Syrups and elixirs

2. Presented by:
M Nauman Siddique 23-E-14
M Arsalan Chishti 85-E-14
Presented to:
Ma’am Bushra

4. What are syrups?
Types of Syrups
Components of syrups
Preparation of Syrups
Aid of preparation of syrup

5. “Syrups are concentrated aqueous
preparations of a sugar or sugar
substitute with or without flavoring agents
and medicinal substances.”

6.  Simple syrup
 Medicated syrups
 Non-medicated syrups

7. A simple syrup contains only sucrose and
purified water (e.g. Syrup USP). Saturated
sugar solution without flavor or medicine.
Concentration of Syrup:
According to B.P:
67.7% W/W
According to USP:
85% W/V

8. “Syrups containing flavoring
agents but not medicinal substances
are called non-medicated or flavored
syrups”
Use:
 These syrups are to serve as pleasant tasting
vehicle for medicinal substances to be added
in the preparation of a standard formula for a
medicated syrup.

9.  Cocoa syrup
Suspension of cocoa powder in aqueous vehicle sweetened
and thickened with sucrose, liquid glucose, glycerin; flavored with
vanilla, sodium chloride. Particularly effective in administering
bitter-tasting drugs to children
 Orange syrup
Sucrose-based syrup uses sweet orange peel tincture, citric
acid as the source of flavor and tartness. Resembles orange juice in
taste; good vehicle for drugs stable in acidic medium.
 Raspberry syrup
Sucrose-based syrup with raspberry juice about 48% by
volume. Pleasant-flavored vehicle to disguise salty or sour taste of
saline medicaments

11. Syrups containing therapeutic
agent are called medicated
Syrups.

12. Examples of medicated syrup:
Syrup Commercial
Product
Uses product
Analgesic
Mepridine HCL
Progesic
paracetamol
(FT metiska Farma)
paracetamol, is
commonly used
for its analgesic
and antipyretic
effects.
Anticholinergics
Diclomine HCL
Bentyl
(Axcam
Scandipharm)
Adjunctive therapy
in treatment of
peptic ulcer.

13. Syrup Commercial
product
Use Product
Anticonvulsant
(Sodium valproate)
Depkene syrup
(Abbott)
Sole or
adjunctive
therapy in
simple,complex
absence seizure
disorder
Antiviral
(Amantadine HCL)
Symmetral syrup
(ALLAINCE)
• Prevention of
respiratory
infections
caused byA2
viral strains.
• Treatment of
iodopethic
parkinson
disease

16. Functions of sucrose or its derivatives:
i. Viscosity
ii. Sweetness
iii. Flavoring agent
iv. Masking bitter taste.

17.  Most syrups contain a high proportion of sucrose, usually
60% to 80% not only because of desirable sweetness and
viscosity of such solutions but also because of their
inherent stability in contrast to the un stable character of
dilute sucrose solutions.
 Aqueous sugar medium dilute sucrose has efficient
nutrient medium for growth of microorganisms.
 While concentrated sugar solutions are quite resistant to
microbial growth because of unavailability of water
required for growth of microorganisms.
 So, concentrated sugar solutions generally no require
additional preservatives if it is to be used soon;
preservative are added if syrup is to be stored.

20. The amount of a preservative required to protect a
syrup against microbial growth varies with the proportion of
water available for microbial growth and capability of
preservative itself.
Most commonly used preservative:
Composition
i. Benzoic acid (0.1 to 0.2%)
ii. Sodium benzoate (0.1 to 0.2%)
iii. Methyl-, propyl-, and butylparabens (0.1%)
iv. Alcohol (15 to 20%) [if alcohol soluble components are present
in syrup]

21. Syrups can be preserved by:-
i) Storage at low temperature
ii) Adding preservatives in the formulation
iii) By the maintenance of a high concentration of
sucrose as a part of the formulation.

22. Most syrups are flavored with:-
1. Naturally occurring materials:
Volatile oils i.e. Orange oil.
2. Synthetic flavorants:
Vanillin and others.
Purpose:
To render the syrup pleasant taste.
Note:
Sometime small amount of alcohol is added to ensure
continued solution of poorly water soluble flavorants.

23. To enhance the appeal of the syrup , a coloring agent
that correlate with the flavorant employed is used:
Characteristics:
The colorant is generally:
 water soluble,
 nonreactive with the other syrup components,
 color stable at the pH range and under the intensity of light.

24. Preparation of Syrups

25.  Syrups are frequently prepared by one of four general
methods.
1) solution of the ingredients with the aid of heat,
2) solution of the ingredients by agitation without the use
of heat, or the simple admixture of liquid components,
3) addition of sucrose to a prepared medicated liquid or
to a flavored liquid,
4) percolation of either the source of the medicating
substance or of the sucrose.
Sometimes a syrup is prepared by more than
one of these methods.

