Pharmaceutical Solvents

Solvents are chemical substances that can dissolve, suspend or extract other materials usually
without chemically changing either the solvents or the other materials. Solvents can be
organic or inorganic. For example, alcohol is an organic solvent and water is an inorganic
solvent. They may be used for clarification of drugs, for isolation or extraction from crude
drug or for cosmetic.
Properties of Solvents
Solvents for pharmaceutical use should have this properties:
1. Should be non-toxic.
2. Should be stable.
3. Should be not highly volatile (stable)
Uses of Solvent in Pharmaceutical Preparations
1. Synthesis of active pharmaceutical ingredients.
2. In formulation.
3. Cleaning the equipment
4. In separation and purification of drugs.
Types of Solvents For Pharmaceutical Use
1. Tap water
Tap (drinking) water is not normally used for the manufacture of pharmaceutical solutions or
for extemporaneous compounding, as it contains dissolved substances. It can interfere with
the formulation, for example, reduce drug solubility and stability (signs of incompatibility,
such as precipitation, discoloration and occasionally effervescence). It is allowed to use in
washing & extraction of a crude drugs. Also used in preparation of product for external use. It
contains inorganic salts usually Na, K, Ca, iron, Mg, Cl, sulfate and bicarbonate.
2. Purified water
Distilled water and deionized (DI) water have been the most common forms of purified water
It is used in preparation of all medication except parenteral solutions.
 Deionization method possesses a number of advantages as compared to distillation
process: 1- Elimination of the use of heat. 2- simple equipment 3- Lower cost. 4- Easy
production & storage.
In the deionization method, we use the exchangers which are synthetic polymeric resins of
high molecular weight insoluble in water & high content of free amino, sulfonic acid or
phenolic functions. Polymeric resins are of two types:  Cationic resins  Anionic resins
Water can be purified by other processes including Reverse osmosis, carbon filtration,
microfiltration, ultrafiltration and electro dialysis.
Tap water 100ml after evaporation & drying yields about 100mg of residue while 100ml
purified water after evaporation & drying yields not more than 1mg of residue. These
residues are the dissolved solids in water so the only difference between tap water & purified
water is in the amount of total dissolved solids. Water is clear, colorless & odorless. It's pH is
neutral.
Advantages
1. It has the widest range employed in pharmaceutical dispensing & manufacturing.
2. It is a good solvent for most inorganic salts & for many organic compounds.
3. It is miscible with other solvents such as alcohol & glycerin and make it useful
vehicle for many pharmaceutical preparations.
4. Tasteless & physiological compatible.
5. Lack of pharmacologic activity & toxicity.
Disadvantages:
1- Favorable medium for many chemical reactions.
2- Support growth of microorganisms when contaminated.
3. Water for injection:
This is a pyrogen free water purified by distillation. It is used for preparation of products for
parenteral use (intravenous, intramuscular). It is used as a solvent only in solution that are to
be sterilized after preparation. It contains no added substances & meets the requirement of
pyrogen test for purified water.
4. Sterile water for injection:
It is sterilized water for injection & packaged in a suitable single dose container of glass type
of not larger than 1000ml size. The preparation must meet the requirement of pyrogen test &
sterility test.
5. Bacteriostatic water for injection:
Bacteriostatic Water is sterile water containing 0.9% benzyl alcohol that is used to dilute or
dissolve medications. It may be packaged in a single dose container not larger than 5ml size
& in multidose of not larger than 30ml. It prevents the growth of bacteria in the vial.
6. Carbon dioxide free water:
For formulation of solutions of some drugs (e.g. aminophylline), it must be free from carbon
dioxide. This is obtained by boiling distilled water for 10 minutes, cooled and sealed in the
container and then sterilized.
7. Sterile water for inhalation:
It is prepared from water for injections that is sterilized and suitably packaged. It contains no
anti-microbial agents, except when used in humidifiers or similar devices and when liable
contamination over a period of time or other added substances. This water is usually intended
for use with inhalators and in preparation of inhalation solutions.
Note: Do not use sterile water for inhalation for Parentral administration
8. Sterile water for irrigation:
Sterile Water for Irrigation is a sterile, hypotonic, non-pyrogenic irrigating fluid or
pharmaceutical aid (solvent) entirely composed of Sterile Water for Injection. It is prepared
by distillation and contains no antimicrobial or Bacteriostatic agents or added buffers. The pH
is 5.7. Irrigation means washing, such as washing an organ after a certain surgery
9. Alcohol (Ethanol):
Alcohol has advantages over the water; it is not subjected to deterioration (growth of
microorganisms). Used in liquid products as an antimicrobial preservative alone or with other
agents. Alcohol is frequently used with other solvents such as glycols & glycerin to reduce
the amount of alcohol required.
Advantages
1- Alcohol is the most useful solvent.
2- It is a good solvent for many organic subs. both natural & synthetic.
3-It dissolve important plant constituents such as resins, volatile oils, alkaloids, glycosides &
neutral principles.
4- Together with water it forms hydro-alcoholic solvent which dissolves both water soluble
and alcohol soluble substances and to extract active constituents from crud drug.
5- Dehydrated alcohol (absolute alcohol) contains not less than (99.5%)
Diluted Alcohol: It is prepared by mixing equal volumes of alcohol with purified water. The
final volume of such mixtures is not the sum of the individual volumes of the two
components because the liquids contract upon mixing so the final volume is generally about
3% less than would be expected. Diluted alcohol is a useful hydro alcoholic solvent in
various pharmaceutical processes and preparation.
10. Isopropyl Alcohol:
It is about 70% by volume Isopropyl alcohol, the remaining consisting of water with or
without color additives, stabilizers & perfume oils. It is used externally as a rubefacient &
soothing rub & as a vehicle for topical products. This is commonly used by diabetic patients
in preparing needles & syringes for subcutaneous injections of insulin & for disinfecting the
skin. Also Used as solvent in cosmetic and dermatologic preparations.
11. Glycerin (Glycerol):
1-It's clear liquid with sweet taste.
2- It is miscible with both water and alcohol but not with ether and chloroform.
3- As a solvent it is viscous, therefore solute is slowly soluble in it, unless it is render to less
viscosity by "heating".
4-Glycerin has preservative stabilizer property.
5- It is used in many internally preparations (suppository) and ear drops because it softens the
wax found in the ear.
12. Propylene Glycol: Viscous liquid miscible with water and alcohol in all proportion and
is soluble in ether, acetone and chloroform. It is useful solvent with a wide range of
applications and is frequently substituted with glycerin in modern pharmaceutical & cosmetic
preparations.
13. Poly Ethylene Glycol 400:
1-It is miscible with water, acetone, alcohol & other glycols.
2-It dissolves organic compounds & certain water soluble substances such as acetyl salicylic
acid & theophylline.
14. Ketone
There are only two official solvent-vehicles in the ketone group. 1. Acetone 2. Methyl iso
Butyl Ketone. it is used as a solvent for assays, tests and processing. Officially ketone have
limited usefulness because of their Volatility, flammability and toxicity. They do have some
unique solvent properties which make them useful.
It is miscible with water, alcohol, ether, chloroform and in most of the oils. It is stored in tight
containers and stored away from fire.
15. Oils
Some special vegetables and essential oils used primarily as flavors and scents such as Anise
oil, Lemon oil and Rose oil. Insoluble in water, miscible in mineral oil, slightly soluble in
alcohol and soluble in other fixed oils, chloroform, and ether.