Course: M.
Pharm – I Semester
Subject: Modern Pharmaceutics
Unit- V
Study of consolidation parameters:
Part 2
Dr. C. Sowmya, M. Pharm., Ph.D
Assistant Professor
Sri Ramachandra Faculty of Pharmacy
[email protected] DISSOLUTION PARAMETERS
➢ Dissolution is a process in which a solid substance solubilizes in a given
solvent i.e. mass transfer from the solid surface to the liquid phase.
Dissolution parameters:
Effect of agitation
Effect of dissolution fluid
Influence of pH of dissolution fluid
EFFECT OF AGITATION
➢ The relationship between the intensity of agitation and
the rate of dissolution varies considerably according to
the type of agitation used, the shape and design of
the stirrer and the physicochemical properties of the
solid.
➢ For the basket method, 100 rpm usually is utilized, while
for the paddle procedure, a 50 – 75 rpm is
recommended.
EFFECT OF DISSOLUTION FLUID
➢Selection of proper medium for dissolution testing depends
largely on the physicochemical properties of the drug.
➢FSSGF
➢FESGF
➢FSSIF
➢FESIF
INFLUENCE OF PH OF DISSOLUTION FLUID
➢ simulated gastric fluid as the test medium for tablets
containing ingredients which reacted more readily in acid
solution than in water (e.g., calcium carbonate).
EFFECT OF VISCOSITY OF THE
DISSOLUTION MEDIUM
➢ If the interaction at the interfaces, occurs much faster than the rate
of transport, such as in the case of diffusion controlled dissolution
processes, it would be expected that the dissolution rate decreases
with an increase in viscosity.
➢ The rate of dissolution of zinc in HCl solution containing
sucrose was inversely proportional to the viscosity of solution.
VOLUME OF DISSOLUTION MEDIUM AND
SINK CONDITIONS
➢ The proper volume of the dissolution medium depends mainly
on the solubility of the drug in the selected fluid. (500 ml – 5 L)
➢ If the drug is poorly soluble in water, a relatively large amount of
fluid should be used if complete dissolution is to be expected.
DEAERATION OF THE DISSOLUTION
MEDIUM
➢ Presence of dissolved air or other gases in the dissolution
medium may influence the dissolution rate of certain
formulations and lead to variable and unreliable results.
➢ Example, the dissolved air in distilled water could significantly
lower its pH and consequently affect the dissolution rate of
drugs that are sensitive to pH changes, e.g., weak acids.
EFFECT OF TEMPERATURE OF THE DISSOLUTION
MEDIUM
➢ Drug solubility is temperature dependent, therefore careful
temperature control during the dissolution process is extremely
important.
➢ Generally a temperature of 37°±0.5 is maintained during
dissolution determination of oral dosage forms and suppositories.
➢ For topical preparations as low as 30° and 25°have been used.
Diffusion
Diffusion, process resulting from random
motion of molecules by which there is a net
flow of matter from a region of high
concentration to a region of low
concentration.
DIFFUSION PARAMETERS
➢ This is given by Higuchi.
𝑄 = 𝐾√𝑻
Where
Q is the amount of drug released in time‘t’ per unit area,
K is higuchi constant
T is time in hr.
➢ Plot: The data obtained is to be plotted as cumulative percentage
drug release versus Square root of time.
➢ Application: modified release pharmaceutical dosage forms,
transdermal systems and matrix tablets with water soluble drugs.
Higuchi model describes the release of
drugs from insoluble matrix as a square
root of time dependent process
The data obtained were plotted as cumulative
percentage drug release versus square root
of time.
Permeability coefficient :A quantitative measure of the rate
at which a molecule can cross a membrane such as a lipid
bilayer; expressed in units of cm/s and equal to the diffusion
coefficient divided by the width of the membrane
Kp= J/C
Where, J is flux: C is the initial concentration of drug in the gel/ointment
Flux (J): Quantity of drug diffused /area of diffusion
The flux of a solute is simply. defined as the mass or number of
molecules moving through a given cross- sectional area
during a given period of time.
