Pharmaceutics – II

Dosage From Science:

ELIXIRS
Definition:
Elixirs are clear, sweetened, hydroalcoholic solutions intended for oral use, and
are usually flavored for palatability.

Alcoholic Content:
Its alcoholic content may vary from as low as 5% to as high as 40%.

Types:

 HIGH ALCOHOLIC ELIXIRS (HAE)

These elixirs contain 75% to 78% alcohol e.g. Phenobarbital Elixir, USP
 LOW ALCOHOLIC ELIXIRS (LAE)
These elixirs contain 8% to 10% alcohol e.g. Glycyrrhiza Elixir, NF

Note:
Elixirs containing at least 10% to 12% alcohol are already “self preserving”.

Need for Elixirs:

 Some drugs 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.

Components of Elixir Formulation:

 Alcohol and water (primary solvent)

 Glycerin and propylene glycol-adjuncts (viscosity builders and stabilizer )
 Sweeteners
 Flavorants and colorants
 Medical substances
 It contains approximately 10-12% alcohol. So, these are self preservatives and do
not require the addition of antimicrobial agent.
Muhammad Muneeb
D16M137
PUCP
Difference between Elixirs and Syrups:

Syrups Elixirs
Definition
Concentrated aqueous preparations of 85% Elixirs are clear, sweetened,
of sugar or sugar substitute with or without hydroalcoholic solutions intended for oral
flavoring agents and medicinal substances use, and are usually flavored for
palatability
Viscosity
Syrups are more viscous Elixirs are less viscous
Preservation
Syrups may or may not contain preservative Elixirs have no preservative
Alcohol Content
Syrups are less alcoholic Elixirs are more alcoholic
Necessity of Alcohol
Alcohol is not necessary component. Alcohol is a necessary component.
Sweetness
More sweet than elixirs Less sweet than syrup
Sugar Concentration
High concentration of sugar Less portion of sugar
Stability
Less stable than elixirs More stable than syrups
Formulation
Difficult to formulate than elixirs Easy to formulate than syrups
Taste Masking
More effecting in masking the taste of Less effecting in masking the taste of
medicinal agents medicinal agents
Type of Formulation
May not be clear formulations These are clear formulations
Diabetic Patients
Sucrose syrup cannot be used for diabetic Can be used for diabetic patients easily
patient but if used exercise care
Classification of Elixirs
1. Non-medicated Elixirs

 These are employed as vehicle.

 Example:
o Aromatic Elixirs, NF
o Iso-alcoholic Elixirs
2. Medicated Elixirs:

Muhammad Muneeb
D16M137
PUCP
  It contains medically active ingredients.
 Example:
o Diphenhydramine Elixirs
o Phenobarbital Elixirs
o Digoxin Elixirs

Preparation:
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, rather than the reverse, 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 the volume
with the specified solvent or vehicle.
 Frequently, the final mixture will be cloudy, principally because of separation of
some of the flavoring oils by the reduced alcoholic concentration. If this occurs,
the elixir is usually permitted to stand for a prescribed number of hours to ensure
saturation of the hydroalcoholic solvent and to permit the oil globules to coalesce
so that they may be more easily removed by filtration.
 Talc, a frequent filter aid in the preparation of elixirs, absorbs the excessive
amounts of oils and therefore assists in their removal from the solution.
 The presence of glycerin, syrup, sorbitol, and propylene glycol in elixirs generally
contributes to the solvent effect of the hydroalcoholic vehicle, assists in the
dissolution of the solute, and enhances the stability of the preparation.
 However, the presence of these materials adds to the viscosity of the elixir and
slows the rate of filtration.

Storage and Preservation of Elixirs:

 Stored in a tightly closed, light-resistant containers

 Protected from excessive heat (do not store above 40⁰C)
 Protect from direct sunlight

Dose:
For the most elixir one to two tea spoon (5ml) or 5- 10 ml provided for adult dose.

Muhammad Muneeb
D16M137
PUCP
Uses:

 Used as vehicle for medicated elixir.

 Used for dilution of medicated elixir
 As flavouring agent

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.

Preparation of Aromatic Elixirs (B.P.C 1949):

INGREDIENTS:

Sprit of orange………………..33.3 ml
Alcohol (90%) ……………….218.75ml
Simple syrup………………….375 ml
Purified water q.s.…………….1000ml
PROCEDURE:

 Mix together alcohol 90% and sprit of orange in a beaker.

 Add prepared simple syrup to this mixture and stir it well.
 Pour the above mixture in cylinder and purified water.
 Add 25 gm of talc in prepared mixture and shake well and allow standing it for 30
minutes.
 Shake it occasionally, filter the mixture to get final product.
USES:

 Used as flavouring agent.

 Used as sedatives.
 Used as a vehicle for medicated solution.
DOSE:

5 to 10 ml per day

USE OF INGREDIENTS:

 Sprit of orange: Flavouring agents.

Muhammad Muneeb
D16M137
PUCP
  Alcohol: Sedatives, Anti-microbial agent, As integral parts of elixirs.
 Simple syrup: Used as sweetning agents.
STORAGE:

 Keep the container below 30°C.

 Should be stored in light resistance container.
 Protect from direct sunlight.

Advantages of Elixirs:

 Insoluble drug compounds can be incorporated into the hydroalcoholic vehicle;

drug concentrates can be prepared in high-alcohol-containing elixirs
 Hydroalcoholic vehicles can be self-preserving;
 Elixirs are less viscous and contain a lower proportion of sugar.
 Better able to maintain both water-soluble and alcohol-soluble components in
solution
 They’re easily prepared by simple solution.
 They can be easily administered in patients having problems of swallowing solid
dosage form.

Disadvantages of Elixirs:

 They cannot be administered to pediatric patients and patients on antidepressant

medication;
 The concentration of active and inactive ingredients may vary if not preserved in
cool places;
 Water-insoluble drug compounds may precipitate due to alcohol evaporation.
 Less effective than syrups in making taste of medicated substances
 They 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.
 They’re needed to keep away from sources of ignition.

Difference between Elixir and Spirit:

Elixirs Spirits
Contain sweetening agent Don’t contain sweetening agent
More viscous Less viscous
Need preservative if alcohol content is less Do not need preservative
Muhammad Muneeb
D16M137
PUCP
than 10-12%

Water and alcohol are usually primary Alcohol is usually the primary
solvent
For internal use only For external and internal use
Alcohol conc. is 4 – 40% Conc. of alcohol is 62 – 87%

Muhammad Muneeb
D16M137
PUCP