This document discusses liquid dosage forms, specifically pharmaceutical solutions. It defines solutions as liquid preparations containing one or more substances dissolved in a suitable solvent. It describes the classification of solutions as monophasic or biphasic and for internal or external use. The key components of solutions are discussed including solvent systems, drug properties, excipients, stability considerations, and factors influencing drug solubility. Specific liquid dosage forms like elixirs are also outlined. In summary, the document provides an overview of the formulation and properties of pharmaceutical solutions as a type of liquid dosage form.

1. Pharmaceutics-IIB (Dosage Form Science Lab) Pharm 406
“GROUP NO. 5 A”
Submitted to: Ma’am Tehmina Adnan
Submitted by:
• Aleeza Rashid (R-008), CMS: 112-2019
• Hafiza Ameema (R-028), CMS: 108-2019
• Nashia Farid (R-064), CMS: 114-2019
• Sara Ishaque Shaikh (R-078),CMS: 117-2019
• Taqdees Sohail (R-094), CMS: 111-2019

2. INTRODUCTION
DOSAGE FORMS:
There are four types of dosage forms:
1- Solid
2- Semi solid
3- Liquid
4- Gaseous
LIQUID DOSAGE FORM:
Liquid dosage forms are essential pharmaceutical products which involves a mixture of
active components and excipients.
ROUTES OF DRUG ADMINISTERATION:
Routes of
drug delivery
Parenteral Oral
Oral
cavity
Topical Pulmonary
Otic
(ear)
Nasal Ocular Vaginal Rectal

3. CLASSIFICATION OF LIQUID DOSAGE FORM:
Classification
of liquid
dosage form
Monophasic
liquid
dosage form
Biphasic
liquid
dosage form
Internal use External use Internal use External use
Elixir Mouth:
Syrup Gargles
Linctus Mouth washes
Oral lavage solution Skin:
Oral rehydrating solution Lotions, Liniments
Parenteral Others:
Nasal drops
Ear drop
Suspension Emulsion

4. MONOPHASIC LIQUID DOSAGE FORMS:
Monophasic liquid dosage form contains two or more components in one phase system. It is
represent by true solution.
● A true solution is a clear homogenous mixture that is prepared by dissolving solute in a suitable
solvent.
MONOPHASIC LIQUID DOSAGE FORM FOR ORAL USE:
 Elixirs
 Syrups
 Linctuses
 Oral Rehydrating Solutions (ORS)
 Oral lavage solutions
 Gargles
 Mouth washes

5. PHARMACEUTICAL SOLUTIONS:
Solutions are liquid preparations that contain one or more chemical substances dissolved in a
suitable solvent or mixture of mutually miscible solvents.
● Most solutions intended for oral administration contain flavorants and colorants to make the
medication more attractive and palatable. When needed, they may also contain stabilizers to maintain
the chemical and physical stability of the medicinal agents and preservatives to prevent the growth of
microorganisms in the solution.
● Pharmaceutical solutions are preparations in which the solid solutes, i.e. drug and excipients, are
dissolved in a liquid solvent system.
● Solutions can be prepared by simple mixing of the solutes with the solvent system. In industry,
solutions are prepared in large mixing vessels.

6. ADVANTAGES AND DISADVANTAGES OF
PHARMACEUTICAL SOLUTIONS
ADVANTAGES
● The drug is already dissolved in the solvent
system; hence drug action can be rapid, allowing
its use in emergencies.
● The drug immediately available for
absorption.
● Solutions provide dose uniformity.
● Oral solutions are easily swallowed.
● Solutions are generally easier to manufacture
than other dosage forms.
DISADVANTAGES
● Many drugs are inherently unstable, and
instability is increased when a drug is present in
solution (i.e. as molecules).
● Many drugs are poorly soluble in water. Their
formulation as a solution is challenging.
● Liquids are bulky and less easy for the patient
to carry (e.g. the daily dose) than solid dosage
forms. Liquids are also more expensive to
transport, which increases the medicine’s cost.
● Oral solutions can undergo the process of
liver first pass metabolism which decreases the
bioavailability.
● The packaging of pharmaceutical solutions
requires materials of higher quality.

7. THE SOLVENT SYSTEM:
AQUEOUS SYSTEM:
● The majority of pharmaceutical solutions are water based. Water is the most commonly used solvent
due to its many advantages, such as its lack of toxicity and low cost.
● For non parenteral solutions Potable (drinking) water is purified, for example, by distillation, ion
exchange or reverse osmosis to produce ‘Purified Water’.
● For parenteral solutions, potable water is further purified to remove pyrogens (water-soluble, fever-
producing compounds) producing ‘Water for Injections’.
● In extemporaneous dispensing, potable water, freshly drawn from a mains supply and/or purified
water, freshly boiled and cooled, can be used to prepare oral or external solutions.
● Water does not dissolve many drug compounds to a sufficient degree to enable the preparation of a
pharmaceutical solution. Other water-miscible liquids with greater ability to dissolve drugs may
therefore be added to water to enhance drug solubility. These liquids are called cosolvents. Commonly
used examples include glycerol, propylene glycol, ethanol and polyethylene glycol.
COSOLVENTS:
Cosolvents are generally less innocuous than water, and the concentration used in an aqueous solution
is limited primarily by their toxicity, by drug solubility in the formulation and cost.

