1. 1. Liquid dosage formsLiquid dosage forms Dr. Samar AfifiDr. Samar Afifi King Saud UniversityKing Saud
University Dept. of PharmaceuticsDept. of Pharmaceutics
• 2. IntroductionIntroduction Lecture 1Lecture 1
• 3. Liquid dosage formsLiquid dosage forms Monophasic liquid D.F Solutions Polyphasic liquid D.F
Aqueous solutions Non-aqueous solutions Suspensions Colloids Emulsions
• 4. Liquid dosage formsLiquid dosage forms ■■ Solutions: solutions are clear liquid
preparationsSolutions: solutions are clear liquid preparations containing one or more active ingredients
dissolved in acontaining one or more active ingredients dissolved in a suitable vehicle.suitable vehicle.
■■ Suspensions (Solid in liquid dispersion): liquidSuspensions (Solid in liquid dispersion): liquid
preparations containing one or more active ingredientspreparations containing one or more active
ingredients suspended in a suitable vehicle.suspended in a suitable vehicle. ■■ Emulsions (liquid in
liquid dispersion): emulsions are twoEmulsions (liquid in liquid dispersion): emulsions are two phase
system in which one liquid is dispersed throughoutphase system in which one liquid is dispersed
throughout another liquid in the form of small particles.another liquid in the form of small particles.
• 5. ■■ Colloids: A system in which finely divided particles, whichColloids: A system in which finely
divided particles, which are approximately less than 1 µm in size, are dispersed withinare approximately
less than 1 µm in size, are dispersed within a continuous medium in a manner that prevents them froma
continuous medium in a manner that prevents them from being filtered easily or settled rapidly.being
filtered easily or settled rapidly. Liquid dosage formsLiquid dosage forms
• 6. Liquid dosage formsLiquid dosage forms SolutionsSolutions In pharmaceutical terms solutions are
liquid preparations thatIn pharmaceutical terms solutions are liquid preparations that contain one or
more chemical substances dissolved in a suitablecontain one or more chemical substances dissolved in a
suitable solvent or mixture of mutually miscible solvents.solvent or mixture of mutually miscible
solvents. Solutions are dosage forms prepared by dissolving the activeSolutions are dosage forms
prepared by dissolving the active ingredients in an aqueous or non aqueous solvent.ingredients in an
aqueous or non aqueous solvent. SolutionSolution isis aa homogenoushomogenous mixturemixture
composed of two or morecomposed of two or more substances. In such a mixture, asubstances. In such
a mixture, a solutesolute is dissolved in anotheris dissolved in another substance, known as asubstance,
known as a solventsolvent.. A common example is aA common example is a solidsolid,, such assuch as
saltsalt oror sugarsugar,, dissolved indissolved in waterwater,, aa liquidliquid..
• 7. Classification of solutionsClassification of solutions (i) According to the route of administration(i)
According to the route of administration - Oral solutions through oral route- Oral solutions through oral
route - Otic solutions instilled in the earsOtic solutions instilled in the ears - Ophthalmic solutions
instilled in the eyesOphthalmic solutions instilled in the eyes - Topical solutions applied over skin
surfaceTopical solutions applied over skin surface
• 8. Classification of solutionsClassification of solutions (ii) According to composition and uses(ii)
According to composition and uses -Syrups aqueous solution containing sugarSyrups aqueous solution
containing sugar - ElixirElixir sweetened hydro-alcoholic (combination of water andsweetened hydro-
alcoholic (combination of water and ethanol solution)ethanol solution) - SpiritSpirit solution of aromatic
materials in alcohol. Aromaticsolution of aromatic materials in alcohol. Aromatic water solution of
aromatic material in water.water solution of aromatic material in water.

