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30/10/2025, 00:02 Pharmaceutical Solutions & Sterile Dosage Forms

Solutions stability

A pharmaceutical solution must be stable for the duration of its shelf-life (period of storage and
use). Thus, It must retain the same properties that it possessed at the time of its manufacture:

The product's physical properties (e.g. Colour, clarity, viscosity, odour, taste) and efficacy
must not change, and there should be no significant increase in toxicity.
The drug's chemical nature and potency must not change.
The product should be resistant to microbial growth.

Physical stability Types of Solution Stability
Chemical stability
Therapeutic stability
Microbiological stability

Physical stability 33/77

Change in physical properties can result in either spoiling of the product appearance, chemical
instability and or reduced effectiveness.

Chemical stability

Chemical stability of API:

In general, drug substances undergo chemical degradation as a result of the effect of heat,
oxygen, light and moisture.

Chemical degradation of drugs include mainly:

Hydrolysis
Oxidation
Reduction
Photo-degradation
NOTE: chemical degradation products may be ineffective or toxic.
Q: If you were asked to formulate aspirin suppositories. Choose the suitable base for it:

Glycerinated gelatine base
Fatty base

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