SYRUPS

PHARM. D
3RD SEMESTER
 SYRUPS

Definition
Syrups are concentrated aqueous preparations of a sugar or
sugar substitute with or without flavoring agents and medicinal
substances.
…

 Simple Syrup
When Purified Water alone is used in making the solution of sucrose, the preparation is
known as “syrup,” or “simple syrup,”
 Simple Syrup BP is 66.7% w/w solution of sucrose
 Simple Syrup USP 85% w/v solution of sucrose
 TYPES OF
SYRUPS

Non-
Medicated
medicated
Syrups
Syrups
…

1. Medicated Syrup
Syrups containing therapeutic agents are called medicated syrups.
Medicated syrups are employed in therapeutics for the value of the
medicinal agent present in the syrup.
The most frequently found types of medications administered as medicated
syrups are antitussive agents and antihistamines
2. Non-medicated Syrup
Syrups containing flavoring agents but no drugs are called non-medicated
syrups.
…
COMPONENTS OF SYRUPS

 Most syrups contain the following components in addition to the purified water and
any medicinal agents present:
a) the sugar, usually sucrose, or sugar substitute used to provide sweetness and viscosity
b) Antimicrobial preservatives,
c) Flavorants
d) Colorants
e) Also, many types of syrups, especially those prepared commercially, contain special
solvents (including alcohol), solubilizing agents, thickeners, or stabilizer
a) SUCROSE- AND NON SUCROSE-BASED SYRUPS
 Sucrose is the sugar most frequently employed in syrups, although in special
circumstances, it may be replaced in whole or in part by other sugars or substances
such as sorbitol, glycerin, and propylene glycol
 In some instances, all glycogenetic substances (materials converted to glucose in
the body), including the agents mentioned earlier, are replaced by non-glycogenetic
substances, such as methylcellulose or hydroxyethylcellulose (These two materials are
not hydrolyzed and absorbed into the blood stream, and their use results in an excellent syrup-like
vehicle for medications intended for use by diabetic patients and others whose diet must be
controlled and restricted to nonglycogenetic substances).
• The addition of one or more artificial sweeteners usually produces an excellent
replica of a true syrup.
 …
 The characteristic body that the sucrose and alternative agents seek to impart to the syrup is essentially
the result of attaining the proper viscosity. This quality, together with the sweetness and flavorants, results
in a type of pharmaceutical preparation that masks the taste of added medicinal agents.
 When the syrup is swallowed, only a portion of the dissolved drug actually makes contact with the taste
buds, the remainder of the drug being carried past them and down the throat in the viscous syrup
 Most syrups contain a high proportion of sucrose, usually 60% to 80%, not only because of the desirable
sweetness and viscosity of such solutions but also because of their inherent stability in contrast to the
unstable character of dilute sucrose solutions.
 The aqueous sugar medium of dilute sucrose solutions is an efficient nutrient medium for the growth of
microorganisms, particularly yeasts and molds. On the other hand, concentrated sugar solutions are quite
resistant to microbial growth because of the unavailability of the water required for the growth of
microorganisms.
…
 As formulated, the official syrup is stable and resistant to crystallization and microbial growth.
However, many of the other official syrups and a host of commercial syrups are not intended to be as
nearly saturated as Syrup, NF, and therefore must employ added preservative agents to prevent
microbial growth and to ensure their stability during their period of use and storage.
 As noted earlier, sucrose-based syrup may be substituted in whole or in part by other agents in the
preparation of medicated syrups. A solution of a polyol, such as sorbitol, or a mixture of polyols, such
as sorbitol and glycerin, is commonly used. Sorbitol Solution, USP, which contains 64% by weight of
the polyhydric alcohol sorbitol, is employed as shown in the following example formulations for
medicated syrup
b) ANTI-MICROBIAL PRESERVATIVES

 The amount of a preservative required to protect a syrup against microbial growth varies with the
proportion of water available for growth, the nature and inherent preservative activity of some
formulative materials (e.g., many flavoring oils that are inherently sterile and possess antimicrobial
activity), and the capability of the preservative itself
 Among the preservatives commonly used in syrups with the usually effective concentrations are
 benzoic acid 0.1% to 0.2%,
 sodium benzoate 0.1% to 0.2%, and
 various combinations of methylparabens, propylparabens, and butylparabens totaling about 0.1%
 Frequently, alcohol is used in syrups to assist in dissolving the alcohol-soluble ingredients, but
normally, it is not present in the final product in amounts that would be considered to be adequate for
preservation (15% to 20%)
c) FLAVORANTS

 Most syrups are flavored with synthetic flavorants or with naturally occurring
materials, such as volatile oils (e.g., orange oil), vanillin, and others, to render the
syrup pleasant tasting.
 Because syrups are aqueous preparations, these flavorants must be water soluble.
 However, sometimes a small amount of alcohol is added to a syrup to ensure the
continued solution of a poorly water-soluble flavorant.
 d) COLORANT

 To enhance the appeal of the syrup, a coloring agent that correlates with the
flavorant employed (i.e., green with mint, brown with chocolate) is used.
 Generally, the colorant is water soluble, nonreactive with the other syrup
components, and color stable at the pH range and under the intensity of light
that the syrup is likely to encounter during its shelf life.
 PREPARATION OF SYRUPS
 Syrups are most frequently prepared by one of four general methods, depending on the physical and
chemical characteristics of the ingredients.
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 the sucrose

 Sometimes a syrup is prepared by more than one of these methods, and the selection may simply be a
matter of preference on the part of the pharmacist. Many of the official syrups have no officially
designated method of preparation.
 …

1. Solution with the Aid of Heat

o Syrups are prepared by this method when it is desired to prepare the syrup as quickly as possible and
when the syrup’s components are not damaged or volatilized by heat
o In this method, the sugar is generally added to the purified water, and heat is applied until the sugar is
dissolved.
o Then, other heat-stable components are added to the hot syrup, the mixture is allowed to cool, and its
volume is adjusted to the proper level by the addition of purified water.
o 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 the solution is rapidly
cooled to room temperature.
…

 The use of heat facilitates rapid solution of the sugar and certain other components of syrups;
however, caution must be exercised against becoming impatient and using excessive heat.
 Sucrose, a disaccharide, may be hydrolyzed into monosaccharides, dextrose (glucose), and
fructose (levulose). This hydrolytic reaction is inversion, and the combination of the two
monosaccharide products is invert sugar.
 Should inversion occur, the sweetness of the syrup is altered because invert sugar is sweeter
than sucrose, and the normally colorless syrup darkens because of the effect of heat on the
levulose portion of the invert sugar.
 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.
…

2. Solution by Agitation Without the Aid of Heat

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

 Sometimes, simple syrup or some other non-medicated syrup, rather than sucrose, is
employed as the sweetening agent and vehicle.
 In that case, other liquids that are soluble in the syrup or miscible with it may be added
and thoroughly mixed to form a uniform product. When solid agents are to be added to
a syrup, it is best to dissolve them in minimal amount of purified water and
incorporate the resulting solution into the syrup.
When solid substances are added directly to a syrup, they dissolve slowly because the
viscous nature of the syrup does not permit the solid substance to distribute readily
throughout the syrup to the available solvent and also because a limited amount of
available water is present in concentrated syrups.
 …

3. Addition of Sucrose to a Medicated Liquid or to a Flavored Liquid

 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, some means of
rendering them water soluble is employed.
…

 However, if the alcohol-soluble components are undesirable or unnecessary

components of the corresponding syrup, they are generally removed by mixing the
tincture or fluidextract with water, allowing the mixture to stand until separation of
the water-insoluble agents is complete, and filtering them from the mixture. The
filtrate is the medicated liquid to which the sucrose is added in preparation of the
syrup
 If the tincture or fluidextract is miscible with aqueous preparations, it may be added
directly to simple syrup or to a flavored syrup.
…

4. Percolation
 In the percolation method, either
o sucrose may be percolated to prepare the syrup, or
o the source of the medicinal component may be percolated to form an extractive to
which sucrose or syrup may be added
 This second method really is two separate procedures: first the preparation of the
extractive of the drug and then the preparation of the syrup
 An example of a syrup prepared by percolation is ipecac syrup, which is prepared by
adding glycerin and syrup to an extractive of powdered ipecac obtained by
percolation.