2. • 9. Classification of solutionsClassification of solutions (ii) According to composition and uses(ii)
According to composition and uses -Tincture/fluid extractTincture/fluid extract solution prepared by
extracting active constituentssolution prepared by extracting active constituents from crude drugs e.g
compound cardamon tincture.from crude drugs e.g compound cardamon tincture. They may also be
solution of chemical substancesThey may also be solution of chemical substances dissolved in alcohol or
in hydroalcoholic solvent e.gdissolved in alcohol or in hydroalcoholic solvent e.g tincture of
iodine.tincture of iodine. -InjectionInjection Certain solution prepared to be sterile and pyrogen-Certain
solution prepared to be sterile and pyrogen- free and intended for parenteral administration.free and
intended for parenteral administration.
• 10. Classification of solutionsClassification of solutions (iii)(iii) According to the vehicleAccording to
the vehicle - Aqueous solutionsAqueous solutions Solutions that contain water as the solvent. For
example,Solutions that contain water as the solvent. For example, sugar in water, carbon dioxide in
water, etcsugar in water, carbon dioxide in water, etc.. - Non-aqueous solutionsNon-aqueous solutions
Solutions that contain a solvent other than water. Ether, benzene, petrol, carbon tetrachloride etc., are
some common solvents. For example, sulphur in carbon disulphide, naphthalene in benzene, etc.
• 11. - Concentrated solutions and dilute solutions- Concentrated solutions and dilute solutions
Between two solutions, the solute quantity may be relativelyBetween two solutions, the solute quantity
may be relatively more or less.more or less. The solution that has a greater proportion of solute is said
to beThe solution that has a greater proportion of solute is said to be more concentrated than the other
that has a lesser proportion.more concentrated than the other that has a lesser proportion. If the
proportion of solute is less, the solution is said to beIf the proportion of solute is less, the solution is said
to be dilutedilute..
• 12. Saturated and unsaturated solutionsSaturated and unsaturated solutions - Saturated Solution-
Saturated Solution A solution in which no more solute can be dissolved at a givenA solution in which no
more solute can be dissolved at a given temperature is called a saturated solutiontemperature is called a
saturated solution -- Unsaturated solutionUnsaturated solution A solution in which more solute can be
dissolved at a givenA solution in which more solute can be dissolved at a given temperature is called an
unsaturated solution.temperature is called an unsaturated solution. A given solution that is saturated at
a particular temperatureA given solution that is saturated at a particular temperature may become
unsaturated when the temperature is increasedmay become unsaturated when the temperature is
increased..
• 13. SOLUBILITYSOLUBILITY The solubility of an agent in a particular solvent indicates the maximum
concentrationThe solubility of an agent in a particular solvent indicates the maximum concentration to
which a solution may be prepared with that agent and that solvent. When ato which a solution may be
prepared with that agent and that solvent. When a solvent at a given temperature has dissolved all of
the solute it can, it is said to besolvent at a given temperature has dissolved all of the solute it can, it is
said to be saturatedsaturated..  The solubility of a solute is the maximum quantity of solute that can
dissolve in a certain quantity of solvent or quantity of solution at a specified temperature  How do
substances dissolve? Solvation - there is an interaction between the solute and the solvent.  The solute
particles are usually surrounded by the solvent particles. This process is called solvation. Different
substances have different solubilitiesDifferent substances have different solubilities..  Solubility refers
to the maximum amount of a solute that can be dissolved in an amount of solvent under specific

3. temperature and pressure conditions.  A substance that cannot be dissolved in another (or does so to a
very limited extent) is said to be insoluble.
• 14. Factors affecting the solubilityFactors affecting the solubility Electrostatic attractions between
water and solid ions/molecules play an important role in the solubility of solids in aqueous solutions.
