ANSWER 4

Process validation of oral liquids :-

Oral liquid :-
Oral Liquids are homogeneous liquid preparations, usually
consisting of a solution, an emulsion or a suspension of one or
more active ingredients in a suitable vehicle.

CLASSIFICATION OF LIQUID ORALS

Manufacturing of Monophasic liquid:-
Process validation of liquid orals mainly consists:-

1. Raw material validation

2. Monitoring outputs
3. Filling and packaging validation

Raw material validation :-

It includes mainly following tests
i. Particle size and size distribution
ii. Particle shape or morphology
iii. Microbial count
iv. Rheology of solvent or vehicle
v. PH of the solvent or vehicle
Monitoring outputs:-

Some monitoring outputs to be monitored are as

under:

a. Appearance

b. pH

c. Viscosity

d. Specific gravity

e. Microbial count

f. Content uniformity

APPEARANCE of the final product indicates the signs of

instability and degradation.
For e.g. settling of solid particles in case of
suspension and turbidity in case of emulsion.

TIME for mixing or agitation and temperature of process

can effect the appearance greatly.
PH of aqueous oral formulations should be taken at a
given temperature and only after equilibrium has been
reached in order to minimize the PH drift.

VISCOSITY effects the settling rate of suspended

particles in suspension and coalescence of globules of
internal phase in emulsions and also in case of oral
solutions it affects the overall appearance of the final
product so it must be measured and validated properly.

Specific gravity: A decrease in specific gravity of the

product like suspensions indicates the presence of air
within the structure of the formulation.

Microbial count for the final product is essential to

validate because by performing microbial count we can
select the preservative for the final product storage.
There are specifications for each liquid oral product for the
bioburden content.

Content uniformity affects the dose uniformity in case of

multidose formulations and also affects the homogeneity
of the drug within solvent system.

Dissolution testing: no official method for dissolution

testing of dispersed system
TEST PARAMETERS FOR SUSPENSION :-
TEST PARAMETERS FOR EMULSION :-
 FILLING AND PACKAGING OPERATION
VALIDATION:-

Tests performed:
i. Leakage test for filled bottle
ii. Cap sealing test
iii. Fill volume determination
iv. Water vapour permeability test

These all are main steps in liquid orals products on which

basically the validation is done in industries to obtained a good
quality product.