Capsules Flashcards
Capsule Def
Solid dosage form in which API is enclosed in soft/hard soluble shell (usually consisting of gelatin). Medicine could be a powder, liquid or semisolid
Capsules Advantages
Tasteless, odourless capsules. Combinations of inner material possible, easy to transport
What is the main material capsules can’t contain
Liquids that dissolves gelatin
Hard Capsules Outline
shell 2 pieces: cap and body. 2 steps in manufacturing process: capsule shell manufacturing and capsule shell filling. Capsule = gelatin, starch or HPMC (coated polymer) based
Soft Capsule Outline
1 part to capsule and 1 stage in manufacturing process. Consists of soft gelatin, perseravtive, opacifying and flavouring agents
Benefits of capsules as oral dosage forms
ease administration, taste masking, protection of liable oxidative drugs, unit dose of liquid formulations, flexability in manufacturing method, sustanined release and low melting activities
Formulation Techniques
Dry Granulation, Wet Granulation and Direct Compression
4 types of capsules
immediate release, sustained release, delayed release and combination capsules
Hard Capsule Fillings
Solids, semisolids, liquids (including suspensions)
Soft Capsule fillings
Semisolids and liquids (including suspensions)
Solid Capsule Fillings
Powders, granules, coated pellets/granules and mini tablets (<5 nm)
Semisolid/Liquid Fillings
non-aqueous suspensions, emulsions (water in oil), waxes, medium/high chain fatty acids and high mw PEGs
Factors Influencing Capsule Design/Formulation
Drug dose, drug density, drug flow properties, drug solubility, drug stability, drug compatibility and drug pharmacokinetic
Drug Dose + Density Impact on foemulation
Capsule size required to fit drug and maintain positive organoleptic properties. High doses of semisolid = more viscous dose
What solubility class does capsules tend to fall into
class 2 (high permeability and low solubility) and class 4 (low permeability and low solubility)
Particle size Impact
Need to be homogenous for uniform dispersion, shell disruption and good dissolution rate
Drug Stability
APIs dissolved in solid or semisolids matrixes can become cruystalline. Resulting in lower solubility and lower bioavailability
Components of drug stability in tablets
crystallisation, drug-capsule compatibility, physical and chemical recation between shell and fill and cross linking
Material Selection Factors
What best supports contents (eg solids in hard capsules) and dietary recquirements
Biopharmaceutical Considerations
Liberation and Adsorption profiles, stability in GI (does it need protective cotaing) and bioavailability enhancement (lipid based)
Capsule sizes Outline
Large (000, 00, 0, high dose), medium (1, 2, 3 moderate dose) and small (4, 5 small dose)
Different shapes of capsules
Oval, round and elongated oval
Capsule properties influencing stability
equilibrium moisture content (hygroscopicity), gelatin crosslinking (storage temp, humidity) and solvent presence (packaging)
Extemporaneous Capsules
Created when ingredients/dose isn’t available comercially. Done in the case of allergies/intolerences or weaning off of API
