Pharmaceutical formulation is the process of combining active pharmaceutical ingredients (APIs) with excipients to create final dosage forms that are:
safe
Effective
Stable
Patient-compliant
Pharmaceutical Formulation
APITherapeutic effectVaries by drugBindersProvide cohesion breakdownHPMC (35%), PVP (28%), Starch (20%)DisintegrantsPromoteCroscarmellose Na (45%), SSG (30%)LubricantsPrevent stickingMg Stearate (60%), Stearic Acid (25%)FillersBulk up formulationMicrocrystalline Cellulose (70%), Lactose (20%)
Oral Solids
APITherapeutic effectDrug-specific0.1-40% w/v
SolubilizersEnhance dissolutionPolysorbate 80, PEG 4000.1-5%
PreservativesMicrobial controlBenzalkonium chloride, parabens0.01-0.5%
SweetenersPalatabilitySucrose, sorbitol, aspartame5-85%
Viscosity ModifiersSuspension stabilityXanthan gum, carbomer0.1-2%
Liquids
Formulation Matrix (Topical Cream Example)
ComponentFunctionTechnical SpecificationRationale
Cetostearyl alcoholEmulsifier/ThickenerBP Grade, mp 49-55°CProvides structure & stability
Liquid paraffinEmollientViscosity 75-115 mPa s @40°CSpreadability enhancement
Polysorbate 80O/W EmulsifierHLB 15.0 ±0.5Optimal for dermatologicals
Purified waterContinuous phaseTOC <500 ppb, endotoxin-freeMicrobial control