Process Validation on Semisolid Formulations, Summaries of Pharmacokinetics

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PROCESS VALIDATION ON

SEMISOLID FORMULATIONS

INTRODUCTIO

N

Process Validation

Process validation

provides the flexibility

and constraints in the

production process

controls in the

achievement of desirable

qualities in the drug

product while preventing

undesirable attributes.

USFDA defined process

validation as

“establishing

documented evidence

which provides high

degree of assurance that

a specific process will

consistently produce a

product meeting its pre-

determined

specifications and quality

characteristics.”

Process validation of semisolid dosages form /

formulations

(ointments / creams..)

They are mainly meant for external application ex: cream,

jelly, pastes etc.

The consistency of semisolids lies between the solid and

liquid and thus

the preparation is a challenge for manufacturers

Critical Parameters to be Validated-

Process Temperature: It is critical to process at right temperature for successful

manufacturing. Too much heating during processing can result in chemical degradation and

insufficient heat can lead to batch failures, and excess cooling can result in the precipitation

of solubilized ingredients.

Heating and Cooling Rates: The successful consistency of ointments, for example, depends

on proper rates of heating and cooling.

a) Heating too slowly can result in poor yields from evaporative loss.

b) Heating too rapidly may burn areas of the batch in contact with the heating surface, which

raises the potential for burnt material in the batch.

c) Rapid cooling can result in precipitation/crystallization or increased viscosity.

◦

◦ Flow Rates

◦Optimizing flow rate involves determining the amount of shear or throughput needed. For

example, a water-in oil emulsion may require a slower addition speed than a traditional, oil-in-water

emulsion, and the flow rate must be modified appropriately. Care must be taken for any product

using a pump. Overhearing can occur if the formulation is pumped too quickly. If pumping is too

slow, the formulation will experience extra time in an in-line homogenizer, thus also exposing the

formulation to additional shear.

◦

◦ Addition of Polymers and Gums

◦ Addition of polymers (Carbomers) and gums (Xanthan) must be performed in a very controlled

manner if adding directly to batch. Likewise there are other alternate methods of incorporation

are : Eductors such as Tri – Blenders and Quadro Ytron dispersers and preparation of slurry of

polymers or gum in a medium of low or no solubility.

Unit Operation For

Semisolid System

◦ There are five unit operations in manufacturing of semisolid dosages form.

◦I. Mixing of liquid

◦

2. Mixing of solid

◦

3. Mixing of semisolid

◦4. Dispersing

◦

5. Milling and size reduction of solid and semisolid

PROCESS

VARIABLES,

PROPERTIES

AFFECTED BY

VARIABLES AND

MONITORING

OUTPUT OF MIXING

AND BLENDING OF

SOLIDS.

Process variables, properties affected by variables and monitoring output of semisolid.

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Process variables, properties affected by variables and monitoring output of milling and size

reduction of solid and semisolid

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Conclusion

Validation is a proven assurance of the process efficiency and sturdiness and it is

the full fledged

quality control tool for the pharmaceutical industries. It eliminates the chances of

batch failures as the products are manufactured as per pre optimisation of each

manufacturing steps. The conventional process of testing at last stage created

much problems in maintain uniformity of each batch but with the introduction of

concept of validation, it has been easy to maintain the batch uniformity of the

product along with imparting quality in them. This paper summarises the process

validation stages of solids, liquids and semisolids which are the most common

pharmaceutical dosages form in use.