ELIXIRS
By: M.Zain Idrees
Leads college of Pharmacy
Defination:
The USP XVII defines elixirs as clear, sweetened hydroalcohol liquids
intended for oral use containing flavoring substances or active medicinal
agents. Their primary solvents are alcohol and water, with glycerin, sorbitol
and syrup sometimes as an additional solvent and/or sweetening agents.
They are prepared by simple solution or admixture of the several
ingredients. They are used either as vehicles or for the therapeutic effect of
the medicinal substances that they contain.
Main Ingredients
 Alcohol
 Water
 Glycerin
 Preservatives
 Sorbital
 Flavouring agents
Types of elixirs
Medicated Elixirs
Non medicated Elixirs
Non medicated Elixers:
 Simple, no therapeutic agents
 May only contain alcohol, sweetening agents, colouring agents
 Self preserve
Uses:
 They are used purely as diluting agents
 solvents for drugs [containing approximately 25 percent alcohol, e.g., simple
elixir, Iso-alcoholic elixir or low alcohol elixir (containing 8-10% alcohol), High
alcoholic elixir (containing 75-78% alcohol)]
Example
Aromatic elixir, Isoalcoholic Elixer
Medicated Elixirs
Medicated elixirs are solution of active ingredients dissolved in water and alcohol
and an alcohol along with other exipients such as preservatives.
Examples
 Antihistaminic elixirs: used against allergy: chlorampheniramine
maleate elixirs (USP), diphenhydramine HCl elixirs.
 Sedative and hypnotic elixirs: sedatives induce drowsiness, and
hypnotics induce sleep: pediatric chloral hydrate elixirs.
 Expectorant: used to facilitate productive cough (cough with sputum):
terpin hydrate elixirs.
 Miscellaneous: acetaminophen (paracetamol) elixirs, which are used as
analgesics.
Formulation of Elixirs
Ingredients:
Generally elixirs contain following ingredients
Vehicles
About 10-20% of alcohol is used for keeping oils,vegetable extracts,tannins etc in
solution form. Glycerol and propylene glycol are used as solvent
Stabalizers
In neomycin elixir, citric acid is used to adjust pH 4.0 to 5.0 to minimize the
darkening that occurs on storage. Disodium edetate should be used to sequester
heavy metals that catalyse decomposition of the antibiotics.
Flavouring agents
Sweetning agents and fruit flavours are used in many medicinal preparation eg.,
Black currant syrp in chloral Elixir
Compound orange spirits with gycerol in phenobarbital elixir
Preservatives
In elixir, fermentation and mold growth are inhibited when it contains more than 20% of alcohol,
propylene glycol or glycerol. The commonly used preservatives are double strength chloroform,
spirit, and benzoic acid and methyl ester of p- hydroxy benzoic acid.
Method of prepration:
 Dissolve the water-soluble ingredients in part of the water, add and dissolve the
sucrose in it.
 Dissolve the other ingredients in the alcohol.(Concentration of alcohol should be 5-
40% to make clear solution)
 The aqueous solution is then added to the alcoholic solution with constant stirring
and make up the volume with the solvent or vehicle specified in the formulation.
 Sucrose increases viscosity but decreases the solubility properties of water and so
must be added after primary solution has been carried out.
 A high alcoholic content is maintained during preparation by adding aqueous phase
to the alcoholic solution.
 Elixirs should be brilliantly clear and therefore strained or filtered, if necessary,
subjected to clarifying action of purified talc or siliceous earth.
Dry Elixirs
 Research concerning the preparation of a dry elixir has been
conducted by Kim and co_workers.
 Dry Elixirs containing a nonsteroidal anti-inflammatory drug and
ethanol were encapsulated in a dextrin. The dissolution rate constant
of the drug from the microcapsules usually increased considerably
compared to the drug alone, possibly due to the cosolvent ethanol.
 It is suggested that this type of dosage form may be useful to
improve:
Solubility
Dissolution and
Bioavailability of the drug
Incompatibility of Elixirs
 Elixirs contain alcohol thus incompatible or precipitate tragacanth,
acacia, and agar from aqueous solutions, inorganic salts from similar
solutions. So such substances should be absent form the aqueous
phase or should be present in such concentrations that there is no
danger of precipitating on standing
 Alcohol increases the saline taste of bromides etc. so the formulator
has to seek some other solvent during these conditions.
