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University of Sulaimani School of Pharmacy Dept. of Pharmaceutics Pharmaceutical Compounding
Pharmaceutical compounding I Solutions using mixed solvent systems: Spirits, Elixirs and Extracted Products
Dr. rer. nat. Rebaz H. Ali
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Outlines
• Spirit
• Elixir
• Miscellaneous liquid preparations
• Extracted products
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Spirit
• Spirits are alcoholic or hydroalcoholic solutions of volatile substances. The volatile
substances in the majority of cases are volatile oils.
• The volatile oil content of the official spirits is much greater than of the corresponding
aromatic waters.
• The alcohol content varies from the lower percentage as in Ammonia Spirit 62-68%, to
the highest percentage as in Camphor Spirit 80-87%.
• When mixed with water or with an aqueous preparation, they form a milky preparation.
• For medicinal purposes, spirits may be taken orally, applied externally, or used by
inhalation.
• Depending on the materials, spirits may be prepared by simple solution, solution by
maceration, or distillation.
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Official spirits
• Peppermint spirit: is used as a carminative and flavor. Given orally in small doses
usually 1 ml.
• Preparation:
• Leaves are macerated in water to remove tannins,
xanthophylls, and other principles soluble in water, this
aqueous extract is discarded.
• The leaves are expressed and then macerated in alcohol.
The alcohol dissolves the chlorophyll so that the final
product has a bright green color.
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Official spirits
• Aromatic Ammonia spirit: is prepared from ammonium carbonate and strong
ammonia.
• It is used orally as an antacid and carminative, is also used as a stimulant to revive
conscious state after fainting, through inhalation.
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Official spirit cont.
• Camphor spirit: this is a simple solution of 10% of camphor in alcohol.
• Usually it's applied to cold sores.
• It could be used in case of insect bite, muscle pain, and to relieve cough.
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Outlines
• Spirit
• Elixir
• Miscellaneous liquid preparations
• Extracted products
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Elixir
• Elixirs
• They are sweetened hydroalcoholic solutions containing flavoring materials and,
usually, medicinal substances.
• In the official elixirs, the alcohol content varies from 4 to 40 percent; which is
enough alcohol to keep volatile oils or the medical substances in solution.
• The sugar content in elixir is lower than that of syrups.
• Elixirs are usually less sweet and less viscous and are less effective than syrups in
masking the taste of medicinal substances.
• Because of their hydroalcoholic character, elixirs are
better able than aqueous syrups to maintain both
water-soluble and alcohol-soluble components in
solution.
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Elixir cont.
• Elixirs containing more than 10% to 12% of alcohol are usually self-preserving and
do not require the addition of an antimicrobial agent.
• Elixirs should be stored in tight, light-resistant containers and protected from excessive
heat
• A disadvantage
• For children and for adults who choose to avoid alcohol is their alcoholic content.
• Nonmedicated Elixir
• Addition of a therapeutic agent.
• Dilution of an existing medicated elixir.
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Elixir cont.
• Medicated Elixir
• Most official and commercial elixirs contain a single therapeutic agent.
• Antihistaminics; like Chlorpheniramine Maleate, Diphenhydramine HCl.
• Sedative and Hypnotics: like Phenobarbital, Secobarbital.
• Expectorants: like Terpin hydrate, Terpin Hydrate and Codeine.
• These elixirs cannot be diluted with much water or the slightly water-soluble
terpin hydrate will precipitate.
• These elixirs contain the highest percentage of alcohol (39 to 44%) of all elixirs in
order to keep the terpin hydrate in solution.
• Miscellaneous: digoxin, dexamethasone, acetaminophen, hyoscyamine sulfate
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Outlines
• Spirit
• Elixir
• Miscellaneous liquid preparations
• Douches
• Enemas
• Liniments
• Collodions
• Extracted products
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Douches
• Douches are an aqueous solution directed against a part or into a
cavity of the body. It functions as a cleansing or antiseptic agent.
• Pharyngeal douches are used to prepare the interior of the throat
for an operation and cleanse it in suppurative conditions.
• Douches are often dispensed in the form of a powder with
directions for dissolving in a specified quantity of water (usually
warm).
• Vaginal douches are the most common type of douche and are used
for cleansing the vagina and hygienic purposes.
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Douches cont.
• The ingredients used in vaginal douches:
• Antimicrobial agents, such as benzalkonium chloride, the parabens,
• Anesthetics or antipruritics, such as phenol or menthol.
• Astringents, such as zinc sulfate or potassium alum,
• Chemicals to alter the pH, such as sodium bicarbonate or citric acid.
• Aromatics, for example, menthol, thymol, eucalyptol.
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Outlines
• Spirit
• Elixir
• Miscellaneous liquid preparations
• Douches
• Enemas
• Liniments
• Collodions
• Extracted products
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Enemas
• Enemas are solutions administered rectally for the local effects of the medication
(e.g., hydrocortisone) or for systemic absorption (e.g., aminophylline).
• Corticosteroids are administered as retention enemas as adjunctive treatment of
some patients with ulcerative colitis.
• Also they may possess anthelmintic, nutritive, sedative, or they may contain
radiopaque substances for examination of the lower bowel.
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Enemas
• For evacuation enema, Sodium chloride, sodium bicarbonate,, glycerin, docusate
potassium, and light mineral oil are used in enemas to evacuate the bowel.
• They could be used alone or in combination with irritants, such as soap.
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Liniments
• Liniments are alcoholic or oleaginous solutions or emulsions of various medicinal
substances intended to be rubbed on the skin.
• Liniments with an alcoholic or hydroalcoholic vehicle are useful when rubefacient,
counterirritant, or penetrating action is desired.
• Oleaginous liniments are employed primarily when massage is desired.