TThere are other factors that also play an important role to control solubility of a solute. These include
the various chemical and other physical properties of both the solute and the solvent, pressure, the pH
of the solution, the state of subdivision of the solute, and the physical agitation applied to the solution
as it dissolves. • Temperature is an important factor in determining the solubility of a drug and in
preparing its solution. Most chemicals absorb heat when they are dissolved and are said to have a
positive heat of solution, resulting in increased solubility with an increase in temperature. The addition
of more heat facilitates the dissolving reaction by providing energy to break bonds in the solid. A few
chemicals have a negative heat of solution and exhibit a decrease in solubility with a rise in temperature.
• 15. SOLUBILITY (2) Nature of the solute and the solvent The maximum possible concentration to●
which a pharmacist may prepare a solution varies greatly and depends in part on the chemical
constitution of the solute. For example, calcium hydroxide topical solution, USP, and potassium Iodide
oral solution, USP. The first solution prepared by agitation an excess amount of calcium hydroxide with
purified water, contains only about 140 mg of dissolved solute per 100 ml of solution at 25°C, whereas,
potassium iodide solution contains about 100g of solute per 100 ml of solution, more than 700 times as
much solute as in the calcium hydroxide topical solution. The pharmacist can in certain instances●
dissolve greater quantities of a solute than be possible using different solubilizing agent or a different
chemical salt form of the medicinal agent. For example using of an aqueous solution of potassium iodide
or sodium iodide to increase the soluibility of iodine granules in water such as in iodine topical solution
prepared to contain about 2% iodine and 2.4% sodium iodide. Non polar solutes are soluble in non●
polar solvents; Polar or ionic solutes are soluble in polar solvents. The important organic medicinal●
agents are either weak bases or weak acids and their solubility depends to a large measure on the pH of
the solvent. These drugs react either with strong acids or strong bases to form water-soluble salts.
• 16. -The weak bases including many of the alkaloids (atropine), localThe weak bases including many
of the alkaloids (atropine), local anesthetics (cocaine, procaine) and other important drugs are not
veryanesthetics (cocaine, procaine) and other important drugs are not very soluble in water, but they
are soluble in dilute solutions of acids.soluble in water, but they are soluble in dilute solutions of acids. -
Organic medicinals that are weak acids include barbiturate drugs (e.g- Organic medicinals that are weak
acids include barbiturate drugs (e.g phenobarbital) and sulfonamides (e.g sulfadiazine). These and
otherphenobarbital) and sulfonamides (e.g sulfadiazine). These and other weak acids form water-
soluble salts in basic solution.weak acids form water-soluble salts in basic solution. Substances with
similar intermolecular attractive forces tend to be soluble in one another. This generalization is stated as
"like dissolves like." Salts of organic compounds are more soluble in water than are the corresponding
organic bases. Conversely, the organic bases are more soluble in organic solvents, including alcohol,
than are the corresponding salt forms. Organic compounds are more soluble in organic solvents than in
water. Organic compounds may be somewhat water soluble if they contain polar groups capable of
forming hydrogen bonds with water.
• 17. 05/29/14 17 Solute Polar Solvent Non-polar solvent Polar Soluble Insoluble Non-Polar Insoluble
Soluble Ionic Soluble Insoluble Nature of Solute and Solvent

4. • 18. 05/29/14 18 Molecular size The larger the molecules of the solute are, the larger is their
molecular weight and their size. It is more difficult for solvent molecules to surround bigger molecules.
The larger particles are generally less soluble. In the case of organic compounds the amount of carbon
"BRANCHING" will increase the solubility since more branching will reduce the size (or volume) of the
molecule and make it easier to solvate the molecules with solvent.
• 19. In many instances solubilities of drugs and their differentiation from other drugs areIn many
instances solubilities of drugs and their differentiation from other drugs are critical to the pharmacist for
avoidance of compounding failures or therapeuticcritical to the pharmacist for avoidance of
compounding failures or therapeutic disasters.disasters. Certain combinations of anion and cation seem
to be similar in makeup but do not have similar solubility characteristics. For instance, magnesium
sulfate is soluble, but calcium sulfate is only slightly soluble, barium sulfate is very insoluble and is used
as an opaque medium for x-ray observation of the intestinal tract, but barium sulfide and barium sulfite
are more soluble and their oral use can result in poisoning. Mercurous chloride (HgCl) is insoluble and
was formerly used as cathartic, but mercuric chloride (HgCl2) is soluble in water and is a deadly poison if
taken internally. The ability of a solvent to dissolve organic as well as inorganic solutes depends on
itsThe ability of a solvent to dissolve organic as well as inorganic solutes depends on its effectiveness in
overcoming the electronic forces that hold the atoms of the soluteeffectiveness in overcoming the
electronic forces that hold the atoms of the solute together. During dissolution, the molecules of solvent
and the solute become uniformlytogether. During dissolution, the molecules of solvent and the solute
become uniformly mixed, and cohesive forces of atoms replaced by new forces as a result of the
attractionmixed, and cohesive forces of atoms replaced by new forces as a result of the attraction of the
solute and solvent molecule for one another.of the solute and solvent molecule for one another.
• 20. (3)(3) Pressure The effect of pressure is observed only in the case of gases. An increase in
pressure increases of solubility of a gas in a liquid. For example carbon dioxide is filled in cold drink
bottles (such as coca cola, Pepsi etc.) under pressure. (4)(4) Particle sizesize The solubility of a pure
chemical substance at a given temperatureThe solubility of a pure chemical substance at a given
temperature and pressure is constant, however, its rate of solution depends onand pressure is constant,
however, its rate of solution depends on the particle size of the substance and the extent of
agitation.the particle size of the substance and the extent of agitation. The fine the powder, the greater
the surface area that comes in contactThe fine the powder, the greater the surface area that comes in
contact with the solvent and the more rapid the dissolving process.with the solvent and the more rapid
the dissolving process. (5) Stirring or agitation Agitation makes the solute dissolves more rapidly because
it brings fresh solvent into contact with the surface of the solute. However, agitation affects only the
rate at which a solute dissolves. It cannot influence the amount of solute that dissolves. An insoluble
substance will remain undissolved no matter how much the system is agitated.
• 21. The solubility may be expressed as grams of solute dissolving in milliliters ofThe solubility may be
expressed as grams of solute dissolving in milliliters of solvent for example 1 gm of sodium chloride
dissolves in 2.8 ml of water. Whensolvent for example 1 gm of sodium chloride dissolves in 2.8 ml of
water. When the exact solubility has not beethe exact solubility has not bee n determined , general
expressions of relative solubility may be used.n determined , general expressions of relative solubility
may be used. Descriptive termDescriptive term Parts of solvent required for 1 part ofParts of solvent
required for 1 part of solutesolute Very solubleVery soluble Freely solubleFreely soluble SolubleSoluble
Sparingly solubleSparingly soluble Slightly solubleSlightly soluble Very slightly solubleVery slightly

5. soluble Practically insolublePractically insoluble << 11 1-101-10 10-3010-30 30-10030-100 100-1000100-
1000 1000-10,0001000-10,000 >> 10,00010,000 Relative terms of solubility
• 22. SolutionsSolutions Solutions can be formulated for different routes ofSolutions can be formulated
for different routes of administrationadministration orally such as syrups, elixirs, drops.orally such as
syrups, elixirs, drops. In mouth and throat such as mouth washes, gargles,In mouth and throat such as
mouth washes, gargles, throat spray.throat spray. In body cavities such as douches, enemas, ear
drops,In body cavities such as douches, enemas, ear drops, nasal sprays.nasal sprays. On body surfaces
such as lotionsOn body surfaces such as lotions
• 23. Advantages of solutionsAdvantages of solutions  Liquids are easier to swallow therefore easier
for children,Liquids are easier to swallow therefore easier for children, old age and unconscious
people.old age and unconscious people.  A drug must be in solution before it can be absorbed (moreA
drug must be in solution before it can be absorbed (more quickly effective than tablets and
capsules)quickly effective than tablets and capsules)  A solution is an homogenous system, the drug
will beA solution is an homogenous system, the drug will be uniformly distributed throughout the
preparation (uniformuniformly distributed throughout the preparation (uniform dose than suspension
and emulsion which need shaking)dose than suspension and emulsion which need shaking)  Some
drugs can irritate the gastric mucosa if localized in oneSome drugs can irritate the gastric mucosa if
localized in one area. Irritation is reduced by administration of a solution ofarea. Irritation is reduced by
administration of a solution of the drugthe drug
• 24. Problem associated with the manufacturing of solutionsProblem associated with the
manufacturing of solutions disadvantages of solutionsdisadvantages of solutions  Liquids areLiquids are
bulkybulky and inconvenient to transport and storeand inconvenient to transport and store  TheThe
stabilitystability of ingredients in aqueous solution is oftenof ingredients in aqueous solution is often
poor than in solid dosage formpoor than in solid dosage form  Solution provide suitable media for the
growth of micro-Solution provide suitable media for the growth of micro- organisms and may require
the addition oforganisms and may require the addition of preservativepreservative  Accurate dose
measuring depends on the ability of patientAccurate dose measuring depends on the ability of patient
to measure the dose (needs an accurate spoon to measureto measure the dose (needs an accurate
spoon to measure the dose)the dose)  TheThe tastetaste of a drug is always pronounced when it inof a
drug is always pronounced when it in solution (unpleasant taste or odours are difficult to mask)solution
(unpleasant taste or odours are difficult to mask) Major signs of instability: color change,
precipitation,Major signs of instability: color change, precipitation, microbial growth, chemical gas
formation.microbial growth, chemical gas formation.
1. Presented by:Asst. Prof. Ma. Lourdes L. Mojares, R. Ph.CEU School of PharmacyManila

6. • 2. SOLUTIONS: DEFINITION Liquid preparations that contain one or more chemical substances
dissolved in a suitable solvent or mixture of (mutually miscible) solvents. It may be oral, otic, opthalmic
or topical.
• 3. SOLUBILITYFACTORS AFFECTING SOLUBILITY1. Temperature2. Chemical and physical properties of
the solute and the solvent3. Pressure4. pH of the solution5. State of subdivision of the solute6. Physical
agitation applied to the solution as it dissolves
• 4. 1. Effect of Temperature Chemicals with Positive Heat of Solution The kind that absorbs heat
when dissolved. It results to an increased solubility with an increase in temperature.
• 5. 1. Effect of Temperature Chemicals with Negative Heat of Solution The kind that releases heat
when dissolved. It results to an decreased solubility with an increase in temperature.
• 6. 2. Effect of PhysicochemicalProperties (pressure, temperature) of the solute and solvent The
solubility of a “pure” chemical substance at a given temperature and pressure is constant.
• 7. 3. State of subdivision of the solute (particle size) The “finer” the powder, the greater the surface
area that comes in contact with the solvent. Therefore, the more rapid the dissolving process.
• 8. 4. Physical Agitation Applied to the Solution As It Dissolves The greater the agitation, the more
unsaturated solvent passes over the drug. Therefore, the faster the formation of a solution.
• 9. 5. Effect of pH of the Solution Many important organic medicinal agents are either “weak acids”
or “weak bases.” Drugs as weak bases are not very water-soluble, but are soluble in dilute solutions of
acids.
• 10. 5. Effect of pH of the Solution Drugs as weak acids form water- soluble salts in basic solutions.
These drugs may separate from the solution by lowering the pH of the solvent system.
• 11. Techniques to hasten dissolution Application of heat Reduction of particle size of the solute
Use a solubilizingagent Subject the ingredients to vigorous agitation
• 12. Some solvents for liquid preparations ALCOHOL, USP DILUTED ALCOHOL, NF RUBBING
ALCOHOL GLYCERIN, USP ISOPROPYL RUBBING ALCOHOL PROPYLENE GLYCOL, USP PURIFIED
WATER, USP
• 13. 1. ALCOHOL, USP The most useful solvent, next to water. 94.9% to 96% C2H5OH (v/v) Miscible
with water and has the ability to dissolve many water- insoluble ingredients (flavorants, preservatives).
With preservative effect
• 14. 2. DILUTED ALCOHOL, NF Contains equal volumes of Alcohol, USP and Purified Water, USP. 49%
concentration A useful hydroalcoholic solvent.
• 15. 3. RUBBING ALCOHOL Contains about 70% Ethanol v/v. Volatile and Flammable, should be
stored in tight containers, remote from fire. Used externally as rubefacient, soothing rub, germicide
(for instruments), skin cleanser (prior to injection), vehicle in topical preparations.
• 16. 4. GLYCERIN, USP Glycerol , CH2-OH-CHOH-CH2OH Clear, viscous syrupy liquid with sweet
taste Miscible to both water and alcohol

7. • 17. 4. GLYCERIN, USP Comparable to alcohol, as solvent. Solutes are slowly soluble (requires
heating) Preservative, stabilizer, auxilliary solvent with water and alcohol Used extensively in internal
preparations.
• 18. 5. ISOPROPYL RUBBING ALCOHOL 70% v/v isopropyl alcohol. Commercially available as 91%
External Uses: rubefacient, soothing rub, vehicle for topical products.
• 19. 5. ISOPROPYL RUBBING ALCOHOL Commonly employed by diabetic patients in preparing needles
and syringes for hypodermic injections of insulin. Skin disinfection of diabetic patients.
• 20. 6. PROPYLENE GLYCOL, USP CH3CH(OH)CH2OH Viscous liquid, miscible with water and alcohol.
Useful solvent with a wide range of applications. Substitute for glycerin
• 21. 6. PURIFIED WATER, USP For preparation of aqueous dosage forms, except those intended for
parenteral administration. Contains 1% as much dissolved solids as tap water
• 22. TYPES OF SOLUTIONSAs to its use: As to composition1. Oral solutions  Aromatic waters2. Topical
solutions  Syrups3. Ophthalmic  Elixirs solutions  Spirits4. Nasal and Otic solutions  Tinctures and
fluidextracts  Douches, Enemas and* 3 and 4 are discussed gargles in Chapter 17  Liniments,
collodions, and others
• 23. 1. ORAL SOLUTIONSCOMPONENTS Medicinal agents Flavorants, Colorants and Sweetening
agents Stabilizers (glycerin or sorbitol) – used to inhibit crystallization and to modify solubility
Preservatives (parabens) Vehicles
• 24. ORAL SOLUTIONSADVANTAGES DISADVANTAGES1. Homogenous 1. Bulky2. Easier to swallow than
2. Degrade more the solid dosage forms rapidly3. Onset of action and 3. More likely to bioavailability of
interact with other drugs that have slow constituents dissolution rate are improved
• 25.  DRY POWDER FOR SOLUTIONDry powder for reconstitution prior to useExamples: Cloxacillin
Na, Oxacillin Na and Penicillin VK for oral solution (antibiotics) ORAL REHYDRATION
SOLUTIONAvailable in liquid or packet of powder for reconstitutionExamples: Pedialyte and
Rehydrate solution, Glucolyte, Oresol ORAL COLONIC LAVAGE SOLUTION OTHERS – Magnesium
citrate solution
• 26. PEDIALYTE ORS
• 27. GlucolyteOral Rehydration Solution
• 28. Magnesium citrate Oral Solution
• 29. 2. TOPICAL SOLUTIONS Employed an aqueous vehicle Should be labeled “FOR EXTERNAL USE