26.  Syrups are prepared by this method when it is desired
to prepare the syrup as quickly as possible,when the
syrup’s components are not damaged or volatilized
by heat.
 In this method the sugar is generally added to the
purified water, and heat is applied until the sugar is
dissolved.
 then other heat-stable components are added to the
hot syrup,

27.  the mixture is allowed to cool,
 its volume is adjusted to the proper level by addition of
purified water.
 If heat labile agents or volatile substances, such as
volatile flavoring oils and alcohol, are to be added,
they are generally added to the syrup after the sugar is
dissolved by heat.
 and then solution is rapidly cooled to room temperature.
P.T.O

28.  Use of heat facilitates rapid solution of sugar and certain
other components but caution must be exercised using
excessive heat . Sucrose may be hydrolyzed to Dextrose and
Fructose . Than combination of these mono saccharides
product will be invert sugar. So, syrup containing mixture of
glucose and fructose is termed as invert syrup.
MERITS:
 More sweet than simple syrup.
DEMERITS:
 Susceptible to fermentation and microbial growth.
 Normally colorless darkens because of effect of heat on
levulose portion of invert sugar

29. Precautions
 Because of the prospect of decomposition by heat, syrups
cannot be sterilized by autoclaving.
 The use of boiled purified water in the preparation of
a syrup can enhance its permanency, and the addition
of preservative agents, when permitted, can protect it
during its shelf life.
 Storage in a tight container is a requirement for all
syrups.

30.  To avoid heat-induced inversion of sucrose, a syrup may be
prepared without heat by agitation.
 On a small scale, sucrose and other formulative agents may
be dissolved in purified water by placing the ingredients in
vessel larger then the volume of syrup permitting thorough
agitation of mixture.
 This process is more time consuming than use of heat, but
the product has maximum stability.
 Huge glass-lined or stainless steel tanks with mechanical
stirrers or agitators are employed in large-scale preparation
of syrups.

31.  When solid agents are to be added to a syrup, it is
best to dissolve them in a minimal amount of purified
water and incorporate the resulting solution into the
syrup.

32.  Occasionally a medicated liquid, such as a tincture or
fluidextract, is employed as the source of medication in
the preparation of a syrup.
 Many such tinctures and fluidextracts contain alcohol-
soluble constituents and are prepared with alcoholic or
hydroalcoholic vehicles.
 If the alcohol-soluble components are desired
medicinal agents, then this method is not applicable

33.  However if the alcohol soluble components are
undesirable they are generally removed by mixing the
tincture or fluidextract with water , allowing the mixture
to stand untill separation of water insoluble components
is complete and filter them from mixture,
 The filtrate is the medicated liquid to which the sucrose is
added in prep, of syrup.
 If tincture or fluidextract is miscible with aqueous
preparations it may be directly added to simple syrup or
to flavored syrup.

34.  In the percolation method, there are two possibilities:-
1. sucrose may be percolated to prepare the syrup.
Method:
A sucrose bed is prepared and then water or vehicle
containing therapeutic agent is passed.
2. the source of the medicinal component may be percolated
to form an extractive to which sucrose or syrup may be added.
Method:
 This latter method really is two separate procedures:
1. Preparation of the extractive of the drug.
2. Preparation of the syrup.

36.  This syrup is categorized as an emetic with a usual dose
of 15ml.This amount is commonly used in the
management of poisoning in children when evacuation
of stomach content is required.
 80% of children given that dose will vomit within half
an hour.
Disadvantage:
Excessive use of IPECAC
syrup increase toxicity level in body
tissues which cause irreversible damage
of heart muscles (heart attack)
Symptoms:
•Shortness of breath
•Low blood pressure
•Irregularities of heart
beat

37. Syrup, as a pharmaceutical product requires safe, secure
and tamper-proof handling while packaging. Packaging of syrups
needs to ensure complete protection from contamination and
microbial growth. Our inevitable packaging support assures the
safe and secure packaging of syrups so as to ensure their
extended shelf life.
The general process:
 Filling
 Sealing
 Capping
 Coding & labeling
 Wrapping

38. Process Involved in Syrup Packaging –
Empty Bottles are rinsed though Air-jet cleaning
 After complete cleaning, bottles are tested & transferred
ahead for filling
 Filling machines with their automatic piston fills the bottles
with accurate volume of syrup
 Capping is done on bottle through capping machines
 Plastic or aluminum capsules are bound over the neck of the
bottle for secure sealing
 Important details regarding packaging date & expiry date
are printed on bottles

39. Labeling
Every pharmaceutical preparation requires a label to
be produced before the product can be dispensed or sold to
patient. The accuracy of the label is of paramount
importance as it conveys essential information to the patient
on the use of preparation.
 Storage
All the products dispense extemporaneously require
some form of additional storage instructions to be
detailed on the label. This information can be the addition
of just a product expiry date through to a number of
important additional label

41.  Appropriate for any patient, whatever the age is.

42.  The most natural and easiest route of administration
 Economical and safe to the patient
 No nursing is required, which means the patient can
take it with no help
 The liquid dosage form is expected for certain types of
products like cough medicines.