• All liniments should bear a label indicating that they are suitable only for external use
and must never be taken internally.
• Other liniments contain antipruritics, astringents, emollients, or analgesics
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Collodions
• Collodion is a clear or slightly opalescent viscous liquid prepared by dissolving pyroxylin
(4%w/v) in a 3:1 mixture of ether:alcohol.
• The solution is highly volatile and flammable
• Pyroxylin is a mixture of nitric and sulfuric acids on cotton
• It has the appearance of raw cotton when dry but is harsh to the touch.
• Collodions are intended for external use.
• When applied to the skin the solvent rapidly evaporates,
leaving a filmy residue of pyroxylin.
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Collodions cont.
• This provides an occlusive protective coating to the skin
• Salicylic acid collodion is a 10% solution of salicylic acid in flexible collodion.
• It is used for its keratolytic effects, especially in the removal of corns from the
toes.
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Outlines
• Spirit
• Elixir
• Miscellaneous liquid preparations
• Extracted products
• Extraction methods
• Tincture, fluidextract, extract and resin
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Extracted products
• Crude drugs are vegetable or animal drugs that have undergo no other processes
than collection, cleaning, and drying.
• Tinctures, fluidextracts, and extracts are the pharmaceutical products most
commonly prepared from extractives.
• Advantages of extractives
• Extraction concentrates the active constituents of a crude drug and removes
from it the unwanted matter.
• More potent
• More palatable
• More conveniently for administration
• Comminution of the crude is often desirable.
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Extracted products cont.
• For extraction, use of water alone is discouraged:
• Most active plant constituents are complex organic chemical compounds that
are less soluble in water.
• It dissolves undesirable constituents like starches, coloring principles, and
tannins.
• It serves as good growth media for molds, yeasts, and bacteria.
• Hydroalcoholic mixtures are the most widely employed menstrua.
• Methods of extraction
• Maceration
• Percolation
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Extraction methods
A. Maceration
• It is a process in which the comminuted drug is permitted to soak in the menstruum
until the cellular structure is softened and penetrated by the menstruum and the
soluble constituents are dissolved.
• For drugs containing little or no cellular material, such as aloe, and Tolu, which
dissolve almost completely in the menstruum, maceration is the most efficient
method of extraction.
• After the appropriate time has elapsed, the system is
filtered to remove undissolved material.
• The solvent used is called the menstruum, and the
undissolved portion is called the marc.
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• One approach suggested to overcome this difficulty is to enclose the crude drug in a
permeable membrane or sack, as in a tea bag.
• Decoction; involves placing plant material in water, boiling for about 15 minutes, and
expressing and straining the remaining marc to obtain a maximum amount of water-
soluble principles.
Extraction methods cont.
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• Digestion: is maceration with continued heating, the temperature is usually maintained
between 40 and 60 oC.
• Infusion: is macerating the drug with cold water followed by the addition of boiling
water.
Extraction methods cont.
B. Percolation
• Percolation is as a process in which a comminuted drug is
extracted of its soluble constituents by the slow passage of a
suitable solvent through a column of the drug.
• The extraction apparatus termed a percolator, with the collected
extractive called the percolate
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• Percolation offers the opportunity to extract principles exhaustively with a minimum of
solvent.
• Exhaustive extraction can be monitored by:
• Loss of color in extracted solvent system.
• Loss of bitter taste characteristic of alkaloids.
Extraction methods cont.
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Outlines
• Spirit
• Elixir
• Miscellaneous liquid preparations
• Extracted products
• Extraction methods
• Tincture, fluidextract, extract and resin
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Tinctures
• Tinctures are defined in the USP as alcoholic or hydroalcoholic solutions prepared
from vegetable materials or from chemical substances (Iodine Tincture).
• When they are prepared from chemical substances (iodine), tinctures are prepared
by simple solution.
• When they prepared from vegetable , it prepared by maceration and percolation.
• The potency is 10%
• Cardamom tincture: carminative and flavor
• Belladonna tincture: antispasmodic
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Fluidextracts
• The USP defines fluidextract is a liquid preparations of vegetable drugs, containing
alcohol as a solvent or as a preservative, or both.
• Each mL contains the therapeutic constituents of 1 g of the standard drug that it
represents.
• Senna fluidextract: used as purgative.
• Belladonna fluidextract:
• Glycyrrhiza fluidextract:
• It is able to moisten the mucous membranes, which includes the respiratory
system, the urinary tract and the digestive system.
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Extracts
• Extracts are concentrated of animal or vegetable drugs which first have been extracted.
• They are potent preparations, usually 2 to 6 times as potent as a weight basis as the
crude drug.
• In most cases, after percolation the volume is reduced by evaporation of solvent.
• The extent of removal of the solvent determines the final physical character of the
extract:
• Semi-liquid extracts with a syrup consistency.
• Pilular extracts with a plastic consistency; like Pure
Clycyrrhiza Extract.
• Powdered extracts, brought to complete dryness; like
Cascara Sagrata Extract
• Relief constipation
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Extracts cont.
• For potent products, adjustment of potency is accomplished by the addition of inert
diluents.
• Liquid glucose is often used for the pilular extracts
• Starch is added to powdered extracts.
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Resins
• Resins are solid preparations consisting of the resinous constituents of vegetable
matter.
• They are soluble in alcohol and in most organic solvents but insoluble in water.
• Alcoholic solution is concentrated and poured into water.
• The precipitated resin, subsequently washed with water, dried and powdered.
• Podophyllum resin is a cytotoxic agent and is used to treat the genital warts.
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Resins
• Oleo resins are combinations of volatile oils and naturally occurring resins and are
generally found by cutting into the trunks of trees in which they occur.
• Capsicum oleoresin
• Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain
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