers that are protected from the heat