43.  Delayed onset of action because absorption takes time.
 Not suitable in emergency and for unconscious patients.
 Not convenient for a patient with a certain disorders such
as diarrhea, ulceration, and nausea.
 Can’t avoid first pass metabolism.

44. Elixirs

45. What are Elixirs?
Aid of preparation of Elixirs
Components of Elixirs
Types of Elixirs
Preparation of Elixirs
Contents

46. “Elixirs are , clear,
sweetened, flavored,
hydro-alcoholic solutions
intended for oral Use and
are usually flavored to
enhance their palatability.”
Alcoholic content
vary from 10% to
12% and up to
40%.

47.  Some drug are insoluble in water so in this case we
can’t use syrups & suspension.
 So we have to make a dosage form which could
dissolve non polar compounds
 Aid in masking the unpleasant taste of the active
ingredients.

48.  Alcohol
 Sweetening agents
 Water
 Propylene glycol
 flavorants

49.  The proportion of alcohol in elixir varies widely because
the individual components of the elixir have different
water and alcohol solubility characteristics.
 Each elixir requires a specific blend of alcohol and water
to maintain all of the components in solution.
 Naturally, proportion of requirement of alcohol is greater
for those elixirs having components with poor water
solubility than those elixirs having components with
good water solubility.

50.  Although many elixrs are sweetened with sucrose or with
sucrose syrup,some use sorbitol,glycerine or artificial
sweetner
 Elixirs having a high alcoholic content usually usea an
artificial sweetner such as saccharine,which is required
in very small amount rather than sucrose which is slightly
soluble in alcohol and require in greater quantity for
equalent sweetness.
Propyline glycol:
A colorless viscous liquid used as a solvent in the
preparation of certain medications. It also inhibits the growth
of fungi and microorganisms

51. Elixirs containing more than
10 to 12% of alcohol are usually
self-preserving and do not require
the addition of an antimicrobial
agent.
Parabenes:
Parabens are a class of widely
used preservatives in pharmaceuticals products.
Benzoates:
(salts of Benzoic acid) can refer to:
 Potassium benzoate
 Sodium benzoates

52.  Elixirs are usually prepared by simple solution with agitation
and/or by admixture of two or more liquid ingredients.
 Alcohol-soluble and 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 the highest possible alcoholic strength at all times so
that minimal separation of the alcohol-soluble components
occurs.
 When the two solutions are completely mixed, the mixture is
made to volume with the specified solvent or vehicle.

53.  Frequently the final mixture will be cloudy because
of separation of some of the flavoring oils by the
reduced alcoholic concentration.
 Talc filter is use to absorb excessive amount of oils
and therefore assists in their removal from the
solution.

54. Non medicated
Medicated

55.  These are simple elixirs that do not contain medicated agents.
 Non medicated elixirs may be useful to the pharmacist in
following ways:-
i. The addition of a therapeutic agent to pleasant tasting vehicle
ii. Dilution of an existing medicated elixir.
 These only contain
i. Water
ii. alcohol
iii. sweetening agent
iv. coloring agent
v.

56. If hydroalcoholic vehicle is selected the proportion
of alcohol should be only slightly above the amount needed
to effect and maintain the drug's solution.
If dilution of existing medicated elixer is required
than non medicated elixir choose for dilution should have
same concentration of alcohol as the elixir being diluted.
EXAMPLE:
Most common non medicated elixir are following:
i. Aromatic elixir . perfume
ii. Compound benzaldehyde elixir
iii. Isoalcoholic elixir

57. Medicated elixirs are a solution of
the active ingredient dissolved in water and
an alcohol often along with
other excipients such as preservatives.