8. NON AQUEOUS SYSTEM:
● Nonaqueous solvent systems are used when the drug is insufficiently soluble or stable in aqueous
systems, or when a solution is intended for specific properties, such as sustained drug absorption.
● Nonaqueous solutions are limited to certain delivery routes, such as oral, intramuscular and topical, due
to their toxicity, irritancy or immiscibility with physiological fluids.
● There are huge number of organic liquids in which drugs can dissolve, the majority are toxic, and
consequently only a few are used in pharmaceutical solutions.
● Examples of commonly used organic liquids are alcohols, esters, dimethyl sulfoxide etc. These liquids
are used as cosolvents with water, as cosolvents with other organic liquids, or on their own.
DRUG:
The drug may be a low molecular weight such as aspirin, or a large biotherapeutic molecule, such as
insulin or an antibody. It is present in a solution as molecules or ions throughout the solvent. It is usual to
ensure that the drug concentration in a pharmaceutical solution is well below its saturation solubility.
EXCIPIENTS:
● Excipients are substances other than the drug or prodrug which are included in pharmaceutical
solutions.
● These are used for a number of reasons, such as to enhance product stability, bioavailability or patient
acceptability, or to aid product manufacture and/or identification.
● The excipient must be nontoxic, nonsensitizing and nonirritating, as well as compatible with all the
other
components of the formulation.
● The route of administration is important because many excipients are acceptable by certain, but not all,
routes.

9. EXCIPIENTS USED IN PHARMACEUTICAL SOLUTIONS:
EXCIPIENTS EXAMPLES OF EXCIPIENTS
CO-SOLVENTS Ethanol, glycerol, propylene glycol.
FLAVOURING
AGENTS
Used to mask the taste of drugs.
E.g. vanilla, raspberry, orange oil, and lemon oil are used for oral solutions
and Menthol is used in both oral and nasal solutions.
COLORING AGENTS A coloring agent should correlate with the flavouring agent.
E.g. green with mint flavor.
SWEETNERS Used to improve the palatability of oral solutions.
E.g. sucrose, sorbitol, mannitol.
ANTIMICROBIAL
PRESERVATIVES
Used to preserve multidose preparations.
E.g benzyl alcohol, combination of parabens (methyl, propyl, butyl).
ANTIOXIDANTS Used to stabilize solutions.
E.g. Sodium metabisulfite, sodium sulfite, ascorbic acid.
CHELATING AGENTS Used to increase solution stability. E.g. Disodium edetate
pH ADJUSTERS Acids: E.g. citric acid, buffers.
Alkalis: E.g. sodium hydroxide, buffers.
ISOTONICITY
ADJUSTERS
Sodium chloride, potassium chloride, mannitol.
VISCOSITY
ENHANCERS
Hypromellose, hydroxyethylcellulose, poly(vinyl alcohol), dextran.

10. SOLUTION STABILITY:
A pharmaceutical solution must be stable for the duration of its shelf life (period of storage and use). That
is,
it must retain the same physical, chemical, microbiological, therapeutic and toxicological properties that
it possessed at the time of its manufacture.
Pharmaceutical solutions are therefore formulated at the pH favouring drug stability, and often include
excipients to enhance product stability.
● To reduce photooxidation, solutions are packaged in containers that do not allow light transmission.
● To reduce oxidation, antioxidants and/or metal chelators (as heavy metal ions catalyse oxidation) are
used.
● To inhibit microbial growth during use, preservatives are used in multidose products.
In addition, the excipient must remain in the solution throughout the shelf life of the product. That is,
the concentration of the excipient must not decrease.
DISSOLUTION:
Dissolution is the time-dependent process of a drug dissolving into a solvent to form a solution.
Dissolution is typically the first step in absorption of a drug and is a critical factor in the drug’s
bioavailability.
Dissolution is an extrinsic property which means that dissolution can be modified through changes to the
● Drug’s particle size distribution
● Surface characteristics s
● Solid-state, or
● through inclusion of certain excipients.

11. A drug may also be categorized in terms of relative solubility, where solubility is the parts of solvent
required to dissolve 1 part of solute (drug).USP defines solubility qualitatively as described below;
USP term Solvent parts
required to
dissolve 1 part of
solute/drug
Solubilit
y
(mg/mL
)
Very soluble Less than 1 >1000
Freely
soluble
1–10 100–
1000
Soluble 10–30 30–100
Sparingly
soluble
30–100 10–30
Slightly
soluble
100–1000 1–10
V. Slightly
soluble
1000–10,000 0.1–1
Practically
insoluble
Greater than
10,000
<0.01
If the aqueous solubility of drug at selected pH of formulation is ;
• high therapeutic drug is incorporated into vehicle &formulated as oral sol.
• moderate solubility of drug in sol. must be enhanced using co-solvents.
• low The difference between aqueous solubility of drug & required conc. is
too great to the use of co-solvents or surfactants in the solubilized form & toxic
when administered orally. Therefore drug is to be formulated as a suspension
In case of liquid–liquid solutions, solubility is defined in terms of miscibility. In liquid
solvents,
It exists in 2 states: Completely miscible or partially miscible
"The maximum amount of the drug that can be dissolved in a solvent at a specific
temperature and pressure.”
DRUG SOLUBILITY
“it is the ability of one liquid to mix (or dissolve) in another liquid.”

12. FACTORS
INFLUENCING
SOLUBILITY
DRUG’S PHYSICOCHEMICAL PROPERTIES
Solubility of drug molecules in a solvent are dependent on several physicochemical properties, including molecular
weight, volume, density, and number of hydrogen bonds.
• Particle size ∝ 1/rate of solubility.
• solubility of a chemically related drugs ∝ 1/ melting points of the drugs
• Solubility of a drug is directly affected by the type of chemical substituent groups.
• Solubility of drugs containing hydrophilic groups > those containing lipophilic substituent groups
TEMPERATURE
• In most drug compounds having positive heat of solution; solubility ∝ temperature.
• In cases, where drug may have negative heat of solution; addition of heat decreases its solubility.
pH and pKa
Solubility of therapeutic agents is pH-dependent as majority are either acids or bases. pKa of the drug
is also important as it determines degree of ionization of drug at a specific solvent pH.
• Solubility of acids & bases ∝ degree of ionization.
• When solubility decreases with addition of an electrolyte salting-out.
• If solubility increases with addition of an electrolyte salting-in.
• The solubility of acidic compounds increases as the pH of the sol. is increased (above the pKa) &
solubility of basic compounds increase as pH is lowered (below the pKa)
POLARITY
Solubility follows the rules of “like dissolves like.”
• Polar substances solubilize in polar solvents (water & ethanol) through dipole–dipole interactions & hydrogen bonding,
• Nonpolar substances solubilize in nonpolar solvents (chloroform, Conc. acid or alkali) through Van der Waals interactions.
Equally, the organic bases more soluble in organic solvents than the corresponding salt forms.

