Page 92 - Pharmaceutics IV (02-06-01305)

Challenges in formulation

Dosage form

• For solutions and emulsions, the drug substances should be soluble
and remain soluble during the entire shelf-life of the drug products.

• When drug substances are not soluble, dissolution can be achieved
by pH adjustments or using co-solvents, surfactants, or a soluble pro-
drug or solubility enhancers such as cyclodextrins. All while
considering the target route of administration.

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Challenges in formulation Stability

• Use dry powder for reconstitution.

• Use a stabilizer at the minimum effective concentration (e.g.,

antioxidants, …) Compatibility

A main challenge of is to achieve a good compatibility of the drug

substances with the excipients as well as the compatibility of the

preparations with the primary container (no leachable or adsorption to

container).

Sterilization

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Salma E. EL-Habashy 89