58.  Most official and commercial elixirs contain single
therapeutic agent . The main advantage of having only
single therapeutic agent is that the dosage of that single
drug may be decreased or increased simply by taking more
or less elixir,
Examples of medicated elixirs:
i. Antihistamine Elixir: Diphenhydramine HCl
ii. Analgesic Elixir: acetaminophen
iii. Cardio tonic Elixir: digoxin
iv. Antispasmodic Elixir: hyoscyamine sulfate
v. Sedative Elixir: phenobarbital

59.  Antihistamines elixirs are useful primarily in the symptomatic
relief of certain allergic disorders.
 They supress symptoms caused by histamine(one of the
chemical agents released during antigen -antibody reactions of
allergic response.
 Only minor differences exist in properties of most
antihistamines
 A perscriber's preference may be based on the incidence of
adverse effects that maybe expected to occur.
 The most common adverse effect is sedation and patient taking
antihistamines should be warn against engaging in activities
requiring mental alertness such as driving or operating
machinery.
 Other common adverse effects include dryness of the nose,
throat, and mouth; dizziness; and disturbed concentration.

61.  Barbiturates are sedative and hypnotic agent that use to
produce various degree of CNS depression.
 Large dose increased the effect go from sedation to
hypnosis to respiratory depression , the last being the
cause of death in fatal barbiturate over dosage.
 Barbiturates are administered in small doses in the
daytime hours as sedatives to reduce restlessness and
emotional tension.
 Greater doses may be given before bed time as
hypnotics to release insomnia.

62.  Barbiturates are classified according to the duration of
their hypnotic effect .i.e.
i. Long acting i.e. Phenobarbital
ii. Intermediate acting i.e. Amobabital
iii. Short acting i.e. Secobarbital
iv. Ultra short acting i.e. Thiopental
Untoward effect:
. Drowsiness and lethargy.
. In heavy chronic users abrupt withdrawl may lead
to convulsions,delirium, and occasionally to coma and
death.

63.  Phenobarbital elixir is formulated to contain
phenobarbital 0.4%,which provides about 20 mg of
drug per teaspoonful (5mL)of elixir.
 This elixir is commonly flavored with orange oil , colored
red and sweetened with syrup.
 Official elixir contain 14% alcohol which is use to
dissolve phenobarbital
 Phenobarbital is a long lasting barbiturate with a
duration of action of 4-6 hours
 A usual dose as a sedative of about 30mg and hypnotic
dose of about 100mg .

65.  Phenobarbital 4.0g
 Orange oil 0.25ml
 Propylene glycol 100ml
 Alcohol 200ml
 Sorbitol solution 600ml
 Color q.s
 Purified water 1000ml

66.  Digoxin is a cardiotonic glycoside obtained from the leaves
of Digitalis lanata. It is white crystalline powder that is
insoluble in water but soluble in dilute alcohol solutions.
 There is no official method of preparation is indicated for
digoxin Elixir . however 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.
 Commercial products available for this purpose is packaged
with calibrated dropper to facilitate accurate dosing.

67.  Digoxin is one of many drugs available in more than
single dosage firm.
 Drug administered in different dosage forms may
exhibit different bioavailability characteristics, with
varying pattern of drug release ,rates and extent of
absorption..

69.  Keep below 30°C (at room temperature).
 Container should be tightly closed.
 Keep in light resistant ambered color
container;
 Protect from direct sunlight.

70. Examples of medicated Elixirs
ELIXIR Commercial
product
Use Product
Adrenocortical
steroid
(dexamethsone)
Dexamethasone
elixir
(Qualitest)
Synthetic analogue of
hydrocortisone. Used
for skin diseases ,
allergies and
inflammatory
conditions.
Analgesic
(acetamanophen)
Children’ Tylenol
Elixir
(McNeil)
Reduction of pain and
lowering of fever in
patients sensitive to or
unable to take aspirin

71. ELIXIRS Commercial
product
USES Product
Cardio tonic
(Digoxin)
Lanoxin pediatric
elixir
(Glaxowellcome)
Increase the force of
myocardial
contraction . Used in
CCF , atrial
fibrillation and other
cardiac conditions.
Sedative , hypnotics
(phenobarbital)
Phenobarbital elixir
(Qualitest)
Use as sedative and
hypnotic.
Contain 14% alcohol.

72.  Elixirs containing 10-12% alcohol are self-preservative.
 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.

73.  Less effective than syrups in masking taste of
medicated substances.
 Contains alcohol, can be vicious to children and
adults who avoid alcohol.
 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.

74. Difference between Syrups And
Elixirs:
Syrups Elixirs
1.Alcohol is not necessary
component
2.more sweet than elixir
3.more viscous than elixirs
4.High concentration of sugar
5.Less Stable
6.Difficult to formulate than elixirs
7.More effecting in masking the taste
of medicinal agents
8.May not be clear formulations
9.Sucrose Syrup can not be used for
diabetic patient but if used exercise
care.
1.Alcohol is necessary component
2.Less sweet than syrup
3.Less viscous than syrup
4.Less proportion of sugar
5.More stable
6.Easy to formulate than syrups
7.Less effecting in masking the taste
of medicinal agents
8.These are clear formulations
9.Can be used for Diabetic patients
easily