Solutions

Advantages of solutions:
1) Easy to swallow for pediatrics & geriatrics.
2)A solution is a homogenous system “the drug is uniformly
distributed throughout the preparation”.
3)They provide a rapid absorption rate & so the therapeutic
response is faster.
4)More flexibility in achieving the proper dosage of medication
(drops or mL).
5)When properly formulated, they are pharmaceutically attractive
and elegant.
6)Drugs in solutions are less irritating to stomach than drugs in
solid dosage forms.
Disadvantages of solutions:
1) The taste of a drug, which is usually unpleasant, is always more
pronounced when in solution than in a solid form.
2)Liquids are bulky (of high weight and volume) and therefore
inconvenient to transport and store.
3)The stability of ingredients in aqueous solution is often poorer
than if formulated as a tablet or capsule, particularly if they are
susceptible to hydrolysis.
4)Solutions provide suitable media for the growth of
microorganisms.
5)Inaccurate dosage. Accurate dosage depends on the ability of the
patient to use a spoon or dropper.
Factors affecting the solubility:
1. Temperature:
 The solubility of a solid in a liquid is dependent on the
temperature, nature of the solute and the nature of the solvent.
 Endothermic dissolution: If a solute absorbs heat during the
process of solution, i.e. has a negative heat of solution, its
solubility is increased with increase in temperature. Most solutes
show this behavior.
 Exothermic dissolution: If the solute has a positive heat of
solution (as calcium hydroxide and calcium sulphate), the
solubility will be decreased by increasing the temperature.
 2. Particle size:
 The rate of solution under conditions of constant agitation and
temperature is proportional to the surface area of the solid.
 The rate of solution can be increased by using finely divided
solids which have a high surface area.

3. Agitation:
 The greater the agitation, the more unsaturated solvent passes
over the drug and the faster the formation of the solution.
 4. Effect of pH:
 Many of the organic substances are either weak acids or weak
bases, and their aqueous solubilities are dependent upon the pH of
the solvent.

 They dissociate only slightly, and their molecular or undissociated

forms are only slightly soluble in water. But within certain ranges
of pH, they exist in ionic or dissociated forms which are very
soluble in water and, consequently, their aqueous solubilities may
be increased by adjusting the solvent to an appropriate pH.
 5. Effect of other substances
 The water-solubility of nonelectrolytes may be either decreased
or increased by the addition of electrolytes.
 When the solubility of a nonelectrolyte is decreased, the
phenomenon is referred to as salting – out, such as aromatic
water.
 When the solubility of a nonelectrolyte is increased, the effect is
described as salting – in.
Solvents for liquid
preparations
Water
1. Potable water (drinking water or tap water):
 Naturally occurring water, is impure, containing amounts of
dissolved inorganic salts, e.g. sodium, potassium, calcium,
magnesium, and iron; chlorides, sulfates, and bicarbonates.
 Official water for drinking usually contains less than 0.1% of total
solids, determined by evaporating a 100-mL sample to dryness
and weighing the residue (<100 mg).
 Uses: in the washing, and extraction of crude drugs and in the
preparation of products for external use and other preparations in
which the difference between water and purified water is of no
consequence.
2. Purified water:
 It is used in the preparation of all medication containing water
except ampoules and injections.
 The solid residue is one mg per 100 ml of evaporated sample
(0.001%).
 It is prepared by:
(1) distillation or (2) deionization (ion exchange resin).
 Freshly distilled water has a pH of about 5.6, and usually
changes to about 6 on storage.
 In deionization method: we use two types of ions exchange
resins (cation or acidic and anion or basic), so it can remove all
positive and negative electrolytes from water.
Advantages of deionization over distillation method:
1)The elimination of the use of heat.
2)Simpler equipment with less maintenance.
3)Lower long-term costs.
4)Ease of production and storage.
3. Water for injection (WFI):
 This is a pyrogen-free water, purified by distillation, for the
preparation of products for parenteral use.
Pyrogens are fever-producing substances probably of
bacterial origin.
 Method of sterilization:
Autoclaving (moist heat; steam under pressure): 115 ⁰C for 30
min.
Boiling water for at least 60 minutes.
4. Sterile water for injection:
 It is a water for injection, sterilized and packaged in
suitable single dose container of not larger than 1000
mL-size.
 The following limits for total solids apply for sterile
water for injection:
Up to 30 mL: residue  40 ppm
30 -100 mL: residue  30 ppm
For larger sizes than 100 mL: residue  20 ppm
5. Bacteriostatic water for injection:
 This is Sterile Water for Injection to which one or more
suitable bacteriostatic agents have been added
 Packaged in single dose container of not larger than 5 mL
size or in multiple-dose containers of not larger than 30 mL
size; the label of which indicates the name and the
proportion of the added agent.
 Thank you
Mustafa Shahin