13. Nature of the solubility enhancer depends on; Drug molecule ,Route of administration, Intended patient population.
METHODS TO ENHANCE THE SOLUBILITY
PHYSICAL MODIFICATIONS
• Particle size reduction increased surface area
• Complexation is the interaction of a poorly soluble therapeutic agent with an organic molecule, (e.g. surface-
active agents, hydrophilic polymers) to generate a soluble intermolecular complex.
• Solubilization by surfactants lowered the surface tension.
CHEMICAL MODIFICATIONS
• Salt formation Among the therapeutic agents available in salt form, drug salt with required solubility in
dosage form can be easily selected
• Optimization of pH The acceptable pH range for oral sols is large, ranging from 5 to 8 pH units. For organic
solutes that are ionizable, changing the pH of the system is the simplest and most effective means of increasing
aqueous solubility.
• Use of buffer Buffer maintains the pH of the solution overtime and it reduces or eliminate the potential for
precipitation upon dilution. On dilution pH alteration occurs that decrease solubility.
OTHER METHODS
Co-solvency
Co-solvents are liquid components prepared by mixing miscible or partially miscible solvents & used to enhance
solubility of poorly soluble drugs. E.g. glycerol, propylene glycol, ethanol and polyethylene glycol etc.
Cosolvent system reduces the interfacial tension between the aqueous solution &hydrophobic solute. Choice of co-
solvent for a particular formulation involves consideration of solubility of therapeutic agent in vehicle, toxicity of
vehicle & cost of formulation.

15. ELIXIRS
TYPES OF ELIXIRS
Non Medicated Elixir
employed as vehicle & used in
extemporaneous filling involving
Medicated Elixir
employed for therapeutic effect of the
drug they contain
“Elixirs are clear, sweetened hydro-alcoholic solutions intended
for oral use and are usually flavored to enhance their palatability.”
E.g.
 Antihistamine Elixirs
 Barbiturate Sedative and Hypnotic
Elixirs
 Phenobarbital Elixir
 Digoxin Elixir
 Addition of a therapeutic agent to a
pleasant tasting vehicle
 Dilution of an existing medicated elixir
E.g. Aromatic elixir, Iso-alcoholic elixir,
compound benzaldehyde elixir

16. TYPES OF MEDICATED ELIXIRS
COMMERCIAL PRODUCT USES
Brand: Benadryl Allergy
Generic: (Diphenhydramine Elixir)
Provides fast, effective symptom relief from allergies and allergic reactions:
Skin Itch, Sneezing, Itchy throat, watery eyes, Itchy, runny nose, Hives.
COMMERCIAL PRODUCT USES
Brand: Welldorm
Generic :(Chloral hydrate)
Short term pediatric treatment of insomnia. May also be used as a sedative
before a procedure or test & or to reduce pain and anxiety after surgery.
Antihistamines elixirs are useful primarily in the symptomatic relief of certain allergic disorders.
Side effects: most common untoward effect is sedation. Other common adverse effects include dryness of
the nose, throat, and mouth; dizziness; and disturbed concentration.
Barbiturates are sedative and hypnotic agent that use to produce various degree of CNS depression. They’re
administered in;
• small doses (daytime) as sedatives to reduce restlessness and emotional tension.
• Greater doses (before bed time) as hypnotics to release insomnia.
Side effects: Large dose increases the effect from sedation to hypnosis to respiratory depression , leading to
death due to fatal barbiturate over dosage.
Barbiturates are classified according to the duration of their hypnotic effect .i.e.
i. Long acting i.e. Phenobarbital , ii. Intermediate acting i.e. Amobarbital , iii. Short acting i.e. Secobarbital,
iv. Ultra short acting i.e. Thiopental
ANTIHISTAMINES ELIXIRS
BARBITURATE SEDATIVE/HYPNOTIC ELIXIRS

17. TYPES OF MEDICATED ELIXIRS
COMMERCIAL PRODUCT USES
Brand: Debritone Elixir
Generic: (Phenobarbitone)
Used as an Anticonvulsant & sedative. It help control certain kinds
of seizures & treat sleep problems,insomnia.
COMMERCIAL PRODUCT USES
Brand: Lanoxin PG Elixir
Generic: (Digoxin)
Increases force of myocardial infarction. Used in CFC, A
trial fibrillation and other cardiac conditions
Digoxin is a cardio tonic glycoside obtained from the leaves of Digitalis lanata. It is white crystalline
powder that is insoluble in water but soluble in dilute alcohol solutions. It is required to contain 4.5 to
5.25 mg of digoxin per 100 ml of elixir or about 0.25 mg per 5 ml teaspoon.
Digoxin is poisonous and its dose must be carefully determined and administered to each individual
patient. Official elixir contains about 10% alcohol.
Phenobarbital elixir, a long acting barbiturate is formulated to contain phenobarbital 0.4%,which
provides about 20 mg of drug per teaspoonful (5mL)of elixir, with a duration of action of 4-6 hours .
Official elixir contain 14% alcohol which is use to dissolve phenobarbital.
A usual dose as a sedative of about 30mg and hypnotic dose of about 100mg.
PHENOBARBITAL ELIXIR
DIGOXIN ELIXIR

18. Vehicles
Water, Alcohol,
syrup, glycerin,
sorbitol
&propylene
glycol Adjuncts
improve Safety,
efficacy and
palatability
Chemical
Stabilizer
Citric acid and
disodium edtate in
Neomycin Elixir.
Preservative
20% alcohol,
syrup and methyl
paraben & propyl
paraben
Colouring
Agent
Coal tar dyes
Flavoring agent
black current,
raspberry, lemon
or orange syrup
etc.
FORMULATION/
COMPOSITION
Note : Elixirs containing more than 10 to 12%
of alcohol are usually self-preserving and do
not require the addition of an antimicrobial
agent.

