Question

Describe the activities involved in the Dosage Form Development through clinical development for (choose one):

preformulation

formulation

preliminary stability

package selection

formal stability

manufacture and packaging for clinical studies

Answer 1

Drug development – is a process bringing a create a new pharma drug to market, once a main compound had identified through the process of drug discovery, it may be pre-clinical research on animals or bacteria,

Pre-formulation – this stage in drug development is must require for development of formulations and different sates of drug clinical trial.

• The word pre-formulation derived from pre – previous or before, formulation- preparing something, means activities perform before to formulation.
• Pre-formulation also provide scientific base for drug development
• Pre-formulation process divided into two parts, one is fundamental properties and another is derived properties,

• Fundamental properties depend on the chemical structure of the drug substance, and other hand derived properties of pre-formulation is focus on issue related to development of dosages.

Properties of fundamental pre-formulation

• Solubility
• Permeability
• Stability of solid state
• Properties of solid stage

Properties of derived pre-formulation

• Particle size and physical characteristic
• Density
• Particle behaviour (not required in case for prepare capsule dose)
• Movement properties

Compatibility study is the last activity in the pre-formulation process, by the pre-formulation, helps in know the physical and chemical properties of drugs, provide base for development of formulation, pre-formulation also reducing challenge when development of formulation process also its cost saving