Drug To Tablet Flashcards
Tablet Outline
Contains active dose and excipients (keeps physical, chemical and microbrial stability, enables compression, proper flow properties, taste masking and greater taste masking
Types of oral solid dosage forms
Tablets, capsules and powders
Capsule Outline
Solid oral dosage form: Shell (prevents dose degradation) and filling. Gotten by compressing small volume of uniform particles. Immediate and modified release
Powder Outline
Mix of finely divided solids (contains APIs and excipients). Normally dissolved before oral admin. Important for tablet and capsule manufacture
Tablet Types Outline
Immediate release tablets, moderate release tablets, dispersible (dispersed in water before admin), effervescent (dissolve in water to release CO2), orodispersible (dispersed in mouth), chewable and lozenges
Oral Solid Dosage Form Advantages
Easy self admin, portable, masking organoleptic properties, high dose accuracy, long shelf life (most stable on market), modified delivery, cheap production of high quantities
Solid Dosage Form Progression
Compound discovery, pharmaceutical development and medical product finalisation
Lead Optimization Characterisation
Affinity for target, selectivity, efficacy, physicochemical properties, early ADME, Exploratory toxicology, lead optimisation,
Steps in Development
Preformulation studies, formulation development, process development and GMP and Manufacturer Quality Control. Steps may need to retraced
Formulation Dev Def
Looks at potential complications with route of admin
Preformulation Outline
Determines fundamental physical and chemical properties of a drug molecule (and derived properties of it’s powder). Normally preformed on several drug candidates. Allows optimal and rational selection of API and excipients, improve output and ensures quality guidelines are met. Regulatory Requirement
Solid state properties in preformulation sciences
Melting point (polymorphism, hydrates, solvates), microscopy (morphology, particle size), powder flow/bulk density/repose angle (tablet/capsule formulation), compression properties (excipient choice) and excipient compatibility (excipient choice)
Solid State Formulation Outline
Focuses on excipient selection, recipe formulation and method of formulae. Increased focus on material properties and mass transfer properties
Formulation and preformulation association
Data from preformulation dictates formulation steps. Outcomes of formulation may cause changes in preformulation
Process Development Oral Dosage Form Outline
Upscale to maufacturing ensures that high quantity is produced for low cost. Maintainince standards (quality, efficacy, safety)
Manufacturing Processes Examples
Particle size reduction, mixing, granulation, drying, tableting (compacting)
Relationship between formulation and manufacturing processes
Formulation determines tableting behaviour. Eg flow properties ensures accuracy in large manufacturing. Material must be sufficent for compression into tablets
Granulation Function
Done if powder doesn’t flow in tablet press because it’s too light. Add liquid to create clumps and break down again into slightly bigger particles. Esures API is homogenously spread in tablets
Coating Function
Enteric coating. Coloured, taste masking and appearance enhancement
Tumbling Mixer Function
Machine that consistently keeps powder moving due to shape. None is caught or stationary
Characteristics tested for in quality control
absorption (disintegration, dissolution), uniformity (mass, content) and strength (friability, hardness)
Hardness Outline
How much force a tablet requires to break
Friability Outline
Forces when tablet knock together
Inprocess Quality Control Testing Outline
Sampling at defined intervals in manufacturing process. Build into design to prevent problems before end (real time quality assurance)
Process Analytical Technology Outline
System for designing, analysing and controlling manufacturing process. Includes chemical, physical, microbiological and mathmatical risk analysis. Measurement of critical process parameters. Integrate quality control into process