19. Elixirs should be brilliantly clear and therefore strained or filtered, if necessary, subjected to
clarifying action of purified talc or siliceous earth.
When the 2 solutions are completely mixed, mixture is made to volume with the specified
solvent or vehicle.
Frequently the final mixture will be cloudy because of separation of some of the flavoring
oils by the reduced alcoholic concentration.
Alcohol-soluble &water-soluble components are generally dissolved separately in alcohol
and in purified water, respectively.
Then the aqueous solution is added to the alcoholic solution to maintain highest possible
alcoholic strength at all times so minimal separation of alcohol-soluble components occurs.
Elixirs are usually prepared by
simple solution with agitation
by admixture of two or more liquid
ingredients
PREPARATION

20. • Elixirs usually contain 5-40% alcohol. Individual monograph instructions are followed for alcohol
determination
• It is suitable for examining most fluidextracts ,tinctures and elixirs provided the capacity of the distilling
flask is sufficient (commonly 2to 4times the volume of the liquid to be heated) and the rate of
distillation is such that clear distillates are produced.
• Cloudy distillates can be clarified by agitation with talc, or calcium carbonate filtration.
• After, temperature of the filtrate is adjusted & the alcohol content determined from the specific gravity.
During all operations, take precautions to minimize the loss of alcohol by evaporation.
Viscosity measurement is a highly important quality control test incase of syrups &elixirs. Viscosity is a
property of liquids directly related to the resistance to flow.
Viscosity & consistency directly proportionate with stability of solutions & may be measured through
various methods; U tube, Capillary tube Viscometer, Rotating viscometer method etc.
QUALITY CONTROL TESTS FOR ELIXIRS
DRY ELIXIRS
Dry Elixirs can be produced by dissolving a solution of water-soluble dextrin and drug in an ethanol-water
cosolvent system & spray-drying it. This type of dosage form may be useful to increase:
Solubility, Dissolution & Bioavailability of the drug
1. DETERMINATION OF ALCOHOL CONCENTRATION
2. VISCOSITY MEASUREMENT

21. ELIXIR
 Elixirs containing 10-12% alcohol are
self-preserving.
 Better able to maintain both water-soluble
and alcohol-soluble components in
solution.
 Has stable characteristics.
 Easily prepared by simple solution.
 Easily administered in patients having
problem of swallowing solid dosage
form.
 Used as a vehicle.
 Used for dilution of medicated elixirs.
 Contains alcohol, can be vicious to
children and adults who avoid alcohol.
 Less effective than syrups in masking
taste of medicated substances.
 Because they contain volatile materials,
it must be stored in a air-tight screw-
top jar to avoid their escape.
 Needed to keep away from sources of
ignition.
ADVANTAGES DISADVANTAGES

22. CHOICE OF CONTAINER
STORAGE CONDITIONS
PATIENT COUNSELLING
Plain amber medicine bottle with CRC,
Suggested discard date for most elixirs is about 4 weeks.
Keep below 30°C (at room temperature).
Container should be tightly closed.
Keep in light resistant amber color container;
Protect from direct sunlight.
LABELLING REQUIREMENTS
The functions of a label are to indicate clearly:
 The contents of the container
 How & when the medicinal product should
be taken &used
 How product should be stored & for how
long
 Any warnings or cautions the patient needs
to be made aware of
 Always use the medicine exactly as described in the leaflet or as your doctor or pharmacist has told you.
 After use, wipe the neck of the bottle with a clean damp cloth, which will remove any liquid left before putting the cap back on.
 Do not drink alcohol while you are taking the Elixir as it can affect the way the medicine works.
 Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant, or think you may be
pregnant.
 You should not take Elixir if you are breast-feeding, because small amounts may pass into mothers’ milk which can be harmful
to your baby.
 You may feel drowsy or sleepy while taking this medicine or in the morning after taking this medicine. If this happens, do not
drive or use any tools or machines.
 If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.

24. “Syrups are concentrated aqueous preparations of a sugar or sugar substitute with or
without flavoring agents and medicinal substances”.
TYPES OF SYRUPS
 Sucrose is the sugar employed most frequently in syrups but in special circumstances such as for diabetic patients and
others whose diet is restricted to non-glycogenetic substances (methyl cellulose). Sucrose may be replaced to make
non sucrose based syrups. (sorbitol, Glycerin, propylene glycol).
 The characteristic body that sucrose and alternative agents tends to impart to syrup is the result of achieving the
proper viscosity.
 Pharmaceutical preparation that is made with this consistency along with sweetness and flavors have ability to mask
the taste of added medicaments.
Medicated Syrups Syrups containing medicinal substances e.g. Cough syrup.
Non Medicated Syrups
Syrups containing flavoring agents but not medicinal substances are called non-medicated
or flavored vehicles (syrups). Usually used in extemporaneous preparation e.g. Cherry
syrup
Simple Syrups It is a solution of 85% w/v sucrose dissolved in purified water (USP) e.g. Sucrose syrup.

