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Solutions
“liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or
mixture of mutually miscible solvents”
Classification
Oral- administration by mouth
Otic- given through the ear/ears
Ophthalmic- given on the eye/s
Topical- dermal surface
Formulative components
API
Flavorant
colorant
buffers
Vehicles
SOLUBILITY
Factors affecting Solubility
Temperature- important factor in determining solubility of drug
and in preparing its solution
Pressure
pH of solution
State of subdivision of solute
Physical agitation
Physicochemical properties of solute and solvent
Alcohol, glycerin & propylene glycol are widely used as auxiliary solvents
Acetone, ethyl oxide & isopropyl alcohol are too toxic to be permitted to be permitted in
pharmaceutical preparations to be taken internally, but can be used in the extraction of active
constituents from medicinal plants and reagent solvents in organic chemistry.
Some Solvents For Liquid Preparations
Alcohol, USP: Ethyl Alcohol, Ethanol
- Primary solvent in organic compounds
- Together with water, forms hydroalcoholic mixture that dissolves both alcohol soluble and
water soluble substances
- Useful in extraction of active constituents from crude drugs.
Dehydrated Alcohol USP (a.ka. absolute alcohol) contains not < 99.5% C2H5OH by volume
OTC oral drug products restrict the use of alcohol and include appropriate warnings in the label.
Recommended alcohol content limit for: children under 6 years of age: 0.5%
children 6 to 12 years old: 5%
children over 12 years of age and adults: 10%
Diluted Alcohol, NF- prepared by mixing equal volumes of Alcohol, USP & Purified Water, USP
Rubbing Alcohol (syn: alcohol rubbing compd.) - contains 70% ethyl alcohol by volume and the remains
consists of water, denaturants and stabilizers.
Glycerin, USP (Glycerol)- a clear syrupy liquid w/ sweet taste; miscible w/ water and alcohol;
Has preservative qualities, used as stabilizer and auxiliary solvent
Isopropyl Rubbing Alcohol- has about 70% by volume of isopropyl alcohol, the remains consists of
water, stabilizers and perfume oils.
Propylene Glycol, USP- viscous liquid; substitute for glycerin
Purified Water, USP contains less than 0.1% of total solids; obtained by distillation, ion exchange
treatment and reverse osmosis; not intended for parenteral administration
Naturally Occurring Water is considered impure for they contain amts. of dissolved inorganic salts
along w/organic matter and microorganisms
Tap Water- not acceptable for manufacturing aqueous pharmaceutical preparations or
extemporaneous compounding prescriptions
Preparation of Solutions
1. Dry mixtures for solution- insufficient stability in aqueous solution to meet extended shelf-life
periods.
- dry powder or granule form for reconstitution with a prescribed amount of purified water immediately
before dispensing to the patient
2. Oral solution- commercially prepared oral solution; that required dilution (preparation of a pediatric
form of an adult product; reconstitution; #408
3. Oral Rehydration Solution- available in liquid or powder packet form for reconstitution; these
products should not be mixed with or given with other electrolyte containing liquids, such as milk or
fruit juices
4. Oral Colonic Lavage Solution alternative method to prepare the gastrointestinal tract for a procedure
that requires less time and dietary restriction and obviates cleansing enemas
the pharmacist reconstitutes this powder with water, creating an iso-osmotic solution having a
mildly salty taste
SYRUPS
concentrated aqueous preparations of a sugar or sugar substitute with or without flavoring
agents and medicinal substances
= provide a pleasant taste in a means of administering a liquid form of a disagreeable-tasting drug.
Nonmedicated or flavored vehicles (syrups) containing flavoring agents but not medicinal substances;
flavoured vehicles
Medicated syrup- contain therapeutic agent
Composition of Syrups
Purified/dist water
API
Sucrose/sugar
Antimicrobial preservatives
flavorants
Colorants
Solvents
Solubilizing agents
Thickeners
Stabilizers
Sugar =sucrose most frequently employed in syrups, sorbitol, glycerin and PEG
Sucrose content in syrups is usually 60 to 80%