 If an aqueous solution is added to an elixir, a partial precipitation of
ingredients may occur. This is due to the reduced alcoholic content of
the final preparation.
Storage
 It should be dispensed in narrow mouthed, screw capped, colorless
plain bottle.
 Do not store above 400 C
Advantages

 Elixirs are more fluid than syrups.
 It often is desirable, it is more effective in masking such tastes.
 Elixirs are more readily prepared and manufactured than syrups.
 An Elixir may contain both water and alcohol soluble ingredients.
Disadvantage of elixirs
 Alcohol is not good for children.
 Because they contain volatile materials, it must be stored in a
watertight screw-top jar and away from sources of ignition.
Quality control tests for Elixirs
1. Determination of alcohol Concentration
 Elixirs usually contain 5-40% alcohol.
 The determination of alcohol unless specified in the individual monograph
Continued...
 It is suitable for examining most fluidextracts and tinctures and
elixirs provided the capacity of the distilling flask is sufficient
(commonly two to four times the volume of the liquid to be heated)
and the rate of distillation is such that clear distillates are produced.
 Cloudy distillates may be clarified by agitation with talc, or with
calcium carbonate. And filtration is done.
 After which the temperature of the filtrate is adjusted and the alcohol
content determined from the specific gravity. During all
manipulations, take precautions to minimize the loss of alcohol by
evaporation.
 For Liquids it is Presumed to Contain less than 30% of Alcohol.
Viscosity measurement
 Viscosity is a property of liquids that is directly related to the
resistance to flow.
 viscosity measurement is very important quality control test in case
of syrups an elixirs.
 viscosity and consistency directly relates with stability of solutions
viscosity chance of stability.
Methods used for measurement of Viscosity
Method 1
(U tube Viscometer)
Method 2
(Capillary tube Viscometer)
Method 3
(Rotating viscometer method)
Method 4
Concentric cylinder Viscometer
Method 5
Cone plate Visvometer
Method 6
Spindle Viscometer (relative viscometer)
References
 http://www.preservearticles.com/2011122319112/here-is-your-
short-essay-on-elixirs.html
 Remington-The science and practice of Pharmacy, 21
edition(Page-757)
 http://rxistsource.blogspot.in/2014/12/pharmaceutical-
elixirs.html?m=1
 https://www.slideshare.net/bhatti106/quality-control-tests-
for-syrups-and-elixirs

Pharmaceutical Elixirs

  • 1.
  • 2.
    Defination: The USP XVIIdefines elixirs as clear, sweetened hydroalcohol liquids intended for oral use containing flavoring substances or active medicinal agents. Their primary solvents are alcohol and water, with glycerin, sorbitol and syrup sometimes as an additional solvent and/or sweetening agents. They are prepared by simple solution or admixture of the several ingredients. They are used either as vehicles or for the therapeutic effect of the medicinal substances that they contain.
  • 3.
    Main Ingredients  Alcohol Water  Glycerin  Preservatives  Sorbital  Flavouring agents Types of elixirs Medicated Elixirs Non medicated Elixirs
  • 4.
    Non medicated Elixers: Simple, no therapeutic agents  May only contain alcohol, sweetening agents, colouring agents  Self preserve Uses:  They are used purely as diluting agents  solvents for drugs [containing approximately 25 percent alcohol, e.g., simple elixir, Iso-alcoholic elixir or low alcohol elixir (containing 8-10% alcohol), High alcoholic elixir (containing 75-78% alcohol)] Example Aromatic elixir, Isoalcoholic Elixer
  • 5.
    Medicated Elixirs Medicated elixirsare solution of active ingredients dissolved in water and alcohol and an alcohol along with other exipients such as preservatives. Examples  Antihistaminic elixirs: used against allergy: chlorampheniramine maleate elixirs (USP), diphenhydramine HCl elixirs.  Sedative and hypnotic elixirs: sedatives induce drowsiness, and hypnotics induce sleep: pediatric chloral hydrate elixirs.  Expectorant: used to facilitate productive cough (cough with sputum): terpin hydrate elixirs.  Miscellaneous: acetaminophen (paracetamol) elixirs, which are used as analgesics.
  • 6.