25. TYPES OF MEDICATED SYRUP
 Analgesic
Paracetamol, (Mepridine HCL)
USES : Paracetamol is commonly used for its analgesic and antipyretic effects.
 Anticonvulsant
Depakene syrup (Sodium valproate)
USES : Sole or adjunctive therapy in simple, complex absence seizure disorder
TYPES OF NON MEDICATED SYRUP
 Cherry syrup
Sucrose based syrup with cherry juice 47% by vol.
Acidic Ph makes it useful as a vehicle for drugs requiring acidic medium.
 Cocoa syrup
Suspension of cocoa powder in aqueous vehicle sweetened and thickened with sucrose.
Effective in administering bitter tasting drug to children.

26. COMPONENTS OF SYRUP
In addition to the purified water and any medicinal agents present:
In addition to these, syrups may contain special solvents, solubilizers, thickeners and stabilizers.
PREPARATION OF SYRUPS
 Solution of ingredients with the aid of heat.
 Solution of ingredients by Agitation without aid of heat.
 Addition of sucrose to a medicated or flavored liquid.
 Percolation of either the source of medicating substance or of the sucrose.
• Sugars Usually Sucrose or sugar substitute used to provide sweetness and viscosity.
• Anti microbial
preservatives
benzoic acid 0.1% to 0.2%, sodium benzoate 0.1% to 0.2%, and methyl parabens, propyl
parabens, and butyl parabens totaling about0.1%.
• Flavorants May be synthetic or naturally occurring such as volatile oils, vanillin etc.
• Colorants
a coloring agent that correlates with the flavorant employed(i.e., green with mint, brown
with chocolate,etc.)

27. SOLUTION Of ingredients WITH THE AID OF HEAT
 Used when it is desired to make syrup quickly and the ingredients are heat stable.
After performing QC tests packed and distributed.
BY AGITATION WITHOUT AID OF HEAT
 Used to avoid heat induced inversion of sucrose. It is more time consuming than previous method but product has
max stability.
Purified water
+ sugar
Heat applied
(Dissolution of
sugar occurs)
Heat stable
ingredient
added
Cool the
mixture to
room temp.
Volume is
adjusted by
purified
water
Add heat
labile
substances
Purified water
Sucrose + other
formulative agents are
added in large stainless
steel tank
Mixed them
by agitation

28. ADDITION OF SUCROSE TO A MEDICATED LIQUID OR FLAVORED LIQUID
 Generally Used for tinctures and fluid extracts. Most of them are prepared with alcoholic or hydro alcoholic vehicles.
 If alcohol soluble components are undesirable in corresponding syrup they are generally removed by:
PERCOLATION OF EITHER SOURCE OF MEDICATING SUBSTANCE OR SUCROSE
 This method is used to form an extractive to which sucrose or syrup may be added.
 This method have two separate procedures :first the preparation of the extractive of the drug and then the preparation
of the syrup.
 E.g. Ipecac syrup
Dissolve all
ingredients in
water
Allow the mixture
to stand still for
sometime
Precipitates
formed
Filter the mixture
Add sucrose to
form syrup

29. Quality control tests for syrups
Several tests are peformed, some of them are:
Container Requirements
 The material of container should be inert. It should be closed tightly.
 If the included substances required protection from light, should be maintained in light resistant container e.g. Amber.
 During storage and use of syrup involves crystallization of sugar within the screw cap. This issue can be overcome by
addition of polyhydric alcohols.
Labelling Requirements
Name of the product, List of active ingredients, Batch no assigned by manufacturer, Dosage, Expiry date, storage
conditions, Direction for use, Warnings, Precautions, Name and address of the manufacturer.
• Clean and purified vehicle (Distillation) • Sucrose concentration (Assay of Active ingredient)
• Viscosity • Refractive index
• Visual inspection • Specific gravity
• Ph measurement • Optical rotation

30. Patient Counselling
 Pharmacist should counsel the patient about correct use of corresponding dosage form.
 Possible Side effects and interaction of the medication.
 Counsel the patient about storage conditions.
MERITS DEMERITS
• Ability to mask the bad taste of drugs • Not suitable in emergency and for unconscious patient.
• Can be self administered • Not convenient for a patient having some GIT
disorders.
• Viscous nature contributes to soothing effect on
irritated throat tissues.
• Contain little or no alcohol convenient for both
pediatric and geriatric patient.
• Provide a mean for extemporaneous preparation of
medication.

31. MEDICATED SYRUP NON MEDICATED SYRUP
SIMPLE SYRUP

33. ORAL REHYDRATING SOLUTION
NAME OF PHARMACEUTICAL PRODUCT
GENERAL PRODUCT INFORMATION:
Oral rehydration solution (ORS) is an oral powder–containing mixture of glucose sodium chloride, potassium chloride, and sodium citrate. After being dissolved
in the requisite volume of water they are intended for the prevention and treatment of dehydration due to diarrhea, including maintenance therapy.
Low-osmolarity oral rehydration salts
PHARMACEUTICAL FORM
Oral powder. A white, crystalline powder; odorless
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT CHEMICAL FORMULA CONCENTRATION
Sodium chloride NaCl 2.6
Glucose anhydrous C6H12O6 13.5
Potassium chloride KCl 1.5
Trisodium citrate, dihydrate C6H5Na3O7,2H2O 2.9

