prelim 2 - formulation, research, and development

Studies aimed at collecting basic information on the physical and chemical characteristics of a drug substance (Studies)

Pre-formulation studies

Also known as pharmaceutical development studies

Pre-formulation studies

Studies that identify, document, and control those attributes of the ingredients of the formulation and critical parameters of the manufacturing process

Pre-formulation studies

Pre-formulation studies are a part of the __________ stage in drug discovery

Lead optimization

Pre-clinical studies are pre-formulation studies to determine best formulation for __________ studies

Animal

Volunteer studies are pre-formulation studies to determine best formulation for __________ study

Volunteer

Phase II clinical studies are pre-formulation studies to determine best __________ formulation

Clinical trial

Phase III clinical studies and scale up for launch are pre-formulation studies for __________

Final formulation and manufacture

A process parameter whose variability has an impact on a critical quality attribute

Critical process parameter (CPP)

A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (GMP inspection deficiencies)

Critical quality attribute (CQA)

Activities directed towards evolving of a satisfactory formula for a new product with respect to elegance, stability and efficacy, and developing the technique for its manufacture (Studies)

Formulation studies

__________ should be evaluated for appearance, odor, color, assay, degradation products, dissolution, moisture, and hardness/friability (Dosage form)

Tablets

__________ should be evaluated for appearance (including brittleness), color, and odor of content, etc. (Dosage form)

Hard gelatin capsules (HGC)

Testing of __________ should include appearance, color, and odor of content, assay, degradation products, dissolution, microbial content, pH, leakage, and pellicle formation (Dosage form)

Soft gelatin capsules (SGC)

An evaluation of ___________ should include appearance (including phase separation), color, odor, assay, degradation products, etc. (Dosage form)

Emulsions

The evaluation of ___________ and ___________ should include appearance (including formation of precipitate, clarity for solutions, color, odor, assay, degradation products, pH, viscosity, etc.) (Dosage form) (OS)

Oral solutions, Suspension

___________ should be evaluated for appearance, color, odor, assay, degradation products, moisture, and reconstitution time (Dosage form)

Oral powders for reconstitution

Lactose, dibasic calcium phosphate, starch, microcrystalline cellulose (Types of excipients)

Diluent

Starch and microcrystalline cellulose (Types of excipients)

Disintegrant

Magnesium stearate, stearic acid, hydrogenated vegetable oil, talc (Types of excipients)

Lubricant

Sucrose solution, polyvinyl pyrrolidone solution, methylcellulose (Types of excipients)

Granulating agents

Hydroxypropylmethylcellulose, methylcellulose, cellulose acetate phthlate (Types of excipients)

Coating agent

Sodium carboxymethylcellulose, tragacanth, sodium alginate, xanthan gum, veegum (Types of excipients)

Suspending agent

Sorbitol, sucrose, aspartame (Types of excipients)

Sweetener

Alcohol, propylene glycol (Types of excipients)

Solubilizing agent

Alcohol, methylparaben, propylparaben (Types of excipients)

Preservative

Polysorbates (Types of excipients)

Surfactant

Sesame oil, corn oil (Types of excipients)

Emulsion vehicle

Involve very small batch size (laboratory scale); establish specifications, method of manufacture, and approximate amount of ingredients

Trial formulations

Stability studies under the recommended storage condition for the re-test period or shelf-life proposed for labeling (Types of stability studies)

Real time studies

Stability studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions (Types of stability studies)

Accelerated stability studies

Preformulation phase (Types of stability studies)

Accelerated (NCE alone and in combination with excipients)

Formulation screening (Types of stability studies)

Accelerated

Final formula (Types of stability studies) (AR)

Accelerated, Real-time

Registration (Types of stability studies) (AR)

Accelerated, Real-time