    Formulation of Elixirs Ingredients: Generallyelixirs contain following ingredients Vehicles About 10-20% of alcohol is used for keeping oils,vegetable extracts,tannins etc in solution form. Glycerol and propylene glycol are used as solvent Stabalizers In neomycin elixir, citric acid is used to adjust pH 4.0 to 5.0 to minimize the darkening that occurs on storage. Disodium edetate should be used to sequester heavy metals that catalyse decomposition of the antibiotics. Flavouring agents Sweetning agents and fruit flavours are used in many medicinal preparation eg., Black currant syrp in chloral Elixir Compound orange spirits with gycerol in phenobarbital elixir
  • 7.
    Preservatives In elixir, fermentationand mold growth are inhibited when it contains more than 20% of alcohol, propylene glycol or glycerol. The commonly used preservatives are double strength chloroform, spirit, and benzoic acid and methyl ester of p- hydroxy benzoic acid. Method of prepration:  Dissolve the water-soluble ingredients in part of the water, add and dissolve the sucrose in it.  Dissolve the other ingredients in the alcohol.(Concentration of alcohol should be 5- 40% to make clear solution)  The aqueous solution is then added to the alcoholic solution with constant stirring and make up the volume with the solvent or vehicle specified in the formulation.  Sucrose increases viscosity but decreases the solubility properties of water and so must be added after primary solution has been carried out.  A high alcoholic content is maintained during preparation by adding aqueous phase to the alcoholic solution.  Elixirs should be brilliantly clear and therefore strained or filtered, if necessary, subjected to clarifying action of purified talc or siliceous earth.
  • 8.
    Dry Elixirs  Researchconcerning the preparation of a dry elixir has been conducted by Kim and co_workers.  Dry Elixirs containing a nonsteroidal anti-inflammatory drug and ethanol were encapsulated in a dextrin. The dissolution rate constant of the drug from the microcapsules usually increased considerably compared to the drug alone, possibly due to the cosolvent ethanol.  It is suggested that this type of dosage form may be useful to improve: Solubility Dissolution and Bioavailability of the drug
  • 9.
    Incompatibility of Elixirs Elixirs contain alcohol thus incompatible or precipitate tragacanth, acacia, and agar from aqueous solutions, inorganic salts from similar solutions. So such substances should be absent form the aqueous phase or should be present in such concentrations that there is no danger of precipitating on standing  Alcohol increases the saline taste of bromides etc. so the formulator has to seek some other solvent during these conditions.  If an aqueous solution is added to an elixir, a partial precipitation of ingredients may occur. This is due to the reduced alcoholic content of the final preparation.
  • 10.
    Storage  It shouldbe dispensed in narrow mouthed, screw capped, colorless plain bottle.  Do not store above 400 C Advantages   Elixirs are more fluid than syrups.  It often is desirable, it is more effective in masking such tastes.  Elixirs are more readily prepared and manufactured than syrups.  An Elixir may contain both water and alcohol soluble ingredients.
  • 11.
    Disadvantage of elixirs Alcohol is not good for children.  Because they contain volatile materials, it must be stored in a watertight screw-top jar and away from sources of ignition. Quality control tests for Elixirs 1. Determination of alcohol Concentration  Elixirs usually contain 5-40% alcohol.  The determination of alcohol unless specified in the individual monograph
  • 12.
    Continued...  It issuitable for examining most fluidextracts and tinctures and elixirs provided the capacity of the distilling flask is sufficient (commonly two to four times the volume of the liquid to be heated) and the rate of distillation is such that clear distillates are produced.  Cloudy distillates may be clarified by agitation with talc, or with calcium carbonate. And filtration is done.  After which the temperature of the filtrate is adjusted and the alcohol content determined from the specific gravity. During all manipulations, take precautions to minimize the loss of alcohol by evaporation.  For Liquids it is Presumed to Contain less than 30% of Alcohol.
  • 13.
    Viscosity measurement  Viscosityis a property of liquids that is directly related to the resistance to flow.  viscosity measurement is very important quality control test in case of syrups an elixirs.  viscosity and consistency directly relates with stability of solutions viscosity chance of stability.
  • 14.
    Methods used formeasurement of Viscosity Method 1 (U tube Viscometer)
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.
    Method 6 Spindle Viscometer(relative viscometer)
  • 20.
    References  http://www.preservearticles.com/2011122319112/here-is-your- short-essay-on-elixirs.html  Remington-Thescience and practice of Pharmacy, 21 edition(Page-757)  http://rxistsource.blogspot.in/2014/12/pharmaceutical- elixirs.html?m=1  https://www.slideshare.net/bhatti106/quality-control-tests- for-syrups-and-elixirs