34. APPEARANCE OF PRODUCT
A white, crystalline powder, odorless
APPEARANCE OF SOLUTION
The solution should be clear and odorless, or should have only a faint yellow stain.
PREPARATION OF ORS
Formulations are available for reconstitution . Then add the specific amount of water required to prepare the
powder forms. These products should not be mixed with or given with other electrolyte containing liquids such
as milk or fruit juices.
PREPARATION OF ORS AT HOME
• Six (6) level teaspoons of Sugar.
• Half (1/2) level teaspoon of Salt.
• One Litre of clean drinking or boiled water and then cooled - 5 cup fuls (each cup about 200 ml.)
PACKAGING AND PRESENTATION
ORS is a powder for dilution in 200 mL, 500 mL, and 1 L. Products are packed in hermetically sealed, laminated sachets. The sachets may be made of multi-ply
laminations with aluminum foil or polyethylene foil. The multi-ply laminated aluminum foil sachet is usually recommended for ORS. A compound of polyethylene
(inside), aluminum (middle), and polyester or any other suitable coating compound (outside) has proved to be a satisfactory combination for packing ORS.
The packaging configurations for ORS procured by UNICEF are:
– ORS low osmolarity, 20.5 g/1 L
– ORS low osmolarity, 10.2 g/0.5 L

35. LABELLING
ORS should be procured with packaging designated with:
(1) the total net mass and the mass of the contents of each constituent, both expressed in grams;
(2)the required volume of water to reconstitute the solution;
(3) directions for the preparation of the solution and its administration; and
(4) a warning that any solution that remains unused 24 hours after preparation is to be discarded..
STORAGE, TRANSPORTATION, AND DISTRIBUTION
ORS is stable at room temperature and does not require cold chain storage ORS should be kept in a sealed
packet; if a free-flowing powder is required, it should be kept in an airtight packet, preferably made of
aluminum laminate.
Discard any solution that remains unused 24 hours after preparation.
PRODUCT SPECIFICATIONS
The product must meet pharmacopoeia specifications, such as those of the International Pharmacopoeia,
US Pharmacopoeia, and British Pharmacopoeia, depending on the quality assurance policy of the procurement
agency or the equivalent thereof.
STABILITY
product stability also depends on these conditions: the raw material is dry, the sealing is perfect, and the final product is stored appropriately.
ORS containing citrate (as opposed to bicarbonate containing ORS) is stable at ambient temperatures/humidity and is unlikely to undergo any significant
degradation as a result of heat/humidity if it is properly manufactured, packaged, and sealed.
Storage condition: ORS should be kept in a sealed packet; if a free-flowing powder is required, it should be kept in an airtight packet, preferably made of aluminum
laminate.
Discard any solution that remains unused 24 hours after preparation

36. PATIENT COUNSELLING
RECOMMENDATION OF WHO AND UNICEF
Pharmacists advised patients or guardians, where appropriate, on preparing ORS, on the treatment schedule and instructed on the required storage conditions.
pharmacists would also advise on maintaining adequate nutritional intake
DEGRADATION
Shelf life: 2–3 years, depending on the manufacturer. It is recommended to check the product label before use.
DOSAGE
ORS and zinc are recommended by WHO for combination use to ensure the effective treatment of diarrhea; in order to improve compliance, a copackage of ORS
and zinc in accordance with WHO treatment protocol guidelines is offered by some manufacturers to improve treatment regimen adherence.
Age under
4 months
4 to 11
months
12 to 23
months
2 to 4
years
5 to 14
years
15 years
and over
Weight under 5 kg 5 to 7.9 kg 8 to 10.9
kg
11 to 15.9
kg
16 to 29.9
kg
30 kg and
over
ORS in
ml
200 to 400 400 to 600 600 to 800 800 to
1200
1200 to
2200
2200 to
4000

37. METHOD OF ADMINISTRATION
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ORS is indicated for the treatment of diarrhea and fluid loss due to diarrhea in infants, children, and adults.
The amount of ORS solution needed for rehydration is calculated based on the child’s weight. The amount of solution required also depends on the child’s
dehydration status. Children with more marked signs of dehydration or who continue to pass frequent watery stools will require more solution than those with less
marked signs or who are not passing frequent stools.
Administer with care in cases of acute dehydration, heat cramps, extensive tissue destruction, or if patients are receiving
potassium-sparing diuretics. It is very important to dissolve ORS in water of the correct volume. A weak solution will not contain
optimum glucose and electrolyte concentration and a strong solution may give rise to electrolyte imbalance.
Diarrhea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought. In
other age groups, if symptoms persist for more than 24–48 hours, consult a doctor. Diarrhea can have very serious consequences
in children under 3 years old. Immediate medical advice should be sought. In other age groups, if symptoms persist for more than 24–48 hours, consult a doctor.
UNDESIRABLE EFFECTS
The following adverse effects have been reported although more commonly following excessive amounts: hypernatremia, edema,
nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation, lachrymation, sweating, fever, tachycardia, renal failure,
respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching, coma, convulsions, hyperkalemia,
gastrointestinal ulceration, metabolic alkalosis, muscle hypertonicity, flatulence, dehydration, and raised blood pressure

38. PACKING
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
MANUFACTURING PROCESS
ORS is a straightforward product to manufacture, but some specific procedures should be observed to ensure the quality of the product. Recommendations and
technical procedures that should be considered during the manufacture of ORS include the following;
After prolonged storage in hot and humid climates, the raw materials may have absorbed a substantial amount of moisture,and have a water content higher than the
indicated limit of 1%. The use of such ingredients for the manufacture of ORS may result in accelerated decomposition. Therefore, if a raw material containing
water in excess of the indicated limit is to be used, it is preferable to dry it at the recommended temperature as follows: glucose, anhydrous at max. 105°C; sodium
chloride, potassium chloride, and trisodium citrate at max 130°C.
The kind of packaging material to be used for ORS depends mainly on the required standard of stability, the climatic
conditions, and the available resources.