ONLY”Examples:1. Aluminum Acetate Solution2. Calcium Hydroxide Topical Solution3. Hydrogen
Peroxide Topical Solution4. ChlorhexidineGluconate Solution5. Povidone Iodine Solution6. Strong Iodine
Solution
• 30. TOPICAL SOLUTIONS
• 31. 3. OTIC SOLUTIONS Ear or aural solutionsUSES: For the removal of excessive cerumen
Examples: Cerumenex Ear drop, Debrox Drops For the treatment of ear infections, inflammation, or

8. pain Examples: AuralganOtic Solution, AmericaineOtic, ChloromycetinOtic, CorticosporinOtic, Otobiotic
solution, VoSolOtic Solution
• 32. CERUMENEX and DEBROX OTIC SOLUTIONS
• 33. AURALGAN OTIC SOLUTION
• 34. VOSOL andHYDROCORTISONE OTIC SOLUTIONS
• 35. VoSoL OTIC SOLUTION LABELLING
• 36. METHODS OF PREPARATION of SOLUTIONS SIMPLE SOLUTION METHODExample: Strong Iodine
(Lugol’s) Solution SOLUTION BY CHEMICAL REACTIONExample: Magnesium Citrate Solution SOLUTION
BY EXTRACTION
• 37. PHARMACEUTICAL SOLVENT WATERS PURIFIED WATER, USP WATER FOR INJECTION, USP
STERILE WATER FOR INJECTION, USP BACTERIOSTATIC WATER FOR INJECTION, USP STERILE WATER
FOR INHALATION, USP STERILE WATER FOR IRRIGATION, USP* WFI, SWFI and BWFI are discussed in
Chapter 15
• 38. PURIFIED WATER, USP Obtained by: distillation, reverse osmosis or by ion exchange treatment
pH 5 to 7 Contains NMT 10 ppm of total solids Used in preparations and in finished and manufactured
products, except for the preparation of parenterals and ophthalmic products
• 39. WATER FOR INJECTION, USP Conforms with the standards of Purified Water, USP but is also
pyrogen-free. Intended to be used in the manufacture of injectable products which are to be sterilized
after their preparation. Intended to be used for 24-hours after its collection.
• 40. STERILE WATER FOR INJECTION, USP WFI that has been sterilized Packaged in single-dose
containers of type I or type II glass that do not exceed the capacity of 1 liter Intended to be used as a
solvent, vehicle or diluent for already-sterilized and packaged injectable medications
• 41. BACTERIOSTATIC WATER FOR INJECTION, USP SWFI that contains one or more suitable
bacteriostatic agents Packaged in pre-filled syringes or in vials containing NMT 30 mL Employed as a
sterile vehicle in the preparation of small volumes of injectable preparations (in multiple-dose vials) To
be labeled “NOT FOR USE IN NEWBORNS”
• 42. STERILE WATER FOR IRRIGATION, USP Same requirements as SWFI except in container design,
particulate matter and labeling LabelingRequirements: “ For Irrigation Only ” “ Not for Injection ”
• 43. AROMATIC WATERS Are clear, saturated aqueous solutions of volatile oils or other aromatic or
volatile substances A pleasantly flavored vehicle for water soluble drugs or an aqueous phase in an
emulsion or suspension
• 44. AROMATIC WATERS Addition of electrolytes may result to “salting-out” of the volatile
ingredient Must be free from empyreumatic (smoke-like) odors. Stored in a tightly closed, light-
resistant containers Protect from excessive heat
• 45. Methods of Preparation of Aromatic Waters DISTILLATIONCOHOBATION – the process of
redistillation two or more times until the distillate becomes clear SOLUTION METHOD – the volatile, or

9. aromatic substance is admixed with water, with or without the use of a dispersant (e.g. talc) A. Simple
Solution B. Alternate Solution

10. aromatic substance is admixed with water, with or without the use of a dispersant (e.g. talc) A. Simple
Solution B. Alternate Solution