40. ORAL COLONIC LAVAGE SOLUTION
a colonic lavage solution presently used for gut cleansing in preparation for colonic procedures, can be an effective agent in the treatment of chronic constipation.
Polyethylene glycol-electrolyte solution (PEG-ES)
GENERAL PRODUCT INFORMATION:
NAME OF PHARMACEUTICAL PRODUCT
PHARMACEUTICAL FORM
Oral powder, A white, crystalline powder
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPONENT CONCENTRATION
PEG-3350 236.00 g
Sodium sulfate 22.74 g
Sodium bicarbonate 6.74 g
Sodium chloride 5.86 g
Potassium chloride 2.97 g

41. ORAL COLONIC LAVAGE SOLUTION
a colonic lavage solution presently used for gut cleansing in preparation for colonic procedures, can be an effective agent in the treatment of chronic constipation.
Polyethylene glycol-electrolyte solution (PEG-ES)
GENERAL PRODUCT INFORMATION:
NAME OF PHARMACEUTICAL PRODUCT
PHARMACEUTICAL FORM
Oral powder, A white, crystalline powder
PREPARATION OF COLONIC LAVAGE SOLUTION
You will need to mix your medication with lukewarm water so that it will be ready to drink.
Read the directions that come with medication to see how much water should be added to the powder and whether to mix it in the container it came in or in another
container.
Shake or stir the mixture so that the medication is mixed evenly.
If your medication comes with flavor packets, you may add the contents of one packet to the medication to improve the taste, but should not add any other
flavorings to the medication.
Do not mix medication with any liquid other than water, and do not try to swallow the medication powder without mixing it with water.
After you mix your medication, you may chill it in the refrigerator to make it easier to drink.
However, if giving the medication to an infant, you should not chill it.

42. Cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in
combination with the electrolyte concentration, results in virtually no net absorption or excretion of
ions or water. Accordingly, large volumes may be administered without significant changes in fluid
and electrolyte balance.
CLINICAL PHARMACOLOGY
INDICATION AND USAGE
ADMINISTRATION INSTRUCTIONS PRIOR TO DOSAGE
It is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination
Traditionally, preparation of the bowel for procedures such as a colonoscopy consisted of administration
of a clear liquid diet for 24 to 48 hours preceding the procedure, administration of an oral laxative such
as magnesium citrate or bisacodyl the night before, and a cleansing enema administered 2 to 4 hours
prior to the procedure.
Consequently, an alternative method to prepare the gastrointestinal tract has been devised. This
procedure requires less time and dietary restriction and obviates the cleansing enemas. This method
entails oral administration of a balanced solution of electrolytes with polyethylene glycol
(PEG-3350-Electrolyte Solution), i.e., PEG-ES. Before dispensing it to the patient, the pharmacist
reconstitutes this powder with water, creating an iso-osmotic solution having a mildly salty taste.
Ideally the patient should not have taken any food 3 to 4 hours before beginning to take the solution .
In no case should solid foods be taken by the patient for at least 2 hours before the solution is administered
INSTRUCTIONS AFTER DOSAGE
No food except liquids are permitted after this product is administered and prior to the examination
The product must be stored in the refrigerator after reconstitution, and this is somewhat in decreasing the salty taste
7 DAYS
BEFORE
3 DAYS
BEFORE
2 DAYS
BEFOR
E
1 DAY
BEFORE
ON THE
DAY
take your
medicines
after
talking to
your
doctor
follow low
residue
diet
begin
your
bowel
prep
drink clear
liquids
only
don’t eat
food
continue
your
bowel
prep
finish your
bowel prep
don’t eat
food
don’t drink
anything 4
hrs before
your arrival
time

43. The recommended adult dose of this product is 4L of solution before the gastrointestinal procedure. The patient is instructed to drink 240 ml of solution every 10
mins until about 4L is consumed.
DOSAGE
ADVERSE EFFECTS
INFORMATION TO PATIENTS
no solid food should be ingested during the 3 to 4 hour period prior to the initiation of colonic lavage solution with flavor pack administration
The patient is advised to drink each portion quickly rather than sipping it continuously.
CONTRAINDICATIONS
Nausea, stomach pain, cramps, or fullness, bloating, rectal irritation, weakness, heartburn, thirst, hunger, Chills
Gastrointestinal (GI) obstruction, ileus, or gastric retention
• Bowel perforation
• Toxic colitis or toxic megacolon
• Known allergy or hypersensitivity to any component of solution
PRECAUTIONS
This product may contain inactive ingredients, which can cause allergic reactions or other problems
tell your doctor or pharmacist your medical history, especially of: certain stomach/intestinal problems
history of vomiting easily/often, heart problems not recommended when abdominal pain, nausea, or vomiting are present
Unconscious or semiconscious patients should be observed during the administration of solution

44. WARNING
PRINCIPAL DISPLAY PANEL
No other additional ingredients (e.g., flavorings) should be added to the solution

45. STORAGE AND STABILITY
Store the sachets and bottle at room temperature, between 15oC and 30oC.
Once reconstituted, the solution should be used within 48 hours after mixing if stored at room temperature.
If kept refrigerated (between 2oC and 8°C), use within 30 days. Discard unused
Portion

47. GARGLES & MOUTH WASHES:
GARGLES and MOUTHWASH both are used for different purpose.
•Gargle which is used to treat infections in the throat.
•Mouthwash is used for cleaning and de-odor the oral cavity.
TYPES OF MOUTH WASHES:
THERAPEUTIC MOUTHWASHES:
COSMETIC MOUTHWASHES
Serve clinical purposes, like attacking bacteria and plaque, or strengthening teeth with
fluoride & to reduce plaque, gingivitis, dental caries, and stomatitis.
A word of caution: overuse of an antiseptic mouthwash may cause tooth discoloration.
Serve only to mask bad breath and leave your mouth with a pleasant taste – like a mint
but doesn’t really do much against fighting decay, strengthening tooth enamel, or
protecting teeth.
A word of caution: mouthwash that contains alcohol may dry out the mouth and cause
more dental problems.
“Gargles & Mouthwashes are aqueous solutions that are intended for treatment of the
throat and are generally formulated in a concentrated form.”

48. OTHER TYPES OF MOUTH WASHES:
These are free of fluoride and alcohol. The most common natural mouthwash comes in the form of
warm water and salt. This concoction can reduce inflammation, ease gum bleeding, and fight against
bacteria.
A word of caution: don’t swallow the saltwater, just swish.
Fight against bacteria and prevent the buildup of plaque and gum diseases.
NATURAL MOUTHWASH
FLUORIDE MOUTHWASH
TOTAL CARE MOUTHWASH:
Fluoride mouthwash contains sodium fluoride, which is use to help build strong teeth and protect enamel
from decay.
fluoride mouthwash is not recommended for children under six.
A word of caution: mouthwash that contains alcohol may dry out the mouth and cause more dental
problems.

49. ACTIVE INGREGIENTS: PROPERTIES
1 Alcohol As a co-solvent may act to enhance the
antimicrobial properties of the therapeutic agent.
2 Chlorhexidine As an antiseptic to control plaque & gingivitis.
3 Fluoride Fights tooth decay and strengthens enamel.
4 Cetylpyridinium Chloride Eliminates bad breath and kills bacteria.
5 Hydrogen peroxide Whitens teeth.
6 Essential oils Antifungal and Antibacterial properties
7 Sodium Chloride Retard growth of microorganisms.
8 Sodium Bicarbonate Disinfectant and Antiseptic properties.
9 Sodium Lauryl Sulphate (sls) Anti-palque activity.
FORMULATION

50. INDICATIONS
TOPICAL PAIN
RELIEF
ALVEOLAR OSTEITIS
(DRY SOCKET).
TOOTH DECAY
PLAQUE AND
GINGIVITIS
WHITENING
ORAL
MALODOR
DIAGNOSTIC PURPOSE
XEROSTOMIA

51. Container:Amber fluted medical bottle(50 mL, 100
mL, 200 mL)
LABEL
COMPOUNDIND AND DISPENSING

53. “Linctuses are viscous, monophasic liquid preparation containing a high
concentration of syrup intended to sipped and swallowed slowly for
treatment of cough.”
Linctuses may also be formulated as sugar-free alternatives in which sucrose is
replaced by sorbitol and the required concentration of sweetening agent.
Prepared by Monophasic Liquid Preparation Method.
The usual dose of linctuses is 5.0 ml.
PREPARATION
DOSE
LINCTUSES

54. Vehicles: Syrup, (Tolu syrup), glycerin, sorbitol.
Adjuncts: Used to improve Safety, efficacy and palatability.
1. Chemical Stabilizer: Mostly stable because of syrup.
2. Preservative: High concentration of syrup acting as preservative.
Tolu syrup has antibacterial action due to benzoic acid and cinnamic
acid present in it.Benzoic acid in codeine phosphate linctuses.
3. Coloring Agent: Coal tar dyes.
4. Flavoring agent:black current syrup, lemon syrup, oxymel and
benzaldehyde etc
 Demulcent.
Sedative.
Expectorant action.
COMPOSITION
INDICATIONS

55. •Linctuses are supplied in well closed air tight container having
screw cap stored in a cool place, protected from light.
COMPOUNDIND AND DISPENSING
LABEL

56. REFERENCES:
•Pharmaceutical compounding and dispensing
•Essential pharmaceutics
•Aulton pharmaceutics
5th Edition
•Ansels pharmaceutical dosage forms and drug delivery system
9th Edition
•Remington(The science and practice of pharmacy )
21st Edition
BOOKS:
WEBSITES:
•https://www.webmd.com/drugs/2/drug-63819/elixir-oral/details
•http://www.uobabylon.edu.iq/eprints/publication_3_31959_6264.pdf
•http://pharmacy.uobasrah.edu.iq/images/stage_three/Pharmaceutical_Technology_I/3%20Elixirs.pdf
•https://www.rxlist.com/colyte-drug.htm#medguide
•https://www.pharmacompass.com/active-pharmaceutical-ingredients/golytely
•https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a8b15625-ca7c-4d57-9f36-
3ac2a6d13665&type=display

57. •https://journals.lww.com/ajg/Fulltext/2009/10003/Off_label_Use_of_Polyethylene_Glycol_3350.496.aspx
•https://europepmc.org/article/med/2178398
• https://medicalguidelines.msf.org/viewport/EssDr/english/oral-rehydration-salts-ors-16684387.html
•https://www.webmd.com/drugs/2/drug-13607/colyte-oral/details
•https://www.medlife.com/blog/world-ors-day-special-benefits-preparation/
•https://medlineplus.gov/druginfo/meds/a601097.html#how
•https://www.drugs.com/cons/oral-rehydration-salts.html
•https://www.ndrugs.com/?s=colonic%20lavage%20solution
•Preventive Dentistry - Wexford Dental - Different Types of Mouthwash - Dr. Chad Scott
(paragondentalpgh.com)
•https://www.academia.edu/36403285/Fasttrack_Pharmaceutics_Dosage_Form_and_Design_pdf
•Microsoft Word - DentifricesandMouthwashesIngredientsandtheir use20031.doc (uio.no)
•6.2.1.2.Liquid-preparations-for-oral-use.pdf (who.int)
•Linctuses is a form of Liquid Dosage, prepared using Monophasic Liquid Preparation Method
(preservearticles.com)
•http://flexiblelearning.auckland.ac.nz/pharmacy101/9/files/compounding_lecture_2012_for_cecil.pdf
WEBSITES: